Christopher W. Good, DO; Peter B. Berger, MD
In patients with ST-segment elevation myocardial infarction (STEMI) having primary percutaneous coronary intervention (PCI), how does anticoagulation with bivalirudin (BVD) compare with heparin (HP) plus a glycoprotein (GP) IIb/IIIa inhibitor?
Randomized controlled trial (RCT) (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]).
Unclear if blinded.*
3602 patients 22 to 92 years of age (77% men) who presented within 12 hours of symptom onset and had STEMI. Exclusion criteria included previous use of study drugs, fondaparinux, warfarin, or thrombolytic agents; and contraindications to anticoagulants.
Intravenous (IV) bolus of BVD, 0.75 mg/kg, followed by infusion of 1.75 mg/kg/h (n = 1800); or IV bolus of HP, 60 IU/kg, followed by boluses to achieve target clotting time of 200 to 250 seconds, plus abciximab or eptifibatide (n = 1802).
Major bleeding unrelated to coronary artery bypass grafting and a composite of major bleeding or major cardiovascular event, including mortality, reinfarction, target vessel revascularization, or stroke (net adverse clinical events).
99% (intention-to-treat analysis).
The BVD group had lower risk for major bleeding, net adverse clinical events, cardiac mortality, and all-cause mortality than did the HP-plus-GP inhibitor group (Table). In the first 24 hours, BVD increased risk for acute stent thrombosis compared with the HP-plus-GP inhibitor group (1.3% vs 0.3%, P < 0.001), but groups did not differ at 30 days.
Bivalirudin reduced 30-day major bleeding and increased event-free survival compared with heparin plus a glycoprotein IIb/IIIa inhibitor in patients with ST-segment elevation myocardial infarction having primary percutaneous coronary intervention.
Bivalirudin vs heparin plus glycoprotein IIb/IIIa inhibitor (control) in ST-segment elevation myocardial infarction and percutaneous coronary intervention†
†CABG = coronary artery bypass grafting; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from control event rates and relative risks in article.
‡Composite endpoint of major bleeding or major adverse cardiovascular event, including death, reinfarction (1.8% vs 1.8%), target vessel revascularization (2.6% vs 1.9%), or stroke (0.7% vs 0.6%).
Good CW, Berger PB. Bivalirudin reduced major bleeding and adverse events in patients with STEMI having PCI. Ann Intern Med. 2008;149:JC3–11. doi: 10.7326/0003-4819-149-6-200809160-02011
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Published: Ann Intern Med. 2008;149(6):JC3-11.
Acute Coronary Syndromes, Cardiology, Coronary Heart Disease, Emergency Medicine, Percutaneous Coronary Intervention.
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