Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute st-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the RESOLVE study.
BACKGROUND
Sirolimus-eluting stents (SES) with a biodegradable polymer coating have demonstrated promising results but have not been compared to SES with a durable polymer in high-risk patients. We compared the efficacy of these 2 stent types in patients with acute myocardial infarction (STEMI).


METHODS
One thousand one hundred ninety-two STEMI patients were randomized to receive SES coated with biodegradable (n = 596) or durable polymer (n = 596). The study end-point was the composite of major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction (MI), or target lesion revascularization (TLR) at 1-year follow-up. Secondary end-points included individual components of primary end-point and stent thrombosis.


RESULTS
Compared with durable polymer SES, the noninferiority of SES with biodegradable polymer coating was established by an absolute risk difference of 0.9% in the primary end-point (12.4% vs. 13.3%, P = 0.67) and an upper limit of one-sided 95% confidence interval (CI) of 2.96% (P for noninferiority = 0.001). Rate of death, recurrent MI, and TLR were 7.9% and 8.6% (HR: 0.92; 95% CI: 0.61-1.38, P = 0.67), 2.9% and 3.5% (HR: 0.80; 95% CI: 0.42-1.54, P = 0.51), and 2.0% and 3.2% (HR: 0.62; 95% CI: 0.30-1.30, P = 0.20) in the biodegradable polymer SES and durable polymer SES group at 1-year clinical follow-up, respectively. Despite similar rates of 30-day ARC definite/probable stent thrombosis, late stent thrombosis (stent thrombosis occurring beyond 30 days) was lower with biodegradable polymer SES (0.7% vs. 2.2%, P = 0.028).


CONCLUSIONS
In patients undergoing primary PCI for STEMI, the use of biodegradable polymer SES was associated with noninferior 1-year rates of MACE compared with durable polymer SES.
Department of Cardiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Qi
Q
Zhang
Jian Ping
JP
Qiu
Ajay J
AJ
Kirtane
Tian Qi
TQ
Zhu
Rui Yan
RY
Zhang
Zhen Kun
ZK
Yang
Jian
J
Hu
Feng Hua
FH
Ding
Run
R
DU
Wei Feng
WF
Shen
D020341:Absorbable Implants; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D020123:Sirolimus