A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients.

OBJECTIVES The RESPECT trial was aimed at evaluating safety/efficacy of a new extravascular closure system in diagnostic (Dx) and interventional (Ix) procedures performed through 6 or 7 Fr introducer sheaths. BACKGROUND Although vascular closure devices (VCDs) have been available for two decades, manual compression (MC) remains the standard of care in many institutions. VCDs have not been shown to have greater safety than MC. METHODS The RESPECT trial was a multicenter, randomized comparison of the Vascade VCD (Cardiva Medical, Inc) versus MC in Dx and Ix patients undergoing femoral access. Endpoints included time to hemostasis (TTH), time to ambulation (TTA), time to discharge eligibility (TTDe), device and procedure success, major and minor complications. Subjects were randomized 2:1 (Vascade vs MC). RESULTS A total of 420 patients were enrolled (211 Dx, 209 Ix). Mean age was 62 ± 11 years and 29% were female. For Ix Vascade/MC patients, 77%/69% received bivalirudin, 27%/26% received heparin, and 8%/3% received glycoprotein IIb/IIIa inhibitors, respectively. Patients were followed for 30 ± 7 days. A total of 415 subjects (98.8%) completed follow-up. TTH was 3.0 minutes (range, 0.6-31.6 minutes) for Vascade vs 20.0 minutes (range, 0.0-97.0 minutes) for MC; TTA was 3.2 hours (range, 1.0-78.0 hours) for Vascade vs. 5.2 hours (range, 1.7-22.8 hours) for MC; and TTDe was 3.6 hours (range, 1.4-78.4 hours) for Vascade vs. 5.7 hours (range, 2.2-23.2 hours) for MC. Device and procedure success rates were 98% for Vascade and 100% for MC. Minor events were 1.1% for Vascade and 7% for MC. No major access-site related complications were reported in either arm. CONCLUSION Despite high percentage of bivalirudin use, there were no major access-site related complications in either arm. Vascade use reduced rates of minor access-site related complications, and significantly shortened TTH, TTA, and TTDe compared to MC.