The ProLimus trial: a prospective, non-randomised, multicentre trial to evaluate the safety and clinical performance of the pimecrolimus eluting stent system (ProGenic).

Aims: The aim of this multicentre, non-randomised trial was to evaluate the safety and efficacy at 180+/-14 days of a pimecrolimus eluting coronary stent based on a cobalt-chromium platform and a poly-L-lactic acid (PLLA) bioresorbable polymer. Methods and results: Sixty-one patients, with single de nova coronary lesions <14mm in length and a reference vessel diameter of 3.0 to 3.5 mm, were enrolled in five centres (Germany and Belgium). Angiography and IVUS were performed at baseline, post-procedure and 180+/-14 days later. The primary endpoint was a composite of major adverse cardiac events (MACE) at 180+/-14 days and expected to be below 20%. Patients had single vessel disease in 59%, 2-vessel disease in 28% and 3-vessel disease in 13% of cases. MACE rate at 180+/-14 days was 18.0%. Binary in-stent restenosis was 32.7% due to in-stent late lumen loss of 1.11+/-0.65 mm by QCA. Stent thrombosis rate at 30+/-7 and 180+/-14 days was 1.6% and 3.3%, respectively. Overall TLR rate at 30 7, 180+/-14 days and 12+/-1 months was 1.6%, 27.9% and 32.8% respectively. Conclusions: The primary endpoint was met at 180+/-14 days. However, the anti-restenotic effect of the pimecrolimus eluting stent did not reach levels similar to clinically established DES.