NDLI: Effects of Reviparin, a Low-Molecular-Weight Heparin, on Mortality, Reinfarction, and Strokes in Patients With Acute Myocardial Infarction Presenting With ST-Segment Elevation

Content Provider	JAMA Network
Copyright Year	2005
Abstract	Context: Although reperfusion therapy, aspirin, β-blockers, and angiotensin-converting enzyme inhibitors reduce mortality when used early in patients with acute myocardial infarction ( MI), mortality and morbidity remain high. No antithrombotic or newer antiplatelet drug has been shown to reduce mortality in acute MI. Objective: To evaluate the effects of reviparin, a low-molecular-weight heparin, when initiated early and given for 7 days in addition to usual therapy on the primary composite outcome of death, myocardial reinfarction, or strokes at 7 and 30 days. Design, Setting, and Patients: A randomized, double-blind, placebo-controlled trial ( Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment Evaluation [ CREATE]) of 15 570 patients with ST-segment elevation or new left bundle-branch block, presenting within 12 hours of symptom onset at 341 hospitals in India and China from July 2001 through July 2004. Intervention: Reviparin or placebo subcutaneously twice daily for 7 days. Main Outcome Measure: Primary composite outcome of death, myocardial reinfarction, or stroke at 7 and 30 days. Results: The primary composite outcome was significantly reduced from 854 (11.0%) of 7790 patients in the placebo group to 745 (9.6%) of 7780 in the reviparin group (hazard ratio [ HR], 0.87; 95% CI, 0.79-0.96; P = .005). These benefits persisted at 30 days (1056 [13.6%] vs 921 [11.8%] patients; HR, 0.87; 95% CI, 0.79-0.95; P = .001) with significant reductions in 30-day mortality (877 [11.3%] vs 766 [9.8%]; HR, 0.87; 95% CI, 0.79-0.96; P = .005) and reinfarction (199 [2.6%] vs 154 [2.0%]; HR, 0.77; 95% CI, 0.62-0.95; P = .01), and no significant differences in strokes (64 [0.8%] vs 80 [1.0%]; P = .19). Reviparin treatment was significantly better when it was initiated very early after symptom onset at 7 days (<2 hours: HR, 0.70; 95% CI, 0.52-0.96; P = .03; 30/1000 events prevented; 2 to <4 hours: HR, 0.81; 95% CI, 0.67-0.98; P = .03; 21/1000 events prevented; 4 to <8 hours: HR, 0.85; 95% CI, 0.73-0.99; P = .05; 16/1000 events prevented; and ≥8 hours: HR, 1.06; 95% CI, 0.86-1.30; P = .58; P = .04 for trend). There was an increase in life-threatening bleeding at 7 days with reviparin and placebo (17 [0.2%] vs 7 [0.1%], respectively; P = .07), but the absolute excess was small (1 more per 1000) vs reductions in the primary outcome (18 fewer per 1000) or mortality (15 fewer per 1000). Conclusions: In patients with acute ST-segment elevation or new left bundle-branch block MI, reviparin reduces mortality and reinfarction, without a substantive increase in overall stroke rates. There is a small absolute excess of life-threatening bleeding but the benefits outweigh the risks.
Ending Page	435
Starting Page	427
Page Count	9
File Format	PDF HTM / HTML
ISSN	00987484
DOI	10.1001/jama.293.4.427
Issue Number	4
Journal	JAMA
Volume Number	293
Language	English
Publisher	American Medical Association
Publisher Date	2005-01-26
Access Restriction	Open
Subject Keyword	acute myocardial infarction st segment elevation cerebrovascular accident low-molecular-weight heparin reviparin reperfusion therapy hemorrhage fibrinolytic agents myocardial reinfarction
Content Type	Text
Resource Type	Article
Subject	Medicine

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