Author + information
- Received February 5, 2020
- Revision received March 5, 2020
- Accepted March 9, 2020
- Published online March 30, 2020.
- George Dangas, MD, PhD1,
- Usman Baber, MD, MS1,
- Samin Sharma, MD1,
- Gennaro Giustino, MD1,
- Shamir Mehta, MD, MSc2,
- David Cohen, MD, MSc3,
- Dominick Angiolillo, MD, PhD4,
- Samantha Sartori, PhD1,
- Rishi Chandiramani, MD1,
- Carlo Briguori, MD, PhD5,
- Dariusz Dudek, MD, PhD6,7,
- Javier Escaned, MD, PhD8,
- Kurt Huber, MD9,
- Timothy Collier, MSc10,
- Ran Kornowski, MD11,
- Vijay Kunadian, MBBS, MD12,
- Upendra Kaul, MD13,
- Keith Oldroyd, MBChB, MD (Hons)14,
- Gennaro Sardella, MD15,
- Richard Shlofmitz, MD16,
- Bernhard Witzenbichler, MD17,
- Han Ya-Ling, MD, PhD18,
- Stuart Pocock, PhD10,
- C. Michael Gibson, MD19 and
- Roxana Mehran, MD1,∗ ()
- 1The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States
- 2Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
- 3Kansas City, Missouri, United States
- 4Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, United States
- 5Mediterranea Cardiocentro, Naples, Italy
- 6Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland
- 7Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA), Italy
- 8Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain
- 93rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University, Medical Faculty, Vienna, Austria
- 10Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
- 11Cardiology Department, Rabin Medical Center, Petach, Tikva, Israel
- 12Translational 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
- 13Batra Hospital and Medical Research Center, New Delhi, India
- 14West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom
- 15Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy
- 16St. Francis Hospital, Roslyn, New York, United States
- 17Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany
- 18Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China
- 19Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States
- ↵∗Corresponding author: 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@Drroxmehran
Background Whether a regimen of ticagrelor monotherapy attenuates bleeding complications without increasing ischemic risk in patients undergoing complex percutaneous coronary intervention (PCI) is unknown.
Objectives To evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT trial.
Methods In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 lesions treated, total stent length >60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PCI, surgical bypass graft or chronic total occlusion as target lesions. Bleeding and ischemic endpoints were evaluated at 1 year after randomization.
Results Among 7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients. Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of BARC type 2, 3 or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38-0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21-0.80). There were no significant between-group differences in death, myocardial infarction or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52-1.15), nor in stent thrombosis.
Conclusions Among patients undergoing complex PCI who initially completed 3 months of ticagrelor plus aspirin, continuation of ticagrelor monotherapy was associated with lower incidence of bleeding without increasing the risk of ischemic events compared to continuing ticagrelor plus aspirin.
Dr. Dangas reports receiving consulting fees from Biosensors, Abbott Vascular Laboratories, Boston Scientific, and grant support, paid to his institution, from AstraZeneca, Bayer, Daiichi-Sankyo, and reports owning common stock of Medtronic (entirely divested); Dr. Baber reports receiving honoraria from AstraZeneca and Boston Scientific; Dr Giustino reports receiving consultant fees (Advisory Board) for Bristol-Myers-Squibb/Pfizer; Dr. Mehta reports receiving grant support from and serving on an executive committee and as site investigator for AstraZeneca; 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. 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. Escaned reports receiving consulting fees and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic, and lecture fees from Abiomed, Terumo, and Biosensors; Dr. Huber reports receiving lecture fees from AstraZeneca and Bayer; 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. 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, 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. Mehran reports receiving consulting fees from Abbott Vascular Laboratories, 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. The remaining authors have no disclosures.
Tweet: “Ticagrelor monotherapy reduces bleeding vs. ticagrelor plus aspirin, without increasing the risk of ischemic events in patients undergoing complex PCI”
Clinical trial: (ClinicalTrials.gov Identifier: NCT02270242)
- Received February 5, 2020.
- Revision received March 5, 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.