Sirolimus-eluting stent versus balloon angioplasty for sirolimus-eluting stent restenosis: Insights from the j-Cypher Registry.
BACKGROUND
Optimal treatment strategies for restenosis of sirolimus-eluting stents (SES) have not been adequately addressed yet.


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.
Abe
Mitsuru
M
National Cardiovascular Center, Suita, Japan.
Kimura
Takeshi
T
Morimoto
Takeshi
T
Taniguchi
Takuya
T
Yamanaka
Futoshi
F
Nakao
Kazuhiro
K
Yagi
Nobuhito
N
Kokubu
Nobuaki
N
Kasahara
Yoichiro
Y
Kataoka
Yu
Y
Otsuka
Yoritaka
Y
Kawamura
Atsushi
A
Miyazaki
Shunichi
S
Nakao
Koichi
K
Horiuchi
Kenji
K
Ito
Akira
A
Hoshizaki
Hiroshi
H
Kawaguchi
Ren
R
Setoguchi
Manabu
M
Inada
Tsukasa
T
Kishi
Koichi
K
Sakamoto
Hiroki
H
Morioka
Nobuyuki
N
Imai
Masao
M
Shiomi
Hiroki
H
Nonogi
Hiroshi
H
Mitsudo
Kazuaki
K
D054058:Acute Coronary Syndrome / Q000453:epidemiology; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000379:methods; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D023903:Coronary Restenosis / Q000188:drug therapy / Q000453:epidemiology / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods*; D011446:Prospective Studies; D012042:Registries; D006435:Renal Dialysis / Q000009:adverse effects; D012307:Risk Factors; D055502:Secondary Prevention; D020123:Sirolimus / Q000627:therapeutic use*
D020123:Sirolimus