Publications by authors named "Ecaterina Cristea"

59 Publications

Long-term serial functional evaluation after implantation of the Fantom sirolimus-eluting bioresorbable coronary scaffold.

Catheter Cardiovasc Interv 2021 Feb 20;97(3):431-436. Epub 2020 Feb 20.

Yale University School of Medicine, New Haven, Connecticut, USA.

Background: Quantitative flow ratio (QFR) has been validated as an accurate surrogate of standard wire-based fractional flow reserve. The clinical and angiographic outcomes of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) have been previously studied and reported. We investigate the functional performance of the Fantom BRS.

Methods: The FANTOM II trial prospectively enrolled 240 patients with stable coronary artery disease or unstable angina, of which 235 patients received the Fantom BRS and were included in the present analysis. We performed an independent serial QFR analysis of the target vessel at baseline, post-percutaneous coronary intervention (PCI), and at 6- or 9-month and 24-month follow-up, using a QFR threshold ≤0.80 to define functional ischemia.

Results: QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 30 at 24-month follow-up. At baseline, 119 patients (66.9%) had a QFR ≤0.80, whereas 12 (6.5%) post-PCI, 13 (7.3%) at 6- or 9-month follow-up, and 3 (10.0%) at 24-month follow-up had a QFR ≤0.80. QFR improved from baseline to post-PCI, and decreased from post-PCI up to 24-month follow-up. During follow-up period, 28 patients (11.9%) had target vessel revascularization, of which 21 had analyzable QFR and 16 patients (76.1%) had QFR ≤0.80 at the time of revascularization.

Conclusions: Off-line serial QFR assessment demonstrated that around 30% patients did not have functionally significant lesions at baseline and the time with target vessel revascularization. PCI with the Fantom BRS improved functional ischemia with a slight decrease in QFR values over 24 months.
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http://dx.doi.org/10.1002/ccd.28804DOI Listing
February 2021

The Firehawk Stent: A Review of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent.

Cardiol Rev 2020 Jul/Aug;28(4):208-212

From the Division of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT.

Despite recent advances in drug-eluting stent (DES) technology, late adverse events remain concerns after percutaneous coronary intervention. The persistence of polymer material on DES has been suggested as a trigger for chronic inflammation. The Firehawk, a novel DES, has a unique design with recessed abluminal grooves, to which sirolimus and biodegradable polymer are applied. The Firehawk stent is designed to minimize polymer volume and antiproliferative drug concentration to reduce inflammation and hypersensitivity reactions. Several recent trials have reported the clinical outcomes of this device. This article provides a review of the current clinical evidence concerning the Firehawk stent.
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http://dx.doi.org/10.1097/CRD.0000000000000298DOI Listing
February 2021

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

Implications of ventricular arrhythmia "bursts" with normal epicardial flow, myocardial blush, and ST-segment recovery in anterior ST-elevation myocardial infarction reperfusion: a biosignature of direct myocellular injury "downstream of downstream".

Eur Heart J Acute Cardiovasc Care 2015 Feb 25;4(1):51-9. Epub 2014 Jul 25.

Duke Clinical Research Institute, Duke University Medical Center, USA Department of Medicine, Duke University Medical Center, USA

Aims: Establishing epicardial flow with percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) is necessary but not sufficient to ensure nutritive myocardial reperfusion. We evaluated whether adding myocardial blush grade (MBG) and quantitative reperfusion ventricular arrhythmia "bursts" (VABs) surrogates provide a more informative biosignature of optimal reperfusion in patients with Thrombolysis in Myocardial Infarction (TIMI) 3 flow and ST-segment recovery (STR).

Methods And Results: Anterior STEMI patients with final TIMI 3 flow had protocol-blinded analyses of simultaneous MBG, continuous 12-lead electrocardiogram (ECG) STR, Holter VABs, and day 5-14 SPECT imaging infarct size (IS) assessments. Over 20 million cardiac cycles from >4500 h of continuous ECG monitoring in subjects with STR were obtained. IS and clinical outcomes were examined in patients stratified by MBG and VABs. VABs occurred in 51% (79/154) of subjects. Microcirculation (MBG 2/3) was restored in 75% (115/154) of subjects, of whom 53% (61/115) had VABs. No VABs were observed in subjects without microvascular flow (MBG of 0). Of 115 patients with TIMI 3 flow, STR, and MBG 2/3, those with VABs had significantly larger IS (median: 23.0% vs 6.0%, p=0.001). Multivariable analysis identified reperfusion VABs as a factor significantly associated with larger IS (p=0.015).

Conclusions: Despite restoration of normal epicardial flow, open microcirculation, and STR, concomitant VABs are associated with larger myocardial IS, possibly reflecting myocellular injury in reperfusion settings. Combining angiographic and ECG parameters of epicardial, microvascular, and cellular response to STEMI intervention provides a more predictive "biosignature" of optimal reperfusion than do single surrogate markers.
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http://dx.doi.org/10.1177/2048872614532414DOI Listing
February 2015

Association between intraprocedural thrombotic events and adverse outcomes after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (a Harmonizing Outcomes With RevasculariZatiON and Stents in Acute Myocardial Infarction [HORIZONS-AMI] Substudy).

Am J Cardiol 2014 Jan 2;113(1):36-43. Epub 2013 Oct 2.

Department of Medicine, Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.

The present study sought to determine the extent to which adverse angiographic events encountered during percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI) are associated with adverse clinical outcomes. Patients with STEMI represent a cohort at particularly high risk of intraprocedural thrombotic events (IPTEs). The overall frequency and implications of IPTEs occurring in patients with STEMI have not been systematically quantified in previous studies. A total of 3,163 patients undergoing primary percutaneous coronary intervention with stent implantation for STEMI in the Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial underwent detailed frame-by-frame core laboratory angiographic analysis to assess IPTEs. The clinical outcomes at 30 days were compared between the patients with and without IPTEs. IPTEs, defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, and distal embolization at any point during the procedure, occurred in 386 patients (12.2%). The independent predictors of IPTE were thrombus at baseline, lesion length, and randomization to bivalirudin; the patients with IPTEs were also more likely to receive bailout glycoprotein IIb/IIIa inhibitors and unplanned thrombectomy. Compared with patients without IPTEs, the patients with IPTEs had higher 30-day rates of composite major adverse cardiovascular events (death, myocardial infarction, ischemic target vessel revascularization, and stroke; 7.8% vs 4.2%, p = 0.002), major bleeding not related to coronary artery bypass grafting (11.8% vs 6.5%, p <0.001), and all-cause death (4.2% vs 1.8%, p = 0.002). On multivariate analysis, IPTEs were independently associated with 30-day major adverse cardiovascular events, major bleeding, and death. In conclusion, the development of IPTEs in patients undergoing primary percutaneous coronary intervention for STEMI was associated with subsequent adverse outcomes, including major adverse cardiovascular events, major bleeding, and death. Additional studies of strategies to decrease the occurrence of IPTEs are warranted.
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http://dx.doi.org/10.1016/j.amjcard.2013.08.034DOI Listing
January 2014

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

Evaluation of XIENCE V everolimus-eluting and Taxus Express2 paclitaxel-eluting coronary stents in patients with jailed side branches from the SPIRIT IV trial at 2 years.

Am J Cardiol 2013 Jun 15;111(11):1580-6. Epub 2013 Mar 15.

Yale University School of Medicine, New Haven, Connecticut, USA.

The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p = 0.001), major adverse cardiac events (6.6% vs 12.2%, p = 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p = 0.004), and stent thrombosis (0.6% vs 2.8%, p = 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial.
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http://dx.doi.org/10.1016/j.amjcard.2013.01.330DOI Listing
June 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

Intra-procedural stent thrombosis: a new risk factor for adverse outcomes in patients undergoing percutaneous coronary intervention for acute coronary syndromes.

JACC Cardiovasc Interv 2013 Jan 19;6(1):36-43. Epub 2012 Dec 19.

New York Methodist Hospital, Brooklyn, New York; Cardiovascular Research Foundation, New York, NY 11215, USA.

Objectives: The aim of this study was to examine the incidence, correlates, and consequences of intra-procedural stent thrombosis (IPST) in patients with acute coronary syndromes (ACS).

Background: Stent thrombosis (ST) is a rare but serious complication of percutaneous coronary intervention (PCI). The Academic Research Consortium definition of ST excludes events occurring during PCI.

Methods: Angiograms from the ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) and HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trials were reviewed frame-by-frame at an independent core laboratory for the occurrence of IPST. Patients with versus without IPST were compared to identify baseline characteristics associated with IPST and demonstrate the independent association between IPST and adjudicated events at 30 days and 1 year.

Results: Intra-procedural ST occurred in 47 (0.7%) of 6,591 patients. The occurrence of IPST was associated with ST-segment elevation myocardial infarction presentation, high white blood cell count, treatment of thrombotic and bifurcation lesions, bivalirudin monotherapy, bail-out IIb/IIIa inhibitor use, and implantation of bare-metal (rather than drug-eluting) stents. Major adverse ischemic events were markedly higher in patients with versus without IPST, including mortality at 30 days (12.9% vs. 1.4%, p < 0.0001) and 1 year (12.9% vs. 3.1%, p < 0.0001). Out-of-lab Academic Research Consortium definite or probable ST also occurred significantly more often among IPST patients at 30 days (17.4% vs. 1.8%, p < 0.0001) and 1 year (19.9% vs. 2.7%, p < 0.0001). Intra-procedural ST was a significant independent predictor of 1-year mortality (hazard ratio: 3.86, 95% confidence interval: 1.66 to 9.00, p = 0.002).

Conclusions: Intra-procedural ST is a relatively rare complication of PCI in ACS but is strongly associated with subsequent out-of-lab ST and mortality. Intra-procedural ST should be considered as a distinct category of ST and routinely reported, particularly for ACS patients.
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http://dx.doi.org/10.1016/j.jcin.2012.08.018DOI Listing
January 2013

Long-term prognosis of patients presenting with ST-segment elevation myocardial infarction with no significant coronary artery disease (from the HORIZONS-AMI trial).

Am J Cardiol 2013 Mar 19;111(5):643-8. Epub 2012 Dec 19.

Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.

The clinical features and prognosis of patients with ST-segment elevation myocardial infarction (STEMI) and no significant coronary artery disease (CAD) have not been well studied. We examined the outcomes of patients with STEMI in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial according to the presence or absence of significant CAD. "No-CAD" was defined by the absence of any lesion with a diameter stenosis of ≥30% on quantitative coronary angiography of the baseline coronary angiogram. Of 3,602 patients, 127 (3.5%) had no-CAD. Of these, 86 (67.7%) had angiographically normal coronary arteries, and 41 (32.3%) had mild disease (diameter stenosis <30%). Eight patients had previously been treated with coronary artery bypass grafting. Compared to patients with CAD, patients with no-CAD were younger, had a lower body mass index, were more frequently black, had a lower prevalence of smoking and previous angina, and had a greater left ventricular ejection fraction. Cardiac enzymes were elevated in fewer patients with no-CAD than in those with CAD (63.2% vs 98.7%, p <0.001). At 3 years of follow-up, the patients with no-CAD versus CAD had lower rates of major adverse cardiovascular events (7.7% vs 22.2%, p = 0.002), net adverse clinical events (major adverse cardiovascular events or major bleeding not related to coronary artery bypass grafting, 12.5% vs 26.9%, p = 0.005), and postprocedure coronary revascularization (0% vs 19.5%, p <0.001). The differences in the rates of death or reinfarction, stroke, and major bleeding were not statistically significant. In conclusion, 3.5% of patients with STEMI had no significant CAD. The 3-year prognosis for these patients was favorable compared to that of patients with STEMI and with obstructive CAD.
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http://dx.doi.org/10.1016/j.amjcard.2012.11.011DOI Listing
March 2013

Age- and gender-related changes in plaque composition in patients with acute coronary syndrome: the PROSPECT study.

EuroIntervention 2012 Dec;8(8):929-38

Division of Cardiovascular Diseases, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.

Aims: Atherosclerosis accelerates with increasing age; however, young women presenting with acute coronary syndromes (ACS) have adverse outcomes compared to men despite less obstructive coronary artery disease. We sought to evaluate the in vivo plaque characteristics and composition of untreated non-culprit lesions (NCL) at two ages (<65 years old and ≥65 years old) in patients with ACS and examine the effect of sex in both groups.

Methods And Results: Untreated NCLs from 697 patients with ACS were imaged with greyscale and radiofrequency intravascular ultrasound. NCL plaque morphology, burden, composition, and major adverse cardiac events (MACE) were analysed in both age groups, and a posterior sex-based sub-analysis was performed. Plaques from patients ≥65 (n=974) vs. <65 (n=2,275) years old were longer (median 12.62 mm vs. 10.75 mm, p=0.008) and had greater plaque burden (48.2% vs. 47.5%, p=0.001), necrotic core (12.5% vs. 11.0%, p=0.001) and dense calcium (5.7% vs. 4.0%, p<0.0001). Men <65 years old also had a greater number of fibroatheromas (3.0 vs. 2.0, p=0.007) and NCLs per patient (5.0 vs. 4.0, p=0.004) with larger plaque volumes (47.7% vs. 46.8%, p=0.04), and fewer fibrotic plaques (2.2% vs. 4.4%, p=0.03) than women in the same age group. These sex differences were not observed in patients ≥65 years old. The incidence of MACE during median 3.4 year follow-up did not significantly differ according to age in this study.

Conclusions: The current study confirms in vivo that, with aging, plaque burden, necrotic core and calcium content increase significantly. Moreover, gender-specific differences in the extent and composition of coronary plaque are present in patients <65 years (but not ≥65 years) of age, which suggest differential sex-related effects on atherosclerosis development and progression.
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http://dx.doi.org/10.4244/EIJV8I8A142DOI Listing
December 2012

A new score for risk stratification of patients with acute coronary syndromes undergoing percutaneous coronary intervention: the ACUITY-PCI (Acute Catheterization and Urgent Intervention Triage Strategy-Percutaneous Coronary Intervention) risk score.

JACC Cardiovasc Interv 2012 Nov;5(11):1108-16

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

Objectives: This study sought to develop a new score specific for patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing percutaneous coronary intervention (PCI) (the ACUITY-PCI [Acute Catheterization and Urgent Intervention Triage Strategy-Percutaneous Coronary Intervention] risk score).

Background: The TIMI (Thrombolysis In Myocardial Infarction) and GRACE (Global Registry for Acute Coronary Events) risk scores are recommended for risk stratification of patients with NSTEACS. However, these scores were not optimized for patients undergoing an early invasive strategy with PCI.

Methods: The ACUITY-PCI risk score was created from data for 1,692 patients enrolled in the formal angiographic substudy of the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial by integrating clinical, angiographic, laboratory, and electrocardiographic variables selected by multivariable analysis. The score was subsequently validated in a different population of 846 patients and compared with the GRACE and TIMI risk scores, and the SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) and Clinical SYNTAX scores.

Results: Six variables (2 clinical, 1 laboratory/electrocardiographic, and 3 angiographic) were included in the ACUITY-PCI score: insulin-treated diabetes; renal insufficiency; baseline cardiac biomarker elevation or ST-segment deviation; bifurcation lesion; small vessel/diffuse coronary artery disease; and the extent of coronary artery disease. Event rates increased significantly across tertiles of ACUITY-PCI score. Compared with the other scores, the ACUITY-PCI score had the best discrimination (C-statistic), calibration (Hosmer-Lemeshow statistic), and index of separation. Moreover, the net reclassification improvement varied from 9% to 38% and the integrated discrimination index from 1.9% to 2.7%.

Conclusions: The ACUITY-PCI risk score is a new tool integrating clinical, angiographic, and laboratory/electrocardiographic variables specifically developed for patients with NSTEACS undergoing PCI. This score displayed better prognostic accuracy in terms of discrimination and calibration than other currently available scores for risk stratification of patients with NSTEACS. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158).
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http://dx.doi.org/10.1016/j.jcin.2012.07.011DOI Listing
November 2012

Does clinical presentation affect outcome among patients with acute coronary syndromes undergoing percutaneous coronary intervention? Insights from the Providing Regional Observations to Study Predictors of Events in the Coronary Tree study.

Am Heart J 2012 Oct 20;164(4):561-7. Epub 2012 Sep 20.

New York Methodist Hospital, Brooklyn, NY, USA.

Background: In some prior studies, patients with ST-elevation myocardial infarction (STEMI) as compared with patients with non-STEMI (NSTEMI) tended to have a higher early mortality but similar long-term outcomes. We compared the angiographic and intravascular ultrasound (IVUS) characteristics of patients with STEMI and NSTEMI in the PROSPECT study to evaluate the independent prognostic value of clinical presentation on long-term outcome.

Methods: After successful revascularization, patients had 3-vessel quantitative coronary angiography, gray scale, and radiofrequency intravascular ultrasound (IVUS) imaging. The primary end point was the occurrence of major adverse cardiac events (MACE) (cardiac death, myocardial infarction, or rehospitalization for unstable or progressive angina).

Results: There were 211 patients (31.6%) with STEMI and 457 (68.4%) with NSTEMI. Patients with STEMI and NSTEMI had similar angiographic and IVUS morphologic characteristics. At 3 years, MACE occurred in 22.1% and 19.6%, respectively (hazard ratio [HR] 1.16 [0.81, 1.68], P = .42). There was a higher overall mortality (HR 2.16 [0.94, 4.99], P = .06) and a significantly higher incidence of probable stent thrombosis (HR 4.34 [1.09, 17.36], P = .02) in the STEMI cohort. There were no significant differences between the 2 groups with respect to events related to culprit or to nonculprit lesions. ST-elevation myocardial infarction presentation was not an independent predictor of 3-year MACE (HR 1.14 [0.77, 1.67], P = .52).

Conclusion: Patients with STEMI and NSTEMI did not differ with respect to residual nonculprit lesion angiographic or IVUS characteristics and had similar rates of MACE at 3 years, without late "catch-up" in NSTEMI. However, probable stent thrombosis and mortality were higher in the STEMI cohort.
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http://dx.doi.org/10.1016/j.ahj.2012.07.025DOI Listing
October 2012

Operator versus core laboratory assessment of angiographic reperfusion markers in patients undergoing primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction.

Circ Cardiovasc Interv 2012 Aug 24;5(4):563-9. Epub 2012 Jul 24.

Cardiac Catheterization Laboratory, New York Methodist Hospital, 506 6th St, Brooklyn, NY 11215, USA.

Background: Thrombolysis In Myocardial Infarction (TIMI) flow and Myocardial Blush Grade (MBG) are important prognostic indicators before and after primary percutaneous coronary intervention (PCI) in ST-segment-elevation myocardial infarction; however, the concordance and relative prognostic utility of operator (Op) versus angiography core laboratory (ACL) assessed TIMI flow and MBG are unknown.

Methods And Results: Baseline and final Op and ACL TIMI flow and MBG assessment were compared from the Harmonizing Outcomes with RevascularIZatiON and Stents in AMI trial in 3345 patients undergoing primary PCI using Cohen's κ coefficient. κ Was highest for pre-PCI TIMI flow (0.51, representing moderate agreement) and lowest for post-PCI MBG (0.20, representing fair agreement). Discordance between Op and ACL for final TIMI flow (0 to 2 versus 3) occurred in 12.9% of patients and for final MBG (0 to 1 versus 2 to 3) in 22.4%. Among 415 patients with final TIMI flow 0 to 2 by ACL, Op scoring was TIMI flow 3 in 267 (64.3%). Similarly, among 706 patients with final MBG 0 to 1 by ACL, 563 (79.7%) were classified as MBG 2 to 3 by Op. Post-PCI TIMI 3 flow and MBG 2 to 3 strongly correlated with 3-year survival, as assessed by both Op and ACL (P<0.0001). Mortality was intermediate in patients in whom ACL and Op were discordant, without marked prognostic differences between the discordant groups.

Conclusions: Op and ACL assessment of angiographic markers of reperfusion in ST-segment-elevation myocardial infarction demonstrates fair to moderate agreement. Op tended to favorably grade unfavorable ACL results. Nonetheless, both Op and ACL assessment of reperfusion strongly inform prediction of 3-year mortality.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.112.969022DOI Listing
August 2012

Intraprocedural thrombotic events during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes are associated with adverse outcomes: analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial.

J Am Coll Cardiol 2012 May;59(20):1745-51

Columbia University Medical Center/New York Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York 10022, USA.

Objectives: The purpose of this study was to assess the prognostic impact of intraprocedural thrombotic events (IPTE) during percutaneous coronary intervention (PCI).

Background: Ischemic complications of PCI are infrequent but prognostically important. How often these events are a consequence of intraprocedural complications is unknown, with only limited data assessing the occurrence and importance of IPTE.

Methods: A total of 3,428 patients who underwent PCI for non-ST-segment elevation acute coronary syndrome in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial underwent detailed frame-by-frame core laboratory angiographic analysis. An IPTE, defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, or distal embolization at any time during the procedure, occurred in 121 patients (3.5%).

Results: Patients with IPTE had higher in-hospital, 30-day, and 1-year major adverse cardiac event rates than patients without IPTE (25.6% vs. 6.3% in-hospital, 30.6% vs. 9.3% at 30 days, and 37.0% vs. 20.5% at 1 year; p < 0.0001 for each). An IPTE was strongly associated with Q-wave myocardial infarction and out-of-laboratory definite/probable stent thrombosis (in-hospital 3.3% vs. 0.5%, p = 0.006; 30 days 5.8% vs. 1.3%, p < 0.0001; and 1 year 6.7% vs. 2.0%, p = 0.0002). Unplanned revascularization, target vessel revascularization, and major bleeding not associated with coronary artery bypass graft surgery were also increased among patients with IPTE, as was overall 30-day mortality (3.3% vs. 0.7%, p = 0.002). Moreover, IPTE was an independent predictor of 30-day and 1-year composite death/myocardial infarction, stent thrombosis, and major adverse cardiac events.

Conclusions: Although infrequent among patients undergoing early PCI for moderate and high-risk non-ST-segment elevation acute coronary syndrome, IPTE was strongly associated with subsequent adverse outcomes including death, myocardial infarction, and stent thrombosis.
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http://dx.doi.org/10.1016/j.jacc.2012.02.019DOI Listing
May 2012

Impact of the presence and extent of incomplete angiographic revascularization after percutaneous coronary intervention in acute coronary syndromes: the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial.

Circulation 2012 May 1;125(21):2613-20. Epub 2012 May 1.

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

Background: The clinical significance of incomplete coronary revascularization (ICR) after percutaneous coronary intervention in patients with acute coronary syndromes is unknown.

Methods And Results: We performed quantitative angiography of the entire coronary tree in 2954 patients with acute coronary syndromes in the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. ICR was variably defined if any lesion with diameter stenosis (DS) cutoffs ranging from ≥30% to ≥70% with reference vessel diameter ≥2.0 mm remained after percutaneous coronary intervention. The primary outcome was 1-year composite rate of major adverse cardiac events (death, myocardial infarction, or ischemia-driven unplanned revascularization). With the use of DS cutoffs ≥30%, ≥40%, ≥50%, ≥60%, and ≥70%, the prevalence of ICR after percutaneous coronary intervention was 75%, 55%, 37%, 25%, and 17%, respectively. The 1-year major adverse cardiac event rate was increased among patients with ICR using all of the DS cutoffs. ICR (≥50% DS) was associated with higher 1-year rates of myocardial infarction (12.0% versus 8.2%; hazard ratio, 1.50; 95% confidence interval, 1.18-1.89; P=0.0007) and ischemia-driven unplanned revascularization (15.7% versus 10.2%; hazard ratio, 1.58; 95% confidence interval, 1.28-1.96; P<0.0001), with a trend toward increased mortality (3.1% versus 2.2%; hazard ratio, 1.43; 95% confidence interval, 0.90-2.27; P=0.13). By multivariable analysis, ICR (≥50% DS) was an independent predictor of 1-year major adverse cardiac events (hazard ratio, 1.36; 95% confidence interval, 1.12-1.64; P=0.002). The impact of ICR on major adverse cardiac events was similar regardless of chronic total occlusion presence, but it was more pronounced with a greater number of nonrevascularized lesions.

Conclusions: Depending on the threshold of percent DS, ICR was present in 17% to 75% of patients with acute coronary syndromes after percutaneous coronary intervention. Regardless of the threshold, ICR was strongly associated with 1-year myocardial infarction, ischemia-driven unplanned revascularization, and major adverse cardiac events.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00093158.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.111.069237DOI Listing
May 2012

Implications of pre-procedural TIMI flow in patients with non ST-segment elevation acute coronary syndromes undergoing percutaneous coronary revascularization: insights from the ACUITY trial.

Int J Cardiol 2013 Aug 30;167(3):727-32. Epub 2012 Mar 30.

Division of Cardiology, Eastern Piedmont University, Novara, Italy.

Objectives: The purpose of this study was to evaluate the prognostic implications of preprocedural TIMI flow in ACS patients undergoing early invasive management.

Background: Although the negative prognostic impact of reduced Thrombolysis in Myocardial Infarction (TIMI) flow before percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) has been well described, whether this relationship holds in patients with acute coronary syndromes (ACS; unstable angina and non-STEMI) has not been examined.

Methods: We evaluated 3582 moderate and high-risk patients with ACS undergoing PCI enrolled in the ACUITY trial. Patients were divided in 3 groups according to pre-procedural culprit vessel TIMI flow (TIMI 0/1, TIMI 2 and TIMI 3 flows), determined by an independent angiographic core laboratory.

Results: Baseline culprit vessel flow was absent (TIMI 0/1) in 453 patients (12.6%), reduced (TIMI 2) in 389 patients (10.9%) and normal (TIMI 3) in 2740 patients (76.5%) patients. Post-PCI TIMI 3 flow was achieved in 87.2%, 86.8% and 98.8% of the 3 groups, respectively (P<0.0001). At 1 year, mortality occurred in 2.7%, 2.4% and 3.0% of patients with baseline TIMI 0/1, 2 and 3 flows, respectively (P=0.82). By multivariable analysis, pre-PCI TIMI flow 0/1 (vs. TIMI 3) was not an independent predictor of 1-year mortality (P=0.61).

Conclusions: Reduced baseline TIMI flow in moderate and high-risk patients with ACS undergoing PCI does not appear to affect survival at 1 year, in contrast to that described in patients with STEMI.
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http://dx.doi.org/10.1016/j.ijcard.2012.03.058DOI Listing
August 2013

Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial.

JAMA 2012 May 25;307(17):1817-26. Epub 2012 Mar 25.

Columbia University Medical Center and New York–Presbyterian Hospital, New York, New York 10022, USA.

Context: Thrombus embolization during percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) is common and results in suboptimal myocardial perfusion and increased infarct size. Two strategies proposed to reduce distal embolization and improve outcomes after primary PCI are bolus intracoronary abciximab and manual aspiration thrombectomy.

Objective: To determine whether bolus intracoronary abciximab, manual aspiration thrombectomy, or both reduce infarct size in high-risk patients with STEMI.

Design, Setting, And Patients: Between November 28, 2009, and December 2, 2011, 452 patients presenting at 37 sites in 6 countries within 4 hours of STEMI due to proximal or mid left anterior descending artery occlusion undergoing primary PCI with bivalirudin anticoagulation were randomized in an open-label, 2 x 2 factorial design to bolus intracoronary abciximab delivered locally at the infarct lesion site vs no abciximab and to manual aspiration thrombectomy vs no thrombectomy.

Interventions: A 0.25-mg/kg bolus of abciximab was administered at the site of the infarct lesion via a local drug delivery catheter. Manual aspiration thrombectomy was performed with a 6 F aspiration catheter.

Main Outcome Measures: Primary end point: infarct size (percentage of total left ventricular mass) at 30 days assessed by cardiac magnetic resonance imaging (cMRI) in the abciximab vs no abciximab groups (pooled across the aspiration randomization); major secondary end point: 30-day infarct size in the aspiration vs no aspiration groups (pooled across the abciximab randomization).

Results: Evaluable cMRI results at 30 days were present in 181 and 172 patients randomized to intracoronary abciximab vs no abciximab, respectively, and in 174 and 179 patients randomized to manual aspiration vs no aspiration, respectively. Patients randomized to intracoronary abciximab compared with no abciximab had a significant reduction in 30-day infarct size (median, 15.1%; interquartile range [IQR], 6.8%-22.7%; n = 181, vs 17.9% [IQR, 10.3%-25.4%]; n = 172; P = .03). Patients randomized to intracoronary abciximab also had a significant reduction in absolute infarct mass (median, 18.7 g [IQR, 7.4-31.3 g]; n = 184, vs 24.0 g [IQR, 12.1-34.2 g]; n = 175; P = .03) but not abnormal wall motion score (median, 7.0 [IQR, 2.0-10.0]; n = 188, vs 8.0 [IQR, 3.0-10.0]; n = 184; P = .08). Patients randomized to aspiration thrombectomy vs no aspiration had no significant difference in infarct size at 30 days (median, 17.0% [IQR, 9.0%-22.8%]; n = 174, vs 17.3% [IQR, 7.1%-25.5%]; n = 179; P = .51), absolute infarct mass (median, 20.3 g [IQR, 9.7-31.7 g]; n = 178, vs 21.0 g [IQR, 9.1-34.1 g]; n = 181; P = .36), or abnormal wall motion score (median, 7.5 [IQR, 2.0-10.0]; n = 186, vs 7.5 [IQR, 2.0-10.0]; n = 186; P = .89).

Conclusion: In patients with large anterior STEMI presenting early after symptom onset and undergoing primary PCI with bivalirudin anticoagulation, infarct size at 30 days was significantly reduced by bolus intracoronary abciximab delivered to the infarct lesion site but not by manual aspiration thrombectomy.

Trial Registration: clinicaltrials.gov Identifier: NCT00976521.
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http://dx.doi.org/10.1001/jama.2012.421DOI Listing
May 2012

Long-term follow-up of attenuated plaques in patients with acute myocardial infarction: an intravascular ultrasound substudy of the HORIZONS-AMI trial.

Circ Cardiovasc Interv 2012 Apr 20;5(2):185-92. Epub 2012 Mar 20.

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

Background: Intravascular ultrasound (IVUS)-attenuated plaque is characterized by absence of ultrasound signal behind hypoehcoic plaque and is seen almost exclusively in acute coronary syndromes.

Methods And Results: We analyzed poststenting and 13-month follow-up IVUS in 186 patients (195 lesions) with acute myocardial infarction who underwent primary percutaneous coronary intervention. The primary prespecified IVUS end point was the in-stent percent net volume obstruction at follow-up. Overall, 70.3% of lesions contained attenuated plaques at baseline. During follow-up, attenuation scores decreased significantly, behind paclitaxel-eluting stents (PES) (14.1 [11.9, 16.3] to 7.7 [5.4, 9.9], P<0.0001), behind bare metal stents (BMS) (18.5 [13.2, 23.8] to 12.0 [6.7, 17.3], P<0.0001), and within distal references (3.1 [1.1, 5.1] to 2.2 [0.2, 4.1], P=0.02). There was a greater calcium increase in attenuated than nonattenuated plaques in both PES (Δcalcium score of 4.4 [3.3, 5.5] versus 1.6 [0.9, 2.3], P<0.0001) and BMS (Δcalcium score of 4.1[2.3, 5.9] versus 1.0 [0.3, 1.7], P=0.001). PES implantation into attenuated plaques was particularly associated with late acquired stent malapposition (36.8% versus 15.4% compared with nonattenuated plaques treated with PES, P=0.03). Changes in attenuation scores correlated with changes in calcium scores both in PES (Pearson correlation coefficient=-0.456, P<0.0001] and BMS sites (Pearson correlation coefficient=-0.450, P=0.0006). In 3 years of follow-up, target lesion revascularization was significantly less in patients with attenuated plaque at baseline (6.0% versus 17.4% in patient without attenuated plaques, P=0.019).

Conclusions: Attenuated plaques evolved into calcified plaques after stent implantation. Attenuated plaque is associated with late acquired stent malapposition and related less target lesion revascularization (consistent with less neointimal hyperplasia), especially after PES implantation in patients with acute myocardial infarction.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.111.964684DOI Listing
April 2012

Adverse cardiovascular events arising from atherosclerotic lesions with and without angiographic disease progression.

JACC Cardiovasc Imaging 2012 Mar;5(3 Suppl):S95-S105

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

Objectives: The aim of this study was to use angiography and grayscale and intravascular ultrasound-virtual histology to assess coronary lesions that caused events during a median follow-up period of 3.4 years.

Background: Vulnerable plaque-related events are assumed to be the result of substantial progression of insignificant lesions.

Methods: In the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study, 697 patients with acute coronary syndromes underwent treatment of all culprit lesions followed by 3-vessel imaging to assess the natural history of culprit and untreated nonculprit (NC) lesions. Future adverse cardiovascular events adjudicated to NC lesions were divided into those with versus without substantial lesion progression (SLP) (≥ 20% angiographic diameter stenosis increase).

Results: NC lesion events occurred in 72 patients, 44 (61%) with and 28 (39%) without SLP. Myocardial infarctions (n = 6) occurred only in patients with SLP. Conversely, patients without SLP presented only with unstable or increasing angina requiring rehospitalization. Lesions with versus without SLP occurred later (median time to event 401 vs. 223 days, p = 0.07); were less severe at baseline (median diameter stenosis 26.4% vs. 53.8%, p < 0.0001) but more severe at the time of the event (mean diameter stenosis 73.8% vs. 56%, p < 0.0001); and had comparable baseline median plaque burden (68.7% vs. 70.1%, p = 0.17), minimum luminal area (3.7 vs. 4.0 mm(2), p = 0.60), and intravascular ultrasound-virtual histology phenotype (83.3% vs. 90.9%, p = 0.68; classified as fibroatheromas at baseline).

Conclusions: NC lesions responsible for future cardiovascular events showed angiographic increase during 3.4 years of follow-up, whereas SLP underlay many but not all of them. NC events due to lesions with SLP were angiographically less severe and presented with a delayed time course but were otherwise indistinguishable from NC events that were not associated with SLP.
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http://dx.doi.org/10.1016/j.jcmg.2011.08.024DOI Listing
March 2012

Characteristics and clinical significance of angiographically mild lesions in acute coronary syndromes.

JACC Cardiovasc Imaging 2012 Mar;5(3 Suppl):S86-94

New York Methodist Hospital, Brooklyn, New York 11215, USA.

Objectives: The aim of this study was to assess whether residual nonculprit (NC) lesions, defined as visual diameter stenosis ≥ 30% after successful percutaneous coronary intervention, affect the rate of future events in patients with acute coronary syndromes.

Background: In patients with acute coronary syndromes, approximately one-half of recurrent events after percutaneous coronary intervention arise from untreated lesions.

Methods: Patients enrolled in PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) were divided into 3 groups: those with no NC lesions, 1 NC lesion, or ≥ 2 NC lesions. Time to events for major adverse cardiac events was estimated up to 3 years.

Results: Among 697 patients, 13.3% had no NC lesions, 19.7% had 1 NC lesion, and 67.0% had ≥ 2 NC lesions. The median diameter stenoses of the NC lesions in the latter 2 groups were 36.7% (interquartile range: 31.0% to 43.4%) and 37.4% (interquartile range: 32.0% to 46.5%), respectively (p = 0.22). At least 1 thin-cap fibroatheroma was present in one-half the patients in each group. At 3 years, the incidence of major adverse cardiac events was 8.5%, 15.2%, and 24.3%, respectively (p = 0.0009). NC lesion-related events occurred in 0%, 5.0%, and 15.9% of patients, respectively (p < 0.0001). Of 105 NC lesion-related clinical events occurring during follow-up, 73 (69.5%) originated from angiographically evident baseline NC lesions (of which 36 had diameter stenosis >50%), while the other 32 arose from normal or near normal segments.

Conclusions: Residual NC lesions are common after percutaneous coronary intervention for acute coronary syndromes and portend a higher rate of recurrent ischemic events within 3 years, especially when angiographically more severe. Conversely, the absence of NC lesions by angiography is highly predictive of freedom from events not related to the originally treated culprit lesion(s).
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http://dx.doi.org/10.1016/j.jcmg.2011.12.007DOI Listing
March 2012

Residual plaque burden in patients with acute coronary syndromes after successful percutaneous coronary intervention.

JACC Cardiovasc Imaging 2012 Mar;5(3 Suppl):S76-85

Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Objectives: The aim of this study was to characterize and evaluate the clinical impact of untreated atherosclerotic disease after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS).

Background: Residual atherosclerotic disease after successful PCI may predispose future major adverse cardiovascular events (MACE). Compared with intravascular ultrasound (IVUS), angiography underestimates the presence and severity of coronary artery disease.

Methods: Following successful PCI of all clinically significant lesions in 697 patients with ACS, 3-vessel grayscale and radiofrequency IVUS was performed. Lesions were prospectively characterized, and patients were followed for a median of 3.4 years. A total of 3,229 untreated lesions (4.89 ± 1.98 lesions/patient) were identified by IVUS, with mean plaque burden (PB) of 49.6 ± 4.2%.

Results: By angiography these nonculprit lesions were mild, with mean diameter stenosis of 38.9 ± 15.3%. At least 1 lesion with a PB ≥70% (PB70 lesion) was found in 220 (33%) patients. By multivariable analysis, a history of prior PCI and angiographic 3-vessel disease were independent predictors of PB70 lesions. Patients with PB70 lesions had greater total percent plaque volume, normalized PB, fibroatheromas, thin-cap fibroatheromas, and normalized volumes of necrotic core and dense calcium. Patients with PB70 lesions had greater 3-year rates of MACE due to untreated nonculprit lesions (20.8% vs. 7.7%, p < 0.0001). Among imaged nonculprit lesions, the proportion of PB70 lesions causing MACE was significantly greater than non-PB70 lesions (8.7% vs. 1.0%, p < 0.0001).

Conclusions: After successful PCI of all angiographically significant lesions, overall untreated atherosclerotic burden remains high, and PB70 lesions are frequently present in the proximal and mid-coronary tree. Patients with PB70 lesions have greater atherosclerosis throughout the coronary tree, have more thin-cap fibroatheromas, and are at increased risk for future cardiovascular events. (

Prospect: An Imaging Study in Patients With Unstable Atherosclerotic Lesions; NCT00180466).
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http://dx.doi.org/10.1016/j.jcmg.2012.01.005DOI Listing
March 2012

Coronary plaque composition, morphology, and outcomes in patients with and without chronic kidney disease presenting with acute coronary syndromes.

JACC Cardiovasc Imaging 2012 Mar;5(3 Suppl):S53-61

Mount Sinai Medical Center, New York, New York, USA.

Objectives: This study sought to evaluate the impact of chronic kidney disease (CKD) on coronary atherosclerotic plaque composition, morphology, and outcomes in patients with acute coronary syndromes (ACS).

Background: CKD patients presenting with ACS are at increased risk for adverse events. Whether or not this increased risk reflects differences in coronary plaque composition remains unknown.

Methods: In the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study, patients presenting with ACS in whom percutaneous coronary intervention was successful underwent 3-vessel grayscale and radiofrequency intravascular ultrasound imaging. Lesions were prospectively characterized, and patients were followed for a median of 3.4 years. We conducted a patient-level and lesion-level analysis of study participants by comparing intravascular ultrasound parameters of untreated nonculprit lesions in patients with and without CKD.

Results: Patients with CKD (n = 73, 11.3%) were older, more often female and diabetic compared to those without CKD (n = 573). Nonculprit lesions in patients with (n = 280) versus without (n = 2,390) CKD were more likely to have plaque burden ≥ 70% (11.8% vs. 8.5%, p = 0.05) and minimal luminal area ≤ 4.0 mm(2) (25.9% vs. 19.2%, p = 0.005). The percentage of plaque comprised of necrotic core (15.0% vs. 13.0%, p = 0.0001) and dense calcium (8.2% vs. 6.4%, p < 0.0001) was higher while fibrous tissue (57.7% vs. 59.8%, p < 0.0001) was lower in CKD versus non-CKD lesions. The 3-year composite rate of cardiac death, cardiac arrest, or myocardial infarction (15.1% vs. 3.3%, p < 0.0001) was significantly higher in patients with than in those without CKD, although there were no differences in the rates of events adjudicated to nonculprit lesions.

Conclusions: Following percutaneous coronary intervention of all culprit lesions in ACS, patients with versus without CKD have more extensive and severe atherosclerosis remaining in their coronary tree with plaque composed of greater necrotic core and less fibrous tissue. These influences resulted in nonsignificantly different rates of non-culprit lesion-related adverse events, although cardiac death, arrest, or myocardial infarction were more common in patients with CKD.
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http://dx.doi.org/10.1016/j.jcmg.2011.12.008DOI Listing
March 2012

Definitions and methodology for the grayscale and radiofrequency intravascular ultrasound and coronary angiographic analyses.

JACC Cardiovasc Imaging 2012 Mar;5(3 Suppl):S1-9

Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York 10022, USA.

Objectives: In a prospective study of the natural history of coronary atherosclerosis using angiography and grayscale and radiofrequency intravascular ultrasound (IVUS)-virtual histology (VH), larger plaque burden, smaller luminal area, and plaque composition thin-cap fibroatheroma emerged as independent predictors of future adverse cardiovascular events.

Background: The methodology for IVUS-VH classification for an in vivo natural history study and the prospective image mapping by angiography and grayscale and IVUS-VH have not been established.

Methods: All culprit and nonculprit lesions (defined as ≥ 30% angiographic visual diameter stenoses) were analyzed. Three epicardial vessels as well as all ≥ 1.5-mm-diameter side branches were divided into 29 CASS (Coronary Artery Surgery Study) segments. Each CASS segment was then subdivided into 1.5-mm-long subsegments, and dimensions were analyzed. All grayscale and IVUS-VH slices from the proximal 6 to 8 cm of the 3 coronary arteries were analyzed, with lesions defined as having more than 3 consecutive slices with ≥ 40% plaque burden categorized as: 1) VH thin-cap fibroatheroma; 2) thick-cap fibroatheroma; 3) pathological intimal thickening; 4) fibrotic plaque; or 5) fibrocalcific plaque. The locations of angiographic and grayscale and IVUS-VH lesions were recorded in relation to the corresponding coronary artery ostium and nearby side branches.

Results: The 3-year cumulative rate of major adverse cardiovascular events was 20.4%. Events were adjudicated to culprit lesions in 12.9% of patients and to nonculprit lesions in 11.6%. On multivariate analysis, nonculprit lesions associated with recurrent events were characterized by a plaque burden ≥ 70% (hazard ratio: 5.03; 95% confidence interval: 2.51 to 10.11; p < 0.0001), a minimal luminal area ≤ 4.0 mm(2) (hazard ratio: 3.21; 95% confidence interval: 1.61 to 6.42; p = 0.001), and IVUS-VH phenotype of a thin-cap fibroatheroma (hazard ratio: 3.35; 95% confidence interval: 1.77 to 6.36; p < 0.001).

Conclusions: Three-vessel multimodality coronary artery imaging was feasible and allowed the identification of lesion-level predictors for future events in this natural history study.
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http://dx.doi.org/10.1016/j.jcmg.2011.11.019DOI Listing
March 2012

Comparison of clinical and angiographic prognostic risk scores in patients with acute coronary syndromes: Analysis from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial.

Am Heart J 2012 Mar;163(3):383-91, 391.e1-5

Istituto di Cardiologia, Policlinico S. Orsola, Bologna, Italy.

Background: Several prognostic risk scores have been developed for patients with coronary artery disease, but their comparative use in patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing percutaneous coronary intervention (PCI) has not been examined. We therefore investigated the accuracy of the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score, Clinical Synergy Between PCI With Taxus and Cardiac Surgery score (CSS), New Risk Stratification (NERS) score (NERS), Age, Creatinine, Ejection Fraction (ACEF) score, Global Registry for Acute Coronary Events (GRACE) score, and Thrombolysis in Myocardial Infarction (TIMI) score for risk assessment of 1-year mortality, cardiac mortality, myocardial infarction, target vessel revascularization, and stent thrombosis in patients with NSTEACS undergoing PCI.

Methods: The 6 scores were determined in 2,094 patients with NSTEACS treated with PCI enrolled in the angiographic substudy of the ACUITY trial. The prognostic accuracy of the 6 scores was assessed using the c statistic for discrimination and the Hosmer-Lemeshow test for calibration. The index of separation and net reclassification improvement (NRI) were also determined.

Results: Scores incorporating clinical and angiographic variables (CSS and NERS) showed the best tradeoff between discrimination and calibration for most end points, with the best discrimination for all end points and good calibration for most of them. The CSS had the best index of separation for most ischemic endpoints and displayed an NRI for cardiac death and myocardial infarction (MI) compared to the other scores, whereas NERS displayed an NRI for all-cause death and target vessel revascularization. The 3 scores-CSS, NERS, and SYNTAX-were the only scores to have both good discrimination and calibration for cardiac mortality.

Conclusions: In patients with NSTEACS undergoing PCI, risk scores incorporating clinical and angiographic variables had the highest predictive accuracy for a broad spectrum of ischemic end points.
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http://dx.doi.org/10.1016/j.ahj.2011.11.010DOI Listing
March 2012

Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial.

J Endovasc Ther 2012 Feb;19(1):1-9

UC Davis Health System, Sacramento, California 95817, USA.

Purpose: To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty.

Methods: Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment.

Results: The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented.

Conclusion: In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.
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http://dx.doi.org/10.1583/11-3627.1DOI Listing
February 2012

Diabetes mellitus, myocardial reperfusion, and outcome in patients with acute ST-elevation myocardial infarction treated with primary angioplasty (from HORIZONS AMI).

Am J Cardiol 2012 Apr 13;109(8):1111-6. Epub 2012 Jan 13.

New York Methodist Hospital, Brooklyn, USA.

Diabetes mellitus (DM) increases mortality in acute ST-segment elevation myocardial infarction (STEMI) but the responsible mechanism is not fully elucidated. We compared the rate of successful myocardial reperfusion measured by tissue myocardial perfusion grade (TMPG) and outcomes in patients with and without DM undergoing primary percutaneous coronary intervention (PCI) for STEMI. Patients enrolled in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS AMI) trial were analyzed according to presence of DM with respect to TMPG after PCI and outcomes at 30 days and 3 years. Multivariable logistic regression was performed to identify the independent contribution to mortality of DM and TMPG and the interaction between the 2 was assessed. Complete data were available for 3,265 patients, of whom 533 (16.3%) had DM. Diabetic patients were significantly older and heavier and had more risk factors for coronary disease and more previous MI, revascularization, and heart failure. There were no differences in rates of Thrombolysis In Myocardial Infarction grade 3 flow after PCI in the infarct artery or TMPG 2/3 between patients with and without DM. Compared to nondiabetics, mortality was significantly higher at 30 days and at 3 years in the DM group (1.8% vs 4.5%, p = 0.0002 and 5.4% vs 11.0%, p <0.0001, respectively). DM and TMPG were significantly associated with 3-year mortality, but there was no statistical interaction between DM and TMPG (p = 0.70). In conclusion, DM is associated with a significantly higher risk of death but this association is not mediated by impaired epicardial or myocardial reperfusion.
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http://dx.doi.org/10.1016/j.amjcard.2011.11.046DOI Listing
April 2012

Effect of bivalirudin compared with unfractionated heparin plus abciximab on infarct size and myocardial recovery after primary percutaneous coronary intervention: the horizons-AMI CMRI substudy.

Catheter Cardiovasc Interv 2012 Jun 7;79(7):1083-9. Epub 2011 Dec 7.

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

Background: Myocardial infarct size is a strong independent predictor of mortality in patients with ST-elevation myocardial infarction (STEMI). In the Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor reduced cardiac mortality in STEMI patients, which was attributed to reduced major bleeding. Whether a possible reduction in infarct size with bivalirudin may have contributed to the enhanced survival with this agent is unknown.

Methods: Cardiac magnetic resonance imaging was performed within 7 days and after 6 months in 51 randomized patients from a single center in HORIZONS-AMI trial (N = 28 bivalirudin, N = 23 heparin plus abciximab). Infarct size, microvascular obstruction (MVO), left ventricular ejection fraction (LVEF), and LV end-diastolic and end-systolic volume indices were evaluated.

Results: Infarct size was not significantly different after treatment with bivalirudin compared with heparin plus abciximab either within 7 days (median 9.3% [interquartile range 4.9%, 26.6%] vs. 20.0% [5.9%, 28.2%], P = 0.28) or at 6 months 6.7% [3.8%, 20.0%] vs. 8.2% [1.8%, 16.5%], P = 0.73). MVO was present in 28.6% versus 34.8% of patients respectively (P = 0.63). LVEF and LV volume indices also did not significantly differ between the two groups at either time period, nor were differences in myocardial recovery evident.

Conclusions: In conclusion, in the HORIZONS-AMI Cardiac magnetic resonance imaging (CMRI) substudy, cardiac magnetic resonance imaging within 7 days and at 6 months after primary percutaneous coronary intervention (PCI) did not demonstrate significant differences in infarct size, MVO, LVEF, or LV volume indices in patients treated with bivalirudin compared with unfractionated heparin plus abciximab.
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http://dx.doi.org/10.1002/ccd.23179DOI Listing
June 2012

Relationship between angiographic dynamic and densitometric assessment of myocardial reperfusion and survival in patients with acute myocardial infarction treated with primary percutaneous coronary intervention: the harmonizing outcomes with revascularization and stents in AMI (HORIZONS-AMI) trial.

Am Heart J 2011 Dec 25;162(6):1044-51. Epub 2011 Oct 25.

NY Methodist Hospital, Brooklyn, NY, USA.

Objectives: We evaluated 2 different methods of assessing tissue myocardial perfusion (TMP) and its impact on long-term mortality in patients with ST-segment elevation myocardial infarction (STEMI).

Background: Although primary percutaneous coronary intervention restores brisk epicardial flow in approximately 90% of patients with STEMI, normal TMP is less commonly achieved. Tissue myocardial perfusion has been shown to correlate mostly with early clinical outcomes.

Methods: We analyzed the outcomes of 3,267 patients in the HORIZONS-AMI study according to final TMP, assessed by angiographic dynamic (Dyn) and densitometric (Den) methods. Multivariable analysis was performed to identify the independent influence of TMP grade 2/3 on late survival.

Results: Dyn TMP 2/3 was achieved in 2,600 patients (79.6%), whereas Den TMP 2/3 was achieved in 2,483 (76.0%). Mortality was significantly lower in those with Dyn TMP 2/3 compared with TMP 0/1 at 30 days (1.1% vs 6.9%, P < .0001) and at 3 years (5.1% vs 11.2%, P < .0001). Similar results were obtained with Den TMP. Dyn TMP 2/3 was an independent predictor of mortality at both time points (HR 0.21, 95% CI 0.12-0.37, P < .0001 and HR 0.53, 95% CI 0.38-0.73, P < .0001, respectively), as was Den TMP. Survival was comparable in patients with TMP 2 and TMP 3.

Conclusions: Angiographic TMP can be assessed reliably using either Dyn or Den methods and is a powerful, independent predictor of early and late mortality after primary percutaneous coronary intervention in STEMI.
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http://dx.doi.org/10.1016/j.ahj.2011.08.022DOI Listing
December 2011

Usefulness of minimum stent cross sectional area as a predictor of angiographic restenosis after primary percutaneous coronary intervention in acute myocardial infarction (from the HORIZONS-AMI Trial IVUS substudy).

Am J Cardiol 2012 Feb 24;109(4):455-60. Epub 2011 Nov 24.

Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York, USA.

HORIZONS-AMI was a prospective dual-arm randomized trial of different antithrombotic regimens and stent types in patients with ST-segment elevation myocardial infarction. A formal intravascular ultrasound (IVUS) substudy enrolled 464 patients with baseline and 13-month follow-up at 36 centers. Of them, 318 patients with 355 lesions were evaluated for this study. Angiographic restenosis occurred in 45 of 355 lesions (12.7%). Bare-metal stent use (45.5% vs 21.2%, p <0.001) and diabetes mellitus (29.5% vs 10.9%, p <0.001) were more prevalent in patients with versus without restenosis. Postprocedure IVUS minimum lumen area (5.6 mm(2), 5.0 to 6.1, vs 6.7 mm(2), 6.5 to 6.9, p <0.001), minimum stent area (5.7 mm(2), 5.1 to 6.3, vs 6.9 mm(2), 6.6 to 7.1, p <0.001), and reference average lumen area (7.7 mm(2), 6.8 to 8.6, vs 9.7 mm(2), 9.3 to 10.1, p <0.001) were smaller in restenotic versus nonrestenotic lesions. By multivariable analysis, minimum stent area was an independent predictor of angiographic restenosis (odds ratio 0.75, 95% confidence interval 0.61 to 0.93, p = 0.009) in addition to diabetes, bare-metal stent use, and longer stent length. Attenuated plaque behind the stent struts had a trend to predict less binary restenosis (p = 0.07). In conclusion, a smaller IVUS minimum stent area was an independent predictor of angiographic restenosis after primary percutaneous intervention in patients with ST-segment elevation myocardial infarction, similar to patients with stable coronary artery disease.
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http://dx.doi.org/10.1016/j.amjcard.2011.10.005DOI Listing
February 2012