A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study) |
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Authors: | Jacek Legutko Wojciech Zasada Grzegorz L Kałuża Grzegorz Heba Lukasz Rzeszutko Jacek Jakala Jacek Dragan Artur Klecha Dawid Giszterowicz Wojciech Dobrowolski Łukasz Partyka Swaminathan Jayaraman Dariusz Dudek |
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Institution: | aDepartment of Interventional Cardiology, Jagiellonian University, Krakow, Poland;bDepartment of Invasive Cardiology, Electrotherapy and Angiology, Intercard, Nowy Targ, Poland;cDepartment of Invasive Cardiology, Electrotherapy and Angiology, Intercard, Nowy Sącz, Poland;dKrakow Cardiovascular Research Institute, Krakow, Poland;eCardiovascular Research Foundation, New York, NY, USA;fVascular Concepts Limited, UK |
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Abstract: | AimsEvaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform.Methods and resultsSafety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm.At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up.ConclusionsIn this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up. |
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Keywords: | DES IVUS QCA PF"} {"#name":"keyword" "$":{"id":"kwrd0030"} "$$":[{"#name":"text" "_":"polymer-free EEM"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"external elastic membrane |
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