Publications by authors named "Stephen G Ellis"

290 Publications

Bioabsorbable coronary stents - should they be buried?

Authors:
Stephen G Ellis

EuroIntervention 2022 03;17(16):1286-1287

Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA.

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http://dx.doi.org/10.4244/EIJ-E-21-00012DOI Listing
March 2022

A Validated Model to Identify Patients With Low Likelihood of High-Risk Coronary Artery Disease Anatomy.

Am J Cardiol 2022 03 11;167:27-34. Epub 2022 Jan 11.

Department of Medicine, Cleveland Clinic Foundation, Cleveland, Ohio; Center for Value-Based Care Research, Cleveland Clinic, Cleveland, Ohio. Electronic address:

In stable coronary artery disease (CAD), revascularization improves outcomes only for patients with high-risk coronary anatomy (HRCA). We sought to derive and validate a prediction model, incorporating clinical and exercise stress test characteristics, to identify patients with HRCA. We conducted a retrospective analysis of patients undergoing exercise stress testing at Cleveland Clinic (2005 to 2014), followed by invasive coronary angiography within 3 months. We excluded patients with acute coronary syndrome, known CAD or ejection fraction <50%. HRCA was defined as left main, 3-vessel, or 2-vessel disease involving the proximal left anterior descending artery. Clinical and stress test predictors of HRCA were identified in a multivariable logistic regression model, internally validated with 1,000-fold bootstrapping. The model was then externally validated at the University of Pittsburgh Medical Center (2017 to 2019). The model was derived from 2,758 patients with complete data. HRCA was identified in 418 patients (15.2%) in the derivation cohort. The model consisted of 10 variables: age, male gender, hypertension, hypercholesterolemia, diabetes mellitus, family history of premature CAD, high-density lipoprotein, chest pain, exercise time, and Duke Treadmill Score. Bias-corrected c-statistic was 0.79 (95% confidence interval 0.77 to 0.81) with excellent calibration. In all, 762 patients (27.6%) had a predicted probability and observed prevalence of HRCA <5%. In the validation cohort, the model had a c-statistic of 0.79 (95% confidence interval 0.74 to 0.85) and 210 patients had an observed prevalence of HRCA <5% (40%). In conclusion, an externally validated prediction model, based on clinical characteristics and exercise stress test variables, can identify stable patients with CAD who have HRCA.
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http://dx.doi.org/10.1016/j.amjcard.2021.11.037DOI Listing
March 2022

Prognostic implications and outcomes of cardiac arrest among contemporary patients with STEMI treated with PCI.

Resusc Plus 2021 Sep 15;7:100149. Epub 2021 Jul 15.

Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, OH United States.

Background: Cardiac arrest (CA) complicating ST-elevation myocardial infarction (STEMI) is associated with a disproportionately higher risk of mortality. We described the contemporary presentation, management, and outcomes of CA patients in the era of primary percutaneous coronary intervention (PCI).

Methods: We reviewed 1,272 consecutive STEMI patients who underwent PCI between 1/1/2011-12/31/2016 and compared characteristics and outcomes between non-CA (N = 1,124) and CA patients (N = 148), defined per NCDR definitions as pulseless arrest requiring cardiopulmonary resuscitation and/or defibrillation within 24-hr of PCI.

Results: Male gender, cerebrovascular disease, chronic kidney disease, in-hospital STEMI, left main or left anterior descending culprit vessel, and initial TIMI 0 or 1 flow were independent predictors for CA. CA patients had longer door-to-balloon-time (106 [83,139] vs. 97 [74,121] minutes, p = 0.003) and greater incidence of cardiogenic shock (48.0% vs. 5.9%, p < 0.001), major bleeding (25.0% vs. 9.4%, p < 0.001), and 30-day mortality (16.2% vs. 4.1%, p < 0.001). Risk score for 30-day mortality based on presenting characteristics provided excellent prognostic accuracy (area under the curve = 0.902). However, over long-term follow-up of 4.5 ± 2.4 years among hospital survivors, CA did not portend any additional mortality risk (HR: 1.01, 95% CI: 0.56-1.82, p = 0.97).

Conclusions: In a contemporary cohort of STEMI patients undergoing primary PCI, CA occurs in >10% of patients and is an important mechanism of mortality in patients with in-hospital STEMI. While CA is associated with adverse outcomes, it carries no additional risk of long-term mortality among survivors highlighting the need for strategies to improve the in-hospital care of STEMI patients with CA.
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http://dx.doi.org/10.1016/j.resplu.2021.100149DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8319445PMC
September 2021

Incidence, treatment, and outcomes of acute myocardial infarction following transcatheter or surgical aortic valve replacement.

Catheter Cardiovasc Interv 2022 02 8;99(3):877-888. Epub 2021 Jul 8.

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Objectives: This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR).

Background: Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI.

Methods: We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs.

Results: The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p < 0.001). Post-TAVR AMI patients (n = 1315), compared with post-SAVR AMI patients (n = 1344), were older, had more comorbidities and more frequent non-ST-elevation AMI (NSTEMI: 86.6% vs. 78.0%; p < 0.001). After propensity-score matching, there was no significant difference in in-hospital mortality between post-TAVR and post-SAVR AMIs (14.7% vs. 16.1%; p = 0.531), but the mortality was high in both groups, particularly in ST-elevation AMI (STEMI: 38.8% vs. 29.2%; p = 0.153). Invasive strategy was used less frequently for post-TAVR AMI than post-SAVR AMI (25.6% vs. 38.3%; p < 0.001). Invasive strategy was associated with lower mortality in both post-TAVR (adjusted odds ratio = 0.40; 95% confidence interval = [0.24-0.66]) and post-SAVR groups (0.60 [0.41-0.88]).

Conclusions: AMI, albeit uncommon, was more frequent post-TAVR than post-SAVR. Patients commonly presented with NSTEMI, but the mortality of STEMI was markedly high. Further studies are needed to understand why a substantial percentage of patients do not receive invasive coronary treatment, particularly after TAVR, despite seemingly better outcomes with invasive strategy.
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http://dx.doi.org/10.1002/ccd.29860DOI Listing
February 2022

Optimal dual antiplatelet therapy duration for bioresorbable scaffolds: an individual patient data pooled analysis of the ABSORB trials.

EuroIntervention 2021 Dec 17;17(12):e981-e988. Epub 2021 Dec 17.

Division of Cardiology, VCU Health Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, USA.

Background: Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its three-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischaemic events.

Aims: We sought to evaluate the impact of DAPT duration on ischaemic and bleeding outcomes following BRS implantation.

Methods: We conducted an individual patient data pooled analysis from four ABSORB randomised trials and one prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death up to three-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration.

Results: The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95% CI: 0.10-0.32; p<0.0001) and ST (aHR 0.08, 95% CI: 0.03-0.19; p<0.0001). Conversely, DAPT use between 1 and 3 years did not significantly affect the risk of MI (aHR 1.04, 95% CI: 0.70-1.55; p=0.84) or ST (aHR 0.86, 95% CI: 0.42-1.75; p=0.67). DAPT did not have major effects upon bleeding or death in either period.

Conclusions: DAPT use during the first year after BRS implantation was strongly associated with lower risks of ST and MI. However, a benefit of ongoing DAPT use between 1 and 3 years after BRS implantation was not apparent.
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http://dx.doi.org/10.4244/EIJ-D-21-00263DOI Listing
December 2021

Successful modeling of long term outcomes in end-stage renal disease patients undergoing percutaneous coronary intervention with drug-eluting stents.

Catheter Cardiovasc Interv 2021 08 29;98(2):208-214. Epub 2021 Apr 29.

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Objectives: The objective of this study is to identify and model risk factors for major adverse cardiac events (MACE) and all-cause mortality among patients with ESRD treated with PCI using DES.

Background: Patients with end-stage renal disease (ESRD) have poor long-term outcomes after percutaneous coronary intervention (PCI) compared with non-ESRD patients. However, there is a paucity of literature regarding risk factors associated with outcomes of ESRD patients after PCI with drug-eluding stents (DES).

Methods: This retrospective cohort study includes all patients with ESRD who underwent first-time PCI with DES at a single, high-volume hospital between 1/1/2005 and 12/31/2015, with follow-up through 9/1/2019. Primary outcomes were MACE (cardiac death, myocardial infarction, or unplanned revascularization) and all-cause mortality.

Results: Five-year MACE was 83.0% and five-year morality was 77.9% in patients with ESRD (n = 285). Among ESRD patients, factors independently associated with MACE were C-reactive peptide level, SYNTAX score, peripheral vascular occlusive disease, hemoglobin, and treatment of a restenotic lesion (c-index = 0.66). Factors independently associated with mortality in ESRD patients were age, SYNTAX score, non-use of statins at baseline, insulin-dependent diabetes, chronic obstructive pulmonary disease (COPD), peripheral vascular occlusive disease, and platelet count (c-index = 0.65).

Conclusions: Despite relatively poor 1-and 5-year outcomes among ESRD patients after PCI, risk of MACE and mortality among this cohort can be successfully modelled, which meaningfully informs clinicians regarding management of ESRD patients with coronary artery disease (CAD). Further investigations are necessary to determine whether or not outcomes might be improved through risk profile modification.
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http://dx.doi.org/10.1002/ccd.29707DOI Listing
August 2021

Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials.

J Cardiol 2021 09 21;78(3):224-229. Epub 2021 Apr 21.

Department of Cardiovascular Medicine, Kyoto University Hospital, Kyoto, Japan.

Background: The long-term prognostic impact of IVUS findings following Absorb BVS implantation remains uncertain. This study aimed to identify the IVUS predictors of long-term clinical outcomes following ABSORB bioresorbable vascular scaffold (BVS) implantation from the pooled IVUS substudy cohorts of the ABSORB III and Japan trials.

Methods: A total of 298 lesions in 286 patients were enrolled with 2:1 randomization to ABSORB BVS vs. cobalt-chromium everolimus-eluting stents. This sub-analysis included 168 lesions of 160 patients in the Absorb arm whose post-procedural quantitative IVUS were available. The primary endpoint of this analysis was device-oriented composite endpoint (DOCE) of target lesion failure, including cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The median follow-up duration was 4.9 [3.1-5.0] years.

Results: During follow-up, DOCE occurred in 10.1% of lesions treated with Absorb BVS. Among several post-procedural IVUS indices associated with DOCE, non-uniform device expansion (defined as uniformity index = minimum / maximum device area) (hazard ratio 0.47 per 0.1 increase [95%CI 0.28 to 0.77]; p = 0.003) and residual reference plaque burden (hazard ratio 4.01 per 10% increase [95%CI 1.50 to 10.77]; p = 0.006) were identified as independent predictors of DOCE by Cox multivariable analysis.

Conclusions: Nonuniform device expansion and substantial untreated residual plaque in reference segments were associated with long-term adverse events following BVS implantation. Baseline imaging to identify the appropriate device landing zone and procedural imaging to achieve uniform device expansion if possible (e.g. through post-dilatation) may improve clinical outcomes of BVS implantation.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).
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http://dx.doi.org/10.1016/j.jjcc.2021.03.005DOI Listing
September 2021

Implementation of a Myocardial Perfusion Imaging Risk Algorithm to Inform Appropriate Downstream Invasive Testing and Treatment.

Circ Cardiovasc Imaging 2021 04 26;14(4):e011984. Epub 2021 Mar 26.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Foundation, OH.

Background: To risk stratify patients undergoing single-photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) in accordance with appropriate use criteria for referral to coronary angiography, we developed a risk classification algorithm incorporating appropriate use criteria-defined risk features. We evaluated the association between this algorithm with downstream angiography, revascularization, and all-cause mortality.

Methods: We studied consecutive patients who underwent SPECT-MPI from January 1, 2015, to December 31, 2017, and assigned a scan risk of low, intermediate, high, or indeterminate. With this stratification, we assessed referral for angiography and revascularization within 3 months of SPECT-MPI and intermediate-term mortality.

Results: Among 12 799 patients, the mean age was 66 years, and a majority were men (56.8%). Most patients were low risk (83.6%) followed by intermediate (9.9%) and high risk (5.2%). Compared with low-risk patients, intermediate- and high-risk patients were more frequently referred for angiography (14.8% and 13.6% versus 2.0%; <0.001) and revascularization (7.7% and 6.8% versus 0.7%; <0.001). In 1008 propensity-matched patients, scan risk was independently associated with angiography after adjustment for ischemia, scar, or stress ejection fraction. At a mean follow-up of 2.3 years, mortality was higher with increased scan risk (high, 10.4%; intermediate, 7.1%; low, 4.1%; <0.001). Compared with low scan risk, intermediate (hazard ratio, 1.37 [95% CI, 1.09-1.72]; =0.008) and high scan risk (hazard ratio, 1.98 [95% CI, 1.53-2.56]; <0.001) were associated with mortality in multivariable analysis. Similar findings were observed for those undergoing pharmacological and exercise SPECT-MPI with comparatively worse prognosis among pharmacological patients.

Conclusions: This appropriate use criteria-derived risk classification algorithm for SPECT-MPI guided referral for coronary angiography and revascularization and was significantly associated with mortality. This algorithm may serve as an important tool to reaffirm appropriate use criteria and direct management of patients with stable ischemic heart disease undergoing stress testing.
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http://dx.doi.org/10.1161/CIRCIMAGING.120.011984DOI Listing
April 2021

Prediabetic Patient Outcomes 8 to 15 Years After Drug-Eluting Coronary Stenting.

Am J Cardiol 2021 06 20;149:21-26. Epub 2021 Mar 20.

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Ohio.

Guidelines suggest differential management of diabetics and nondiabetics with coronary artery disease (CAD) referred for revascularization, but pre-diabetics, who now comprise up to 20% to 30% of CAD patients, have been excluded from the diabetic group. To address this, we studied long-term cardiac outcomes in 1,323 consecutively drug-eluting stent (DES)-stented patients from prespecified local zip codes, dividing patients into normal-glycemic patients, prediabetics and diabetics, based upon conventional definitions. Patient age was 63±11 years, 65.5% male, mean baseline SYNTAX score of 10.2±6.8 and residual SYNTAX score=3.0±4.6. Only 2.9% of patients were lost to follow up at 10 years. Duration of follow up for alive patients was 124±33 mos. Major adverse cardiac events (MACE) by Kaplan Meier (KM) was similar for normal glycemics and prediabetics (42.9±2.5% vs 38.6±3.1% at 10 years, p=0.35), whereas that for diabetics was worse (56.7±2.6% at 10 years, p<0.001 vs prediabetics). KM cardiac death rates at 10 years were 14.2±1.8%, 16.0±2.4% and 31.2±2.3% for normal glycemics, prediabetics, and diabetics, respectively (p=0.34 and p<0.001 [covariate adjusted p=0.018] for prediabetics versus normal glycemics and versus diabetics, respectively). We found that prediabetics have long-term post-DES outcomes far more similar to those of normal-glycemic patients than diabetics.
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http://dx.doi.org/10.1016/j.amjcard.2021.03.028DOI Listing
June 2021

Coronary Tortuosity and Long-Term Post-Stent Risk: What Is the Connection?

Authors:
Stephen G Ellis

JACC Cardiovasc Interv 2021 05 24;14(9):1019-1020. Epub 2021 Feb 24.

Cleveland Clinic, Cleveland, Ohio, USA. Electronic address:

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http://dx.doi.org/10.1016/j.jcin.2021.01.015DOI Listing
May 2021

Outcomes of Early Coronary Angiography or Revascularization After Cardiac Surgery.

Ann Thorac Surg 2021 05 16;111(5):1494-1501. Epub 2020 Sep 16.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Early coronary ischemic events are uncommon after cardiac surgery, with little known about their management or associated outcomes. We evaluated clinical outcomes of patients undergoing coronary angiography ± percutaneous coronary intervention or redo coronary artery bypass grafting for suspected coronary ischemia within 3 weeks after index cardiac surgery.

Methods: This is a retrospective observational study based on data from 53,287 patients who underwent cardiac surgery at our institution (1996-2017); 180 patients (0.34%) satisfied the inclusion criteria. The primary outcome was 1-year all-cause mortality. Statistical evaluation involved χ, analysis of variance, Kaplan-Meier, and receiver operating characteristic curve analyses.

Results: Most coronary angiography ± percutaneous coronary intervention and redo coronary artery bypass grafting procedures occurred in the first 2 weeks after index cardiac surgery. Patients presenting with ST elevation myocardial infarction (STEMI)/non-STEMI had the lowest 1-year mortality (13.5%), followed by patients with ventricular tachycardia/fibrillation (28.1%), and patients with non-ventricular tachycardia/fibrillation arrest or hemodynamic instability alone the worst (38.6%) (χ = 17.3, P = .001). Peak troponin T level after cardiac surgery was strongly predictive of 1-year mortality (area under the curve, 0.74; 95% confidence interval, 0.65-0.84; P < .001) but did not predict the presence of coronary compromise. For acute graft failure, 1-year mortality was better with percutaneous coronary intervention (18.2%) than redo coronary artery bypass grafting (23.5%) or no indicated/feasible intervention (29.2%).

Conclusions: Although suspected myocardial ischemia requiring coronary angiography or intervention early after cardiac surgery was rare, mortality was high, particularly in presentations other than STEMI/non-STEMI. In patients with overt signs and symptoms of myocardial ischemia after index cardiac surgery, troponin T was not a reliable marker of underlying coronary or graft obstruction but was a robust predictor of 1-year mortality.
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http://dx.doi.org/10.1016/j.athoracsur.2020.06.113DOI Listing
May 2021

Implementation of a Comprehensive ST-Elevation Myocardial Infarction Protocol Improves Mortality Among Patients With ST-Elevation Myocardial Infarction and Cardiogenic Shock.

Am J Cardiol 2020 11 15;134:1-7. Epub 2020 Aug 15.

Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address:

Mortality in patients with STEMI-associated cardiogenic shock (CS) is increasing. Whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol (CSP) can improve their care delivery and mortality is unknown. We evaluated the impact of a CSP on incidence and outcomes in patients with STEMI-associated CS. We implemented a 4-step CSP including: (1) Emergency Department catheterization lab activation; (2) STEMI Safe Handoff Checklist; (3) immediate catheterization lab transfer; (4) and radial-first percutaneous coronary intervention (PCI). We studied 1,272 consecutive STEMI patients who underwent PCI and assessed for CS incidence per National Cardiovascular Data Registry definitions within 24-hours of PCI, care delivery, and mortality before (January 1, 2011, to July 14, 2014; n = 723) and after (July 15, 2014, to December 31, 2016; n = 549) CSP implementation. Following CSP implementation, CS incidence was reduced (13.0% vs 7.8%, p = 0.003). Of 137 CS patients, 43 (31.4%) were in the CSP group. CSP patients had greater IABP-Shock II risk scores (1.9 ± 1.8 vs 2.8 ± 2.2, p = 0.014) with otherwise similar hemodynamic and baseline characteristics, cardiac arrest incidence, and mechanical circulatory support use. Administration of guideline-directed medical therapy was similar (89.4% vs 97.7%, p = 0.172) with significant improvements in trans-radial PCI (9.6% vs 44.2%, p < 0.001) and door-to-balloon time (129.0 [89:160] vs 95.0 [81:116] minutes, p = 0.001) in the CSP group, translating to improvements in infarct size (CK-MB 220.9 ± 156.0 vs 151.5 ± 98.5 ng/ml, p = 0.005), ejection fraction (40.8 ± 14.5% vs 46.7 ± 14.6%, p = 0.037), and in-hospital mortality (30.9% vs 14.0%, p = 0.037). In conclusion, CSP implementation was associated with improvements in CS incidence, infarct size, ejection fraction, and in-hospital mortality in patients with STEMI-associated CS. This strategy offers a potential solution to bridging the historically elusive gap in their care.
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http://dx.doi.org/10.1016/j.amjcard.2020.08.012DOI Listing
November 2020

Characteristics and Outcomes of Patients With Takotsubo Syndrome: Incremental Prognostic Value of Baseline Left Ventricular Systolic Function.

J Am Heart Assoc 2020 08 5;9(16):e016537. Epub 2020 Aug 5.

Department of Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic Cleveland OH USA.

Background We sought to determine (1) long-term outcomes in patients presenting with documented Takotsubo syndrome (TS), (2) whether left ventricular global longitudinal strain (LV-GLS) provides incremental prognostic value, and (3) prognostic cutoffs of LV ejection fraction (LVEF) and LV-GLS during an acute TS episode. Methods and Results We studied 650 patients with TS (aged 66±14 years, 88% women) who were diagnosed clinically and angiographically between 2006 and 2018. Baseline LVEF and LV-GLS (using velocity vector imaging) were recorded. The primary end point was all-cause mortality. TS triggers were unknown (34%), emotional (16%), physical (41%), and neurologic (10%). Mean LVEF and LV-GLS were 36±10% and -11.6±0.4%; in addition, 94% patients had LVEF <52%, and 80% had apical ballooning. No patient had obstructive coronary artery disease. At a median of 2.2 years (interquartile range, 0.7-4.4), 175 (27%) had died (9% in-hospital deaths). Multivariate Cox survival analysis revealed that higher age (hazard ratio [HR], 1.35), male sex (HR, 1.75), lower baseline LVEF (HR, 1.02), worse LV-GLS (HR, 1.04), neurologic trigger (HR, 2.66), and physical trigger (HR, 2.64) were associated with mortality, whereas aspirin (HR, 0.70) and β-blockers (HR, 0.73) improved survival (all <0.049). The addition of LVEF and LV-GLS to clinical markers (age, sex, cardiogenic shock at presentation, and peak troponin I) significantly increased log-likelihood ratios: clinical (-521.48), clinical plus LVEF (-511.32, <0.001), and clinical plus LVEF and LV-GLS (-500.68, <0.001). On penalized spline analysis, LVEF of 38% and LV-GLS of -10% were cutoffs below which survival was significantly worse. Conclusions Patients with TS with a neurologic or physical trigger had significantly worse survival than those without such a trigger, with baseline LVEF and LV-GLS providing incremental prognostic value.
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http://dx.doi.org/10.1161/JAHA.120.016537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660826PMC
August 2020

End-stage renal disease as an independent risk factor for in-hospital mortality after coronary drug-eluting stenting: Understanding and modeling the risk.

Catheter Cardiovasc Interv 2021 08 19;98(2):246-254. Epub 2020 May 19.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Objectives: We sought to compare in-hospital outcomes between patients with and without end-stage renal disease (ESRD) undergoing coronary drug-eluting stent (DES) placement and to model risk of in-hospital adverse postpercutaneous coronary intervention (PCI) events in ESRD patients.

Background: The effect of ESRD on the risk of in-hospital complications after DES PCI is relatively unclear, as is the ability to prospectively stratify risk in this population.

Methods: Consecutive patients undergoing first-time DES between April 1, 2003 and June 30, 2018 at a single tertiary care hospital were included in a prospective registry. Outcomes in those with ESRD were compared to those without ESRD. The primary endpoint was in-hospital all-cause mortality; secondary endpoints included in-hospital major adverse cardiac events (MACE)-defined as cardiac death, myocardial infarction, or unplanned revascularization-and major bleeding. Multivariate logistic regression modeling was used to identify factors associated with each outcome and to generate risk scores.

Results: Among 18,134 patients in the study population, 382 (2.1%) had ESRD. ESRD was associated with increased risk of in-hospital mortality (7.1 vs. 2.9%, p < .001), in-hospital MACE (6.3 vs. 2.1%, p < .001), and major bleeding (12.0 vs. 2.6%, p < .001). After multivariable risk adjustment, ESRD was independently associated with in-hospital mortality (odds ratio: 1.83, 95% confidence interval: 1.04-3.23, p = .04) but not MACE or major bleeding. Among patients with ESRD, risks of MACE and major bleeding were successfully modeled (c-statistics = .72 and .85, respectively).

Conclusions: ESRD is independently associated with increased risk of in-hospital mortality after coronary DES. Future studies are necessary to validate risk models derived to identify high-risk ESRD patients.
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http://dx.doi.org/10.1002/ccd.28929DOI Listing
August 2021

Use of Polymer-Jacketed, Tapered-Tip, Low-Force Guidewires With Composite-Core, Dual-Coil Design as Part of the Antegrade Approach to Coronary Chronic Total Occlusions.

J Invasive Cardiol 2020 May;32(5):161-168

Cleveland Clinic, 9500 Euclid Avenue, J2-3, Cleveland, OH 44195 USA.

Aims: To investigate the impact of novel, polymer-jacketed, tapered-tip, low-force guidewires with composite-core, dual-coil design (Fielder XT-R and Fielder XT-A; Asahi Intecc) on antegrade wire escalation (AWE) crossing of coronary chronic total occlusion (CTO) lesions.

Methods: From March of 2017 to December 2018, a total of 164 consecutive CTO lesions at a single institution were treated with a primary AWE strategy using either Fielder XT-R or XT-A (XTRA) as the starting wire regardless of lesion characteristics. Success rates, wiring times, and complications were analyzed.

Results: The mean Japanese (J)-CTO score was 3.71 ± 1.27, mean PROGRESS-CTO score was 2.46 ± 1.15, and mean PROGRESS-CTO Complications score was 3.9 ± 2.0. Mean CTO length was 25.0 ± 0.5 mm, 48 lesions (29.3%) were previously bypassed, 77 lesions (47.0%) had moderate to severe calcification, and 62 lesions (37.8%) had moderate to severe tortuosity. Antegrade success rates using XTRA wires were 79%, 60%, and 17% of lesions with J-CTO scores of 0-1, 2-3, and 4-5, respectively. In successful antegrade XTRA cases, median wiring times were 6.5 min (interquartile range [IQR], 5.0-11.0 min), 9.0 min (IQR, 4.2-14.0 min), and 12.0 min (IQR, 9.0-15.0 min) for J-CTO scores of 0-1, 2-3, and 4-5, respectively, and differed non-significantly according to J-CTO score (P=.20). Complication rates were low (In-hospital major adverse cardiac event rate, 1.3%) with no wire perforations caused by XTRA wires.

Conclusions: Use of Fielder XTRA wires as part of an AWE strategy in CTO percutaneous coronary interventions may facilitate more efficient antegrade lesion crossing and overall procedural success in lesions that have been traditionally challenging to treat using an antegrade-first approach.
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May 2020

Association of adoption of transradial access for percutaneous coronary intervention in ST elevation myocardial infarction with door-to-balloon time.

Catheter Cardiovasc Interv 2020 08 27;96(2):E165-E173. Epub 2020 Feb 27.

Heart and Vascular Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, Cleveland, Ohio.

Objectives: We aimed to study adoption of transradial primary percutaneous coronary intervention (TR-PPCI) for ST elevation myocardial infarction (STEMI) ("radial first" approach) and its association with door-to-balloon time (D2BT).

Background: TR-PPCI for STEMI is underutilized in the United States due to concerns about prolonging D2BT. Whether operators and hospitals adopting a radial first approach in STEMI incur prolonged D2BT is unknown.

Methods: In 1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients.

Results: With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005), median hospital level D2BT decreased from 102 min [81, 142] in 2011 to 84 min [60, 105] in 2016 (p-trend<.001). TF crossover (10.3%; n = 57) was not associated with unadjusted D2BT (TR-PPCI success 91 min [72, 112] vs. TF crossover 99 min [70, 115], p = .432) or D2BT adjusted for study year and presenting location (7.2% longer D2BT with TF crossover, 95% CI: -4.0% to +18.5%, p = .208). Among 273 propensity-matched pairs, unadjusted D2BT (TR-PPCI 98 [78, 117] min vs. TF-PPCI 101 [76, 132] min, p = .304), and D2BT adjusted for study year and presenting location (5.0% shorter D2BT with TR-PPCI, 95% CI: -12.4% to +2.4%, p = .188) were similar.

Conclusions: TR-PPCI can be successfully implemented without compromising D2BT performance.
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http://dx.doi.org/10.1002/ccd.28785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496393PMC
August 2020

Readmissions in ST-Elevation Myocardial Infarction and Cardiogenic Shock (from Nationwide Readmission Database).

Am J Cardiol 2019 12 26;124(12):1841-1850. Epub 2019 Sep 26.

Department of Cardiology, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Management of ST-elevation myocardial infarction complicated by cardiogenic shock (STEMI-CS) has evolved in the last decade. There is paucity of data on readmissions in this study population. We aimed to assess the burden, major etiologies, and resource utilization for 30-day readmissions among patients with STEMI and CS. The Nationwide Readmission Database was queried from 2010 to 2014. All adult patients with an index admission for STEMI-CS were identified using International Classification of Diseases, ninth edition codes. Patient with mortality on index admission and transfers to other hospitals were excluded. A total of 18,659 admissions were identified with primary diagnosis of STEMI-CS for the study duration. Percutaneous coronary interventions was performed in 78.1% and mechanical circulatory devices were utilized in 53.9% with a mean length of stay of 10.6 (±0.2) days and mean cost of hospitalization of $47,744 (±327). Among these, 2,404 (12.9%) patients were readmitted within 30 days. Major etiologies for readmission include congestive heart failure (25.7%), acute myocardial infarction (9.4%), arrhythmias (4.5%), and sepsis (4.2%). The mean length of stay and cost of hospitalization for 30-day readmission were 5.9 (±0.3) days and $17,043 (±590), respectively. Older age, female gender, lower socioeconomic status, and discharge to home health care were significant predictors for readmission. In conclusion, there is a significant burden of 30-day readmission among patients with STEMI-CS. Percutaneous coronary interventions and mechanical circulatory devices were utilized in a majority of index admissions. Congestive heart failure was the single most common reason for 30-day readmission. Patients discharged to skilled nursing facility, patients with private insurance and higher socioeconomic status were less likely to be readmitted. Moreover, readmissions among STEMI-CS patients contribute to significant resource utilization.
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http://dx.doi.org/10.1016/j.amjcard.2019.08.048DOI Listing
December 2019

Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study.

JAMA Cardiol 2019 12;4(12):1261-1269

International Centre for Cardiovascular Health, Imperial College, London, England.

Importance: Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown.

Objective: To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals.

Data Sources: We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies.

Study Selection: Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria.

Data Extraction And Synthesis: Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed.

Main Outcomes And Measures: The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years.

Results: Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis.

Conclusions And Relevance: The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease.

Trial Registration: ClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.
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http://dx.doi.org/10.1001/jamacardio.2019.4101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6777269PMC
December 2019

Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial.

Circulation 2019 12 25;140(23):1895-1903. Epub 2019 Sep 25.

New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.).

Background: The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption.

Methods: Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years.

Results: Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; =0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02-2.87] versus 3.23 [95% CI, 1.25-8.30]; =0.056) compared with the 0- to 3-year time period.

Conclusions: In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption.

Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT01751906.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.042584DOI Listing
December 2019

Comparison of Long-Term Clinical Outcomes After Drug-Eluting Stenting in Blacks-vs-Whites.

Am J Cardiol 2019 10 25;124(8):1179-1185. Epub 2019 Jul 25.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

Patients of different racial backgrounds may have socioeconomic, cultural, or genetic differences that impact outcomes after percutaneous coronary intervention (PCI). There are limited data beyond 2 to 3 years for Blacks to inform discussions and perhaps improve outcomes. We studied consecutive limus-stent treated patients, having their first PCI at our institution January 2003 to March 2010 in 2 cohorts; Cohort 1: standard 3-year follow-up (n = 3,782, 12.4% Blacks) and Cohort 2: from nearby zip codes with intended detailed follow-up through 8 to 13 years (n = 616, 31.8% Blacks). The primary outcomes of interest were mortality and death/MI/revascularization (DMIR) (Cohort 1) or major adverse cardiac events (cardiac DMIR) (Cohort 2). In all cohorts, Blacks had a higher prevalence of many risk factors. In Cohort 1, 3-year mortalities were 14.6% and 9.6% (p = 0.001) and DMIR were 32.1% and 25.0% (p = 0.001), for Blacks and Whites, respectively. In Cohort 2, over 9.5 ± 2.0 years, treatment intensity was as high or higher for Blacks, but they continued to have higher low-density lipoprotein-cholesterol and blood pressure values. Major adverse cardiac events and mortality at 10 years were higher for Blacks (59.0% vs 48.1%, p = 0.024 and 44.3% vs 23.0%, p < 0.001). Differences in outcomes, except 10 year mortality, were not significantly different after adjustment for baseline characteristics. Blacks have a higher risk profile at the time of PCI and worse long-term outcomes after drug-eluting stent, most of which is explained by baseline differences.
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http://dx.doi.org/10.1016/j.amjcard.2019.07.020DOI Listing
October 2019

CTO Coronary Perforations: What You Really Need to Know.

Authors:
Stephen G Ellis

JACC Cardiovasc Interv 2019 10 26;12(19):1913-1914. Epub 2019 Jun 26.

Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jcin.2019.05.010DOI Listing
October 2019

ABSORB IV: will the low rate of scaffold thrombosis persist? - Authors' reply.

Lancet 2019 06;393(10189):2392-2393

Carl and Edyth Lindner Research Center at The Christ Hospital, Cincinnati, OH, USA.

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http://dx.doi.org/10.1016/S0140-6736(19)30687-7DOI Listing
June 2019

Incremental Prognostic Value of Guideline-Directed Medical Therapy, Transradial Access, and Door-to-Balloon Time on Outcomes in ST-Segment-Elevation Myocardial Infarction.

Circ Cardiovasc Interv 2019 03;12(3):e007101

Heart and Vascular Institute Center for Healthcare Delivery Innovation (C.P.H., A.K., M.J., M.A., U.N.K.), Cleveland Clinic, OH.

Background: Systems to improve ST-segment-elevation myocardial infarction (STEMI) care have traditionally focused on improving door-to-balloon time. However, prompt guideline-directed medical therapy and transradial primary percutaneous coronary intervention (PCI) are also associated with reduced STEMI mortality. The incremental prognostic value of each facet of STEMI care on clinical outcomes within a STEMI system of care is unknown.

Methods And Results: We implemented systems-based strategies at our hospital to improve 3 STEMI care metrics: (1) prompt guideline-directed medical therapy before sheath insertion for PCI, (2) use of transradial primary PCI, and (3) door-to-balloon time. We assessed the incremental association of metrics achieved with in-hospital adverse events and 30-day mortality. Of 1272 consecutive patients with STEMI treated with PCI at our hospital (January 1, 2011, to December 31, 2016), the percentage with achievement of zero, 1, 2, or 3 STEMI care metrics was 7.1%, 24.1%, 43.8%, and 25.1%; and 30-day mortality was 15.6%, 8.6%, 3.6%, and 3.2%, respectively (log-rank P<0.001). After adjusting for known clinical predictors of STEMI in-hospital mortality, achievement of at least 2 STEMI care metrics was associated with significantly reduced in-hospital mortality (odds ratio, 0.39; 95% CI, 0.16-0.96; P=0.041). Each metric provided incremental prognostic value when modeled in stepwise order of their occurrence in clinical practice (final model C statistic, 0.677; P<0.001).

Conclusions: Prompt guideline-directed medical therapy before sheath insertion for PCI, transradial primary PCI, and door-to-balloon time add incremental prognostic value in STEMI care. Expanding STEMI systems of care from a singular focus on door-to-balloon time to a comprehensive focus on multifaceted STEMI care offers an opportunity to further improve STEMI outcomes.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007101DOI Listing
March 2019

Assessing the Likelihood of Chronic Total Occlusion Percutaneous Coronary Intervention Procedural Success: Not So Easy.

Authors:
Stephen G Ellis

JACC Cardiovasc Interv 2019 02 30;12(4):343-345. Epub 2019 Jan 30.

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jcin.2018.10.031DOI Listing
February 2019

Angiographic predictors of adverse outcomes after percutaneous coronary intervention in patients with radiation associated coronary artery disease.

Catheter Cardiovasc Interv 2019 Sep 28;94(3):E104-E110. Epub 2019 Jan 28.

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.

Objectives: To determine procedural predictors of long-term outcomes for patients with radiation associated coronary artery disease (CAD) treated with percutaneous coronary intervention (PCI).

Background: Patients who develop CAD after external beam radiation therapy (XRT) for cancer are at high-risk for adverse events following PCI. It is unknown if specific angiographic features can predict outcomes in this population.

Methods: This is an observational study of 157 patients with malignancy who received XRT prior to PCI. Rates of major adverse cardiovascular and cerebrovascular events (MACCEs; all-cause mortality, myocardial infarction, repeat revascularization, or stroke) were compared across patient characteristics over time with the Cox proportional hazards and Kaplan-Meier's analyses.

Results: During follow-up of 5.4 ± 4.5 years, 91 (58%) patients had MACCE. On Kaplan-Meier's analysis of angiographic characteristics, MACCE was more frequent in patients with at least moderate target vessel calcification (P = 0.023), ostial stenosis (P = 0.049), target vessel diameter ≥ 3.0 mm (P = 0.018), a SYNTAX score ≥ the median of 11 (P = 0.014), or bare metal stenting (BMS)/balloon angioplasty (BA) compared to drug-eluting stenting (DES) (P = 0.006). Cardiac death was more frequent in patients with SYNTAX score ≥ 11 (P = 0.028) or BMS (P = 0.043). After multivariable adjustment for both angiographic and clinical characteristics, independent predictors of MACCE were BMS placement (P = 0.013), chronic kidney disease ≥ stage 3 (P = 0.019), New York Heart Association (NYHA) heart failure class ≥3 (P = 0.034), and SYNTAX score ≥ 11 (P = 0.041).

Conclusions: In patients previously exposed to XRT treated with PCI, independent angiographic predictors of MACCE include SYNTAX score ≥ 11 and BMS placement, suggestive that DES should be preferred in this population.
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http://dx.doi.org/10.1002/ccd.28107DOI Listing
September 2019

How Should We Treat Patients With Silent Myocardial Ischemia?: Learning From Relevant Evidence.

Authors:
Stephen G Ellis

JACC Cardiovasc Interv 2019 02 16;12(3):242-244. Epub 2019 Jan 16.

Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jcin.2018.12.003DOI Listing
February 2019

Long-Term Time-Varying Risk of Readmission After Acute Myocardial Infarction.

J Am Heart Assoc 2018 11;7(21):e009650

2 Department of Quantitative Health Sciences Research Institute Cleveland OH.

Background Readmission after myocardial infarction ( MI ) is a publicly reported quality metric with hospital reimbursement linked to readmission rates. We describe the timing and pattern of readmission by cause within the first year after MI in consecutive patients, regardless of revascularization strategy, payer status, or age. Methods and Results We identified patients discharged after an MI from April 2008 to June 2012. Readmission within 12 months was the primary end point. Readmissions were classified into 4 groups: MI related, other cardiovascular, noncardiovascular, and planned. A total of 3069 patients were discharged after an MI (average age, 65±13 years; and 1941 [63%] men). A total of 655 patients (21.3%) were readmitted at least once (897 total readmissions). A total of 147 patients (4.8%) were readmitted ≥2 times, accounting for 389 readmissions (43%). The instantaneous risk of all-cause readmission was highest (15 readmissions/100 patients per month; 95% confidence interval, 12-19 readmissions/100 patients per month) immediately after discharge, decreased by almost half (8.1 readmissions/100 patients per month; 95% confidence interval, 7.2-9.0 readmissions/100 patients per month) within 15 days, and was substantially lower and relatively constant (1.4 readmissions/100 patients per month; 95% confidence interval, 1.2-1.6 readmissions/100 patients per month) out to 1 year. Cardiovascular causes of readmission were more common early after discharge. Conclusions Most patients with MI are never readmitted, whereas a small minority (≈5%) account for nearly half of 1-year readmissions. The readmission pattern after MI is characterized by an early peak (first 15 days) of cardiovascular readmissions, followed by a middle period (months 1-4) of noncardiovascular readmissions, and ending with a low-risk period (>4 months) during which the risk appears independent of cause.
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http://dx.doi.org/10.1161/JAHA.118.009650DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6404216PMC
November 2018

Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial.

Lancet 2018 10 25;392(10157):1530-1540. Epub 2018 Sep 25.

The Carl and Edyth Lindner Research Center at The Christ Hospital, Cincinnati, OH, USA.

Background: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded.

Methods: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual.

Findings: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided p=0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided p=0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference -0·3%, 95% CI -3·4% to 2·9%; one-sided p=0·0008; two-sided p=0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586).

Interpretation: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES.

Funding: Abbott Vascular.
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http://dx.doi.org/10.1016/S0140-6736(18)32283-9DOI Listing
October 2018
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