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Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639].

ABSTRACT: Coronary artery disease remains the dominant cause of mortality in developed countries. While platelets have been recognized to play a pivotal role in atherothrombosis, the ideal antiplatelet regime after coronary artery surgery remains elusive. The evolution of CABG has presently moved beyond technical improvements to involve modulation of pharmacologic management designed to improve patient outcomes. The aim of this trial will be to test the hypothesis that the addition of clopidogrel to patients with documented postoperative aspirin resistance will reduce the incidence of major cardiovascular events.Patients scheduled for isolated coronary artery surgery will be eligible for the study. Patients in whom postoperative multiple electrode aggregometry documents aspirin resistance will be randomized into two groups. The control group will receive 300 mg of aspirin. The dual antiplatelet group will receive 75 mg of clopidogrel in addition to 300 mg of aspirin. Patients will be followed for 6 months. Major adverse cardiac and cerebrovascular events (death from any cause, myocardial infarction, stroke, hospitalization due to cardiovascular pathology) as well as bleeding events will be recorded.This will be the first trial that will specifically address the issue of dual antiplatelet therapy in patients undergoing coronary artery surgery who have been found to be aspirin resistant. In the event that the addition of clopidogrel proves to be beneficial in this subset of surgical patients, this study could significantly impact their future antiplatelet management. This randomized controlled trial has been registered at the ClinicalTrials.gov website (Identifier NCT01159639).

SUBMITTER: Gasparovic H

PROVIDER: S-EPMC3502596 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

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Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639].

Gasparovic Hrvoje H Petricevic Mate M Kopjar Tomislav T Djuric Zeljko Z Svetina Lucija L Biocina Bojan B

Trials 20120825

<h4>Background</h4>Coronary artery disease remains the dominant cause of mortality in developed countries. While platelets have been recognized to play a pivotal role in atherothrombosis, the ideal antiplatelet regime after coronary artery surgery remains elusive. The evolution of CABG has presently moved beyond technical improvements to involve modulation of pharmacologic management designed to improve patient outcomes. The aim of this trial will be to test the hypothesis that the addition of c ...[more]

PMID: 22920307

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Project description:IntroductionSaphenous vein graft (SVG) is the most common conduit used for coronary artery bypass grafting (CABG) surgery. Unfortunately, SVG are associated with poor long-term patency rates; a significant predictor of re-operation rates and survival. As such, medical therapy to prevent SVG narrowing or occlusion is of paramount importance. Aspirin (ASA) monotherapy is the standard of care after CABG, to improve long-term major adverse cardiovascular events (MACE) and graft patency. Benefits of dual antiplatelet therapy (DAPT) have not been well established in all CABG patients. We present a protocol for a network meta-analysis (NMA) comparing the effects of various antiplatelet therapy regimens on SVG patency, mortality, and bleeding among adult patients following CABG.MethodsWe will search CENTRAL, MEDLINE, EMBASE, CINAHL ACPJC, and grey literature sources (AHA, ACC, ESC, and CCC conference proceedings, ISRCTN Register, and WHO ICTRP) for randomized controlled trials (RCTs) which fit our criteria. RCTs that evaluate different antiplatelet regimens at least 3-months after CABG and have any of SVG patency, mortality, MACE, and major bleeding as outcomes will be selected. We will perform title and abstract screening, full-text screening, and data extraction independently and in duplicate. Two independent reviewers will also assess risk of bias (ROB) for each study, as well as evaluate quality of evidence using the GRADE framework. We will use R to perform the NMA and use low-dose ASA as reference within our network. We will report results as odds ratios with confidence intervals for direct comparisons, and credible intervals for indirect or mixed comparisons. We will use the surface under the cumulative ranking curve (SUCRA) to estimate the ranking of interventions.DiscussionGiven the limited direct comparison of various antiplatelet regimens, a network approach is ideal to clarify the optimum antiplatelet therapy after CABG. We hope that our NMA will be the largest quantitative synthesis evaluating antiplatelet regimens among patients requiring CABG. It should inform clinicians and guideline developers in selecting the most effective and safest antiplatelet regimen.Systematic Review registration: International Prospective Register for Systematic Reviews (PROSPERO)-CRD42019127695.

Project description:ImportanceGuidelines recommend dual antiplatelet therapy after coronary artery bypass grafting (CABG) for patients with acute coronary syndrome (ACS). However, the evidence for these recommendations is weak.ObjectiveTo compare midterm outcomes after CABG in patients with ACS treated postoperatively with acetylsalicylic acid (ASA) and ticagrelor or with ASA monotherapy.Design, setting, and participantsThis cohort study used merged data from several national registries of Swedish patients who were diagnosed with ACS and subsequently underwent CABG. All included patients underwent isolated CABG in Sweden between 2012 and 2017 with an ACS diagnosis less than 6 weeks before the procedure, survived 14 days after discharge from hospital, and were treated postoperatively with ASA plus ticagrelor or ASA monotherapy. A multivariable Cox regression model was used for the main analysis, and propensity score-matched models were performed as sensitivity analysis. Data were analyzed between May and September 2020.ExposuresPostoperative antiplatelet treatment, defined as filled prescriptions, with either ASA and ticagrelor or ASA only.Main outcomes and measuresMajor adverse cardiovascular events (MACE), defined as all-cause mortality, myocardial infarction, and stroke, and major bleeding, at 12 months and at the end of follow-up.ResultsA total of 6558 patients (5281 [80.5%] men; mean [SD] age at surgery, 67.6 [9.3] years) were included; 1813 (27.6%) were treated with ASA plus ticagrelor and 4745 (72.4%) were treated with ASA monotherapy. Crude MACE rate was 3.0 per 100 person years (95% CI, 2.5-3.6 per 100 person years) in the ASA plus ticagrelor group and 3.8 per 100 person years (95% CI, 3.5-4.1 per 100 person years) in the ASA group. After adjustment, there was no significant difference in MACE risk between ASA plus ticagrelor vs ASA only, neither during the first 12 months (adjusted hazard ratio [aHR], 0.84; 95% CI, 0.58-1.21; P = .34) or during total follow-up (aHR, 0.89; 95% CI, 0.71-1.11; P = .29). The use of ASA plus ticagrelor was associated with a significantly increased risk for major bleeding during the first 12 months (aHR, 1.90; 95% CI, 1.16-3.13; P = .011). Sensitivity analyses confirmed the results.Conclusions and relevanceIn patients with ACS who survived 2 weeks after CABG, no significant difference in the risk of death or ischemic events could be demonstrated between ASA plus ticagrelor and patients treated with ASA only, while the risk for major bleeding was higher in patients treated with ASA plus ticagrelor. Sufficiently powered prospective randomized trials comparing different antiplatelet therapy strategies after CABG are warranted.

Dataset Information

Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639].

Publications

Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639].

Similar Datasets

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