Author + information
- Received June 3, 2017
- Revision received August 7, 2017
- Accepted August 13, 2017
- Published online October 2, 2017.
- Gennaro Giustino, MDa,b,
- Roxana Mehran, MDa,b,
- George D. Dangas, MD, PhDa,b,
- Ajay J. Kirtane, MD, MScb,c,
- Björn Redfors, MD, PhDb,
- Philippe Généreux, MDb,d,
- Sorin J. Brener, MDb,e,
- Jayne Prats, PhDf,
- Stuart J. Pocock, PhDg,
- Efthymios N. Deliargyris, MDh and
- Gregg W. Stone, MDb,c,∗ ( )()
- aZena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- bCardiovascular Research Foundation, New York, New York
- cDivision of Cardiology, New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York
- dMorristown Medical Center, Morristown, New Jersey
- eDepartment of Medicine, New York Methodist Hospital, New York, New York
- fThe Medicines Company, Parsippany, New Jersey
- gLondon School of Hygiene and Tropical Medicine, London, United Kingdom
- hScience and Strategy Consulting Group, Basking Ridge, New Jersey
- ↵∗Address for correspondence:
Dr. Gregg W. Stone, Columbia University Medical Center, Cardiovascular Research Foundation, 111 East 59th Street, 11th Floor, New York, New York 10022.
Background The risk of recurrent ischemic and bleeding events after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) may not be uniform over time, which may affect the benefit-to-risk ratio of guideline-recommended antithrombotic therapies in different intervals.
Objectives This study sought to characterize the average daily ischemic rates (ADIRs) and average daily bleeding rates (ADBRs) within the first year after primary PCI for STEMI.
Methods Among 3,602 patients with STEMI who were enrolled in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial, all ischemic and bleeding events, including recurrent events, were classified according to the timing of their occurrence as acute (≤24 h after PCI), subacute (1 day to 30 days), and late (30 days to 1 year). Patients were treated with aspirin and clopidogrel for the entire year. ADIRs included cardiac death, reinfarction, and definite stent thrombosis. ADBRs included non–coronary artery bypass graft–related Thrombolysis In Myocardial Infarction major and minor bleeding. ADIRs and ADBRs were calculated as the total number of events divided by the number of patient-days of follow-up in each interval assuming a Poisson distribution. Generalized estimating equations were used to test the absolute least square mean differences (LSMD) between ADIRs and ADBRs.
Results The ADIR and ADBR both exponentially decreased from the acute to the late periods (p < 0.0001). Although there were no significant differences in ADIR and ADBR in the acute phase (LSMD: +0.11%; 95% confidence interval [CI]: −0.35% to 0.58%; p = 0.63), the ADBR was greater than the ADIR in the subacute phase (LSMD: −0.39%; 95% CI: −0.58% to −0.20%; p < 0.0001). In the late phase, the ADIR exceeded the ADBR (LSMD: +1.51%; 95% CI: 1.04% to 1.98%; p < 0.0001).
Conclusions After primary PCI, the ADIR and ADBR both markedly decreased over time. Although the rates for bleeding exceeded those for ischemia within 30 days, the daily risk of ischemia significantly exceeded the daily risk of bleeding beyond 30 days, supporting the use of intensified platelet inhibition during the first year after STEMI.
- average daily rate
- bleeding events
- ischemic events
- percutaneous coronary intervention
- ST-segment elevation myocardial infarction
Drs. Mehran and Dangas have received institutional research grant support from Eli Lilly/Daiichi-Sankyo, Inc., Bristol-Myers Squibb, AstraZeneca, The Medicines Company, OrbusNeich, Bayer, CSL Behring, Abbott Laboratories, Watermark Research Partners, Novartis Pharmaceuticals, Medtronic, AUM Cardiovascular, Inc., and Beth Israel Deaconess Medical Center; are on the executive committees of Janssen Pharmaceuticals and Osprey Medical, Inc.; are on the data safety monitoring board of Watermark Research Partners; are consultants for Abbott Laboratories, CardioKinetix, Spectranetix, Medscape, The Medicines Company, Boston Scientific, Merck & Company, Cardiovascular Systems, Inc. (CSI), Sanofi USA, LLC, Shanghai BraccoSine Pharmaceutical Corp., and AstraZeneca; and hold equity in Claret Medical Inc. and Elixir Medical Corporation. Dr. Kirtane has received institutional research grants from Boston Scientific, Medtronic, Abbott Vascular, Abiomed, St. Jude Medical, Vascular Dynamics, CathWorks, Siemens, and Eli Lilly. Dr. Généreux has received speaker fees from Abbott Vascular and Edwards Lifesciences; has received consulting fees from Cardiovascular Systems Inc., PiCardia, and Soundbite Medical Solutions; and has received institutional research grants from Boston Scientific and Tryton Medical. Dr. Pocock is a consultant for Abbott Vascular. Dr. Deliargyris is a shareholder in The Medicines Company. Dr. Prats is a former employee of The Medicines Company. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Derek P. Chew, MBBS, MPH, served as Guest Editor for this paper.
- Received June 3, 2017.
- Revision received August 7, 2017.
- Accepted August 13, 2017.
- 2017 American College of Cardiology Foundation