Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions

Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark reduction in restenosis with sirolimus-eluting stents (Cypher, Cordis Corporation) compared to conventional bare metal stents in TCO. In the PRISON III trial, we observed similar favourable results with second-generation zotarolimus-eluting stent (Resolute, Medtronic Inc.). Another drugs-eluting stent mounted with everolimus (Xience Prime, Abbott) also demonstrated favourable results in TCO. Recently, drug-eluting stents (DES) with bioresorbable polymer coatings were developed, to address safety concerns regarding the observation of very late stent thrombosis, due to hypersensitivity reactions, and chronic inflammation, on the durable polymer coating of DES. However, none of these DES with bioresorbable polymers were evaluated in patients with TCO. The PRISON IV trial is a prospective, randomized, single-blinded, multi-center trial, designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (ORSIRO, Biotronik Inc.) compared to everolimus-eluting stents with durable polymers (Xience Prime, Abbott) in patients with successfully recanalized TCOs.

INCLUSION CRITERIA: * the estimated duration of the occlusion is at least 4 weeks. * signs of ischemia related to the occluded coronary artery. * successful recanalization of the occluded artery is achieved. * reference diameter is \> 2.5 mm. * written informed consent obtained. EXCLUSION CRITERIA: * primary or rescue PCI for acute myocardial infarction * the lesion could not be crossed. * lesions with complex anatomy making successful stent deployment unlikely. * the guide wire is not in the true lumen distal to the occlusion. * Sirolimus or zotarolimus allergy * venous or arterial bypass grafts * pregnant or nursing women. * participation in an other trial. * factors making long-term follow-up difficult or unlikely. * life expectancy \< 1 year. * contraindications for ASA or Clopidogrel or heparin. * use of coumadins that could not be stopped before the procedure.