Author + information
- Received November 13, 2015
- Revision received March 10, 2016
- Accepted April 11, 2016
- Published online July 11, 2016.
- Usman Baber, MD, MSa,
- George Dangas, MD, PhDa,
- Jaya Chandrasekhar, MBBSa,
- Samantha Sartori, PhDa,
- Philippe Gabriel Steg, MDb,
- David J. Cohen, MD, MScc,
- Gennaro Giustino, MDa,
- Cono Ariti, MScd,
- Bernhard Witzenbichler, MDe,
- Timothy D. Henry, MDf,
- Annapoorna S. Kini, MDa,
- Mitchell W. Krucoff, MDg,
- C. Michael Gibson, MDh,
- Alaide Chieffo, MDi,
- David J. Moliterno, MDj,
- Giora Weisz, MDk,
- Antonio Colombo, MDi,
- Stuart Pocock, PhDd and
- Roxana Mehran, MDa,∗ ()
- aIcahn School of Medicine at Mount Sinai, New York, New York
- bUniversité Paris-Diderot, Sorbonne Paris-Cité, Paris, France
- cSt. Luke's Mid America Heart Institute, University of Missouri–Kansas City, Kansas City, Missouri
- dLondon School of Hygiene and Tropical Medicine, London, United Kingdom
- eHelios Amper-Klinikum, Dachau, Germany
- fCedars-Sinai Medical Center, Los Angeles, California
- gDuke University School of Medicine, Durham, North Carolina
- hDivision of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- iCardio-Thoracic Department, San Raffaele Scientific Institute, Milan, Italy
- jUniversity of Kentucky, Lexington, Kentucky
- kShaare Zedek Medical Center, Jerusalem, Israel
- ↵∗Reprint requests and correspondence:
Dr. Roxana Mehran, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
Objectives The aim of this study was to examine the independent associations between actionable bleeding (AB) and coronary thrombotic events (CTE) on mortality risk after percutaneous coronary intervention (PCI).
Background The independent impact of AB and CTE on mortality risk after PCI remains poorly characterized.
Methods A post hoc analysis was conducted of the PARIS (Patterns of Non-Adherence to Dual Antiplatelet Therapy in Stented Patients) registry, a real-world cohort of 5,018 patients undergoing PCI with stent implantation. CTE included definite or probable stent thrombosis or myocardial infarction. AB was defined as Bleeding Academic Research Consortium type 2 or 3. Associations between CTE and AB, both of which were modeled as time-dependent covariates, and 2-year mortality risk were examined using extended Cox regression.
Results Over 2 years, the cumulative incidence of CTE, AB, and all-cause mortality was 5.9% (n = 289), 8.1% (n = 391), and 4.7% (n = 227), respectively. Adjusted hazard ratios for mortality associated with CTE and AB were 3.3 (95% confidence interval: 2.2 to 4.9) and 3.5 (95% confidence interval: 2.3 to 5.4), respectively. Temporal gradients in risk after either event were highest in the first 30 days and declined rapidly thereafter. Thrombotic events occurring while patients were on versus off dual-antiplatelet therapy were associated with a higher mortality risk, whereas risk related to AB was not influenced by dual-antiplatelet therapy status at the time of bleeding.
Conclusions Intracoronary thrombosis and AB are associated with mortality risks of comparable magnitude over a 2-year period after PCI, findings that might inform risk/benefit calculations for extension versus discontinuation of dual-antiplatelet therapy.
This study was funded by Bristol-Myers Squibb and Sanofi. Dr. Dangas has received consulting fees and honoraria from Johnson & Johnson, Sanofi, Covidien, The Medicines Company, Merck, CSL Behring, AstraZeneca, Medtronic, Abbott Vascular, Bayer, Boston Scientific, Osprey Medical, and GE Healthcare; and research grant support from Sanofi, Bristol-Myers Squibb, and Lilly/Daiichi Sankyo. Dr. Steg has served as an adviser or a consultant for Amarin, AstraZeneca Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Eli Lilly, Medtronic, Otsuka Pharmaceutical, Pfizer, Roche, Sanofi, Servier, Takeda Pharmaceuticals North America, The Medicines Company, and Vivus; and has received clinical research grants from Sanofi and Servier. Dr. Cohen has received research grant support from Abbott Vascular, AstraZeneca, Biomet, Boston Scientific, Cardiovascular Systems, Daiichi Sankyo, Edwards Lifesciences, Eli Lilly, and Medtronic; and is a consultant for Abbott Vascular, Medtronic, and Merck. Dr. Henry has received research grant support from Eli Lilly and Daiichi Sankyo. Dr. Kini serves on the Speakers Bureau of the American College of Cardiology; and has received consulting fees from WebMD. Dr. Krucoff has received consulting fees from Abbott Vascular, Abbott, OrbusNeich, Angelmed, Volcano, Biosensors, Svelte, Medtronic, and Terumo; and research grant support from Abbott, Terumo, Angelmed, Ikaria, OrbusNeich, Medtronic, CSI, Eli Lilly, and Medtronic. Dr. Gibson has received research grant support from Angel Medical Corporation, Atrium Medical Systems, Bayer, Ikaria, Janssen/Johnson & Johnson, Lantheus Medical Imaging, Merck, Portola Pharmaceuticals, Roche Diagnostics, Sanofi, Stealth Peptides, St. Jude Medical, Volcano, and Walk Vascular; consulting fees from AstraZeneca, Baxter Healthcare, Bayer, CRF, Consensus Medical Communications, CSL Behring, Cytori Therapeutics, Eli Lilly/Daiichi Sankyo, Exeter Group, Genentech, GlaxoSmithKline, Janssen/Johnson & Johnson, Ortho McNeil, St. Jude Medical, The Medicines Company; and royalty fees from UpToDate in Cardiovascular Medicine. Dr. Colombo has received consulting fees and honoraria from CID and other financial benefit from Direct Flow Medical. Dr. Mehran has received institutional grant support from The Medicines Company, Bristol-Myers Squibb/Sanofi, and Eli Lilly/Daiichi Sankyo; and is a consultant to Janssen Pharmaceuticals and Maya Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 13, 2015.
- Revision received March 10, 2016.
- Accepted April 11, 2016.
- American College of Cardiology Foundation