COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents

Laura Mauri, Dean J Kereiakes, Robert W Yeh, Priscilla Driscoll-Shempp, Donald E Cutlip, P Gabriel Steg, Sharon-Lise T Normand, Eugene Braunwald, Stephen D Wiviott, David J Cohen, David R Holmes, Mitchell W Krucoff, James Hermiller, Harold L Dauerman, Daniel I Simon, David E Kandzari, Kirk N Garratt, David P Lee, Thomas K Pow, Peter Ver Lee, Michael J Rinaldi, Joseph M Massaro
New England Journal of Medicine 2014 December 4, 371 (23): 2155-66
25399658

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: Patients were enrolled after they had undergone a coronary stent procedure in which a drug-eluting stent was placed. After 12 months of treatment with a thienopyridine drug (clopidogrel or prasugrel) and aspirin, patients were randomly assigned to continue receiving thienopyridine treatment or to receive placebo for another 18 months; all patients continued receiving aspirin. The coprimary efficacy end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events (a composite of death, myocardial infarction, or stroke) during the period from 12 to 30 months. The primary safety end point was moderate or severe bleeding.

RESULTS: A total of 9961 patients were randomly assigned to continue thienopyridine treatment or to receive placebo. Continued treatment with thienopyridine, as compared with placebo, reduced the rates of stent thrombosis (0.4% vs. 1.4%; hazard ratio, 0.29 [95% confidence interval {CI}, 0.17 to 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 to 0.85]; P<0.001). The rate of myocardial infarction was lower with thienopyridine treatment than with placebo (2.1% vs. 4.1%; hazard ratio, 0.47; P<0.001). The rate of death from any cause was 2.0% in the group that continued thienopyridine therapy and 1.5% in the placebo group (hazard ratio, 1.36 [95% CI, 1.00 to 1.85]; P=0.05). The rate of moderate or severe bleeding was increased with continued thienopyridine treatment (2.5% vs. 1.6%, P=0.001). An elevated risk of stent thrombosis and myocardial infarction was observed in both groups during the 3 months after discontinuation of thienopyridine treatment.

CONCLUSIONS: Dual antiplatelet therapy beyond 1 year after placement of a drug-eluting stent, as compared with aspirin therapy alone, significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but was associated with an increased risk of bleeding. (Funded by a consortium of eight device and drug manufacturers and others; DAPT ClinicalTrials.gov number, NCT00977938.).

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Rashmin Sharif

so which is better? dual antiplatelet therapy or alone aspirin?

9

Balbir Singh

With the results of the study no conclusion can be made about the use of dual antiplatelet therapy after one year of putting DES.

8

Ffg Kknn

Take a look at table 2. The number of deaths related to non cardiovascular causes with thienopyrodines is roughly double that of those in aspirin alone even though the number of total patients is roughly the same in both groups. You'll see this is the only component within the causes of death that was statistically significant. However non cardiovascular death might be caused by any factor not related to the effects of thienopyrodines so it might not be a sensitive measure indicating that it actually increases risk of death. If you remove his component outcome from the analysis it would likely not find a significant difference in death.

2

Michael Spencer Chapman

The significantly increased risk of death in the longer dual anti-platelet group is enough to convince me that it's not the best idea..

2

Jared Bradshaw

I am also confused since the risk of death seems higher while on dual therapy compared to mono therapy but their data says it reduces risk of MI, stroke, etc. Are they advocating dual therapy even with an increased risk of death?

0

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