The CLOSER trial: a multi-center study on the clinical safety and effectiveness of CloserTM VSS, a novel resorbable transfemoral vascular access sealing system.

OBJECTIVES: To evaluate the safety and effectiveness of the Closer Vascular Sealing System (VSS) against prespecified performance goals (PGs) in sealing femoral arterial access following 5-7 Fr procedures. BACKGROUND: Inconsistent safety profiles, costs and learning curves of earlier generation vascular closure devices have limited their widespread use following transfemoral procedures. METHODS: In this prospective single-arm, multi-center trial, we compared the clinical outcomes in patients undergoing 5-7 Fr transfemoral diagnostic or interventional procedures and access sites managed with Closer VSS against pre-specified PGs. The primary endpoints were time to hemostasis (TTH) and 30-day access site closure-related major complications; secondary endpoints included time to ambulation (TTA), time to discharge eligibility (TTDE), time to discharge (TTD), 30-day access site minor complications, procedure and device success. RESULTS: A total of 220 subjects (49.5% interventional) were enrolled. The mean TTH was 1.78 ± 7.81 min in the intention to treat and 0.98 ± 3.71 min in the per protocol cohort. Median TTH was 0 min with immediate hemostasis achieved in 80.5% of subjects, mean TTA was 2.50 ± 1.05 hr, and mean TTDE was 2.83 ± 1.54 hr. Thirty-day follow-up was completed on 219 subjects. There were no access site closure-related major complications, minor complication rate was 0.0% for diagnostic and 2.75% for interventional procedures. CONCLUSIONS: In patients undergoing 5-7 Fr transfemoral diagnostic and interventional procedures, the CLOSER Trial met both its primary effectiveness and safety PGs. Immediate hemostasis was achieved in the majority of patients without major complication.

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.

Comparison of pharmacokinetics of lanoteplase and alteplase during acute myocardial infarction.

OBJECTIVE: Lanoteplase is a rationally designed variant of tissue plasminogen activator. The aim of this study was to examine the pharmacokinetics and functional activity of a single intravenous bolus dose of lanoteplase with those of a bolus plus two-step infusion of alteplase. DESIGN: Seven-centre substudy of the InTIME-I angiographic trial in patients presenting within 6 hours of onset of suspected acute myocardial infarction. PATIENTS AND PARTICIPANTS: A total of 31 patients (28 males, 3 females) enrolled in this substudy [mean age 59 (range 26 to 76) years]. METHODS: Twenty-three patients randomised to lanoteplase received single bolus doses of 15 kU/kg (n = 5), 30 kU/kg (n = 3), 60 kU/kg (n = 9), or 120 kU/kg (n = 6). Eight patients received alteplase