Author + information
- Received February 4, 2020
- Revision received February 28, 2020
- Accepted March 9, 2020
- Published online March 30, 2020.
- Dominick J. Angiolillo, MD, PhD1,
- Usman Baber, MD, MS2,
- Samantha Sartori, PhD2,
- Carlo Briguori, MD, PhD3,
- George Dangas, MD, PhD2,
- David J. Cohen, MD, MSc4,
- Shamir R. Mehta, MD, MSc5,
- C. Michael Gibson, MD6,
- Rishi Chandiramani, MD2,
- Kurt Huber, MD7,
- Ran Kornowski, MD8,
- Giora Weisz, MD9,
- Vijay Kunadian, MBBS, MD10,
- Keith G. Oldroyd, MBChB, MD (Hons)11,
- Han Ya-Ling, MD, PhD12,
- Upendra Kaul, MD13,
- Bernhard Witzenbichler, MD14,
- Dariusz Dudek, MD, PhD15,16,
- Gennaro Sardella, MD17,
- Javier Escaned, MD, PhD18,
- Samin Sharma, MD2,
- Richard A. Shlofmitz, MD19,
- Timothy Collier, MSc20,
- Stuart Pocock, PhD20 and
- Roxana Mehran, MD2,∗ ()
- 1Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
- 2The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States
- 3Mediterranea Cardiocentro, Naples, Italy
- 4Kansas City, Missouri, United States
- 5Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
- 6Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States
- 73rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University, Medical Faculty, Vienna, Austria
- 8Cardiology Department, Rabin Medical Center, Petach Tikva, Israel
- 9Department of Cardiology, Montefiore Medical Center, The Bronx, New York, United States
- 10Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom
- 11West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom
- 12Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China
- 13Batra Hospital and Medical Research Center, New Delhi, India
- 14Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany
- 15Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland
- 16Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy
- 17Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy
- 18Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain
- 19St. Francis Hospital, Roslyn, New York, United States
- 20Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
- ↵∗Address for correspondence: Roxana Mehran, MD Center for Interventional Cardiovascular Research and Clinical Trials The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai One Gustave L. Levy Place, Box 1030 New York, New York 10029-6574 Tel: +1 (212) 659-9649; Fax: +1 (646) 537-8547 Twitter: @Drroxmehran
Background P2Y12 inhibitor monotherapy with ticagrelor after a brief period of dual antiplatelet therapy can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with diabetes mellitus (DM) remains unknown.
Objectives To examine the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with DM undergoing PCI.
Methods This was a pre-specified analysis of the DM cohort in the TWILIGHT trial. After 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke.
Results Patients with DM comprised 37% (n=2620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of BARC 2, 3 or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (HR 0.65; 95% CI 0.47-0.91; p=0.012). Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs 5.9%; HR 0.77; 95% CI 0.55 to 1.09; p=0.14). In the overall trial population, there was no significant interaction between DM status and treatment group for the primary bleeding or ischemic endpoints.
Conclusions Compared with ticagrelor plus aspirin, the effect of ticagrelor monotherapy in reducing the risk of clinically relevant bleeding without any increase in ischemic events was consistent among patients with or without DM undergoing PCI.
Disclosures: Dr. Angiolillo reports receiving grant support, consulting fees, and honoraria from Amgen, Aralez, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi Sankyo, Eli Lilly, Janssen, Merck, and Sanofi, consulting fees and honoraria from Haemonetics, PhaseBio, PLx Pharma, Pfizer, and the Medicines Company, grant support and fees for review activities from CeloNova, fees for review activities from St. Jude Medical, and grant support from CSL Behring, Eisai, Gilead, Idorsia Pharmaceuticals, Matsutani Chemical Industry, Novartis, Osprey Medical, and RenalGuard Solutions; Dr. Baber reports receiving honoraria from AstraZeneca, Boston Scientific and Amgen Inc.; Dr. Dangas reports receiving consulting fees and advisory board fees from AstraZeneca, consulting fees from Biosensors, and previously holding stock in Medtronic; Dr. Cohen reports receiving grant support, paid to his institution, and consulting fees from AstraZeneca, Medtronic, Abbott Vascular, and Boston Scientific; and grant support, paid to his institution from AstraZeneca; Dr. Mehta reports receiving grant support from and serving on an executive committee and as site investigator for AstraZeneca; Dr. Gibson reports receiving grant support and consulting fees from Angel Medical, Bayer, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson, and Portola Pharmaceuticals, consulting fees from the Medicines Company, AstraZeneca, Eli Lilly, Gilead Sciences, Novo Nordisk, WebMD, UpToDate Cardiovascular Medicine, Amarin Pharma, Amgen, Boehringer Ingelheim, Chiesi, Merck, PharmaMar, Sanofi, Somahlution, Verreseon Corporation, Boston Scientific, Impact Bio, MedImmume, Medtelligence, MicroPort, PERT Consortium, and GE Healthcare, holding equity in nference, serving as chief executive officer of Baim Institute, and receiving grant support, paid to Baim Institute, from Bristol-Myers Squibb; Dr. Huber reports receiving lecture fees from AstraZeneca and Bayer; Dr. Weisz reports receiving grant support and advisory board fees from Corindus, advisory board fees from and holding equity in Filterlex, serving on advisory board for and holding options in Trisol, serving on advisory board for and holding options in Magenta, serving on advisory board for and holding options in Intratech, and receiving institutional grant support from Abbott, Ancora, CSI, and ShockWave; Dr. Kunadian reports receiving consulting fees/honoraria from Bayer, Amgen, Daiichi Sankyo, Abbott Vascular, AstraZeneca and major institutional research grant from AstraZeneca; Dr. Oldroyd reports receiving grant support and lecture fees from AstraZeneca and lecture fees from Biosensors, Abbott Vascular and GE; Dr. Escaned reports receiving consulting fees and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic, and lecture fees from Abiomed, Terumo, and Biosensors; Dr. Sharma reports relationships with Abbott Vascular (speaker bureau), Boston Scientific (speaker bureau and advisory board), and Cardiovascular Systems, Inc (speaker bureau); Dr. Mehran reports receiving consulting fees from Abbott Vascular, Boston Scientific, Medscape/WebMD, Siemens Medical Solutions, Phillips/Volcano/Spectranetics, Roviant Sciences, Sanofi Italy, Bracco Group, Janssen, and AstraZeneca, grant support, paid to her institution, from Bayer, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Osprey Medical, PLC/RenalGuard, and Abbott Vascular, grant support and advisory board fees, paid to her institution, from BMS, fees for serving on a data and safety monitoring board from Watermark Research Funding, advisory fees and lecture fees from Medintelligence (Janssen), and lecture fees from Bayer. All other authors report no conflicts of interest.
Source of Funding: Investigator-initiated grant from AstraZeneca
Tweet: “Ticagrelor monotherapy reduces bleeding vs. ticagrelor plus aspirin, without increasing the risk of ischemic events in diabetic patients undergoing PCI”
ClinicalTrials.gov number: NCT02270242
- Received February 4, 2020.
- Revision received February 28, 2020.
- Accepted March 9, 2020.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.