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).
BACKGROUND
Clinical data of sirolimus-eluting stent (SES) implantation are under investigation in Japan.


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.
Ikari
Yuji
Y
Tokai University School of Medicine, Isehara, Japan. ikari@is.icc.u-tokai.ac.jp
Kotani
Junichi
J
Kozuma
Ken
K
Kyo
Eishou
E
Nakamura
Masato
M
Yokoi
Hiroyoshi
H
D000368:Aged; D001241:Aspirin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing; D012042:Registries; D020123:Sirolimus; D013988:Ticlopidine / Q000627:therapeutic use*; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D010975:Platelet Aggregation Inhibitors; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus