Faculty Bibliography

BACKGROUND:The COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multi-Vessel Disease After Early PCI for STEMI) demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular events in patients with ST-segment-elevation myocardial infarction and multivessel coronary artery disease. It is unclear whether consistent benefit is observed in patients undergoing a pharmacoinvasive strategy compared with primary PCI. METHODS:Following culprit lesion PCI, 4041 patients with ST-segment-elevation myocardial infarction and multivessel coronary artery disease were randomized to either routine nonculprit lesion PCI or culprit lesion only PCI. In a prespecified analysis, we determined the treatment effect in 303 patients undergoing a pharmacoinvasive strategy versus 3738 patients undergoing primary PCI on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. RESULTS:=0.07). CONCLUSIONS:Among patients with ST-segment-elevation myocardial infarction and multivessel disease, complete revascularization with multivessel PCI consistently reduces major cardiovascular events in patients undergoing an initial pharmacoinvasive strategy as well as in those undergoing primary PCI. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01740479.

Importance:Randomized clinical trials (RCTs) are critical in advancing patient care, yet conducting such large-scale trials requires tremendous resources and coordination. Clinical site start-up performance metrics can provide insight into opportunities for improved trial efficiency but have not been well described. Objective:To measure the start-up time needed to reach prespecified milestones across sites in large cardiovascular RCTs in North America and to evaluate how these metrics vary by time and type of regulatory review process. Design, Setting, and Participants:This cohort study evaluated cardiovascular RCTs conducted from July 13, 2004, to February 1, 2017. The RCTs were coordinated by a single academic research organization, the Duke Clinical Research Institute. Nine consecutive trials with completed enrollment and publication of results in their target journal were studied. Data were analyzed from December 4, 2019, to January 11, 2021. Exposures:Year of trial enrollment initiation (2004-2007 vs 2008-2012) and use of a central vs local institutional review board (IRB). Main Outcomes and Measures:The primary outcome was the median start-up time (from study protocol delivery to first participant enrollment) as compared by trial year and type of IRB used. The median start-up time for the top 10% of sites was also reported. Secondary outcomes included time to site regulatory approval, time to contract execution, and time to site activation. Results:For the 9 RCTs included, the median site start-up time shortened only slightly over time from 267 days (interquartile range [IQR], 185-358 days) for 2004-2007 trials to 237 days (IQR, 162-343 days) for 2008-2012 trials (overall median, 255 days [IQR, 177-350 days]; P < .001). For the top 10% of sites, median start-up time was 107 days (IQR, 95-121 days) for 2004-2007 trials vs 104 days (IQR, 84-118 days) for 2008-2012 trials (overall median, 106 days [IQR, 90-120 days]; P = .04). The median start-up time was shorter among sites using a central IRB (199 days [IQR, 140-292 days]) than those using a local IRB (287 days [IQR, 205-390 days]; P < .001). Conclusions and Relevance:This cohort study of North American research sites in large cardiovascular RCTs found a duration of nearly 9 months from the time of study protocol delivery to the first participant enrollment; this metric was only slightly shortened during the study period but was reduced to less than 4 months for top-performing sites. These findings suggest that the use of central IRBs has the potential to improve RCT efficiency.

Patients with coronavirus disease 2019 (COVID-19) are at heightened risk of venous thromboembolic events (VTE), though there is no data examining when these events occur following a COVID-19 diagnosis. We therefore sought to characterize the incidence, timecourse of events, and outcomes of VTE during the COVID-19 pandemic in a national healthcare system using data from Veterans Affairs Administration.

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Cardiac catheterization procedures have rapidly evolved and expanded in scope and techniques over the past few decades. However, although some practices have emerged based on evidence, many traditions have persisted based on beliefs and theoretical concerns. The aim of this review is to highlight common preprocedure, intraprocedure, and postprocedure catheterization laboratory practices where evidence has accumulated over the past few decades to support or discount traditionally held practices.

AIMS/OBJECTIVE:To model the safety and effectiveness of drug-coated stents (DCS) vs. bare-metal stents (BMS) in high bleeding risk (HBR) patients according to the Academic Research Criteria (ARC) criteria. METHODS AND RESULTS/RESULTS:Participants from the LEADERS FREE (LF) and LEADERS FREE (LFII) studies were pooled into one dataset. Participants were treated with 30 days of DAPT. The primary safety (composite of cardiac death, myocardial infarction, or stent thrombosis) and effectiveness (target-lesion revascularization) endpoints were compared between DCS and BMS in the subgroup of patients satisfying the ARC-HBR definition using propensity-score modelling. From the 3,635 participants included in the combined LF &amp; LFII dataset, 2,898 (79.7%) satisfied the ARC-HBR criteria (DCS: 1,923; BMS: 975). The primary safety endpoint occurred in 184 (9.8%) and in 132 (13.8%) participants in the DCS and BMS groups, respectively (adjusted HR: 0.72; 95% CI: 0.57-0.91; p=0.006). The risk of the primary effectiveness endpoint was also significantly lower with DCS (6.2%) vs. BMS (8.8%) (adjusted HR: 0.70; 95% CI: 0.52-0.94; p=0.016). Safety and effectiveness of DCS vs. BMS were consistent according to ARC-HBR status (p interaction = 0.206 and 0.260, respectively). CONCLUSIONS:DCS are safer and more effective than BMS in an ARC-defined HBR population.

Optimal treatment of stable ischemic heart disease for those in the transportation industry is considered in the context of the individual's health, as well as with the perspective that sudden impairment could have catastrophic consequences for others. This article focuses on two high risk occupations that one may encounter in practice: commercial motor vehicle drivers and commercial pilots. This article discusses coronary heart disease in patients in high risk occupations and covers current guideline recommendations for screening, treatment, and secondary prevention. The importance of the complimentary perspectives of the regulatory agency, medical examiners, physicians, and pilot or driver are considered in this narrative review, as are considerations for future guideline updates.