Efficacy and safety of a biodegradable polymer sirolimus-eluting stent in primary percutaneous coronary intervention: a randomized controlled trial

Abstract

IntroductionWith long-term follow-up, whether biodegradable polymer drug-eluting stents (DES) is efficient and safe in primary percutaneous coronary intervention (PCI) remains a controversial issue. This study aims to assess the long-term efficacy and safety of DES in PCI for ST-segment elevation myocardial infarction (STEMI).Material and methodsA prospective, randomized single-blind study with 3-year follow-up was performed to compare biodegradable polymer DES with durable polymer DES in 332 STEMI patients treated with primary PCI. The primary end point was major adverse cardiac events (MACE) at 3 years after the procedure, defined as the composite of cardiac death, recurrent infarction, and target vessel revascularization. The secondary end points included in-segment late luminal loss (LLL) and binary restenosis at 9 months and cumulative stent thrombosis (ST) event rates up to 3 years.ResultsThe rate of the primary end points and the secondary end points including major adverse cardiac events, in-segment late luminal loss, binary restenosis, and cumulative thrombotic event rates were comparable between biodegradable polymer DES and durable polymer DES in these 332 STEMI patients treated with primary PCI at 3 years.ConclusionsBiodegradable polymer DES has similar efficacy and safety profiles at 3 years compared with durable polymer DES in STEMI patients treated with primary PCI.

Stent Thrombosis with Biodegradable Polymer Drug-Eluting Stents versus Durable Polymer Sirolimus-Eluting Stents: An Update Meta-Analysis

“…However, 6 studies [4,5,10,14,15,17] reported the incidence of early stent thrombosis: early stent thrombosis was diagnosed in 26 patients in the BP-DES group and in 19 patients in the DP-SES group. BP-DES was associated with a comparable rate of early stent thrombosis (OR, 1.36; 95% CI, 0.76-2.43; p = 0.30; I 2 = 22.9%) and late stent thrombosis (OR, 0.55; 95% CI, 0.26-1.08; p = 0.12; I 2 = 0.4%) compared with controls.…”

“…Incidence of very late stent thrombosis identified in the meta-analysis of 3 trials [4,14,17]. Fixed-effect model (I 2 = 0.0%; p = 0.98).…”

“…Eleven trials [4,5,10,11,12,13,14,15,16,17,18] randomized the participants. However, 1 trial did not report any details [10].…”

Systematic review/Meta-analysis Clinical outcomes of second- versus first-generation drug-eluting stents in patients with acute myocardial infarction: a meta-analysis of randomized controlled trials

“…A growing number of drug-eluting stents (DES) are used for treatment of acute myocardial infarction (AMI) during primary percutaneous coronary intervention (PCI) [ 1 , 2 ]. For these subjects with a highly thrombotic environment, the introduction of DES has greatly alleviated the major problem of in-stent restenosis in the bare-metal stent era [ 3 ].…”

“…found that the incidence of early stent thrombosis was similar for SES (1.1%) and PES (1.3%), but late stent thrombosis was more frequent with PES (1.8%) than with SES (1.4%) [ 5 ]. Late-acquired stent malapposition, incomplete stent endothelialisation, fibrin deposition and persistent inflammation have been suggested as responsible in the pathogenesis of DES thrombosis [ 1 , 7 ]. The SES-aspirate plasma induced more significant vasoconstriction than PES-aspirate.…”