Why the study?
Does a biolimus-eluting stent with biodegradable polymer improve clinical outcomes compared to an everolimus-eluting stent with durable polymer in patients undergoing PCI for de novo lesions?
Does a biolimus-eluting stent with biodegradable polymer improve clinical outcomes compared to an everolimus-eluting stent with durable polymer in patients undergoing PCI for de novo lesions?
Biolimus-eluting stents with biodegradable polymers demonstrate similar 12-month safety and efficacy compared to everolimus-eluting stents with durable polymers for de novo coronary lesions.
Supports stent selection by factors other than 12-month outcomes; extends randomized evidence for biodegradable-polymer biolimus-eluting stents.
INTRODUCTION: Drug-eluting stents (DES) have significantly decreased the need for repeat coronary revascularization but concerns remain regarding the safety of first and second generation DES. We compared the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with an everolimus-eluting stent (with durable polymer) one. METHODS: We performed a randomized trial to compare the two types of stents. Two hundred patients undergoing PCI for de novo lesions were randomly assigned 1:1 to treatment with either biolimus-eluting (BioMatrix) or everolimus -eluting (Xience V) stent. The primary endpoint was a composite of cardiac death, myocardial infarction, and clinically driven target vessel revascularization within 12 months. RESULTS: Demographics, clinical, and lesion characteristic were comparable between two groups. The 30-day major adverse car-diac event (MACE) rate was 2% in BioMatrix group versus 0% in Xience group (p > 0.05). After 12 months, the rates of cardiac death (0% in both groups), MI (2% versus 0%, p=0.49) and clinically -driven target vessel revascularization (0% in both groups) were similar for BioMatrix and Xience. No stent thrombosis was reported at 1, 6, 9 or 12 months after intervention in either group. CONCLUSION: BES (Biolimus-eluting stent) with biodegradable polymer and EES (Everolimus-eluting stent) with durable polymer appear similar with respect to MACE and stent thrombosis in this patient population. Many studies with longer follow up are needed to define better the role of BES with biodegradable polymer in treatment of coronary artery lesions.
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Separham et al. (2011) studied this question.
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