1. 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
- Author
-
Feng Hua Ding, Jian Ping Qiu, Tian Qi Zhu, Rui Yan Zhang, Qi Zhang, Run Du, Zhen Kun Yang, Ajay J. Kirtane, Jian Hu, and Wei Feng Shen M.D.
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Myocardial Infarction ,Electrocardiography ,Percutaneous Coronary Intervention ,Absorbable Implants ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,cardiovascular diseases ,Myocardial infarction ,Sirolimus ,business.industry ,Absolute risk reduction ,Stent ,Percutaneous coronary intervention ,Drug-Eluting Stents ,Middle Aged ,medicine.disease ,Confidence interval ,Surgery ,Treatment Outcome ,Conventional PCI ,Female ,Cardiology and Cardiovascular Medicine ,business ,Mace ,medicine.drug - Abstract
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. (J Interven Cardiol 2014;27:131–141)
- Published
- 2014
- Full Text
- View/download PDF