{"id":"5aa81beff7dd","type":"article","url":"https://hartvaat.nl/2020/03/26/polymer-versus-polymeervrije-stents-bij-hoog-bloedingsrisico-nejm-leaders-free-2/","title":"Polymer- versus polymeervrije stents bij hoog bloedingsrisico: NEJM LEADERS FREE 2","title_en":"Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1910021","source_url":"https://doi.org/10.1056/NEJMoa1910021","authors":["Stephan Windecker","Azeem Latib","Elvin Kedhi","Ajay J Kirtane","David E Kandzari","Roxana Mehran","Matthew J Price","Alexandre Abizaid","Daniel I Simon","Stephen G Worthley","Azfar Zaman","Martin Hudec","Petra Poliacikova","A Kahar Bin Abdul Ghapar","Kamaraj Selvaraj","Ivo Petrov","Darren Mylotte","Eduardo Pinar","Raul Moreno","Franco Fabbiocchi","Sanjeevan Pasupati","Hyo-Soo Kim","Adel Aminian","Charles Tie","Adrian Wlodarczak","Seung-Ho Hur","Steven O Marx","Ivana Jankovic","Sandeep Brar","Lisa Bousquette","Minglei Liu","Gregg W Stone"],"significance":7,"published":"2020-03-26","source_date":"2020-03-26","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/mitraclip-transcatheter-mitralisreparatie/","https://hartvaat.nl/kennis/antistolling/doac-versus-vka-keuze/"],"congress":"","summary_en":"This NEJM trial compared polymer-based with polymer-free drug-coated stents in patients at high bleeding risk, evaluating whether newer polymer-free designs with ultra-short DAPT provide comparable outcomes.","created":"2026-07-03T10:28:29Z","updated":"2026-07-03T13:27:39Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM gerandomiseerde trial van polymer-gebaseerde versus polymeervrije stents bij patiënten met hoog bloedingsrisico.","abstract_original":"BACKGROUND: Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority). CONCLUSIONS: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.)."}