There is no strong evidence in the literature that the polymer type isolated (permanent or degradable) influences clinical outcomes after angioplasty and if the time of double anti-aggregation should be different with the degradable polymer. This work, with non-inferiority design, aimed to compare the sirolimus-eluting biodegradable polymer stent (Tivoli) versus the permanent polymer sirolimus-eluting stent (Firebird 2). The primary end point was a composite of cardiac death, myocardial infarction related to the vessel and target vessel revascularization.
2737 patients from 32 Chinese centers were randomized, demonstrating non-inferiority of the biodegradable polymer stent at 12 months with 6.3% events versus 6.1% of the permanent polymer stent. Comparing each component of the primary end point individually no significant differences were observed between the two devices.
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Bo Xu
2014-09-17
Original title: A Prospective, Randomized Trial of a Biodegradable Polymer, Cobalt Chromium, Sirolimus-Eluting Stent Versus a Durable Polymer, Cobalt Chromium, Sirolimus-Eluting Stent in Patients with Coronary Artery Disease.