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

Area of Science:

• Cardiovascular Research
• Medical Device Trials
• Clinical Endpoints

Background:

• The 2007 endpoint definitions for coronary device trials required updates due to advancements in device technology and patient complexity.
• Novel devices like bioresorbable vascular scaffolds necessitate refined evaluation criteria.
• The evolving landscape of clinical trials and regulatory pathways demanded a consensus-based revision.

Purpose of the Study:

• To revise and update clinical and angiographic endpoint definitions for coronary device trials.
• To incorporate patient-related outcomes into clinical trial designs.
• To provide standardized, consensus-based definitions for evaluating cardiovascular devices.

Main Methods:

• Collaborative effort involving the Academic Research Consortium-2 (ARC-2), comprising academic research organizations, device manufacturers, and regulatory bodies from the US, Europe, and Asia.
• Multiple in-person meetings were conducted to discuss technological advancements, clinical trial evolution, and regulatory considerations over the past decade.
• A consensus-based approach was employed to derive and endorse the updated endpoint definitions.

Main Results:

• Revised clinical and angiographic endpoint definitions suitable for complex lesion and patient populations.
• Recommendations for integrating patient-related outcomes into coronary device trial protocols.
• Endorsement of consensus-based definitions by key stakeholders, including regulatory bodies.

Conclusions:

• The updated ARC-2 definitions offer enhanced standardization for coronary device trials.
• These definitions facilitate improved interpretation and comparison of trial outcomes.
• The revised endpoints will aid in a more robust evaluation of the safety and effectiveness of novel cardiovascular devices.