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Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial.

ABSTRACT: Despite 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.To 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.International, 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.Continued 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.Stent thrombosis, MACCE, and moderate or severe bleeding.Among 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?

SUBMITTER: Kereiakes DJ

PROVIDER: S-EPMC4481320 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial.

Kereiakes Dean J DJ Yeh Robert W RW Massaro Joseph M JM Driscoll-Shempp Priscilla P Cutlip Donald E DE Steg P Gabriel PG Gershlick Anthony H AH Darius Harald H Meredith Ian T IT Ormiston John J Tanguay Jean Francois JF Windecker Stephan S Garratt Kirk N KN Kandzari David E DE Lee David P DP Simon Daniel I DI Iancu Adrian Corneliu AC Trebacz Jaroslaw J Mauri Laura L

JAMA 20150301 11

<h4>Importance</h4>Despite 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.<h4>Objective</h4>To compare (1) rates of stent thrombosis and major adve ...[more]

PMID: 25781440

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Project description:ImportanceA significant number of patients receive bare-metal stents (BMSs) instead of drug-eluting stents (DESs) to shorten the duration of dual antiplatelet therapy (DAPT). Emerging evidence suggests that new-generation DESs, particularly those optimized for biocompatibility, may be more efficacious and safer than BMSs, even with a single month of DAPT after stent implantation.ObjectiveTo evaluate the efficacy and safety of DESs compared with BMSs for coronary intervention with a single month of DAPT.Data sourcesHuman studies found in PubMed, the Cochrane databases through April 2018, and reference lists of selected articles.Study selectionRandomized clinical trials were included if they enrolled patients undergoing percutaneous coronary intervention and randomly assigned each patient to treatment with either DESs or BMSs. The additional inclusion criterion was use of only 1 month of DAPT poststent implantation.Data extraction and synthesisTwo reviewers independently extracted the data. Odds ratios (ORs) were calculated using random-effects models.Main outcomes and measuresThe efficacy end points were major adverse cardiac events, myocardial infarction, target vessel revascularization, ischemia-driven target lesion revascularization, cardiac mortality, and all-cause mortality at 1 year. The safety outcomes were stent thrombosis and bleeding complications.ResultsData from 3 randomized clinical trials involving 3943 patients were included (2457 men [62.3%]; mean [SD] age ranging from 75.7 [9.3] years to 81.4 [4.3] years per trial subgroup). Coronary intervention with DESs reduced the rates for major adverse cardiac events (OR, 0.68 [95% CI, 0.57-0.82]; P < .001), target lesion revascularization (OR, 0.38 [95% CI, 0.22-0.67]; P = .001), target vessel revascularization (OR, 0.50 [95% CI, 0.38-0.65]; P < .001), and myocardial infarction (OR, 0.51 [95% CI, 0.31-0.83]; P = .01) compared with BMSs at 1 year. The incidence of stent thrombosis was also lower with DESs compared with BMSs (1.8% vs 2.8%), but this difference was not statistically significant in the random-effects model. Additionally, the 2 stent types did not differ in the risks of all-cause mortality, cardiac mortality, and bleeding.Conclusions and relevanceIn the limited number of randomized clinical trials comparing DESs with BMSs with shortened DAPT durations in patients who have high bleeding risk or are uncertain candidates for prolonged DAPT, coronary intervention with specific DESs optimized for biocompatibility is not only safe but also efficacious, even with only 1 month of DAPT.

Dataset Information

Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial.

Publications

Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial.

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