Randomised comparison of the efficacy and safety of a novelDES with biodegradable polymer and cobalt-chromium alloy -Inspiron I trial

ABSTRACT

Aims: The efficacy of a novel drug eluting stents with biodegradable polymer andcobalt-chromium alloy should be tested in the context of randomised trials, evenwhen using drugs known to be effective, such as sirolimus. The objective of thepresent study was to evaluate the safety and efficacy of a novel formulation of asirolimus-eluting stent with biodegradable polymer and cobalt-chromium alloyagainst a stent with the same metallic structure but without polymer coating or drugelution.Methods and results: The INSPIRON-I trial is a multicenter 2-arm randomisedtrial, conducted in 4 Brazilian institutions, which included 58 patients allocated forthe Inspiron sirolimus-eluting stent or the Cronus bare metal stent in a 21 ratio.Patients had de novo coronary lesions in native vessels with a diameter between2.5 and 3.5 mm, amenable for treatment with a single stent of 19 mm or less in length. The primary objective was to compare the in-stent late loss at 6 months of the sirolimus-eluting versus the control bare metal stent. Important secondary objectives included the comparison of major adverse cardiac events (MACE) ofdeath, myocardial infarction and target lesion revascularisation at 12 months. The study randomised 58 patients, 39 in the Inspiron group and 19 in the Cronusgroup. The great majority of the patients included had stable angina (76%).Baseline clinical and angiographic characteristics from both groups were similar, and 55.6% of the lesions were B2/C. The angiographic restudy at 6 months showed that percent diameter stenosis was significantly lower in the Inspiron group (15.8% vs. 38.7%, respectively; p=0.03), as well as late lumen loss (0.18 vs. 0.67 mm; p=0.009). Binary restenosis was also lower for Inspiron group, but without statistical difference (p=0.42)...