A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.
| Autor: | de Winter RJ; Academic Medical Center, Amsterdam, Netherlands., Katagiri Y; Academic Medical Center, Amsterdam, Netherlands., Asano T; Academic Medical Center, Amsterdam, Netherlands., Milewski KP; Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji PAKS, American Heart of Poland SA, Tychy, Poland., Lurz P; Department of Internal Medicine and Cardiology, University of Leipzig-Heart Center, Leipzig, Germany., Buszman P; Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland., Jessurun GAJ; Department of Cardiology, Treant Zorggroep, Emmen, Netherlands., Koch KT; Academic Medical Center, Amsterdam, Netherlands., Troquay RPT; VieCuri Medical Center for Northern Limburg, Venlo, Netherlands., Hamer BJB; Meander Medisch Centrum, Amersfoort, Netherlands., Ophuis TO; Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands., Wöhrle J; Universitätsklinikum Ulm, Ulm, Germany., Wyderka R; Zgierskie Centrum Kardiologii Med-Pro, Zgierz, Poland., Cayla G; Department of Cardiology, CHU Nîmes, Université de Montpellier, Montpellier, France., Hofma SH; Medisch Centrum Leeuwarden, Leeuwarden, Netherlands., Levesque S; CHU de Poitiers, Poitiers, France., Żurakowski A; Małopolskie Centrum Sercowo-Naczyniowe PAKS, Chrzanow, Poland., Fischer D; Universitätsklinikum Münster, Münster, Germany., Kośmider M; Oddzial Kardiologiczny PAKS, Bełchatów, Poland., Goube P; CH Sud Francilien Corbeil Essonne, Corbeil Essonnes, France., Arkenbout EK; Department of Cardiology, Tergooi Hospital, Blaricum, Netherlands., Noutsias M; Department of Cardiology, Pneumonology and Intensive Care Medicine, Clinic for Internal Medicine I, University Hospital Jena, Friedrich-Schiller-University, Jena, Germany., Ferrari MW; Dr Horst Schmidt Kliniken Wiesbaden, Wiesbaden, Germany., Onuma Y; ThoraxCenter, Erasmus Medical Center, Rotterdam, Netherlands., Wijns W; Cardiovascular Research Center Aalst, Aalst, Belgium; National University of Ireland Galway, The Lambe Institute for Translational Medicine and CURAM, Galway, Ireland., Serruys PW; National Heart and Lung Institute, Imperial College London, London, UK. Electronic address: patrick.w.j.c.serruys@gmail.com. |
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| Jazyk: | angličtina |
| Zdroj: | Lancet (London, England) [Lancet] 2018 Feb 03; Vol. 391 (10119), pp. 431-440. Date of Electronic Publication: 2017 Dec 05. |
| DOI: | 10.1016/S0140-6736(17)33103-3 |
| Abstrakt: | Background: MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. Methods: We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Findings: Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference -0·8% [95% CI -3·3 to 1·8], p Interpretation: The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice. Funding: The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France). (Copyright © 2018 Elsevier Ltd. All rights reserved.) |
| Databáze: | MEDLINE |
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