Abstract 2831: Safety of the CYPHER® Sirolimus-eluting Stent under an Aspirin and Ticlopidine Regimen in Routine Clinical Practice: Interim Results from the Japanese Post-Marketing Surveillance Registry Mandated 8-Month Angiographic Follow-up
Background: At the time of approval there existed no clinical evidence of efficacy and safety of the CYPHER® Stent in Japanese patients. Additionally, in Japan Ticlopidine, not Clopidogrel, is the primary anti-platelet drug in use. A 5-year Post-Marketing Surveillance study of the CYPHER® Stent, a condition of regulatory approval, has been conducted since September 2004 on Japanese patients, as a real world registry.
Method: This is a prospective registry designed to evaluate the safety and efficacy of the CYPHER® Stent in routine clinical practice under Aspirin and Ticlopidine (200mg) as the primary dual anti-platelet therapy at 50 centers representative of the clinical environment nationwide. Target enrollment is 1000 cases/year, 2000 cases total over two years. Each center enrolls consecutive patients up to their allocated target; there are no exclusion criteria in order to reflect routine practice. The protocol specifies 8-month angiographic follow-up, and clinical follow-up at 3-month and annually out to 5 years. This registry is fully monitored.
Results: As of March 2006, 1987 patients with 2388 lesions treated with the CYPHER® Stent were enrolled. Mean age was 67.1 years, 43.6% had diabetes, 60.0% had a history of previous PCI and 80.6% had ACC/AHA Type B2/C lesions (30.6% had calcified lesions). One-year clinical follow-up data was available for 945 patients with 1124 lesions. Clinical events at one-year are presented below. Predictors of TLR were diabetes, dialysis and moderate/severe calcification.
Conclusions: This interim data suggests that CYPHER® Stent implantation under a ticlopidine regimen can be considered safe and is not associated with exaggerated incidence of clinical events and stent thrombosis out to one-year. 8-month angiographic and one-year clinical follow-up outcomes of well over 1000 patients enrolled will be presented.