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Prognostic Impact of Periprocedural Bleeding and Myocardial Infarction After Percutaneous Coronary Intervention in Unselected Patients

Results From the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) Registry

Jason B. Lindsey, MD^_*, Steven P. Marso, MD^_*, Michael Pencina, PhD, Joshua M. Stolker, MD^_*, Kevin F. Kennedy, MS^_*, Charanjit Rihal, MD, Greg Barsness, MD, Robert N. Piana, MD, Steven L. Goldberg, MD^||, Donald E. Cutlip, MD^¶, Neal S. Kleiman, MD^#, David J. Cohen, MD, MSc^_*,_* on behalf of the EVENT Registry Investigators

^_* Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri
Statistical Consulting Unit, Boston University, Boston, Massachusetts
Mayo Clinic, Rochester, Minnesota
Vanderbilt University Medical Center, Nashville, Tennessee
^|| University of Washington Medical Center, Seattle, Washington
^¶ Beth Israel Deaconess Medical Center, Boston, Massachusetts
^# Methodist DeBakey Heart Center, Houston, Texas

^_* Reprint requests and correspondence: Dr. David J. Cohen, Saint Luke's Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111 (Email: dcohen{at}saint-lukes.org).

Objectives: Our aim was to examine the prognostic importance of hemorrhagic and ischemic complications after percutaneous coronary intervention (PCI) in unselected patients.

Background: In randomized trials of PCI, major bleeding and periprocedural myocardial infarction (pMI) have been associated with increased mortality. Whether similar associations exist among un-selected PCI patients is unknown.

Methods: We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry—a multicenter registry of unselected patients undergoing PCI—to examine the association between both in-hospital bleeding and pMI and 1-year mortality. Cardiac enzyme levels were assessed in all patients, and pMI was defined as a peak creatine kinase-MB value 3x the upper limit of normal. Post-PCI bleeding was classified by Thrombolysis In Myocardial Infarction criteria.

Results: After excluding patients with elevated pre-PCI creatine kinase-MB values and ST-segment elevation myocardial infarction at presentation (n = 1,626), a total of 5,961 patients were available for evaluation. Rates of post-PCI bleeding and pMI were 3.0% and 7.1%, respectively; 1-year all-cause mortality was 2.8%. After multivariable adjustment, both post-PCI bleeding (adjusted hazard ratio [HR]: 3.83, 95% confidence interval: 2.48 to 5.90, p < 0.001) and pMI (adjusted HR: 1.84, 95% confidence interval: 1.17 to 2.89, p = 0.009) were independently associated with 1-year mortality. Time period-specific analyses demonstrated that the adjusted HR for bleeding was similar for 30-day mortality and mortality between 1 month and 1 year, while the adjusted HR for pMI was greater for 30-day mortality as compared with mortality between 1 month and 1 year.

Conclusions: Among unselected PCI patients, both post-PCI bleeding and pMI are independently associated with increased 1-year mortality. Continued efforts to reduce these complications after PCI are warranted.

Key Words: bleeding • myocardial infarction • percutaneous coronary intervention • mortality

Abbreviations and Acronyms   ACS = acute coronary syndrome   CI = confidence interval   CK = creatine kinase   DES = drug-eluting stent(s)   HR = hazard ratio   MI = myocardial infarction   PCI = percutaneous coronary intervention   pMI = periprocedural myocardial infarction   STEMI = ST-segment elevation myocardial infarction   ULN = upper limit of normal