Author + information
- Received October 11, 2011
- Revision received June 27, 2012
- Accepted July 5, 2012
- Published online November 1, 2012.
- George D. Dangas, MD, PhD⁎,†,⁎ ( )(, )
- Bimmer E. Claessen, MD, PhD†,‡,
- Roxana Mehran, MD⁎,†,
- Ke Xu, PhD†,
- Martin Fahy, MSc†,
- Helen Parise, PhD†,
- José P.S. Henriques, MD, PhD‡,
- E. Magnus Ohman, MD§,
- Harvey D. White, MD∥ and
- Gregg W. Stone, MD†,¶
- ↵⁎Reprint requests and correspondence
: Dr. George D. Dangas, Cardiovascular Institute, Mount Sinai Medical Center, One Gustave L. Levy Place, Box 1030, New York, New York 10029
Objectives This study sought to develop a practical risk score to predict the risk of stent thrombosis (ST) after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS).
Background ST is a rare, yet feared complication after PCI with stent implantation. A risk score for ST after PCI in ACS can be a helpful tool to personalize risk assessment.
Methods This study represents a patient-level pooled analysis of 6,139 patients undergoing PCI with stent implantation for ACS in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trials who were randomized to treatment with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor. The cohort was randomly divided into a risk score development cohort (n = 4,093) and a validation cohort (n = 2,046). Cox regression methods were used to identify clinical, angiographic, and procedural characteristics associated with Academic Research Consortium–defined definite/probable ST at 1 year. Each covariate in this model was assigned an integer score based on the regression coefficients.
Results Variables included in the risk score were type of ACS (ST-segment elevation myocardial infarction, non-ST-segment elevation ACS with ST deviation, or non–ST-segment elevation ACS without ST changes), current smoking, insulin-dependent diabetes mellitus, prior PCI, baseline platelet count, absence of early (pre-PCI) anticoagulant therapy, aneurysmal/ulcerated lesion, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0/1, final TIMI flow grade <3, and number of treated vessels. Risk scores 1 to 6 were considered low risk, 7 to 9 intermediate risk, and 10 or greater high risk for ST. Rates of ST at 1 year in low-, intermediate-, and high-risk categories were 1.36%, 3.06%, and 9.18%, respectively, in the development cohort (p for trend <0.001), and 1.65%, 2.77%, and 6.45% in the validation cohort (p for trend = 0.006). The C-statistic for this risk score was over 0.65 in both cohorts.
Conclusions The individual risk of ST can be predicted using a simple risk score based on clinical, angiographic, and procedural variables. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966) (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACUITY]; NCT00093158)
The HORIZONS-AMI trial was supported by the Cardiovascular Research Foundation, with grant support from Boston Scientific and The Medicines Company. Dr. Dangas has received speaker honoraria from AstraZeneca, Bristol-Myers Squibb, The Medicines Company, sanofi-aventis, and Abbott Vascular. Dr. Mehran has received a research grant from sanofi-aventis and honoraria from The Medicines Company, Abbott Vascular, sanofi-aventis, Bristol-Myers Squibb, Cordis, and AstraZeneca. Dr. Ohman has received research grants from Daiichi Sankyo, Eli Lilly and Company, and Maquet; and has received consulting fees from Roche, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Liposcience, Merck, Pozen Inc., sanofi-aventis, The Medicines Company, Gilead Sciences, and WebMD. Dr. White has received research grants from sanofi-aventis, Eli Lilly and Company, The Medicines Company, National Institutes of Health, Pfizer, Roche, Johnson & Johnson, Schering-Plough, Merck Sharpe and Dohme, AstraZeneca, GlaxoSmithKline, Daiichi Sankyo Pharma Development, and Bristol-Myers Squibb; and has received consultant fees from Regado Biosciences. Dr. Stone is on the scientific advisory boards for and has received honoraria from Abbott Vascular and Boston Scientific; and has served as a consultant to The Medicines Company, Eli Lilly and Company, BMS/Sanofi, and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 11, 2011.
- Revision received June 27, 2012.
- Accepted July 5, 2012.
- American College of Cardiology Foundation