Early sheath removal after coronary artery interventions with use of a suture-mediated closure device: clinical outcome and results of Doppler US evaluation.

PURPOSE: To evaluate the safety and efficacy of a suture-mediated closure device by comparing clinical outcomes of its use to those of manual compression and by using Doppler ultrasound (US) examination.
MATERIALS AND METHODS: One hundred patients were randomized to treatment with either suture-mediated closure (n = 50) or manual compression (n = 50) after percutaneous transluminal coronary angioplasty (PTCA). The 50 patients randomized to receive suture-based treatment were allowed to get out of bed 4 hours after the procedure, whereas bed rest was required for 1 day in the patients treated with manual compression. All patients underwent clinical and US examination before getting out of bed and before discharge from the hospital.
RESULTS: Forty-seven of 50 patients randomized to undergo suture-mediated closure were ambulatory the day of intervention, in 6.2 hours +/- 4.7 (mean +/- SE) after undergoing PTCA. The results of the US examination for these patients demonstrated the absence of bleeding complications after getting out of bed. All patients treated with use of manual compression were ambulatory the following day, 18.3 hours +/- 2.2 after undergoing PTCA. There was no difference in the occurrence of vascular complications between the two groups.
CONCLUSION: Suture-based closure is a safe and effective method of achieving immediate hemostasis and shorter bed rest without increasing the risk of bleeding complications in PTCA procedures.

RCT Entities:   Population Interventions Outcomes