Why the study?
The benefits and risks of prolonged dual antiplatelet therapy after coronary stent implantation may differ for patients presenting with acute MI compared with more stable presentations.
Does extending dual antiplatelet therapy with a thienopyridine plus aspirin to 30 months compared with 12 months reduce stent thrombosis and MACCE in patients undergoing coronary stenting with and without acute myocardial infarction?
RCT (n=11,648)
Double-blind
1:1 ratio, computer-generated, stratified by stent type, hospital site, thienopyridine type, and stent thrombosis risk factors
Yes
Does extending dual antiplatelet therapy with a thienopyridine plus aspirin to 30 months compared with 12 months reduce stent thrombosis and MACCE in patients undergoing coronary stenting with and without acute myocardial infarction?
Extending dual antiplatelet therapy with a thienopyridine and aspirin to 30 months after coronary stenting significantly reduces late stent thrombosis and myocardial infarction in patients presenting with or without acute MI, with a greater reduction in MACCE among MI patients, at the cost of increased moderate or severe bleeding.
Answers are grounded in this paper and cite their sources.
Tailor extended DAPT post-PCI by MI status; extends randomized evidence on differential ischemic-bleeding trade-offs.
Background The benefits and risks of prolonged dual antiplatelet therapy may be different for patients with acute myocardial infarction (MI) compared with more stable presentations. Objective To assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation following presentation with and without MI. Methods The DAPT Study was a randomized double-blind, placebo-controlled trial comparing 30 versus 12 months of dual antiplatelet therapy after coronary stenting. The effect of continued thienopyridine on ischemic and bleeding events among patients initially presenting with versus without MI was assessed. The co-primary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE, a composite of death, myocardial infarction, or stroke). The primary safety endpoint was GUSTO moderate or severe bleeding. Results Of 11,648 randomized patients (9961 treated with drug-eluting, 1687 with bare metal stents), 3,576 (30.7%) presented with MI. Between 12 and 30 months, continued thienopyridine reduced stent thrombosis compared with placebo in patients with and without MI at presentation (MI group 0.5% vs. 1.9%, hazard ratio [HR] 0.27, p<0.001; No MI group, 0.4% vs. 1.1%, HR 0.33, p<0.001; interaction p=0.69). The reduction in MACCE for continued thienopyridine was greater for patients with MI (3.9% vs. 6.8%, HR 0.56, p<0.001) compared to those with no MI (4.4% vs. 5.3%, HR 0.83, p=0.08, interaction p=0.03). In both groups, continued thienopyridine reduced MI (2.2% vs. 5.2%, HR 0.42, p<0.001 for MI; 2.1% vs. 3.5%, HR 0.60, p<0.001 for no MI, interaction p=0.15) but increased bleeding (1.9% vs. 0.8%, p=0.005 for MI; 2.6% vs. 1.7%, p=0.007 for no MI; interaction p = 0.21). Conclusions Compared with 12 months of therapy, 30 months of dual antiplatelet therapy reduced the risk of stent thrombosis and myocardial infarction in patients with and without MI, and increased bleeding.
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Yeh et al. (2015) conducted an RCT in Coronary artery disease undergoing percutaneous coronary intervention with stent implantation (with and without acute myocardial infarction) (n=11,648). Continued thienopyridine (clopidogrel or prasugrel) plus aspirin (30 months total DAPT) vs. Placebo plus aspirin after 12 months of DAPT (12 months total DAPT) was evaluated on Major adverse cardiovascular and cerebrovascular events (MACCE: composite of death, myocardial infarction, or stroke) in patients presenting with MI (HR 0.56, 95% CI 0.42-0.76, p=<0.001).
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