Kenneth Tandjung1, Hanim Sen1, Ming Kai Lam1, Mounir W Z Basalus1, J Hans W Louwerenburg1, Martin G Stoel1, K Gert van Houwelingen1, Frits H A F de Man1, Gerard C M Linssen2, Salah A M Saïd3, Mark B Nienhuis4, Marije M Löwik1, Patrick M J Verhorst1, Job van der Palen5, Clemens von Birgelen6. 1. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands. 2. Department of Cardiology, Ziekenhuisgroep Twente, Almelo, the Netherlands. 3. Department of Cardiology, Ziekenhuisgroep Twente, Hengelo, the Netherlands. 4. Department of Cardiology, Streekziekenhuis Koningin Beatrix, Winterswijk, the Netherlands. 5. Department of Epidemiology, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, the Netherlands. 6. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, MIRA-Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.
Abstract
OBJECTIVES: The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months. BACKGROUND: Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents. METHODS: The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694). RESULTS: Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00). CONCLUSIONS: After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650).
RCT Entities:
OBJECTIVES: The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months. BACKGROUND: Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents. METHODS: The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694). RESULTS: Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00). CONCLUSIONS: After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650).
Authors: Joseph P Drozda; Jove Graham; Joseph B Muhlestein; James E Tcheng; James Roach; Tom Forsyth; Stacey Knight; Andrew McKinnon; Heidi May; Natalia A Wilson; Jesse A Berlin; Edgar P Simard Journal: JAMIA Open Date: 2022-05-25
Authors: Eliano P Navarese; Kenneth Tandjung; Bimmer Claessen; Felicita Andreotti; Mariusz Kowalewski; David E Kandzari; Dean J Kereiakes; Ron Waksman; Laura Mauri; Ian T Meredith; Aloke V Finn; Hyo-Soo Kim; Jacek Kubica; Harry Suryapranata; Toni Mustahsani Aprami; Giuseppe Di Pasquale; Clemens von Birgelen; Elvin Kedhi Journal: BMJ Date: 2013-11-06