Patients With Diabetes at High Bleeding Risk With 1-Month Dual Antiplatelet Therapy: Onyx ONE Clear Results.
Autor: | Kedhi E; University of Brussels, Brussels, Belgium.; Silesian Medical University, Katowice, Poland., Windecker S; University Hospital, University of Bern, Bern, Switzerland., Latib A; Montefiore Medical Center, New York, New York., Kirtane AJ; Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.; Cardiovascular Research Foundation, New York, New York., Kandzari D; Piedmont Heart Institute, Atlanta, Georgia., Mehran R; The Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York., Price MJ; Scripps Clinic, La Jolla, California., Abizaid A; Instituto do Coracao, São Paulo, Brazil., Simon DI; University Hospitals Cleveland Medical Center, Cleveland, Ohio., Zaman A; Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom., Fabbiocchini F; Centro Cardiologico Monzino IRCCS, Milano, Italy., Tie C; St Andrew's Hospital, Adelaide, Australia., van 't Hof A; Maastricht University Medical Center, Maastricht, the Netherlands., de la Torre Hernandez JM; Marques de Valdecilla University Hospital, IDIVAL Santander, Spain., Hammett CJ; Royal Brisbane and Women's Hospital, Brisbane, Australia., McLaurin B; AnMed Health Medical Center, Anderson, South Carolina., Potluri S; The Heart Hospital Baylor Plano, Plano, Texas., Smith T; The Christ Hospital, Cincinnati, Ohio., Waksman R; MedStar Washington Hospital Center, Washington, DC., Ragosta M; University of Virginia Medical Center, Charlottesville, Virginia., Parke M; Medtronic, Santa Rosa, California., Lung TH; Medtronic, Santa Rosa, California., Stone GW; Cardiovascular Research Foundation, New York, New York.; The Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. |
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Jazyk: | angličtina |
Zdroj: | Journal of the Society for Cardiovascular Angiography & Interventions [J Soc Cardiovasc Angiogr Interv] 2022 Aug 25; Vol. 1 (5), pp. 100441. Date of Electronic Publication: 2022 Aug 25 (Print Publication: 2022). |
DOI: | 10.1016/j.jscai.2022.100441 |
Abstrakt: | Background: Patients with diabetes mellitus (DM) are at a higher risk of ischemic events compared with patients without DM. Percutaneous coronary intervention (PCI) with the Resolute Onyx zotarolimus-eluting stent (ZES) followed by 1-month dual antiplatelet therapy (DAPT) is safe and effective in patients with high bleeding risk. However, outcomes in patients with DM are not fully understood. Methods: Onyx ONE Clear was a prospective, multicenter study that included patients receiving the Resolute Onyx ZES during PCI and 1-month DAPT. The primary end point was a composite of cardiac death (CD) or myocardial infarction from 1 month to 12 months. Results: Among the Onyx ONE Clear population (N = 1506), 39% had DM. Patients with DM had a higher incidence of hypertension, hyperlipidemia, and previous PCI and a higher body mass index than patients without DM. Patients with diabetes were also younger, more likely to be anemic, and experience renal failure. After adjusting for baseline differences between the groups, the Kaplan-Meier rates of CD or myocardial infarction (9.3% vs 6.1%; P = .122, unadjusted P = .010) and target lesion failure (10.2% vs 7.7%; P = .294, unadjusted P = .056) between 1 month and 12 months were not significantly different in patients with and without DM. The rates of target lesion revascularization were also similar in both groups, and stent thrombosis was very low and comparable in both arms after adjusting for baseline differences. Non-CD and bleeding were more frequent in patients with DM. Conclusions: Patients with diabetes treated with the Resolute Onyx ZES followed by 1-month DAPT had favorable 12-month ischemic outcomes after accounting for baseline differences between patients with and without DM, supporting the safety and efficacy of the treatment in selected patients with DM at high bleeding risk. (© 2022 Medtronic.) |
Databáze: | MEDLINE |
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