RESTRICTIVE ANTITHROMBOTIC STRATEGIES FOR PATIENTS REQUIRING ANTICOAGULATION FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (TERRA PRETA): A SYSTEMATIC REVIEW AND META-ANALYSIS OF THROMBOTIC OUTCOMES
CCC ePoster Library. Haghbayan H. 10/26/19; 280320; 262
Dr. Hourmazd Haghbayan
Dr. Hourmazd Haghbayan
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BACKGROUND: Patients with indications for long-term anticoagulation frequently have comorbid coronary disease and may require DAPT following ACS or PCI. While conventional triple therapy (TT) comprising aspirin, a P2Y12 receptor inhibitor (P2Y12i), and a VKA offers well-established anti-thrombotic potency, the associated bleeding risk is very high. Recent large RCTs have demonstrated reduced bleeding events with restrictive antithrombotic strategies, based on aspirin-omission and use of DOACs in lieu of VKAs (dual therapy, DT). However, none of these trials were adequately powered for thrombotic outcomes, and the antithrombotic efficacy of DT strategies in this population remains unknown. We therefore undertook a systematic review and meta-analysis of RCT-data on thrombotic outcomes to determine, with high power, whether the incidence of thrombotic outcomes differ between VKA-based TT and aspirin-omitted DOAC-based DT.

METHODS AND RESULTS: Following protocol registration, we undertook a systematic review and meta-analysis of RCTs in accordance with the Cochrane Collaboration and PRISMA statements. We systematically searched MEDLINE and EMBASE between 01/2010-04/2019. Eligible studies were RCTs of adult patients requiring both DAPT and long-term anticoagulation post-ACS or post-PCI, with at least one arm randomized to restrictive antithrombotic strategy (with aspirin-omission) compared to a control of TT with a VKA. Incidence rate ratios (RRs) were calculated in each study for DT compared with TT and then pooled via random-effects models. Our search identified 4,248 citations of which four (n=12,670) were eligible for inclusion (Table). Mean age was 70.5 and 22.3% of participants were female. Clopidogrel was the P2Y12i employed in most patients (88-100%) and 54.9% of patients were recruited in the context of ACS. Compared with TT, patients randomized to an aspirin-omitted DT consisting of solely a P2Y12i and a DOAC at full-dose did not have significantly increased rates of thrombotic events (RR=1.01; 95%CI, 0.83-1.23; I2=0%, Figure). Mortality similarly did not differ between the two strategies (RR=1.06; 95%CI, 0.78-1.33; I2=0%, Figure).

CONCLUSION: In patients requiring therapeutic anticoagulation following ACS or PCI, our meta-analysis of RCTs demonstrates that a restrictive antithrombotic strategy omitting aspirin and consisting solely of a P2Y12i and full-dose DOAC confers similar thrombotic efficacy to traditional TT strategies consisting of DAPT coupled with a VKA. Given the measure of association's proximity to the null and the low heterogeneity, this is unlikely to change with the publication of future trials. Considering the well-established decreased bleeding-risk with restrictive antithrombotic strategies, our meta-analysis confers valuable evidence reassuring clinicians that restrictive strategies may be safely and effectively employed.
BACKGROUND: Patients with indications for long-term anticoagulation frequently have comorbid coronary disease and may require DAPT following ACS or PCI. While conventional triple therapy (TT) comprising aspirin, a P2Y12 receptor inhibitor (P2Y12i), and a VKA offers well-established anti-thrombotic potency, the associated bleeding risk is very high. Recent large RCTs have demonstrated reduced bleeding events with restrictive antithrombotic strategies, based on aspirin-omission and use of DOACs in lieu of VKAs (dual therapy, DT). However, none of these trials were adequately powered for thrombotic outcomes, and the antithrombotic efficacy of DT strategies in this population remains unknown. We therefore undertook a systematic review and meta-analysis of RCT-data on thrombotic outcomes to determine, with high power, whether the incidence of thrombotic outcomes differ between VKA-based TT and aspirin-omitted DOAC-based DT.

METHODS AND RESULTS: Following protocol registration, we undertook a systematic review and meta-analysis of RCTs in accordance with the Cochrane Collaboration and PRISMA statements. We systematically searched MEDLINE and EMBASE between 01/2010-04/2019. Eligible studies were RCTs of adult patients requiring both DAPT and long-term anticoagulation post-ACS or post-PCI, with at least one arm randomized to restrictive antithrombotic strategy (with aspirin-omission) compared to a control of TT with a VKA. Incidence rate ratios (RRs) were calculated in each study for DT compared with TT and then pooled via random-effects models. Our search identified 4,248 citations of which four (n=12,670) were eligible for inclusion (Table). Mean age was 70.5 and 22.3% of participants were female. Clopidogrel was the P2Y12i employed in most patients (88-100%) and 54.9% of patients were recruited in the context of ACS. Compared with TT, patients randomized to an aspirin-omitted DT consisting of solely a P2Y12i and a DOAC at full-dose did not have significantly increased rates of thrombotic events (RR=1.01; 95%CI, 0.83-1.23; I2=0%, Figure). Mortality similarly did not differ between the two strategies (RR=1.06; 95%CI, 0.78-1.33; I2=0%, Figure).

CONCLUSION: In patients requiring therapeutic anticoagulation following ACS or PCI, our meta-analysis of RCTs demonstrates that a restrictive antithrombotic strategy omitting aspirin and consisting solely of a P2Y12i and full-dose DOAC confers similar thrombotic efficacy to traditional TT strategies consisting of DAPT coupled with a VKA. Given the measure of association's proximity to the null and the low heterogeneity, this is unlikely to change with the publication of future trials. Considering the well-established decreased bleeding-risk with restrictive antithrombotic strategies, our meta-analysis confers valuable evidence reassuring clinicians that restrictive strategies may be safely and effectively employed.
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