Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document

Abstract

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study

“…Moreover, there is a significant learning curve and one has to assume that the procedural skills from study centers are not easily transferable to other cardiac centers. Despite the generally accepted recommendation for endpoint definition [27], we used the cumulative mortality rate instead of the cumulative cardiac death rate to pay tribute to the observational, clinical routine setting of this study which was mandated by regulatory agencies. A control angiography would have to be mandatory to meet this criterion.…”

Ticagrelor Monotherapy in Patients with Concomitant Diabetes Mellitus and Chronic Kidney Disease: A post Hoc Analysis of The GLOBAL LEADERS Trial

“…The site-reported MI was de ned according to the Third Universal Myocardial Infarction de nition, as pre-speci c in the study protocol [13]. The patient-oriented composite endpoint (POCE) -advocated by Academic Research Consortium (ARC)-2, and net adverse clinical events (NACE) were explored up to two years [17,19]. [19], whereas NACE combined POCE with BARC type 3 or 5 bleeding events.…”

“…The patient-oriented composite endpoint (POCE) -advocated by Academic Research Consortium (ARC)-2, and net adverse clinical events (NACE) were explored up to two years [17,19]. [19], whereas NACE combined POCE with BARC type 3 or 5 bleeding events. Composite endpoints were analyzed hierarchically and the individual components of the composite endpoints were reported non-hierarchically.…”

First‐in‐man study of a thinner‐strut sirolimus‐eluting bioresorbable scaffold (FUTURE‐I): Three‐year clinical and imaging outcomes

“…The primary endpoint was target lesion failure (TLF) at 30 days, defined as a composite of cardiac death, target vessel myocardial infarction (MI), or ischemia‐driven target lesion revascularization (ID‐TLR). Secondary endpoints included acute success, patient‐oriented composite endpoint (PoCE, defined as composite of all death, all MI, or any revascularization), the individual components of TLF and PoCE; ischemia‐driven target vessel revascularization (ID‐TVR); and definite or probable scaffold thrombosis . Adverse clinical events were adjudicated by an independent group of cardiologists who were not involved in the index procedures from same institution.…”