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Optimal Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents: Shorter or Longer?

ABSTRACT: Use of dual antiplatelet therapy (DAPT; the combination of aspirin and an inhibitor of platelet P2Y12) is the key pharmacological component in the management of acute coronary syndrome and percutaneous coronary intervention (PCI) with stent implantation, but the optimal treatment duration is still unclear. Although current guidelines recommend prescription of DAPT for at least 12 months after implantation of drug-eluting stents (DES) if patients are not at high risk of bleeding, several studies showed conflicting results. Observational studies have shown inconsistent findings (i.e., some studies suggested longer duration would be better, and others vice versa) and small-to-moderate sized randomized clinical trials suggested that prolonged use of DAPT beyond 12 months would not be more beneficial and could be detrimental in safety outcomes. However, these studies suffer from insufficient statistical power, data from old version of DES, and non-uniform duration of DAPT. Given there might be the relative risk and benefit associated with combination of DES use and DAPT prescription, the optimal decision making with regard to DAPT duration would be essential for patients who underwent PCI with DES. Thus, by understanding and comparing the evidences of recent studies that support for shorter and longer duration of DAPT, we sought to guide the treating physician in deciding optimal duration of DAPT in such patients. Up to now, there is no strong evidence supporting that longer duration of DAPT is better than shorter duration of DAPT in terms of efficacy and safety outcomes after DES placement.

SUBMITTER: Chang M

PROVIDER: S-EPMC4265232 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Optimal Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents: Shorter or Longer?

Chang Mineok M Park Duk-Woo DW

Cardiology and therapy 20141101 1-2

Use of dual antiplatelet therapy (DAPT; the combination of aspirin and an inhibitor of platelet P2Y12) is the key pharmacological component in the management of acute coronary syndrome and percutaneous coronary intervention (PCI) with stent implantation, but the optimal treatment duration is still unclear. Although current guidelines recommend prescription of DAPT for at least 12 months after implantation of drug-eluting stents (DES) if patients are not at high risk of bleeding, several studies ...[more]

PMID: 25367504

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Project description:ImportanceDespite antirestenotic efficacy of coronary drug-eluting stents (DES) compared with bare metal stents (BMS), the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Although dual antiplatelet therapy (DAPT) beyond 1 year provides ischemic event protection after DES, ischemic event risk is perceived to be less after BMS, and the appropriate duration of DAPT after BMS is unknown.ObjectiveTo compare (1) rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE; composite of death, myocardial infarction, or stroke) after 30 vs 12 months of thienopyridine in patients treated with BMS taking aspirin and (2) treatment duration effect within the combined cohorts of randomized patients treated with DES or BMS as prespecified secondary analyses.Design, setting, and participantsInternational, multicenter, randomized, double-blinded, placebo-controlled trial comparing extended (30-months) thienopyridine vs placebo in patients taking aspirin who completed 12 months of DAPT without bleeding or ischemic events after receiving stents. The study was initiated in August 2009 with the last follow-up visit in May 2014.InterventionsContinued thienopyridine or placebo at months 12 through 30 after stent placement, in 11,648 randomized patients treated with aspirin, of whom 1687 received BMS and 9961 DES.Main outcomes and measuresStent thrombosis, MACCE, and moderate or severe bleeding.ResultsAmong 1687 patients treated with BMS who were randomized to continued thienopyridine vs placebo, rates of stent thrombosis were 0.5% vs 1.11% (n = 4 vs 9; hazard ratio [HR], 0.49; 95% CI, 0.15-1.64; P = .24), rates of MACCE were 4.04% vs 4.69% (n = 33 vs 38; HR, 0.92; 95% CI, 0.57-1.47; P = .72), and rates of moderate/severe bleeding were 2.03% vs 0.90% (n = 16 vs 7; P = .07), respectively. Among all 11,648 randomized patients (both BMS and DES), stent thrombosis rates were 0.41% vs 1.32% (n = 23 vs 74; HR, 0.31; 95% CI, 0.19-0.50; P < .001), rates of MACCE were 4.29% vs 5.74% (n = 244 vs 323; HR, 0.73; 95% CI, 0.62-0.87; P < .001), and rates of moderate/severe bleeding were 2.45% vs 1.47% (n = 135 vs 80; P < .001).Conclusions and relevanceAmong patients undergoing coronary stent placement with BMS and who tolerated 12 months of thienopyridine, continuing thienopyridine for an additional 18 months compared with placebo did not result in statistically significant differences in rates of stent thrombosis, MACCE, or moderate or severe bleeding. However, the BMS subset may have been underpowered to identify such differences, and further trials are suggested.Trial registrationclinicaltrials.gov Identifier: NCT00977938.

Project description:Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications, yet the benefits and risks of treatment beyond 1 year are uncertain.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.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.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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Optimal Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents: Shorter or Longer?

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Optimal Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents: Shorter or Longer?

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