Publications by authors named "Helen Parise"

103 Publications

Evaluation of Transcatheter Alcohol-Mediated Perivascular Renal Denervation to Treat Resistant Hypertension.

J Clin Med 2020 Jun 16;9(6). Epub 2020 Jun 16.

Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, 40-635 Katowice, Poland.

Catheter-based renal denervation (RDN) has been investigated for hypertension (HTN) treatment with variable success. One of the novel approaches to RDN is the delivery of micro-doses of dehydrated alcohol to the adventitial space of the renal artery to perform perivascular ablation of the sympathetic nerves. We sought to assess the safety and efficiency of transcatheter alcohol-mediated perivascular renal denervation in patients with resistant hypertension. Fifty adult patients who had been referred for resistant HTN were screened. To qualify for the study, the patients had to have a mean 24 h systolic pressure ≥ 135 mmHg based upon ambulatory blood pressure monitoring (ABPM) and acceptable renal artery anatomy confirmed by the contrast computer tomography (AngioCT) and nephrologist consultation. Ten patients were eligible for chemical RND. There were no safety issues throughout the 24 months of follow-ups. The mean decrease in the office BP (OBP) was significant during 24 months of follow-up ( < 0.01). The difference in the BP in the ABPM was statistically significant in the 1st, 3rd and 12th months ( < 0.01), whereas during the 3-month follow-up, a trend was observed. The modifications of anti-hypertension drugs throughout the follow-up period were minimal. This study has shown that transcatheter alcohol-mediated renal denervation in patients with resistant hypertension is feasible and safe. Nevertheless, it is a hypothesis-generating study.
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http://dx.doi.org/10.3390/jcm9061881DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356226PMC
June 2020

Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study.

Circ Heart Fail 2020 04 8;13(4):e006512. Epub 2020 Apr 8.

Cardiovascular Research Foundation, New York (D.B.).

Background: Prior studies of cardiac contractility modulation (CCM) employed a 3-lead Optimizer system. A new 2-lead system eliminated the need for an atrial lead. This study tested the safety and effectiveness of this 2-lead system compared with the 3-lead system.

Methods: Patients with New York Heart Association III/IVa symptoms despite medical therapy, left ventricular ejection fraction 25% to 45%, and not eligible for cardiac resynchronization therapy could participate. All subjects received an Optimizer 2-lead implant. The primary end point was the estimated difference in the change of peak VO from baseline to 24 weeks between FIX-HF-5C2 (2-lead system) subjects relative to control subjects from the prior FIX-HF-5C (3-lead system) study. Changes in New York Heart Association were a secondary end point. The primary safety end point was a comparison of device-related adverse events between FIX-HF-5C2 and FIX-HF-5C subjects.

Results: Sixty subjects, 88% male, 66±9 years old with left ventricular ejection fraction 34±6% were included. Baseline characteristics were similar between FIX-HF-5C and FIX-HF-5C2 subjects except that 15% of FIX-HF-5C2 subjects had permanent atrial fibrillation versus 0% in FIX-HF-5C. CCM delivery did not differ significantly between 2- and 3-lead systems (19 892±3472 versus 19 583±4998 CCM signals/day, CI of difference [-1228 to 1847]). The change of peak VO from baseline to 24 weeks was 1.72 (95% Bayesian credible interval, 1.02-2.42) mL/kg per minute greater in the 2-lead device group versus controls. 83.1% of 2-lead subjects compared with 42.7% of controls experienced ≥1 class New York Heart Association improvement (<0.001). There were decreased Optimizer-related adverse events with the 2-lead system compared with the 3-lead system (0% versus 8%; =0.03).

Conclusions: The 2-lead system effectively delivers comparable amount of CCM signals (including in subjects with atrial fibrillation) as the 3-lead system, is equally safe and improves peak VO and New York Heart Association. Device-related adverse effects are less with the 2-lead system. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03339310.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.006512DOI Listing
April 2020

Alcohol-Mediated Renal Denervation Using the Peregrine System Infusion Catheter for Treatment of Hypertension.

JACC Cardiovasc Interv 2020 02;13(4):471-484

Division of Cardiology, Department of Cardiovascular Diseases, Cliniques Universitaires Saint-Luc and Pole of Cardiovascular Research, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.

Objectives: The aim of this multicenter, open-label trial was to evaluate the safety and efficacy of alcohol-mediated renal denervation using a novel catheter system (the Peregrine System Infusion Catheter) for the infusion of dehydrated alcohol as a neurolytic agent into the renal periarterial space.

Background: The number of hypertensive patients with uncontrolled blood pressure (BP) remains unacceptably low. The renal sympathetic nervous system has been identified as an attractive therapeutic target.

Methods: Forty-five patients with uncontrolled hypertension on ≥3 antihypertensive medications underwent bilateral renal denervation using the Peregrine Catheter with 0.6 ml alcohol infused per renal artery.

Results: All patients were treated as intended. Mean 24-h ambulatory BP reduction at 6 months versus baseline was -11 mm Hg (95% confidence interval [CI]: -15 to -7 mm Hg) for systolic BP and -7 mm Hg (95% CI: -9 to -4 mm Hg) for diastolic BP (p < 0.001 for both). Office systolic BP was reduced by -18/-10 mm Hg (95% CI: -25 to -12/-13 to -6 mm Hg) at 6 months. Antihypertensive medications were reduced in 23% and increased in 5% of patients at 6 months. Adherence to the antihypertensive regimen remained stable over time. The primary safety endpoint, defined as the absence of periprocedural major vascular complications, major bleeding, acute kidney injury, or death within 1 month, was met in 96% of patients (95% CI: 85% to 99%). Two patients had major adverse events of periprocedural access-site pseudoaneurysms, with major bleeding in one. There were no deaths or instances of myocardial infarction, stroke, transient ischemic attack, or renal artery stenosis. Transient microleaks were noted in 42% and 49% of the left and right main renal arteries, respectively. There were 2 cases of minor vessel dissection that resolved without treatment.

Conclusions: Primary results from this trial suggest that alcohol-mediated renal denervation using the Peregrine Catheter safely reduces blood pressure and as such may represent a novel approach for the treatment of hypertension.
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http://dx.doi.org/10.1016/j.jcin.2019.10.048DOI Listing
February 2020

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation.

JACC Heart Fail 2018 10 10;6(10):874-883. Epub 2018 May 10.

Heart Center of Göttingen, University Medical Center Göttingen, Göttingen, Germany.

Objectives: This study sought to confirm a subgroup analysis of the prior FIX-HF-5 (Evaluate Safety and Efficacy of the OPTIMIZER System in Subjects With Moderate-to-Severe Heart Failure) study showing that cardiac contractility modulation (CCM) improved exercise tolerance (ET) and quality of life in patients with ejection fractions between 25% and 45%.

Background: CCM therapy for New York Heart Association (NYHA) functional class III and IV heart failure (HF) patients consists of nonexcitatory electrical signals delivered to the heart during the absolute refractory period.

Methods: A total of 160 patients with NYHA functional class III or IV symptoms, QRS duration <130 ms, and ejection fraction ≥25% and ≤45% were randomized to continued medical therapy (control, n = 86) or CCM (treatment, n = 74, unblinded) for 24 weeks. Peak Vo (primary endpoint), Minnesota Living With Heart Failure questionnaire, NYHA functional class, and 6-min hall walk were measured at baseline and at 12 and 24 weeks. Bayesian repeated measures linear modeling was used for the primary endpoint analysis with 30% borrowing from the FIX-HF-5 subgroup. Safety was assessed by the percentage of patients free of device-related adverse events with a pre-specified lower bound of 70%.

Results: The difference in peak Vo between groups was 0.84 (95% Bayesian credible interval: 0.123 to 1.552) ml O/kg/min, satisfying the primary endpoint. Minnesota Living With Heart Failure questionnaire (p < 0.001), NYHA functional class (p < 0.001), and 6-min hall walk (p = 0.02) were all better in the treatment versus control group. There were 7 device-related events, yielding a lower bound of 80% of patients free of events, satisfying the primary safety endpoint. The composite of cardiovascular death and HF hospitalizations was reduced from 10.8% to 2.9% (p = 0.048).

Conclusions: CCM is safe, improves exercise tolerance and quality of life in the specified group of HF patients, and leads to fewer HF hospitalizations. (Evaluate Safety and Efficacy of the OPTIMIZER System in Subjects With Moderate-to-Severe Heart Failure; NCT01381172).
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http://dx.doi.org/10.1016/j.jchf.2018.04.010DOI Listing
October 2018

Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial).

Am J Cardiol 2016 Nov 23;118(10):1519-1526. Epub 2016 Aug 23.

Division of Cardiology, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.

Cerebral embolization during transcatheter aortic valve implantation (TAVI) can lead to a spectrum of clinically relevant manifestations, ranging from overt stroke to mild neurologic or cognitive deficits and subclinical cerebral infarcts. This study sought to determine the frequency of neurologic injury, cerebral ischemic lesions, and cognitive dysfunction in subjects undergoing contemporary commercial TAVI in the United States. Neuro-TAVR is the first prospective, multicenter study to use serial systematic neurologic and cognitive assessments and diffusion-weighted magnetic resonance imaging (at 4 ± 2 days after procedure) to investigate the incidence and severity of neurologic injury after contemporary unprotected TAVI in the United States. A total of 44 consecutive patients underwent TAVI at 5 US sites. Diffusion-weighted magnetic resonance imaging lesions were detected in 94%, with a mean of 10.4 ± 15.3 lesions per subject and a median total lesion volume of 295 mm (interquartile range 71.6 to 799.6 mm). New neurologic impairment (worsening in National Institutes of Health Stroke Scale score from baseline with new cerebral lesions) occurred in 22.6% (7 of 31) of subjects at discharge and 14.8% (4 of 27) at 30 days. In addition, cognitive decrements from baseline were identified by the Montreal Cognitive Assessment in 33% (12 of 36) of subjects at discharge and 41% (13 of 32) at 30 days. In conclusion, this contemporary cohort of US patients confirms that TAVI results in cerebral infarction in most patients and that 1 in 5 patients have measurable neurologic impairment and 1 in 3 patients have decrease in cognitive measures by Montreal Cognitive Assessment score after TAVI, reinforcing the need for methods to mitigate the risk of brain injury during TAVI.
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http://dx.doi.org/10.1016/j.amjcard.2016.08.013DOI Listing
November 2016

Simplified prediction of postoperative cardiac surgery outcomes with a novel score: R2CHADS2.

Am Heart J 2016 07 29;177:153-9. Epub 2016 Apr 29.

Columbia University Division of Cardiology, Mount Sinai Medical Center, Miami Beach, FL. Electronic address:

Objective: To compare the accuracy of R2CHADS2, CHADS2, and CHA2DS2-VASc scores vs the Society of Thoracic Surgeons (STS) score as predictors of morbidity and mortality after cardiovascular surgery.

Methods: All patients who underwent cardiothoracic surgery at our institution from January 2008 to July 2013 were analyzed. Only those patients who fulfilled the criteria for STS score calculation were included. The R2CHADS2 score was computed as follows: 2 points for GFR < 60 mL/min/1.73 m(2) (R2), prior stroke or TIA (S2); 1 point for history of congestive heart failure (C), hypertension (H), age ≥75 years (A), or diabetes (D). Area under the curve (AUC) analysis was used to estimate the accuracy of the different scores. The end point variables included operative mortality, permanent stroke, and renal failure as defined by the STS database system.

Results: Of the 3,492 patients screened, 2,263 met the inclusion criteria. These included 1,160 (51%) isolated valve surgery, 859 (38%) coronary artery bypass graft surgery, and 245 (11%) combined procedures. There were 147 postoperative events: 75 (3%) patients had postoperative renal failure, 48 (2%) had operative mortality, and 24 (1%) had permanent stroke. AUC analysis revealed that STS, R2CHADS2, CHADS2, and CHA2DS2-VASc reliably estimated all postoperative outcomes. STS and R2CHADS2 scores had the best accuracy overall, with no significant difference in AUC values between them.

Conclusion: The R2CHADS2 score estimates postoperative events with acceptable accuracy and if further validated may be used as a simple preoperative risk tool calculator.
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http://dx.doi.org/10.1016/j.ahj.2016.04.019DOI Listing
July 2016

Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions: 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial.

JACC Cardiovasc Interv 2016 Jan;9(1):51-64

University of Bonn, Bonn, Germany.

Objectives: The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions.

Background: The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland).

Methods: A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD "standard dose" (BFD) or BFD "low dose" (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany.

Results: Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported.

Conclusions: The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119).
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http://dx.doi.org/10.1016/j.jcin.2015.09.008DOI Listing
January 2016

Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies).

Am J Cardiol 2016 Feb 7;117(4):532-538. Epub 2015 Dec 7.

Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

We compared the outcomes of a novel, thin-strut, cobalt-chromium, absorbable, polymer sirolimus-eluting stent (APSES; MiStent) to the durable polymer cobalt-chromium everolimus-eluting stent (EES; Xience). A propensity-matched analysis was performed comparing data from the DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries (DESSOLVE) I and II studies, evaluating the APSES to the EES arm of the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents-4 study. Target lesion failure (TLF) and its components were evaluated at 12 months and annually to 3 years; 805 patients (APSES = 153; EES = 652) were included with propensity matching in 204 patients (APSES = 102; EES = 102). APSES compared with EES had lower TLF at 1 year (3.0% vs 8.0%, p = 0.12) driven by a difference in target lesion revascularization (TLR; 1% vs 6%, p = 0.05), with no difference in target vessel myocardial infarction (p = 0.56) or stent thrombosis (p = 0.31). At 3 years, TLF (5.0% vs 12.5%, p = 0.07) and TLR (2.0% vs 8.4%, p = 0.04) remained lower with APSES. By landmark analysis, there was no significant difference in TLF between 1 and 3 years (p = 0.36). In conclusion, in a propensity-matched analysis, the APSES demonstrated reduced clinically indicated TLR rates at 1 and 3 years compared with the durable polymer EES, with minimal accrual of events between 1 and 3 years.
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http://dx.doi.org/10.1016/j.amjcard.2015.11.044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5975354PMC
February 2016

Prevalence and impact of high platelet reactivity in chronic kidney disease: results from the Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents registry.

Circ Cardiovasc Interv 2015 Jun;8(6):e001683

From the Icahn School of Medicine at Mount Sinai, New York (U.B., R.M., G.C.); Cardiovascular Research Foundation, New York (R.M., A.J.K., A.M., G.W., K.X., H.P., G.W.S.); NewYork-Presbyterian/Columbia University Medical Center, New York, NY (A.J.K., A.M., G.W., G.W.S.); Sinai Hospital of Baltimore, MD (P.A.G.); Helios Amper-Klinikum, Dachau, Germany (B.W.); Shaare Zedek Medical Center, Jerusalem, Israel (G.W.); Sanger Heart and Vascular Institute/Carolinas HealthCare System, Charlotte, NC (M.J.R.); Wellmont CVA Heart Institute, Kingsport, TN (D.C.M.); Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, MN (T.D.H.); Lehigh Valley Health Network, Allentown, PA (D.A.C.); Reid Heart Center, FirstHealth of the Carolinas, Pinehurst, NC (P.L.D.); The Ohio State University Wexner Medical Center, Columbus (E.L.M.); and LeBauer Cardiovascular Research Foundation/Cone Health, Greensboro, NC (B.R.B., T.D.S.).

Background: Chronic kidney disease (CKD) is associated with increased rates of adverse events after percutaneous coronary intervention. We sought to determine the impact of CKD on platelet reactivity in clopidogrel-treated patients and whether high platelet reactivity (HPR) confers a similar or differential risk for adverse events among patients with CKD and non-CKD.

Methods And Results: We performed a post hoc analysis of the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) registry, which included 8582 patients undergoing percutaneous coronary intervention with drug-eluting stents and platelet function testing using the VerifyNow assay. We compared HPR and its impact on ischemic and bleeding events >2 years among patients with CKD and non-CKD. Patients with CKD (n=1367) were older, more often female, diabetic, and had lower ejection fraction compared with their non-CKD counterparts (n=7043). Although HPR prevalence increased with worsening renal function in unadjusted analyses, these associations were no longer present after adjustment. Major adverse cardiac event rates at 2 years among those without CKD or HPR, HPR alone, CKD alone, and both CKD and HPR were 9.0%, 11.2%, 13.3%, and 17.5%, respectively (P<0.001). Associations between HPR and adverse events were uniform across CKD strata without evidence of interaction.

Conclusions: HPR is more common among those with versus without CKD, an association that is attributable to confounding risk factors that are more prevalent in CKD. The impact of HPR on ischemic and bleeding events is similar irrespective of CKD status.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00638794.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.001683DOI Listing
June 2015

A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial.

Eur Heart J 2015 Aug 19;36(31):2070-2078. Epub 2015 May 19.

Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.

Aims: To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI).

Methods And Results: From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects (P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task (P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days.

Conclusion: TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls.
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http://dx.doi.org/10.1093/eurheartj/ehv191DOI Listing
August 2015

Prognostic utility of myocardial blush grade after PCI in patients with NSTE-ACS: Analysis from the ACUITY trial.

Catheter Cardiovasc Interv 2016 Aug 18;88(2):215-24. Epub 2015 Nov 18.

Division of Cardiology, Department of Medicine, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.

Objective: We evaluated the ability of post-procedural myocardial blush grade (MBG) to stratify outcomes of patients undergoing percutaneous coronary intervention (PCI) for non-ST segment elevation acute coronary syndromes (NSTE-ACS).

Background: MBG strongly correlates with survival after reperfusion therapy in patients with ST-segment elevation myocardial infarction (STEMI).

Methods: Of 13,819 NSTE-ACS patients randomized in the ACUITY trial, 3,115 patients underwent PCI and had MBG analyzed by an independent angiographic core laboratory. We examined net adverse clinical events (NACE; composite ischemia or bleeding), composite ischemia (death, MI or ischemia-driven revascularization) and non-CABG major bleeding according to final MBG.

Results: At 30 days, patients with MBG-0/1 had higher rates of NACE (25.1% vs. 13.9%, P = 0.002) and composite ischemia (19.1% vs. 9.4%, P = 0.002) than patients with MBG-2/3. At 1-year follow-up, MBG-0/1 patients had significantly higher rates of composite ischemia compared to other patients (27.8% vs. 19.8%, P = 0.02). By multivariable analysis, MBG-0/1 was an independent predictor of 30-day ischemia-driven revascularization (OR 5.74 [2.63, 12.54], P < 0.0001) in the total population and among patients with normal post-PCI epicardial TIMI-3 flow (OR 6.39 [2.06, 19.78], P = 0.001). However, 1-year outcomes were similar between patients with and without normal myocardial perfusion.

Conclusions: In conclusion, MBG is a predictor of 30-day revascularization in the overall population and in patients with normal epicardial flow but fails to stratify 1-year outcomes. Thus, unlike in STEMI patients, the prognostic value of MBG in NSTE-ACS patients appears to be limited to the short-term. © 2015 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.25865DOI Listing
August 2016

Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients – long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study.

Circ J 2015 27;79(1):96-103. Epub 2014 Nov 27.

Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital.

Background: This study evaluated the safety and efficacy of the RESOLUTE(TM)zotarolimus-eluting stent (R-ZES; Medtronic, Inc, Santa Rosa, CA, USA) in Japanese patients for the treatment of de novo native coronary lesions.

Methods And Results: Both RESOLUTE Japan (R-Japan) and RESOLUTE Japan Small Vessel Study (R-Japan SVS) were prospective, multicenter, single-arm observational studies. R-Japan enrolled 100 patients (reference vessel diameter, 2.5-3.5 mm) and R-Japan SVS enrolled 65 patients (at least 1 lesion suitable for 2.25-mm stent) treated with R-ZES. In R-Japan, in-stent late lumen loss (LLL; the primary endpoint) at 8 months was 0.12 ± 0.22 mm and volume obstruction on intravascular ultrasound was 2.33 ± 3.51%. At 4 years, there were no cases of clinically driven target lesion revascularization (TLR); the target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, and clinically driven TLR) was 5.6% (5/90). In R-Japan SVS, in-stent LLL at 9 months was 0.27 ± 0.33 mm, TLF (primary endpoint) was 4.6% (3/65), without incidence of TLR. At 3 years, TLF was 7.9% (5/63) and clinically driven TLR, 3.2% (2/63).

Conclusions: R-Japan and R-Japan SVS demonstrate substantial suppression of neointimal hyperplasia, low LLL, and excellent and sustained long-term clinical outcome with R-ZES in Japanese patients.
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http://dx.doi.org/10.1253/circj.CJ-14-0836DOI Listing
February 2016

Prognostic value of angiographic lesion complexity in patients with acute coronary syndromes undergoing percutaneous coronary intervention (from the acute catheterization and urgent intervention triage strategy trial).

Am J Cardiol 2014 Dec 18;114(11):1638-45. Epub 2014 Sep 18.

Division of Cardiology, Columbia University Medical Center, New York, New York; Division of Cardiology, Cardiovascular Research Foundation, New York, New York.

Although lesion complexity is predictive of outcomes after balloon angioplasty, it is unclear whether complex lesions continue to portend a worse prognosis in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with contemporary interventional therapies. We sought to assess the impact of angiographic lesion complexity, defined by the modified American College of Cardiology/American Heart Association classification, on clinical outcomes after PCI in patients with ACS and to determine whether an interaction exists between lesion complexity and antithrombin regimen outcomes after PCI. Among the 3,661 patients who underwent PCI in the Acute Catheterization and Urgent Intervention Triage strategy study, patients with type C lesions (n = 1,654 [45%]) had higher 30-day rates of mortality (1.2% vs 0.6%, p = 0.049), myocardial infarction (9.2% vs 6.3%, p = 0.0006), and unplanned revascularization (4.3% vs 3.1%, p = 0.04) compared with those without type C lesions. In multivariate analysis, type C lesions were independently associated with myocardial infarction (odds ratio [95% confidence interval] = 1.37 [1.04 to 1.80], p = 0.02) and composite ischemia (odds ratio [95% confidence interval] = 1.49 [1.17 to 1.88], p = 0.001) at 30 days. Bivalirudin monotherapy compared with heparin plus a glycoprotein IIb/IIIa inhibitor reduced major bleeding complications with similar rates of composite ischemic events, regardless of the presence of type C lesions. There were no interactions between antithrombotic regimens and lesion complexity in terms of composite ischemia and major bleeding (p [interaction] = 0.91 and 0.80, respectively). In conclusion, patients with ACS with type C lesion characteristics undergoing PCI have an adverse short-term prognosis. Treatment with bivalirudin monotherapy reduces major hemorrhagic complications irrespective of lesion complexity with comparable suppression of adverse ischemic events as heparin plus glycoprotein IIb/IIIa inhibitor.
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http://dx.doi.org/10.1016/j.amjcard.2014.09.003DOI Listing
December 2014

Relation of C-reactive protein levels to instability of untreated vulnerable coronary plaques (from the PROSPECT Study).

Am J Cardiol 2014 Aug 16;114(3):376-83. Epub 2014 May 16.

Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York. Electronic address:

C-reactive protein (CRP) levels predict adverse coronary events, but it is uncertain if they predict the burden or stability of vulnerable coronary plaques. In the Providing Regional Observations to Study Predictors of Events in the Coronary Tree study, 697 patients with acute coronary syndromes underwent percutaneous coronary intervention followed by 3-vessel angiography, gray-scale intravascular ultrasound (IVUS), and radiofrequency IVUS. Major adverse cardiac events (MACE) during 3 years of follow-up were adjudicated to initially treated culprit lesions or to untreated nonculprit lesions (NCLs). NCLs at greatest risk of causing subsequent MACE had plaque burden ≥70%, minimal luminal area ≤4.0 mm(2), and/or thin-cap fibroatheroma morphology. Here, we examine the interaction of high-risk NCLs with CRP levels, which were measured at presentation, 1 month, and 6 months, then categorized at each time as normal (<3 mg/L), elevated (3 to 10 mg/L), or very elevated (>10 mg/L). We found that patients with elevated CRP levels at any time did not have more high-risk NCLs; however, untreated high-risk NCLs were more likely to cause subsequent MACE in patients with very elevated compared with normal 6-month CRP levels (for thin-cap fibroatheromas, 13.8% vs 1.9%, p = 0.0003; for lesions with minimal luminal area ≤4.0 mm(2), 15.6% vs 2.2%, p <0.0001). As expected, patients with very elevated 6-month CRP levels had higher rates of subsequent NCL-related MACE (19.0% vs 7.2%, p = 0.039). In conclusion, the higher rates of NCL-related MACE in post-acute coronary syndrome patients with very elevated CRP levels may reflect greater instability of high-risk NCLs, rather than a larger burden of such lesions.
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http://dx.doi.org/10.1016/j.amjcard.2014.04.048DOI Listing
August 2014

Body mass index and acute and long-term outcomes after acute myocardial infarction (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction Trial).

Am J Cardiol 2014 Jul 16;114(1):9-16. Epub 2014 Apr 16.

Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address:

The clinical outcome of acute cardiovascular events may be more favorable in patients with a high body mass index (BMI), although obesity increases the risk for cardiovascular diseases. The authors sought to define the association between BMI and acute and long-term outcome of patients presenting within 12 hours of ST-segment myocardial infarction (STEMI) in a large multinational cohort. A total of 3,579 patients enrolled in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial were stratified according to BMI quartiles: <24.5, 24.5 to <27.1, 27.1 to 30.1, and >30.1 kg/m(2) (quartiles 1, 2, 3, and 4, respectively). Death, myocardial reinfarction, ischemia-driven target vessel revascularization, stroke, and noncoronary artery bypass grafting-related major bleeding events were centrally adjudicated for the acute, 30 days, and yearly follow-up. Patients with a BMI in the highest quartile were younger than patients in the lower BMI quartiles and more frequently had hypertension, hyperlipidemia, and diabetes mellitus. Complete occlusions and noncalcified lesions were more common in patients with a high BMI. In-hospital mortality decreased with increasing BMI due to lower cardiac mortality (2.9%, 2.3%, 1.2%, and 1.0% for quartiles 1, 2, 3, and 4, respectively, p <0.05). Out-of-hospital 3-year mortality was also lower in higher-weight patients due to lower noncardiac mortality (4.2%, 2.6%, 2.3%, and 1.7% for quartiles 1 to 4, respectively, p = 0.01). After adjustment for covariates, BMI was no longer predictive of acute or long-term mortality after STEMI. In conclusion, as BMI increases, patients have a more extensive adjusted cardiovascular risk profile and disease burden and premature STEMI onset but similar adjusted acute and long-term outcomes.
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http://dx.doi.org/10.1016/j.amjcard.2014.03.057DOI Listing
July 2014

Impact of coronary lesion complexity on drug-eluting stent outcomes in patients with and without diabetes mellitus: analysis from 18 pooled randomized trials.

J Am Coll Cardiol 2014 May 13;63(20):2111-2118. Epub 2014 Mar 13.

New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address:

Objectives: The aim of this study was to investigate whether baseline lesion complexity affects drug-eluting stent (DES) outcomes according to diabetic status.

Background: Previous studies have reported conflicting results regarding DES safety and efficacy in patients with and without diabetes mellitus (DM).

Methods: Patient-level data from 18 prospective randomized trials were pooled. DES treatment outcomes in patients with versus without DM were analyzed in 2 propensity score-matched groups further stratified according to lesion complexity (American College of Cardiology and American Heart Association class A/B1 vs. B2/C). Remaining baseline differences were adjusted for by multivariate analysis.

Results: DM was present in 3,467 of 18,441 patients (18.8%). DM was a predictor of 1-year repeat revascularization (target lesion revascularization: hazard ratio: 1.34; 95% confidence interval: 1.05 to 1.70; target vessel revascularization: hazard ratio: 1.40; 95% confidence interval: 1.15 to 1.72) and cardiac death or myocardial infarction (hazard ratio: 1.40; 95% confidence interval: 1.09 to 1.81). Rates of target lesion and target vessel revascularization were significantly higher in patients with versus those without DM with type B2/C lesions (8.0% vs. 4.5% and 10.6% vs. 5.9%, respectively, p < 0.0001 for both), but not in patients with only type A/B1 lesions (4.6% vs. 4.8%, p = 0.87, and 7.4% vs. 6.8%, p = 0.47, respectively), with a significant interaction between DM and lesion type observed for both endpoints (p = 0.01 and p = 0.02, respectively). No interaction was observed for death or myocardial infarction (p = 0.28).

Conclusions: In the DES era, patients with DM remain at increased risk for cardiac death or myocardial infarction. However, DM is a risk factor for repeat revascularization only in those patients with complex lesions; patients with DM and noncomplex lesions have similar rates of 1-year freedom from repeat revascularization as do patients without DM.
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http://dx.doi.org/10.1016/j.jacc.2014.01.064DOI Listing
May 2014

Relationship between ST-segment resolution and anterior infarct size after primary percutaneous coronary intervention: analysis from the INFUSE-AMI trial.

Eur Heart J Acute Cardiovasc Care 2014 Mar 3;3(1):78-83. Epub 2013 Oct 3.

Columbia University, New York, NY, USA.

Aims: ST-segment resolution (STR) after reperfusion therapy has been shown to correlate with prognosis in patients with ST-segment elevation myocardial infarction (STEMI). We investigated whether acute ECG measurements also correlate with ultimate infarct size.

Methods And Results: The INFUSE-AMI trial randomized 452 patients with anterior STEMI to intracoronary bolus abciximab vs. no abciximab, and to thrombus aspiration vs. no aspiration. Infarct size as percentage of total LV mass was calculated by cardiac magnetic resonance imaging (MRI) 30 days post intervention. Five ECG methods were analysed for their ability to predict MRI infarct mass: (1) summed STR across all infarct-related ECG leads (ΣSTR); (2) STR in the single lead with maximum baseline ST-segment elevation (maxSTR); (3) summed residual ST-segment elevation across all infarct-related leads at 60 min post intervention (ΣST residual); (4) maximum residual ST-segment elevation in the worst single lead at 60 min post intervention (maxST residual); (5) number of new significant Q-waves (Qwave) at 60 min. All ECG methods strongly correlated with 30-day MRI infarct mass (all p<0.003). Simpler ECG measurements such as maxSTresidual and Qwave were as predictive as more complex measurements. A subset analysis of 158 patients who had microvascular obstruction (MVO) determined by MRI 5 days post intervention also showed strong correlations of MVO with the ECG measures.

Conclusions: ST-segment and Q-wave changes after primary PCI in anterior STEMI strongly correlated with 30-day infarct size by MRI. In particular, maxST residual and Qwave at 60 min are simple ECG parameters that offer rapid analysis for prognostication.
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http://dx.doi.org/10.1177/2048872613508658DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3932776PMC
March 2014

Comparative effectiveness of upstream glycoprotein IIb/IIIa inhibitors in patients with moderate- and high-risk acute coronary syndromes: an Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) substudy.

Am Heart J 2014 Jan 19;167(1):43-50. Epub 2013 Oct 19.

Department of Cardiology, Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY. Electronic address:

Background: Tirofiban and eptifibatide are both small-molecule, competitive glycoprotein IIb/IIIa receptor inhibitors (GPIs) that are guideline-supported for upstream therapy in acute coronary syndromes (ACS). This study sought to compare the efficacy and safety of tirofiban and eptifibatide in patients with ACS.

Methods: Within the ACUITY trial, 4,323 patients with moderate- and high-risk ACS received upstream, adjunctive GPI (tirofiban or eptifibatide) in addition to an antithrombin. Primary outcomes included 30-day rates of composite major adverse cardiac events (MACE), major bleeding (not related to coronary artery bypass grafting), and composite net adverse clinical events (NACE). The outcomes were compared based on the upstream GPI administered.

Results: There were significant differences in the baseline characteristics of patients treated with tirofiban vs eptifibatide, particularly related to country/region. In unadjusted analyses, treatment with upstream tirofiban vs eptifibatide was associated with similar rates of major bleeding (5.8% vs 6.5%, P = .39) and nonsignificantly lower rates of MACE (6.1% vs 7.6%, P = .06) and NACE (10.6% vs 12.6%, P = .06). After propensity-based multivariable adjustment, there were no significant differences between tirofiban and eptifibatide with respect to 30-day major bleeding, MACE, or NACE.

Conclusions: Among more than 4,000 patients with moderate- and high-risk ACS treated with upstream GPI as part of an early invasive management strategy, the use of tirofiban and eptifibatide resulted in similar clinical outcomes. These data suggest equivalence of these 2 agents for upstream use, while highlighting some of the difficulties of nonrandomized comparative effectiveness analyses, specifically the difficulty in addressing geographic differences in the use of nonrandomized treatments.
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http://dx.doi.org/10.1016/j.ahj.2013.10.013DOI Listing
January 2014

Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study.

Circulation 2014 Jan 26;129(4):463-70. Epub 2013 Nov 26.

From Amper Kliniken AG, Dachau, Germany (B.W.); NewYork-Presbyterian/Columbia University Medical Center, New York, NY (A.M., G.W., G.W.S.); Cardiovascular Research Foundation, New York, NY (A.M., G.W., K.X., H.P., R.M., G.S.M., G.W.S.); Universitäts-Herzzentrum Freibrug Bad Krozingen, Bad Krozingen, Germany (F.N.); Sanger Heart and Vascular Institute/Carolinas HealthCare System, Charlotte, NC (M.J.R.); Wellmont CVA Heart Institute, Kingsport, TN (D.C.M.); Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN (T.D.H.); Lehigh Valley Health Network, Allentown, PA (D.A.C.); Reid Heart Center, FirstHealth of the Carolinas, Pinehurst, NC (P.L.D.); LeBauer Cardiovascular Research Foundation/Moses Cone Hospital, Greensboro, NC (B.R.B., T.D.S.); The Ohio State University, Columbus, OH (E.L.M.); and Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).

Background: Prior small to modest-sized studies suggest a benefit of intravascular ultrasound (IVUS) guidance in noncomplex lesions. Whether IVUS guidance is associated with improved clinical outcomes after drug-eluting stent (DES) implantation in an unrestricted patient population is unknown.

Methods And Results: Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) was a prospective, multicenter, nonrandomized "all-comers" study of 8583 consecutive patients at 11 international centers designed to determine the frequency, timing, and correlates of stent thrombosis and adverse clinical events after DES. Propensity-adjusted multivariable analysis was performed to examine the relationship between IVUS guidance and 1-year outcomes. IVUS was utilized in 3349 patients (39%), and larger-diameter devices, longer stents, and/or higher inflation pressures were used in 74% of IVUS-guided cases. IVUS guidance compared with angiography guidance was associated with reduced 1-year rates of definite/probable stent thrombosis (0.6% [18 events] versus 1.0% [53 events]; adjusted hazard radio, 0.40; 95% confidence interval, 0.21-0.73; P=0.003), myocardial infarction (2.5% versus 3.7%; adjusted hazard radio, 0.66; 95% confidence interval, 0.49-0.88; P=0.004), and composite adjudicated major adverse cardiac events (ie, cardiac death, myocardial infarction, or stent thrombosis) (3.1% versus 4.7%; adjusted hazard radio, 0.70; 95% confidence interval, 0.55-0.88; P=0.002). The benefits of IVUS were especially evident in patients with acute coronary syndromes and complex lesions, although significant reductions in major adverse cardiac events were present in all patient subgroups those with including stable angina and single-vessel disease.

Conclusions: In ADAPT-DES, the largest study of IVUS use to date, IVUS guidance was associated with a reduction in stent thrombosis, myocardial infarction, and major adverse cardiac events within 1 year after DES implantation.

Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT00638794.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.113.003942DOI Listing
January 2014

Complementary prognostic utility of myocardial blush grade and ST-segment resolution after primary percutaneous coronary intervention: analysis from the HORIZONS-AMI trial.

Am Heart J 2013 Oct 13;166(4):676-83. Epub 2013 Sep 13.

New York Methodist Hospital, Brooklyn, NY; Cardiovascular Research Foundation, New York, NY. Electronic address:

Background: Both ST-segment resolution (STR) and myocardial blush grade (MBG) have prognostic utility after primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction. We sought to clarify how frequently MBG and STR provide discordant measures of reperfusion success and to determine the independent prognostic significance of each on long-term outcomes.

Methods: In HORIZONS-AMI, core laboratory measures of both MBG and STR were assessed in 2,367 patients undergoing primary PCI. Four groups were identified based on MBG (grades 2/3 vs 0/1) and STR (≥50% vs <50%). A multivariable model identified predictors of death and major adverse cardiac events at 3 years.

Results: Myocardial blush grade 2/3 was achieved in 77.7% of patients, and STR ≥50% was achieved in 75.1% of patients. Myocardial blush grade and STR were discordant in 765 patients (30.9%). By multivariable analysis, MBG 2/3 compared with 0/1 was an independent predictor of lower mortality at 3 years (4.4% vs 8.4%, adjusted hazard ratio [HR] = 0.57 [0.39, 0.82], P = .003). In contrast, STR ≥50% compared with <50% was not associated with mortality (5.1% vs 5.9%, adjusted HR = 1.11 [0.68, 1.56], P = .89). However, repeated revascularization at 3 years was less frequent when STR ≥50% (12.4% vs 17.6%, adjusted HR = 0.74 [0.58, 0.95], P = .02). In contrast, MBG 2/3 vs 0/1 was not associated with reduced repeated revascularization (13.6% vs 14.1%, adjusted HR = 1.02 [0.79, 1.33], P = .85).

Conclusions: In HORIZONS-AMI, MBG and STR after primary PCI were concordant in only 70% of patients and provided complementary prognostic information. Myocardial blush grade predicted long-term survival, whereas STR predicted freedom from repeated revascularization.
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http://dx.doi.org/10.1016/j.ahj.2013.07.025DOI Listing
October 2013

Relation between white blood cell count and final infarct size in patients with ST-segment elevation acute myocardial infarction undergoing primary percutaneous coronary intervention (from the INFUSE AMI trial).

Am J Cardiol 2013 Dec 21;112(12):1860-6. Epub 2013 Sep 21.

Dipartimento Cardiovascolare, Policlinico S. Orsola, Bologna, Italy.

Although it has been shown that elevated white blood cell count (WBCc) on presentation is associated with an increased risk of cardiac mortality in patients with ST-segment elevation myocardial infarction (STEMI), the responsible mechanisms are unknown. We therefore sought to investigate whether elevated WBCc is associated with increased infarct size measured with cardiac magnetic resonance imaging 30 days after primary percutaneous coronary intervention in the Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction trial. INFUSE AMI randomized patients with STEMI and proximal or mid-left anterior descending coronary artery occlusion to bolus intracoronary abciximab versus no abciximab and to manual aspiration versus no aspiration. WBCc at hospital admission was available in 407 of 452 randomized patients. Patients were stratified according to tertiles of WBCc. At 30 days, a significant stepwise increase in infarct size (percentage of total left ventricular mass) was apparent across tertiles of increasing WBCc (median [interquartile range] for tertiles I vs II vs III = 11.2% [3.8% to 19.6%] vs 17.5% [0.5% to 22.9%] vs 19.1% [13.7 to 26.0], respectively, p <0.0001). Absolute infarct mass in grams and abnormal wall motion score were also significantly increased across tertiles of WBC. By multivariate linear regression analysis, WBCc was an independent predictor of infarct size along with intracoronary abciximab randomization, age, time from symptom onset to first device, proximal left anterior descending location, and baseline TIMI flow of 0/1. In conclusion, in patients with anterior wall STEMI, an elevated admission WBCc is a powerful independent predictor of infarct size measured with cardiac magnetic resonance imaging 30 days after primary percutaneous coronary intervention.
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http://dx.doi.org/10.1016/j.amjcard.2013.08.010DOI Listing
December 2013

Platelet reactivity and clinical outcomes after coronary artery implantation of drug-eluting stents (ADAPT-DES): a prospective multicentre registry study.

Lancet 2013 Aug 26;382(9892):614-23. Epub 2013 Jul 26.

Columbia University Medical Center, New York-Presbyterian Hospital, New York, NY 10022, USA.

Background: The relation between platelet reactivity and stent thrombosis, major bleeding, and other adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterised. We aimed to determine the relation between platelet reactivity during dual therapy with aspirin and clopidogrel and clinical outcomes after successful coronary drug-eluting stent implantation.

Methods: ADAPT-DES was a prospective, multicentre registry of patients successfully treated with one or more drug-eluting stents and given aspirin and clopidogrel at 10-15 US and European hospitals. We assessed platelet reactivity in those patients after successful percutaneous coronary intervention using VerifyNow point-of-care assays, and assigned different cutoffs to define high platelet reactivity. The primary endpoint was definite or probable stent thrombosis; other endpoints were all-cause mortality, myocardial infarction, and clinically relevant bleeding. We did a propensity-adjusted multivariable analysis to determine the relation between platelet reactivity and subsequent adverse events. This study is registered with ClinicalTrials.gov, number NCT00638794.

Findings: Between Jan 7, 2008, and Sept 16, 2010, 8665 patients were prospectively enrolled at 11 sites, of which 8583 were eligible. At 1-year follow-up, stent thrombosis had occurred in 70 (0·8%) patients, myocardial infarction in 269 (3·1%), clinically relevant bleeding in 531 (6·2%), and death in 161 (1·9%) patients. High platelet reactivity on clopidogrel was strongly related to stent thrombosis (adjusted HR 2·49 [95% CI 1·43-4·31], p=0·001) and myocardial infarction (adjusted HR 1·42 [1·09-1·86], p=0·01), was inversely related to bleeding (adjusted HR 0·73 [0·61-0·89], p=0·002), but was not related to mortality (adjusted HR 1·20 [0·85-1·70], p=0·30). High platelet reactivity on aspirin was not significantly associated with stent thrombosis (adjusted HR 1·46 [0·58-3·64], p=0·42), myocardial infarction, or death, but was inversely related to bleeding (adjusted HR 0·65 [0·43-0·99], p=0·04).

Interpretation: The findings from this study emphasise the counter-balancing effects of haemorrhagic and ischaemic complications after stent implantation, and suggest that safer drugs or tailored strategies for the use of more potent agents must be developed if the benefits of greater platelet inhibition in patients with cardiovascular disease are to be realised.

Funding: Boston Scientific, Abbott Vascular, Medtronic, Cordis, Biosensors, The Medicines Company, Daiichi-Sankyo, Eli Lilly, Volcano, and Accumetrics.
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http://dx.doi.org/10.1016/S0140-6736(13)61170-8DOI Listing
August 2013

Relationship between myocardial reperfusion, infarct size, and mortality: the INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial.

JACC Cardiovasc Interv 2013 Jul;6(7):718-24

Department of Medicine, New York Methodist Hospital, Brooklyn, New York 11215, USA.

Objectives: This study sought to compare infarct size (IS) measured by magnetic resonance imaging in patients with successful (myocardial blush grade [MBG] 2/3) versus unsuccessful (MBG 0/1) microcirculatory reperfusion in the INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial.

Background: Successful microcirculatory reperfusion, defined angiographically by MBG 2 or 3, is associated with improved outcomes in patients with ST-segment elevation myocardial infarction. The precise mechanism underlying this association is not well defined.

Methods: The INFUSE-AMI trial randomized 452 patients with anterior ST-segment elevation myocardial infarction to intracoronary bolus abciximab delivered locally at the infarct lesion versus no abciximab, and to manual thrombus aspiration versus no aspiration. The primary endpoint was IS (percentage of left ventricular mass) at 30 days.

Results: MBG 2/3 was achieved in 367 patients (81.4%). IS was significantly lower in patients with MBG 2/3 than in those with MBG 0/1 (median: 16.7% [interquartile range (IQR): 7.0 to 22.7] vs. 19.5% [IQR: 11.1 to 29.2]; p = 0.002). Intracoronary abciximab further reduced IS in patients with MBG 2/3 (median: 14.4% [IQR: 5.4 to 20.9] vs. 17.4% [IQR: 10.5 to 23.8]; p = 0.01). MBG 2/3 was associated with ∼30% reduction in infarct mass (p = 0.002) and ∼90% reduction in microvascular obstruction on day 5. Ejection fraction was higher with MBG 2/3 at 30 days: median: 50.3% (IQR: 43.8 to 57.8) versus 46.9% (IQR: 37.5 to 54.0); p = 0.004. At 30 days, the rate of death was significantly lower (1.7% vs. 8.3%; p = 0.0008) in the MBG 2/3 group.

Conclusions: MBG 2/3 occurs in 80% of ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention and is associated with smaller infarct size, less microvascular obstruction, improved ejection fraction, and significantly lower 30-day mortality. (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction [INFUSE-AMI]; NCT00976521).
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http://dx.doi.org/10.1016/j.jcin.2013.03.013DOI Listing
July 2013

Infarct size and mortality in patients with proximal versus mid left anterior descending artery occlusion: the Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction (INFUSE-AMI) trial.

Am Heart J 2013 Jul 30;166(1):64-70. Epub 2013 Apr 30.

New York Methodist Hospital, Brooklyn, NY, USA.

Objective: This study aimed to compare infarct size and clinical outcomes in patients with proximal versus mid left anterior descending (mLAD) infarction.

Background: The extent of myocardium at risk is an important prognostic determinate in patients with ST-segment elevation myocardial infarction.

Methods: The INFUSE-AMI trial randomized patients with anterior ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation to intracoronary (IC) bolus abciximab versus no abciximab and to thrombus aspiration versus no aspiration. The primary end point was magnetic resonance imaging infarct size (% of left ventricular mass) at 30 days. Lesion location was independently assessed and was defined as proximal (pLAD) if present before or at first significant septal perforator branch, or mLAD if beyond.

Results: Among 452 patients, 292 (64.7%) had pLAD and 159 (35.3%) had mLAD occlusions. Patients with pLAD infarcts were significantly more likely to have Killip class >1 heart failure and ejection fraction <40% and to present earlier to the hospital. Proximal LAD infarcts had significantly lower rates of final Thrombolysis In Myocardial Infarction flow 3 and procedural success but similar rates of myocardial blush grade 2/3 and ST-segment resolution compared with mLAD infarcts. Infarct size at 30 days was significantly greater in the pLAD group (19.3% [9.2-25.9] vs 14.3% [6.2-18.9], P < .0001). Mortality at 30 days was also higher in the pLAD group (4.2% vs 0.6%, P = .04). The effect of IC abciximab on reducing infarct size was comparable in both groups.

Conclusion: ST-segment elevation myocardial infarction caused by pLAD compared with mLAD occlusion results in larger infarcts and greater mortality even with contemporary reperfusion therapy.
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http://dx.doi.org/10.1016/j.ahj.2013.03.029DOI Listing
July 2013

Impact of scheduled angiographic follow-up in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

J Interv Cardiol 2013 Aug 24;26(4):319-24. Epub 2013 Jun 24.

Cardiovascular Research Foundation, New York, New York, USA.

Routine scheduled angiographic follow-up (SAF) after percutaneous coronary intervention (PCI) has been associated with a higher rate of target vessel revascularization (TVR). Its benefits are not known. SAF at 13 months after ST-segment elevation myocardial infarction (STEMI) was planned in the first 1,800 successfully stented patients enrolled in the Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. We compared the outcomes of patients with and without SAF at 1 year (before SAF) and at 3 years (after SAF). There were 1,197 patients (66.5% of expected) with and 2,207 patients without SAF. Prior to SAF, the 1-year composite rate of death or myocardial infarction (MI) was not significantly different between the 2 groups (2.7% vs. 3.9%, respectively, P=0.06), although the rate of death was lower (0.1% vs. 2.2%, P<0.0001), nor were there differences in the 1-year rates of TVR, stent thrombosis or major adverse cardiac and cerebral events). At 3 years, death or MI rates were again similar between the groups (8.3% vs. 9.5%, P=0.22), but TVR was more common in the SAF group (17.0% vs. 8.6%, P<0.0001), due to an increase in TVR at time of SAF. In the SAF group, patients in whom TVR was performed before or after the 13-month SAF window had markedly higher 3-year rates of MI and stent thrombosis than patients in whom TVR was performed during SAF or not at all. In conclusion, SAF after primary PCI in STEMI is associated with doubling of the rate of revascularization without an improvement in death or MI, and therefore cannot be recommended.
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http://dx.doi.org/10.1111/joic.12038DOI Listing
August 2013

Impact of bivalirudin and paclitaxel-eluting stents on outcomes in patients undergoing primary percutaneous coronary intervention of the left anterior descending artery.

Am J Cardiol 2013 Sep 6;112(6):753-60. Epub 2013 Jun 6.

Department of Internal Medicine II, University of Ulm, Ulm, Germany.

Patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) of the left anterior descending artery (LAD) are at increased risk for cardiovascular events compared with patients undergoing non-LAD PCI. We assessed the impact of bivalirudin and paclitaxel-eluting stenting (PES) in patients with STEMI who underwent LAD PCI. In the HORIZONS-AMI trial, 1,445 patients had LAD PCI and 1,884 patients had non-LAD PCI. The 3-year composite rates of death, reinfarction, stroke, or ischemia-driven target vessel revascularization were significantly higher in patients who underwent LAD PCI compared with non-LAD PCI (24.0% vs 20.6%, hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.04 to 1.39, p = 0.013), driven by a statistically significant increase in cardiac death (5.4% vs 2.7%, HR 2.00, 95% CI 1.40 to 2.86, p = 0.001). For patients who underwent LAD PCI, treatment with bivalirudin resulted in significantly lower rates of cardiac death (3.8% vs 6.8%, HR 0.55, 95% CI 0.34 to 0.89, p = 0.01), reinfarction (5.3% vs 9.5%, HR 0.55, 95% CI 0.37 to 0.83, p = 0.004), and major bleeding events (7.3% vs 11.8%, HR 0.60, 95% CI 0.43 to 0.86, p = 0.004) compared with unfractionated heparin plus glycoprotein IIb/IIIa inhibitor. Randomization to PES compared with bare-metal stenting resulted in a significant lower rate of target vessel revascularization (13.2% vs 19.8%, HR 0.64, 95% CI 0.47 to 0.86, p = 0.003) with no significant differences in stent thrombosis, reinfarction, or death. In conclusion, in patients with STEMI who underwent primary PCI of LAD, the use of bivalirudin was associated with a reduction in mortality and bleeding rates at 3 years. PES reduced revascularization rates in this population but did not have a significant impact on mortality.
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http://dx.doi.org/10.1016/j.amjcard.2013.05.006DOI Listing
September 2013

Relationship between ST-segment recovery and clinical outcomes after primary percutaneous coronary intervention: the HORIZONS-AMI ECG substudy report.

Circ Cardiovasc Interv 2013 Jun 7;6(3):216-23. Epub 2013 May 7.

Peter Munk Cardias Centre and Heart and Stroke Lewar Centre, Toronto, ON, Canada.

Background: In patients with ST-segment elevation myocardial infarction undergoing thrombolytic therapy, the degree of ST-segment resolution (STR) correlates with long-term cardiovascular mortality. The long-term predictive value of STR after primary percutaneous coronary intervention (PCI) is less well understood. We sought to determine the long-term prognostic value of STR after primary PCI in ST-segment-elevation myocardial infarction.

Methods And Results: In a formal substudy from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, 2484 patients with ST-segment-elevation myocardial infarction undergoing primary PCI with interpretable baseline and 60-minute post-PCI electrocardiograms had at least 1 mm of baseline ST-segment elevation in ≥2 contiguous leads. Patients were categorized by the degree of STR at 60 minutes: (1) complete (>70%); (2) partial (30%-70%); and (3) absent (<30%). Absent, incomplete, and complete STR were achieved in 514 (20.7%), 712 (28.7%), and 1258 (50.5%) patients, respectively. STR <30% was associated with a greater likelihood of hypertension, diabetes mellitus, longer symptom onset to balloon time, lower left ventricular ejection fraction, and final thrombolysis in myocardial infarction flow <3. At 3 years, patients with STR<30% experienced a higher rate of major adverse cardiovascular events (death, reinfarction, ischemia-driven target vessel revascularization or stroke; 29.9% versus 20.1% versus 19.6%; P<0.0001), ischemia-driven target vessel revascularization (20.4% versus 14.0% versus 11.7%; P<0.001), and mortality (8.4% versus 5.0% versus 5.6%; P=0.03) than those with partial and complete STR, respectively. By multivariable analysis, STR<30% was an independent predictor of 3-year major adverse cardiovascular events (hazard ratio, 1.58; 95% confidence interval, 1.24-2.00; P=0.0002) and 3-year ischemia-driven target vessel revascularization (hazard ratio, 1.87; 95% confidence interval, 1.41-2.48; P<0.0001).

Conclusions: In this large international study, absent STR 60 minutes after primary PCI was present in ≈1 in 5 patients with ST-segment-elevation myocardial infarction and was a significant independent predictor of major adverse cardiovascular events and target vessel revascularization at 3 years.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.112.000142DOI Listing
June 2013

Objective simulator-based evaluation of carotid artery stenting proficiency (from Assessment of Operator Performance by the Carotid Stenting Simulator Study [ASSESS]).

Am J Cardiol 2013 Jul 18;112(2):299-306. Epub 2013 Apr 18.

Center for Interventional Vascular Therapy, New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA.

Studies have suggested that operator proficiency has a substantial effect on complication rates and procedural outcomes. Endovascular simulators have been used for training and have been proposed as an alternative to the conventional assessment of skills. The present study sought to validate simulation as an objective method for proficiency evaluation in carotid artery stenting. Interventional cardiologists classified as novice, intermediate, or experienced practitioners performed 3 simulated, interactive carotid stenting cases on an AngioMentor endovascular simulator. An automated algorithm scored the participants according to the technical performance, medical management, and angiographic results. A total of 33 interventional cardiologists (8 novices, 15 intermediates, and 10 experts) completed 82 simulated procedures. The composite scores for the case simulations varied significantly by operator experience, with better scores for the more experienced groups (p <0.0001). The metrics that discriminated between operator experience groups included fluoroscopy time, crossing the carotid lesion with devices other than a 0.014-in. wire before filter deployment, and incomplete coverage of the lesion by the stent. In conclusion, the results of the present study validate that a simulator with an automated scoring system is able to discriminate between levels of operator proficiency for carotid artery stenting. Simulator-based performance assessment could have a role in initial and ongoing proficiency evaluations and credentialing of interventional operators of high-risk endovascular procedures.
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http://dx.doi.org/10.1016/j.amjcard.2013.02.069DOI Listing
July 2013

The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent.

JACC Cardiovasc Interv 2013 Apr 20;6(4):334-43. Epub 2013 Mar 20.

Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.

Objectives: This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months.

Background: Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations.

Methods: One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events.

Results: The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group.

Conclusions: In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.
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http://dx.doi.org/10.1016/j.jcin.2012.10.018DOI Listing
April 2013

Dynamic nature of nonculprit coronary artery lesion morphology in STEMI: a serial IVUS analysis from the HORIZONS-AMI trial.

JACC Cardiovasc Imaging 2013 Jan;6(1):86-95

Columbia University Medical Center/The Cardiovascular Research Foundation, New York, New York 10022, USA.

Objectives: The authors sought to report the temporal stability of an untreated, nonculprit lesion phenotype in patients presenting with ST-segment elevation myocardial infarction (STEMI).

Background: The temporal stability of the untreated, nonculprit lesion phenotype has been studied using intravascular ultrasound-virtual histology (IVUS) in patients with stable ischemic heart disease, but not in STEMI patients.

Methods: As part of a formal substudy of the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial, baseline and 13-month follow-up IVUS was performed in 99 untreated nonculprit lesions in 63 STEMI patients. Lesions were classified as pathological intimal thickening (PIT), IVUS-derived thin-cap fibroatheroma (TCFA), thick-cap fibroatheroma (ThCFA), fibrotic plaque, or fibrocalcific plaque.

Results: The frequency of TCFA increased from 41% at baseline to 54% at follow-up, whereas ThCFAs decreased from 41% to 34% and PIT decreased from 16% to 8%. Among the 41 lesions classified at baseline as TCFA, at follow-up, 32 (78%) were still classified as TCFA, whereas 9 (22%) were classified as ThCFAs or fibrotic plaques. An additional 21 lesions at follow-up were newly classified as TCFA, developing from either PIT or ThCFA. TCFA at baseline that evolved into non-TCFAs trended toward a more distal location than TCFA that did not change (p = 0.12). In lesions classified as TCFA, the minimum lumen area (MLA) decreased from 8.1 (interquartile range [IQR]: 7.4 to 8.8) mm(2) at baseline to 7.8 (IQR: 7.2 to 8.4) mm(2) at follow-up, p < 0.05; this was associated with an increase in percent necrotic core at the MLA site (14% [IQR: 12 to 16] to 19% [IQR: 17 to 22], p < 0.0001) and over the entire length of the lesion (14% [IQR: 12 to 16] to 18% [IQR: 17 to 20], p < 0.0001).

Conclusions: Untreated nonculprit lesions in STEMI patients frequently have TCFA morphology that does not change during 13-month follow-up and is accompanied by a decrease in MLA and an increase in necrotic core. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966).
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http://dx.doi.org/10.1016/j.jcmg.2012.08.010DOI Listing
January 2013