Safety and efficacy of suture-mediated closure after percutaneous coronary interventions.

Percutaneous coronary interventions (PCI) performed with concomitant use of heparin and platelet inhibitors are safe procedures with reported vascular complication rates of approximately 6.1%. EPILOG investigators demonstrated that utilizing a low-dose heparin regimen with abciximab, along with early sheath removal, vascular access-related bleeding was significantly lower than that reported in EPIC. Recently, a suture-mediated closure (SMC) device has been reported to be safe, appears effective, and may improve patient comfort by allowing early ambulation. We conducted a retrospective analysis (January 1999 to March 2000) of complication frequencies among PCI patients who underwent SMC and those who had manual compression (non-SMC). Furthermore, we compared the overall rates of complications to patients who underwent PCI prior to the introduction of SMC (1995-1998). When comparing the current cohort to the historical cohort, there was a significant decrease in the number of retroperitoneal bleeds (0.3% vs. 0.9%; P = 0.003), hematomas (5% vs. 9%; P < 0.001), pseudoaneurysms (1.2% vs. 2.7%; P < 0.001), and need for vascular surgery (0.9% vs. 2.8%; P < 0.001). There was no difference in the number of arterio-venous fistulas and a slight increase in transfusion needs (12% vs. 10%; P = 0.03). Within the current cohort, there was no difference in the vascular complications between SMC and non-SMC PCI patients, although there were lower rates of pseudoaneurysms (0.5% vs. 1.8%; P = 0.02) and transfusion requirements (72/880 vs. 132/874; P < 0.001). These results suggest that the complication rates for SMC are not different and may be lower when compared to non-SMC patients after PCI. At our institution, the practice of early sheath removal and less aggressive heparin dosing has led to a decrease in vascular complication rates and a 66% reduction in vascular surgeries on post-PCI patients. Because of the limitations of retrospective analyses, further studies will be necessary to confirm these findings.

Randomized comparison of ticlopidine and clopidogrel after intracoronary stent implantation in a broad patient population.

BACKGROUND: Although clopidogrel is used to prevent subacute stent thrombosis, its safety and efficacy have not been compared with ticlopidine in a randomized manner in the United States. METHODS AND RESULTS: Patients with successful intracoronary stent implantation were randomly assigned to therapy with ticlopidine or clopidogrel. Loading doses were administered immediately after the procedure, and the drugs were prescribed for 2 weeks. One thousand sixteen patients were enrolled: 522 patients were randomly assigned to ticlopidine therapy and 494 to clopidogrel. High-risk characteristics included recent myocardial infarction in 41.4% of the cases, angiographically evident thrombus in 20.9%, and abrupt or threatened closure in 3.64%. An intravenous glycoprotein IIb/IIIa inhibitor was used in 48.2% of the cases, and thrombocytopenia occurred in 1.43% of these patients. Failure to complete 2 weeks of therapy occurred in 3.64% of the patients treated with ticlopidine and in 1.62% of the patients treated with clopidogrel (P=0.043). Within 30 days, thrombosis of the stent occurred in 1.92% of the patients in the ticlopidine group and in 2.02% of the clopidogrel group (P=0.901). A major adverse cardiac event occurred in 4.60% of patients receiving ticlopidine and in 3.85% of patients receiving clopidogrel (P=0.551). CONCLUSIONS: Clopidogrel is better tolerated than ticlopidine during a 2-week regimen after intracoronary stent implantation. Combining either thienopyridine with an intravenous platelet IIb/IIIa inhibitor appears to be safe. When applied to a broad spectrum of patients receiving stent implantation, clopidogrel confers similar protection as ticlopidine against subacute stent thrombosis and major adverse cardiac events.