Maayan Konigstein1, Ori Ben-Yehuda2, Pieter C Smits3, Michael P Love4, Shmuel Banai5, Gidon Y Perlman6, Mordechai Golomb7, Melek Ozgu Ozan7, Mengdan Liu7, Martin B Leon2, Gregg W Stone2, David E Kandzari8. 1. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel. 2. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. 3. Maasstad Ziekenhuis, Rotterdam, the Netherlands. 4. University of Manitoba, St. Boniface General Hospital, Winnipeg, Manitoba, Canada. 5. Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel. 6. Hadassah Hebrew University Medical Center, Jerusalem, Israel; Medinol Ltd., Tel Aviv, Israel. 7. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 8. Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org.
Abstract
OBJECTIVES: The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial. BACKGROUND: Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI). METHODS: A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years. RESULTS: The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients. CONCLUSIONS: Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.
RCT Entities:
OBJECTIVES: The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial. BACKGROUND:Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI). METHODS: A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years. RESULTS: The overall prevalence of DM was 29.1% (559 of 1,919). DMpatients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabeticpatients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabeticpatients compared with nondiabeticpatients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients. CONCLUSIONS: Despite advances in interventional therapies, and the implementation of new-generation DES, diabeticpatients still have worse angiographic and clinical outcomes compared with nondiabeticpatients undergoing PCI.
Authors: Eline H Ploumen; Tineke H Pinxterhuis; Paolo Zocca; Ariel Roguin; Rutger L Anthonio; Carl E Schotborgh; Edouard Benit; Adel Aminian; Peter W Danse; Carine J M Doggen; Clemens von Birgelen; Marlies M Kok Journal: Cardiovasc Diabetol Date: 2021-10-30 Impact factor: 9.951
Authors: Nousjka P A Vranken; Saman Rasoul; Jasper J P Luijkx; Tobias F S Pustjens; Sonja Postma; Evelien J Kolkman; Elvin Kedhi; Sodiqur Rifqi; Michael K Y Lee; Henning Ebelt; Béla Merkely; Monica Verdoia; Wojtek Wojakowski; Arnoud A W J van 't Hof; Harry Suryapranata; Giuseppe De Luca Journal: Diabetes Metab Res Rev Date: 2022-04-22 Impact factor: 8.128
Authors: T M Hommels; R S Hermanides; B Berta; E Fabris; G De Luca; E H Ploumen; C von Birgelen; E Kedhi Journal: Cardiovasc Diabetol Date: 2020-10-02 Impact factor: 9.951
Authors: Nicole D van Hemert; Rik Rozemeijer; Michiel Voskuil; Mèra Stein; Peter Frambach; Saskia Z Rittersma; Adriaan O Kraaijeveld; Geert E H Leenders; Pim van der Harst; Pierfrancesco Agostoni; Pieter R Stella Journal: Catheter Cardiovasc Interv Date: 2021-04-03 Impact factor: 2.585