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Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation
George D Dangas1, Mikkel M Schoos2, Philippe Gabriel Steg2
1From the Division of Cardiology, Mount Sinai Medical Center, New York, NY (G.D.D., M.M.S., R.M.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.D.D., R.M., G.W.S.); Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (M.M.S., P.C.); French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodelling, Université Paris-Diderot, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Department of Cardiology, Hôpital Bichat, Paris, France (P.G.S.); National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Department of Medicine, Nykoebing Falster Hospital, Denmark (P.C.); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); The Medicines Company, Parsippany, NJ (J.P., D.B., E.N.D.); Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.); and Department of Cardiology, Zealand University Hospital, Denmark (M.M.S.). George.Dangas@mountsinai.org.
Insights
Early stent thrombosis (ST) is a risk after percutaneous coronary intervention. Bivalirudin increased early ST but significantly reduced mortality compared to heparin plus glycoprotein IIb/IIIa inhibitors.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Early stent thrombosis (ST) within 30 days of primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction (STEMI) is a critical complication.
- Understanding predictors and mortality risk associated with early ST based on antithrombotic therapy is crucial for patient outcomes.
Purpose of the Study:
- To evaluate the predictors and mortality risk of early stent thrombosis (ST) following primary PCI in STEMI patients.
- To compare the incidence of early ST and associated mortality between bivalirudin and heparin plus glycoprotein IIb/IIIa inhibitors (GPI).
Main Methods:
- A pooled patient-level analysis of 4935 patients from the HORIZONS-AMI and EUROMAX trials was conducted.
- Patients underwent primary PCI with stent implantation and were randomized to bivalirudin or heparin±GPI.
- Outcomes, including early ST and 30-day mortality, were analyzed based on treatment allocation.
Main Results:
- Early ST occurred in 2.0% of patients, with a 20.0% mortality rate among those affected.
- Bivalirudin was associated with higher rates of early ST (2.5% vs 1.6%, P=0.04), primarily due to acute ST within 24 hours (1.5% vs 0.2%, P<0.0001).
- Despite higher early ST rates, 30-day mortality attributable to early ST was significantly lower with bivalirudin (0.2% vs 0.7%, P=0.007).
Conclusions:
- Early ST is more frequent with bivalirudin compared to heparin±GPI, largely driven by ST within 4 hours post-PCI.
- However, bivalirudin treatment is associated with a significantly lower mortality risk attributable to early stent thrombosis.
- These findings highlight a critical trade-off between ST incidence and mortality in antithrombotic strategies for primary PCI.
Background:
Early stent thrombosis (ST) within 30 days after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction is a serious event. We sought to determine the predictors of and risk of mortality after early ST according to procedural antithrombotic therapy.
Methods And Results:
In a patient-level pooled analysis from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) and European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) trials, we examined 30-day outcomes in 4935 patients undergoing primary percutaneous coronary intervention with stent implantation at 188 international sites, randomized to either bivalirudin or heparin±a glycoprotein IIb/IIIa inhibitor (GPI). Early ST occurred in 100 patients (2.0%), 20 of whom (20.0%) died. Bivalirudin was associated with higher rates of early ST compared with heparin±GPI (2.5% versus 1.6%, P=0.04), because of more acute (≤24 h) ST (1.5% versus 0.2%, P<0.0001), with the risk limited to the first 4 hours after percutaneous coronary intervention. The rates of subacute (1-30 days) ST were similar with bivalirudin and heparin±GPI (1.0% versus 1.4%, P=0.24). Among patients with early ST, mortality within 30 days occurred in 4 of 60 (6.7%) bivalirudin-treated patients compared with 16 of 40 (40.0%) heparin±GPI-treated patients (adjusted hazard ratio, 0.12; 95% CI, 0.04-0.39; P=0.0004 and adjusted hazard ratio, 0.122; 95% CI, 0.04-0.39; P=0. 0004). Thus, 30-day mortality attributable to early ST occurred in 4 of 2479 (0.2%) bivalirudin-treated patients versus 16 of 2456 (0.7%) heparin±GPI-treated patients (P=0.007).
Conclusions:
In the present large-scale pooled analysis from 2 multicenter randomized trials, early ST was more frequent in patients treated with bivalirudin compared with heparin±GPI because of increased ST within 4 hours after primary percutaneous coronary intervention. However, the mortality attributable to early ST was significantly lower after bivalirudin than after heparin±GPI.
Clinical Trial Registration:
URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00433966 (HORIZONS-AMI) and NCT01087723 (EUROMAX).
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