Sirolimus-eluting stent versus balloon angioplasty for sirolimus-eluting stent restenosis: Insights from the j-Cypher Registry.

Abstract

BACKGROUND:

Optimal treatment strategies for restenosis of sirolimus-eluting stents (SES) have not been adequately addressed yet.

METHODS AND RESULTS:

During the 3-year follow-up of 12 824 patients enrolled in the j-Cypher registry, 1456 lesions in 1298 patients underwent target-lesion revascularization (TLR). Excluding 362 lesions undergoing TLR for stent thrombosis or TLR using treatment modalities other than SES or balloon angioplasty (BA), 1094 lesions with SES-associated restenosis in 990 patients treated with either SES (537 lesions) or BA (557 lesions) constituted the study population for the analysis of recurrent TLR and stent thrombosis after the first TLR. Excluding 24 patients with both SES- and BA-treated lesions, 966 patients constituted the analysis set for the mortality outcome. Cumulative incidence of recurrent TLR in the SES-treated restenosis lesions was significantly lower than that in the BA-treated restenosis lesions (23.8% versus 37.7% at 2 years after the first TLR; P<0.0001). Among 33 baseline variables evaluated, only hemodialysis was identified to be the independent risk factor for recurrent TLR by a multivariable logistic regression analysis. After adjusting for confounders, repeated SES implantation was associated with a strong treatment effect in preventing recurrent TLR over BA (odds ratio, 0.44; 95% confidence interval, 0.32 to 0.61; P<0.0001). The 2-year mortality and stent thrombosis rates between the SES- and the BA-treated groups were 10.4% versus 10.8% (P=0.4) and 0.6% versus 0.6%, respectively.

CONCLUSIONS:

Repeated implantation of SES for SES-associated restenosis is more effective in preventing recurrent TLR than treatment with BA, without evidence of safety concerns.

• Authors: Mitsuru Abe, Takeshi Kimura, Takeshi Morimoto, Takuya Taniguchi, Futoshi Yamanaka, Kazuhiro Nakao, Nobuhito Yagi, Nobuaki Kokubu, Yoichiro Kasahara, Yu Kataoka, Yoritaka Otsuka, Atsushi Kawamura, Shunichi Miyazaki, Koichi Nakao, Kenji Horiuchi, Akira Ito, Hiroshi Hoshizaki, Ren Kawaguchi, Manabu Setoguchi, Tsukasa Inada, Koichi Kishi, Hiroki Sakamoto, Nobuyuki Morioka, Masao Imai, Hiroki Shiomi, Hiroshi Nonogi, Kazuaki Mitsudo, j-Cypher Registry Investigators
• Journal: Circulation (Circulation) Vol. 122 Issue 1 Pg. 42-51 (Jul 06 2010) ISSN: 1524-4539 [Electronic] United States
• PMID: 20566954 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Sirolimus

Topics

• Acute Coronary Syndrome (epidemiology)
• Aged
• Aged, 80 and over
• Angioplasty, Balloon (adverse effects, methods)
• Coronary Angiography
• Coronary Artery Bypass (statistics & numerical data)
• Coronary Restenosis (drug therapy, epidemiology, surgery)
• Drug-Eluting Stents
• Female
• Follow-Up Studies
• Graft Occlusion, Vascular (epidemiology)
• Humans
• Japan
• Male
• Middle Aged
• Myocardial Revascularization (methods)
• Prospective Studies
• Registries
• Renal Dialysis (adverse effects)
• Risk Factors
• Secondary Prevention
• Sirolimus (therapeutic use)