Author + information
- Received February 24, 2016
- Revision received March 29, 2016
- Accepted April 7, 2016
- Published online July 25, 2016.
- Sorin J. Brener, MDa,∗ (, )
- Ajay J. Kirtane, MD, SMb,c,
- Thomas D. Stuckey, MDd,
- Bernhard Witzenbichler, MDe,
- Michael J. Rinaldi, MDf,
- Franz-Josef Neumann, MDg,
- D. Christopher Metzger, MDh,
- Timothy D. Henry, MDi,j,
- David A. Cox, MDk,
- Peter L. Duffy, MD, MMMl,
- Ernest L. Mazzaferri Jr., MDm,
- Roxana Mehran, MDb,n,
- Rupa Parvataneni, MSb,
- Bruce R. Brodie, MDd and
- Gregg W. Stone, MDb,c
- aNew York Methodist Hospital, Brooklyn, New York
- bCardiovascular Research Foundation, New York, New York
- cNew York Presbyterian-Columbia University Medical Center, New York, New York
- dLeBauer Cardiovascular Research Foundation/Cone Health, Greensboro, North Carolina
- eHelios Amper-Klinikum, Dachau, Germany
- fSanger Heart & Vascular Institute/Carolinas HealthCare System, Charlotte, North Carolina
- gUniversitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany
- hWellmont CVA Heart Institute, Kingsport, Tennessee
- iMinneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
- jCedars-Sinai Heart Institute, Los Angeles, California
- kLehigh Valley Health Network, Allentown, Pennsylvania
- lReid Heart Center, First Health of the Carolinas, Pinehurst, North Carolina
- mThe Ohio State University Wexner Medical Center, Columbus, Ohio
- nIcahn School of Medicine at Mount Sinai, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. Sorin J. Brener, New York Methodist Hospital, Cardiac Catheterization Laboratory, 506 6th Street, KP-2, Brooklyn, New York 11215.
Objectives The aim of this study was to understand the impact of the timing of ischemic and hemorrhagic events after percutaneous coronary intervention (PCI) with drug-eluting stents on subsequent mortality.
Background These events have been strongly associated with subsequent death.
Methods In the multicenter, prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug Eluting Stents) study, patients at 11 clinical sites with successful PCI with drug-eluting stents underwent assessment of platelet function and were followed for 2 years. Events occurring after PCI—definite or probable stent thrombosis (ST), myocardial infarction (MI) not related to ST, and clinically relevant bleeding (CB)—were classified as early (≤30 days), late (31 to 365 days), or very late (>365 days). Mortality within 30 days of each event was estimated by Kaplan-Meier methodology. Cox regression multivariate modeling was used to analyze the relationship between each event (as a time-updated variable) and mortality over the entire study period.
Results Among 8,582 patients, 1,060 (12.4%) had events—691 (8.1%) had CB, 294 (3.4%) had MI, and 75 (0.9%) had ST—and 7,522 (87.6%) had no events. The highest risk was associated with early ST (38.5% mortality at 30 days after the event), whereas very late MI (7.5%) and late CB (7.3%) were less dangerous. By multivariate analysis, each event was independently predictive of death, with hazard ratios of 2.4, 1.8, and 11.4, respectively (p < 0.0001).
Conclusions Approximately 1 in 8 patients successfully undergoing PCI with drug-eluting stents had CB, MI, or ST during the ensuing 2 years. These events are associated with an increased hazard of mortality, particularly within the first 30 days following the event, warranting efforts to prevent their occurrence.
Dr. Kirtane has received institutional research grants to Columbia University from Boston Scientific, Medtronic, Abbott Vascular, Abiomed, St. Jude Medical, Vascular Dynamics, and Eli Lilly. Dr. Stuckey is an advisory board member for Boston Scientific; and has received speaking honoraria from Boston Scientific and Eli Lilly/Daiichi Sankyo. Dr. Witzenbichler is a consultant for Volcano. Dr. Rinaldi is an advisory board member for Abbott Vascular, Boston Scientific, and Volcano. Dr. Metzger has received symposium honoraria from Abbott Vascular and Boston Scientific. Dr. Henry is a scientific advisory board member for Abbott Vascular, Boston Scientific, and The Medicines Company; and a member of the steering committee for the TRANSLATE study, sponsored by Eli Lilly and Daiichi Sankyo. Dr. Cox is a consultant for Abbott Vascular, Boston Scientific, Medtronic, and The Medicines Company. Dr. Duffy is a consultant and speaker for Philips Medical Systems/Volcano. Dr. Mehran has received research grant support from Eli Lilly, AstraZeneca, The Medicines Company, Bristol-Myers Squibb/Sanofi; has received consulting fees from AstraZeneca, Bayer, CSL Behring, Janssen Pharmaceuticals, Merck, Osprey Medical, and Watermark Research Partners; and is a scientific advisory board member for Abbott Laboratories, Boston Scientific, Covidien, Janssen Pharmaceuticals, The Medicines Company, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 24, 2016.
- Revision received March 29, 2016.
- Accepted April 7, 2016.
- American College of Cardiology Foundation