Key result
Sirolimus-eluting stent implantation in an unselected Japanese population was feasible and safe, with a major adverse cardiac event rate of 17.7% and an angiographic binary restenosis rate of 14.0%.
Observational (n=249)
No
Sirolimus-eluting stents demonstrate acceptable safety and efficacy with a 14.0% binary restenosis rate at 8 months in an unselected Japanese real-world population.
Answers are grounded in this paper and cite their sources.
Supports sirolimus-eluting stent safety in unselected Japanese patients; hypothesis-generating for broader adoption pending randomized trials.
BACKGROUND: Studies in Western countries have shown that sirolimus-eluting stents (SES) are clinically effective in the real world, but the detailed serial angiographic analyses are limited to some complex lesions. In addition, the efficacy of SES has not been fully investigated in a Japanese population. METHODS AND RESULTS: The study population consisted of 249 consecutive unselected patients who underwent percutaneous coronary intervention (PCI) with SES. Clinical and angiographic follow-up were evaluated at 8 months. Clinical follow-up was obtained in all patients and angiographic follow-up was obtained in 228 patients (91.6%) with 272 lesions (91.0%). Major adverse cardiac events were documented in 44 patients (17.7%). There were 2 stent thromboses within 24 h and 11 days after PCI (0.8%). Late lumen loss in the proximal edge, in-stent, and distal edge was 0.06+/-0.44 mm, 0.26+/-0.60 mm, and -0.05+/-0.30 mm, respectively. The rate of angiographic in-segment binary restenosis was 14.0% (proximal edge: 3.3%, in-stent: 10.7%, distal edge: 0.7%). By multivariate analysis, an increased risk of restenosis was significantly associated with hemodialysis, diabetes, lesion length, and impaired left ventricular ejection fraction. CONCLUSION: In accordance with previous reports, SES is considered to be feasible, safe and effective based on the results in an unselected Japanese population. ).
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Nakazawa et al. (2006) conducted an observational in Coronary artery disease requiring percutaneous coronary intervention (n=249). Sirolimus-eluting stents was evaluated on Major adverse cardiac events (MACE) at 8 months. Sirolimus-eluting stent implantation in an unselected Japanese population was feasible and safe, with a major adverse cardiac event rate of 17.7% and an angiographic binary restenosis rate of 14.0%.
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