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

Publication ,  Journal Article
Mauri, L; Kereiakes, DJ; Yeh, RW; Driscoll-Shempp, P; Cutlip, DE; Steg, PG; Normand, S-LT; Braunwald, E; Wiviott, SD; Cohen, DJ; Holmes, DR ...
Published in: N Engl J Med
December 4, 2014

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

December 4, 2014

Volume

371

Issue

23

Start / End Page

2155 / 2166

Location

United States

Related Subject Headings

  • Time Factors
  • Ticlopidine
  • Thrombosis
  • Thiophenes
  • Prasugrel Hydrochloride
  • Platelet Aggregation Inhibitors
  • Piperazines
  • Myocardial Ischemia
  • Middle Aged
  • Male
 

Citation

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Mauri, L., Kereiakes, D. J., Yeh, R. W., Driscoll-Shempp, P., Cutlip, D. E., Steg, P. G., … DAPT Study Investigators. (2014). Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med, 371(23), 2155–2166. https://doi.org/10.1056/NEJMoa1409312
Mauri, Laura, Dean J. Kereiakes, Robert W. Yeh, Priscilla Driscoll-Shempp, Donald E. Cutlip, P Gabriel Steg, Sharon-Lise T. Normand, et al. “Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents.N Engl J Med 371, no. 23 (December 4, 2014): 2155–66. https://doi.org/10.1056/NEJMoa1409312.
Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155–66.
Mauri, Laura, et al. “Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents.N Engl J Med, vol. 371, no. 23, Dec. 2014, pp. 2155–66. Pubmed, doi:10.1056/NEJMoa1409312.
Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand S-LT, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM, DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155–2166.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

December 4, 2014

Volume

371

Issue

23

Start / End Page

2155 / 2166

Location

United States

Related Subject Headings

  • Time Factors
  • Ticlopidine
  • Thrombosis
  • Thiophenes
  • Prasugrel Hydrochloride
  • Platelet Aggregation Inhibitors
  • Piperazines
  • Myocardial Ischemia
  • Middle Aged
  • Male