Clinical endpoints in peripheral endovascular revascularization trials: a case for standardized definitions
N Diehm1, P M Pattynama, M R Jaff
1Swiss Cardiovascular Center, Division of Clinical and Interventional Angiology, Inselspital, University of Bern, Freiburgstrasse, Bern, Switzerland. diehm@gmx.ch
Summary
Standardized definitions are needed for peripheral arterial disease (PAD) revascularization trials. This consensus aims to improve consistency in clinical endpoint definitions for chronic lower limb ischemia, enhancing trial comparability and patient outcome evaluation.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Radiology
Background:
- Endovascular therapy is a growing treatment for peripheral arterial disease (PAD).
- Current studies lack uniform clinical endpoint definitions, hindering interpretation and comparison.
- Few studies report patient-centered outcomes in PAD treatment.
Purpose of the Study:
- To establish consensus on baseline and endpoint definitions for endovascular revascularization trials in chronic lower limb ischemia.
- To improve consistency and comparability of clinical trials in PAD.
- To facilitate evaluation of endovascular revascularization effectiveness and safety.
Main Methods:
- A multidisciplinary DEFINE Group reviewed existing literature.
- Consensus was reached through teleconferences and meetings.
- Input was gathered from regulatory bodies (FDA) and industry stakeholders.
Main Results:
- Proposed standard definitions for baseline and endpoints in chronic lower limb PAD trials.
- The consensus provides a framework for consistent trial design.
- Adherence to definitions will improve evaluation of endovascular revascularization techniques.
Conclusions:
- A consensus document on definitions was developed with input from medical, industry, and regulatory stakeholders.
- The proposed definitions are valuable for designing future clinical trials in chronic lower limb ischemia.
- These definitions will aid regulatory review and standardization of PAD research.
Related Concept Videos
01:21Peripheral Arterial Disease II: Clinical Manifestations and Diagnostic Evaluation
Clinical manifestationsPeripheral Arterial Disease (PAD) manifests through a range of symptoms, from the characteristic intermittent claudication to atypical presentations and severe complications in advanced stages. Intermittent claudication, a hallmark symptom of PAD, presents as exercise-induced muscle pain that typically resolves within minutes of rest. This pain is reproducible and stems from inadequate blood flow, leading to the accumulation of lactic acid produced during anaerobic...
01:27Peripheral Artery Disease III: Interprofessional Care
Peripheral Artery Disease (PAD) is characterized by narrowed arteries that diminish blood flow to the extremities. Effective management of PAD requires an interprofessional approach involving various healthcare professionals. The critical aspects of interprofessional care for PAD patients focus on risk factor modification, drug therapy, exercise therapy, nutrition therapy, critical limb ischemia care, and interventional radiology and surgical procedures.The primary treatment goal for PAD...