Abstract
BackgroundsDrug-eluting stents (DES) with biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation DES. We aimed to determine the efficacy and safety of biodegradable polymer biolimus-eluting stents (BES) versus durable polymer DES.MethodsSystematic database searches of MEDLINE (1950 to June 2013), EMBASE (1966 to June 2013), the Cochrane Central Register of Controlled Trials (Issue 6 of 12, June 2013), and a review of related literature were conducted. All randomized controlled trials comparing biodegradable polymer BES versus durable polymer DES were included.ResultsEight randomized controlled trials investigating 11,015 patients undergoing percutaneous coronary interventions were included in the meta-analysis. The risk of major adverse cardiac events did not differ significantly between the patients treated with the biodegradable polymer BES and the durable polymer DES (Relative risk [RR], 0.970; 95% CI, 0.848–1.111; p = 0.662). However, biodegradable polymer BES was associated with reduced risk of very late ST compared with the durable polymer DES, while the risk of early or late ST was similar (RR for early or late ST, 1.167; 95% CI 0.755–1.802; p = 0.487; RR 0.273; 95% CI 0.115–0.652; p = 0.003; p for interaction = 0.003).ConclusionsIn this meta-analysis of randomized controlled trials, treatments with biodegradable polymer BES did not significantly reduce the risk of major adverse cardiac events, but demonstrated a significantly lower risk of very late ST when compared to durable polymer DES. This conclusion requires confirmation by further studies with long-term follow-up.PROSPERO register number http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004364#.UnM2lfmsj6J
Highlights
First-generation drug-eluting stents (DES) made of durable polymer are well-established for reducing the risk of restenosis and the need for repeat revascularization than bare metal stents (BMS) [1,2]
Data Sources and Searches We conducted a search of MEDLINE (1950 to June 2013) and EMBASE (1966 to June 2013) via EMBASE.com, and the Cochrane Central Register of Controlled Trials (Issue 6 of 12, June 2013) to identify all published randomized controlled trials (RCTs) that compared biodegradable polymer Biolimus-eluting stents (BES) with durable polymer DES
Eight full-text articles [16,17,18,25,26,27,28,29] and 2 meeting abstracts [30,31] investigating 8 RCTs were included in the meta-analysis, one of which is only available in the form of a meeting abstract
Summary
First-generation drug-eluting stents (DES) made of durable polymer are well-established for reducing the risk of restenosis and the need for repeat revascularization than bare metal stents (BMS) [1,2]. The durable polymer in these DES can cause hypersensitivity reactions and chronic inflammation in the vessel wall persistently after completed drug release, and may lead to delayed artery healing, incomplete re-endothelialization and artery remodeling, and very late stent thrombosis [5,6,7]. In order to overcome this issue, new DES platforms with biodegradable polymers have been developed [8] and early studies have demonstrated the these stents are feasible, safe, and effective both in short-term and long-term follow-up studies [9,10]. Biolimus is released gradually through biodegradable polymers, and the polymer will be absent from the vessel wall, decreasing the chance of persistent inflammation and thrombosis [15]
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