Assessment of Sirolimus-Eluting Coronary Stent Implantation With Aspirin Plus Low Dose Ticlopidine Administration: One Year Results From CYPHER Stent Japan Post-Marketing Surveillance Registry (J-PMS)

• Published in: Circulation Journal 2009, Vol.73(6), pp.1038-1044
• Main Authors: Ikari, Yuji, Kotani, Junichi, Kozuma, Ken, Kyo, Eishou, Nakamura, Masato, Yokoi, Hiroyoshi, group, The J-PMS study
• Format: Article
• Language: English
• Subjects: Aged; Antiplatelet therapy; Aspirin - therapeutic use; Combined Modality Therapy; Coronary Angiography; Coronary disease; Coronary Thrombosis - diagnostic imaging; Coronary Thrombosis - pathology; Coronary Thrombosis - prevention & control; Coronary Vessels - diagnostic imaging; Coronary Vessels - pathology; Dose-Response Relationship, Drug; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Platelet Aggregation Inhibitors - therapeutic use; Product Surveillance, Postmarketing; Registries; Sirolimus; Thrombosis; Ticlopidine - therapeutic use; Treatment Outcome; Ultrasonography, Interventional
• ISSN: 1346-9843; 1347-4820
• DOI: 10.1253/circj.CJ-08-0732

Background: Clinical data of sirolimus-eluting stent (SES) implantation are under investigation in Japan. Methods and Results: The CYPHER stent Japan Post-Marketing Surveillance Registry (J-PMS) was conducted at 50 medical centers to assess the results of SES in daily clinical practice exclusively under aspirin plus low dose ticlopidine (200 mg/day). A total of 2,459 lesions in 2,054 patients were treated with 3,285 SES. The mean age was 67.1 ±10.1 years, 75.6% were men and 43.3% were diabetics. Intravascular ultrasound was used in 77.2%. The 8-month angiographic and 1-year clinical follow-up data were available in 85.4% and 96.8%, respectively. Quantitative coronary angiography showed the reference vessel diameter and percentage diameter stenosis at baseline were 2.47 ±0.58 mm and 72.0 ±16.1%. The 8-month late loss was 0.20 ±0.50 mm. The major adverse cardiovascular events at 1 year was 7.3%; cardiac death: 1.1%, myocardial infarction (MI): 1.2%, and target lesion revascularization (TLR): 4.2%. The rates of definite and probable stent thrombosis at 1 year were 0.30% and 0.10%, respectively. Hemodialysis was the strongest predictor of death/MI or TLR. Conclusions: J-PMS showed the effectiveness of SES implantation under aspirin plus low dose ticlopidine administration at 1 year, although further studies are necessary to demonstrate the safety. (Circ J 2009; 73: 1038-1044)