Standardized definitions and clinical endpoints in trials investigating endovascular repair of aortic dissections.
OBJECTIVE
Endovascular therapy is a rapidly expanding option for the treatment of patients with aortic dissection (AD) and various studies have been published. These trials, however, are often difficult to interpret and compare because they do not utilize uniform clinical endpoint definitions.


METHODS
The DEFINE Group is a collaborative effort of an ad hoc multidisciplinary team from various specialties involved in AD therapy in Europe and the United States. DEFINE's goal was to arrive at a broad based consensus for baseline and endpoint definitions in trials for endovascular therapy of various vascular pathologies. In this project, which started in December 2006, the individual team members reviewed the existing pertinent literature. Following this, a series of telephone conferences and face-to-face meetings were held to agree upon definitions. Input was also obtained from regulatory (United States Food and Drug Administration) and industry (device manufacturers with an interest in peripheral endovascular revascularization) stakeholders, respectively.


RESULTS
These efforts resulted in the present document containing proposed baseline and endpoint definitions for clinical and morphological outcomes. Although the consensus has inevitably included certain arbitrary consensus choices and compromises, adherence to these proposed standard definitions would provide consistency across future trials, thereby facilitating evaluation of clinical effectiveness and safety of various endovascular revascularization techniques.


CONCLUSIONS
This current document is based on a broad based consensus involving relevant stakeholders from the medical community, industry and regulatory bodies. It is proposed that the consensus document may have value for study design of future clinical trials in endovascular AD therapy as well as for regulatory purposes.
Swiss Cardiovascular Center, Division of Clinical and Interventional Angiology, Inselspital, University of Bern, Switzerland. Electronic address: nicolas.diehm@insel.ch.
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Diehm
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Vermassen
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van Sambeek
D000784:Aortic Dissection / Q000401:mortality / Q000601:surgery*; D001011:Aorta / Q000473:pathology; D001014:Aortic Aneurysm / Q000401:mortality / Q000601:surgery*; D001018:Aortic Diseases / Q000150:complications; D001019:Aortic Rupture / Q000150:complications; D002986:Clinical Trials as Topic / Q000592:standards*; D057510:Endovascular Procedures / Q000009:adverse effects; D023381:Endpoint Determination / Q000592:standards*; D006406:Hematoma / Q000150:complications; D006801:Humans; D007511:Ischemia / Q000150:complications; D007668:Kidney / Q000098:blood supply; D035002:Lower Extremity / Q000098:blood supply; D019233:Retreatment; D013116:Spinal Cord / Q000098:blood supply; D020521:Stroke / Q000150:complications; D014456:Ulcer / Q000150:complications; D034941:Upper Extremity / Q000098:blood supply; D014654:Vascular Patency; D014781:Viscera / Q000098:blood supply
Endpoint definitions; Reporting standards; Standardization; Thoracic aortic dissection