Effectiveness of a novel biodegradable polymer, sirolimus-eluting stent platform in percutaneous coronary intervention.

BACKGROUND: The purpose of this registry is to report the immediate and long-term safety and efficacy of the BIOTRONIK Orsiro stent in an unselected population during everyday practice. METHODS: Between May 2012 and June 2013, 246 consecutive coronary angioplasty procedures were performed using at least one Orsiro drug-eluting stent, in 225 patients and 303 lesions. RESULTS: Diabetes was present in 34.7% of patients. Procedures were non-elective percutaneous coronary intervention (PCI) in 17.1% of cases and acute coronary syndromes were 55.1%. Radial vascular access was used in 78% of cases, multivessel PCI was performed in 19.5% of the procedures. In 81.6% of cases lesions were B2/C type, 20.7% of procedures had bifurcation lesions. Procedural success was 99.6%. No acute thrombosis occurred. Clinical follow-up median period was 24.3 (+/-8.28) months and FU was available in 93.7% of patients. Death for any cause occurred in 11 patients (5.2%), 6 of them were non cardiac-related. Cardiac-related death rate was 2.4%. Two patients had in-stent restenosis. The overall target lesion failure rate was 3.3%. CONCLUSIONS: This observational data regards our experience with BIOTRONIK Orsiro stent in an unselected population. This initial data, although limited by a mainly clinical follow-up and restricted number of patients, confirms the good clinical performance of this sirolimus-eluting stent with a biodegradable polymer in everyday practice, including complex lesions, according to current larger studies in the literature.