STACCATO (Assessment of Stent sTrut Apposition and Coverage in Coronary ArTeries with Optical coherence tomography in patients with STEMI, NSTEMI and stable/unstable angina undergoing everolimus vs. biolimus A9-eluting stent implantation): a randomised controlled trial

AIMS: To compare tissue coverage in coronary lesions stented with durable fluoropolymer-coated everolimus-eluting stents (EES) vs. biodegradable polymer-coated biolimus A9-eluting stents (BES). METHODS AND RESULTS: Sixty-four patients (64 lesions) with de novo coronary artery lesions were randomised to percutaneous treatment with XIENCE EES (Abbott Vascular, Santa Clara, CA, USA) vs. BioMatrix BES (Biosensors, Morges, Switzerland). The primary endpoint was the percentage of uncovered struts, as assessed with OCT, at nine months. The average percentage of uncovered struts was significantly lower with EES (4.3±4.8% vs. 8.7±7.8% with BES, p=0.019). There was no difference in the average percentage of malapposed struts at baseline (6.8±6.9% vs. 6.9±7.0%, respectively, p=0.974) and at follow-up (0.1±0.3% vs. 0.6±1.3%, p=0.143). Neointimal thickness at nine months was 109±43 µm in EES vs. 64±18 µm in BES (p<0.001), and angiographic LLL was 0.15 mm in EES vs. 0.10 mm in BES (p=0.581). We did not observe differences in the incidence of MACE and ST. CONCLUSIONS: A significantly higher percentage of uncovered struts was detected in the BioMatrix BES compared with the XIENCE EES at nine-month follow-up. Our findings do not support a preferential use of stents with biodegradable polymer-based biolimus elution to reduce the risk for ST.