Dataset Information

Randomised controlled trial to investigate optimal antithrombotic therapy in patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention: a study protocol of the OPTIMA-AF trial.

ABSTRACT:

Introduction

The optimal antithrombotic strategy for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) is uncertain. For patients with non-AF, many trials are now evaluating short 1-month dual antiplatelet therapy. In patients with AF undergoing PCI, in contrast, short dual therapy (P2Y₁₂ inhibitor +direct oral anticoagulant (DOAC)) has not yet been evaluated.

Methods and analysis

The OPTIMA-AF trial (OPTIMAl antiplatelet therapy in combination with direct oral anticoagulants in patients with non-valvular Atrial Fibrillation undergoing percutaneous coronary intervention with everolimus-eluting stent) is an investigator-initiated, open-label, nationwide, multicentre, prospective, randomised controlled trial. The primary objective is to compare the efficacy and safety of short dual therapy (1-month DOAC +P2Y₁₂ inhibitor followed by DOAC monotherapy) against long dual therapy (12-month DOAC +P2Y₁₂ inhibitor followed by DOAC monotherapy) in the treatment of AF subjects undergoing PCI. The primary efficacy endpoint is a composite of death or thromboembolic events (myocardial infarction, definite stent thrombosis, stroke or systemic embolism) at 365 days; and the primary safety endpoint is bleeding (International Society on Thrombosis and Haemostasis major or clinically relevant non-major bleeding) at 365 days. This trial is intended to show the non-inferiority of short dual therapy versus long dual therapy in terms of the primary efficacy endpoint and show superiority in terms of the primary safety endpoint. A total of 1090 subjects will be randomised in a 1:1 ratio at approximately 60 sites.

Ethics and dissemination

This study received approval from the Certified Review Board of Osaka University (a certified research ethics committee by the Japanese Clinical Research Act). The findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

Japan Registry of Clinical Trials: jRCTs051190053; Pre-results.

SUBMITTER: Sotomi Y

PROVIDER: S-EPMC8671924 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceAntithrombotic treatment in patients with atrial fibrillation (AF) and percutaneous coronary intervention (PCI) presents a balancing act with regard to bleeding and ischemic risks.ObjectivesTo evaluate the safety and efficacy of 4 antithrombotic regimens by conducting an up-to-date network meta-analysis and to identify the optimal treatment for patients with AF undergoing PCI.Data sourcesOnline computerized database (MEDLINE).Study selectionFive randomized studies were included (N?=?11?542; WOEST, PIONEER AF-PCI, RE-DUAL PCI, AUGUSTUS, ENTRUST-AF PCI).Data extraction and synthesisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used in this network meta-analysis, in which bayesian random-effects models were applied. The data were analyzed from September 9 to 29, 2019.Main outcomes and measuresThe primary safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding and the primary efficacy outcome was trial-defined major adverse cardiovascular events (MACE).ResultsThe total number of participants included in the study was 11 532. The mean age of the participants ranged from 70 to 72 years, 69% to 83% were male, 20% to 26% were female, and the participants were predominantly white (>90%). Compared with vitamin K antagonists (VKA) plus dual antiplatelet therapy (DAPT) (reference), the odds ratios (ORs) (95% credible intervals) for TIMI major bleeding were 0.57 (0.31-1.00) for VKA plus P2Y12 inhibitor, 0.69 (0.40-1.16) for non-VKA oral anticoagulant (NOAC) plus DAPT, and 0.52 (0.35-0.79) for NOAC plus P2Y12 inhibitor. For MACE, using VKA plus DAPT as reference, the ORs (95% credible intervals) were 0.97 (0.64-1.42) for VKA plus P2Y12 inhibitor, 0.95 (0.64-1.39) for NOAC plus DAPT, and 1.03 (0.77-1.38) for NOAC plus P2Y12 inhibitor.Conclusions and relevanceThe findings of this study suggest that an antithrombotic regimen of VKA plus DAPT should generally be avoided, because regimens in which aspirin is discontinued may lead to lower bleeding risk and no difference in antithrombotic effectiveness. The use of a NOAC plus a P2Y12 inhibitor without aspirin may be the most favorable treatment option and the preferred antithrombotic regimen for most patients with AF undergoing PCI.

Project description:BackgroundAlthough triple antithrombotic therapy (TAT) is recommended in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), guidelines allow an option of dual antithrombotic therapy (DAT). This study assesses the everyday practice of 10 cardiology departments in antithrombotic therapy in AF patients undergoing PCI and its agreement with current guidelines.MethodsThis analysis included medical data of AF patients enrolled in the prospective, observational registry (The POLish Atrial Fibrillation-POL-AF) that underwent PCI [elective or due to acute coronary syndrome (ACS)].ResultsOf the 3,999 consecutive subjects included, a final analysis was performed on 359 patients that underwent PCI: 148 with urgent PCI due to ACSand 211 patients with elective PCI. Eighty patients in the ACS-group and 120 patients in the elective-PCI group were treated with TAT, although guidelines also allowed DAT. Of 316 patients treated with oral anticoagulants as a part of combination therapy, 275 were on non-vitamin K antagonist oral anticoagulant (NOAC). Reduced doses of NOAC were used in 74 patients treated with rivaroxaban, 60 patients with dabigatran, and 54 patients with apixaban. The proportion of patients treated with reduced NOAC doses adequately to the guidelines was 29%, 100%, and 33% for rivaroxaban, dabigatran, and apixaban, respectively. Inappropriate low doses of NOACs were used in 71% of subjects on rivaroxaban and 67% on apixaban.ConclusionsIn patients with AF undergoing PCI, NOACs are definitely preferred over vitamin-K antagonists (VKAs) in TAT/DAT, and an aggressive antithrombotic strategy with TAT is frequently chosen even if DAT is permissible by the guidelines. Label adherence of using reduced NOAC dose during combination therapy is not satisfactory for apixaban and rivaroxaban and probably results from too cautious an approach to the known indications for reduced therapy. The study is registered in the database Clinical Trials-NCT04419012.

Project description:BackgroundIn patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), selecting an antithrombotic regimen requires balancing risks of ischemic cardiac events, stroke, and bleeding.MethodsWe studied 467 patients with AF undergoing PCI in the time period from December 2015 to July 2018 identified via a chart audit by 47 Canadian cardiologists in the CONNECT AF+PCI (the Coordinated National Network to Engage Interventional Cardiologists in the Antithrombotic Treatment of Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) study, to determine patterns of initial antithrombotic therapy selection.ResultsThe median (25th, 75th percentile) CHADS2 score was 2 (1, 3), and PCI was performed in the setting of acute coronary syndrome in 62.1%. Triple antithrombotic therapy (TAT) was the initial treatment in 62.7%, dual-pathway therapy in 25.7%, and dual antiplatelet therapy in 11.6%, with a temporal increase in use of dual-pathway therapy during the course of the study; median intended TAT duration was 1 (1, 3) month. Compared with patients selected for TAT, patients selected for dual-pathway therapy were less likely to have prior myocardial infarction (35.8% vs 25.8%, P = 0.045) and prior PCI (33.8% vs 23.3%, P = 0.03), and they received shorter total length of stents (38 [23, 56] vs 30 [20, 46] mm, P = 0.03). Patients selected for dual-pathway therapy had a higher prevalence of prior stroke/transient ischemic attack (13.0% vs 23.3%, P = 0.01). There was no difference in prevalence of anemia (21.5% vs 25.8%, P = 0.30). Use of dual-pathway therapy was similar among patients with acute coronary syndrome and those with stable disease (24.1% vs 28.2%, P = 0.32).ConclusionsApproximately one-quarter of AF patients undergoing PCI are treated with dual-pathway therapy in Canadian practice, with its use increasing during the studied period. Patients selected for dual-pathway therapy have less-complex coronary disease history and intervention.