Dataset Information

Duration of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Treated With New Generation Stents: A Meta-Analysis of Randomized Controlled Trials.

ABSTRACT: Background and Objective: The optimum duration of dual antiplatelet therapy (DAPT) remains uncertain in patients with acute coronary syndrome treated with new generation stents. This meta-analysis was performed to investigate ischemia and bleeding outcomes with different DAPT strategies. Methods: PubMed, Embase, Cochrane and Web of science from inception to May 27, 2020, were systematically searched. Randomized controlled trials were included to compare short-term (6 months or less) with standard (12 months) DAPT in patients with acute coronary syndrome treated with new generation stents. The primary endpoints were myocardial infarction, definite or probable stent thrombosis and major bleeding. The secondary endpoints included all-cause death, cardiovascular death, stroke, target vessel revascularization and net adverse clinical events. Random effect model and fixed effect model were used to calculate the odds ratio (OR) and 95% confidence interval (CI) of each endpoint. Results: Four randomized controlled trials and seven subgroup analyses of larger randomized controlled trials, including a total of 21,344 patients with acute coronary syndrome, met our inclusion criteria. The shorter DAPT was associated with significantly lower major bleeding compared with the standard DAPT (OR 0.71, 95% CI 0.56-0.90, P = 0.005, I ² = 25%), while without increasing the risk of myocardial infarction (OR 1.18, 0.88-1.58, P = 0.28, I ² = 20%), definite or probable stent thrombosis (OR 1.60, 0.98-2.59, P = 0.06, I ² = 0%). No significantly difference was observed in the risk of all-cause death (OR 0.96, 0.72-1.27, P = 0.76, I ² = 2%), cardiovascular death (OR 0.91, 0.62-1.33, P = 0.62, I ² = 0%), stroke (OR 0.84, 0.54-1.30, P = 0.43, I ² = 0%), target vessel revascularization (OR 1.14, 0.84-1.55, P = 0.41, I ² = 8%), and net adverse clinical events (OR 0.93, 0.80-1.07, P = 0.3, I ² = 18%) between the two groups. Conclusions: In patients with acute coronary syndrome treated with new generation stents, the shorter DAPT leads to a marked reduction in the risk of major bleeding compared with the standard DAPT. This benefit is achieved without increasing the risk of mortality or ischemic outcomes. The study protocol was registered in PROSPERO (CRD42020189871).

SUBMITTER: Zhang WJ

PROVIDER: S-EPMC7886789 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Duration of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Treated With New Generation Stents: A Meta-Analysis of Randomized Controlled Trials.

Zhang Wen-Jiao WJ Qiao Xuan X Guo Wen-Fen WF Liang Xi-Ying XY Li Yan Y Wang Zhi-Lu ZL

Frontiers in cardiovascular medicine 20210203

<b>Background and Objective:</b> The optimum duration of dual antiplatelet therapy (DAPT) remains uncertain in patients with acute coronary syndrome treated with new generation stents. This meta-analysis was performed to investigate ischemia and bleeding outcomes with different DAPT strategies. <b>Methods:</b> PubMed, Embase, Cochrane and Web of science from inception to May 27, 2020, were systematically searched. Randomized controlled trials were included to compare short-term (6 months or less ...[more]

PMID: 33614748

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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:BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug-eluting stent (DES) remains unclear. This is a prespecified sub-study from the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short-term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent.MethodsIn this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow-up.ResultsA total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow-up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all-cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups.ConclusionsThis sub-analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high-risk patients.

Project description:BackgroundDual antiplatelet therapy (DAPT) is recommended for ≥12 months following coronary drug-eluting stents (DES) to reduce risk of major adverse ischemic events. Randomized trials suggest an abbreviated DAPT duration (≤6 months) is adequately protective. However, these trials are individually underpowered to detect differences in rare but serious events such as stent thrombosis (ST).ObjectivesWe performed a meta-analysis of published randomized trials to define the impact of abbreviated DAPT (≤6 months) on death, myocardial infarction (MI), stent thrombosis (ST), and bleeding complications compared to standard-duration DAPT (≥12 months).MethodsSeven randomized controlled trials comparing abbreviated vs. standard DAPT regimens following DES use were identified by two independent investigators. Study characteristics were reviewed and clinical endpoint data were abstracted and analyzed in aggregate using fixed and random-effects models.ResultsThe seven trials included 15,874 randomized patients. Second-generation DES were used in most patients. Compared to standard-duration DAPT, abbreviated DAPT was not associated with an increase in mortality (OR 0.93; CI: 0.73 to 1.17; P = 0.52), MI (OR 1.14; CI: 0.89 to 1.45; P = 0.30) or ST (OR 1.25; CI: 0.81 to 1.93; P = 0.31). Abbreviated DAPT was associated with significantly fewer major bleeding complications (OR 0.52; CI: 0.34 to 0.82; P = 0.005). The results were consistent between fixed and random-effects models, with no heterogeneity. Sensitivity analyses adjusting for inclusion of bare metal stents, 1st generation DES and/or abbreviated DAPT regimens of 3 months resulted in similar conclusions.ConclusionsIn a meta-analysis of >15,000 patients primarily treated with second-generation DES, abbreviated-duration DAPT (≤6 months) was associated with a significant reduction in major bleeding complications with no evidence of a significant increase in risk of death, MI or ST. Accordingly, abbreviated DAPT should be strongly considered for patients receiving second generation DES.

Project description:Background and Objective: Dual antiplatelet therapy (DAPT) is the basis for preventing ischemic events after percutaneous coronary intervention (PCI), and DAPT for 12 months has been the standard strategy recommended by the guidelines. However, patients with acute coronary syndrome (ACS) have a higher risk of thrombosis, and the application of very short-term DAPT (1-3 months) in patients with ACS is consistently controversial. The purpose of this study is to explore the efficacy and safety of DAPT for 1-3 months in patients with ACS who were implanted with drug-eluting stents (DES). Methods: We conducted a systematic review and meta-analysis of randomized controlled trials that compared the very short-term (3 months or less) with long-term (12 months or more) DAPT in patients with ACS after PCI. The randomized controlled trials were included by searching PubMed, EMBASE, and Cochrane Library database. The relative risk (RR) and 95% CIs for endpoint events were calculated by the fixed effects model, and trial sequential analysis was applied to calculate the anticipated sample size and assess the results. Result: A total of eight randomized controlled trials with 16,492 patients who met the inclusion criteria were conducted. There were no significant statistic differences in myocardial infarction (RR 1.05, 0.82-1.35, P = 0.68), stents thrombosis (RR 1.32, 0.85-2.07, P = 0.22), all-cause death (RR 0.87, 0.66-1.13, P = 0.29), and target vessel revascularization (RR 0.93, 0.76-1.13, P = 0.47). However, there were significant differences in major bleeding (RR 0.60, 0.50-0.73, P < 0.00001) and the net adverse cardiac and cerebrovascular events (RR 0.84, 0.74-0.95, P = 0.007). Conclusions: The strategy of DAPT for 1-3 months not only has a significant effect in patients with ACS who were implanted with DES but also reduces the risk of major bleeding. The scheme of short-term DAPT followed by P2Y12 receptor inhibitor monotherapy is especially beneficial for patients with ACS. The results of this systematic review and meta-analysis are based on the application of new generation DES and new oral antiplatelet drugs in patients with ACS, which are difficult to use in the general population (Registered by PROSPERO, CRD 42020210520). Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/, identifier: CRD 42020210520.

Dataset Information

Duration of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Treated With New Generation Stents: A Meta-Analysis of Randomized Controlled Trials.

Publications

Duration of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Treated With New Generation Stents: A Meta-Analysis of Randomized Controlled Trials.

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