Background
Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications, yet the benefits and risks of treatment beyond 1 year are uncertain.
Methods
Subjects were enrolled after a drug-eluting coronary stent procedure. After 12 months of thienopyridine (clopidogrel bisulfate [Plavix] or prasugrel [Effient/Efient]) with aspirin, subjects were randomized to continued thienopyridine or placebo for another 18 months; all continued aspirin. The co-primary effectiveness end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events (a composite of death, myocardial infarction, or stroke) at 12 to 30 months. The primary safety end point was moderate or severe bleeding.
Results
Subjects (N=9,961) were randomized to continued thienopyridine or placebo. Continued thienopyridine reduced stent thrombosis (0.4% vs. 1.4%, hazard ratio 0.29, 95% confidence interval [CI] 0.17-0.48, P<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%, hazard ratio 0.71, 95% CI 0.59-0.85, P<0.001). Myocardial infarction was reduced (2.1% vs. 4.1%, hazard ratio 0.47, P<0.001). Rates of all-cause mortality in the continued thienopyridine and placebo groups were 2.0 and 1.5%, respectively (hazard ratio 1.36, 95% CI 1.00-1.85, P=0.052). Moderate or severe bleeding was increased with continued thienopyridine (2.5% vs. 1.6%, P=0.001). An elevated hazard for stent thrombosis and myocardial infarction was observed in both groups during the 3 months following thienopyridine discontinuation.
Conclusion
Dual antiplatelet therapy beyond one year after drug-eluting stent placement significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events compared with aspirin alone, but was associated with increased bleeding.
We conclude that using fluoro to guide vascular access leads to lower complication rates and a shorter length of stay. This approach may become our regional standard of care.
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