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Ticagrelor monotherapy after PCI in patients with concomitant diabetes mellitus and chronic kidney disease: TWILIGHT DM-CKD.
Dehghani, Payam; Cao, Davide; Baber, Usman; Nicolas, Johny; Sartori, Samantha; Pivato, Carlo A; Zhang, Zhongjie; Dangas, George; Angiolillo, Dominick J; Briguori, Carlo; Cohen, David J; Collier, Timothy; Dudek, Dariusz; Gibson, Michael; Gil, Robert; Huber, Kurt; Kaul, Upendra; Kornowski, Ran; Krucoff, Mitchell W; Kunadian, Vijay; Mehta, Shamir; Moliterno, David J; Ohman, E Magnus; Escaned, Javier; Sardella, Gennaro; Sharma, Samin K; Shlofmitz, Richard; Weisz, Giora; Witzenbichler, Bernhard; Pocock, Stuart; Mehran, Roxana.
Affiliation
  • Dehghani P; Department of Cardiology, Prairie Vascular Research, Regina, Saskatchewan, Canada.
  • Cao D; Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029-6574, USA.
  • Baber U; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
  • Nicolas J; Department of Cardiology, the University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
  • Sartori S; Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029-6574, USA.
  • Pivato CA; Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029-6574, USA.
  • Zhang Z; Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029-6574, USA.
  • Dangas G; Cardio Center, IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy.
  • Angiolillo DJ; Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029-6574, USA.
  • Briguori C; Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029-6574, USA.
  • Cohen DJ; Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
  • Collier T; Department of Cardiology, Mediterranea Cardiocentro, Naples, Italy.
  • Dudek D; Cardiovascular Research Foundation, New York, NY, USA.
  • Gibson M; Department of Cardiology, St. Francis Hospital, Roslyn, NY, USA.
  • Gil R; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
  • Huber K; Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
  • Kaul U; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
  • Kornowski R; Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
  • Krucoff MW; 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Medical Faculty, Sigmund Freud University, Vienna, Austria.
  • Kunadian V; Heart Centre, Batra Hospital and Medical Research Centre, New Delhi, India.
  • Mehta S; Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.
  • Moliterno DJ; Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.
  • Ohman EM; Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
  • Escaned J; Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada.
  • Sardella G; Division of Cardiovascular Medicine, Gill Heart Institute, University of Kentucky, Lexington, KY, USA.
  • Sharma SK; Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.
  • Shlofmitz R; Department of Cardiology, Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain.
  • Weisz G; Department of Cardiology, Policlinico Umberto I University, Roma, Italy.
  • Witzenbichler B; Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029-6574, USA.
  • Pocock S; Department of Cardiology, St. Francis Hospital, Roslyn, NY, USA.
  • Mehran R; Division of Cardiology, NewYork Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA.
Eur Heart J Cardiovasc Pharmacother ; 8(7): 707-716, 2022 Sep 29.
Article in En | MEDLINE | ID: mdl-35325085
AIMS: We aimed to evaluate the treatment effects of ticagrelor monotherapy in the very high risk cohort of patients with concomitant diabetes mellitus (DM) and chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, after 3-month dual antiplatelet therapy with ticagrelor and aspirin post-PCI, event-free patients were randomized to either aspirin or placebo in addition to ticagrelor for 12 months. Those with available information on DM and CKD status were included in this subanalysis and were stratified by the presence or absence of either condition: 3391 (54.1%) had neither DM nor CKD (DM-/CKD-), 1822 (29.0%) had DM only (DM+/CKD-), 561 (8.9%) had CKD only (DM-/CKD+), and 8.0% had both DM and CKD (DM+/CKD+). The incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding did not differ according to DM/CKD status (P-trend = 0.13), but there was a significant increase in BARC 3 or 5 bleeding (P-trend < 0.001) as well as the key secondary endpoint of death, myocardial infarction, or stroke (P-trend < 0.001). Ticagrelor plus placebo reduced bleeding events compared with ticagrelor plus aspirin across all four groups, including DM+/CKD+ patients with respect to BARC 2-5 [4.5% vs. 8.7%; hazard ratio (HR) 0.49, 95% confidence interval (CI) 0.24-1.01] as well as BARC 3-5 (0.8% vs. 5.3%; HR 0.15, 95% CI 0.03-0.53) bleeding, with no evidence of heterogeneity. The risk of death, myocardial infarction, or stroke was similar between treatment arms across all groups. CONCLUSION: Irrespective of the presence of DM, CKD, and their combination, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischaemic events compared with ticagrelor plus aspirin.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Platelet Aggregation Inhibitors / Diabetes Mellitus / Renal Insufficiency, Chronic / Percutaneous Coronary Intervention / Ticagrelor Type of study: Clinical_trials / Diagnostic_studies Limits: Humans Language: En Journal: Eur Heart J Cardiovasc Pharmacother Year: 2022 Document type: Article Affiliation country: Country of publication:

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Platelet Aggregation Inhibitors / Diabetes Mellitus / Renal Insufficiency, Chronic / Percutaneous Coronary Intervention / Ticagrelor Type of study: Clinical_trials / Diagnostic_studies Limits: Humans Language: En Journal: Eur Heart J Cardiovasc Pharmacother Year: 2022 Document type: Article Affiliation country: Country of publication: