Morgantown, WV—Two medications appear to be safer than three in reducing risks for major bleeding after percutaneous coronary intervention.

That’s according to a systematic review and meta-analysis published in Annals of Internal Medicine.

West Virginia University–led researchers determined that use of dual therapy with a direct oral anticoagulant (DOAC) in addition to a P2Y12 inhibitor appeared to reduce risk of major bleeding versus triple therapy with a vitamin K antagonist (VKA) plus aspirin and P2Y12 inhibitor for PCI patients. 

Background information in the article notes the difficulty in determining the optimal antithrombotic regimen in patients with ischemic heart disease and atrial fibrillation undergoing PCI. While evidence generally leans toward DOAC over VKA for atrial fibrillation management in these patients, that might not always be the case when antiplatelet therapy is also needed following PCI. The authors cite recent trials indicating an alternative approach—dual therapy consisting of a DOAC and a P2Y12 inhibitor versus triple therapy comprising a VKA and dual antiplatelet therapy.

The authors explain that cardiovascular benefits accruing from use of triple therapy could be offset by higher bleeding risk on one hand, while, on the other, withdrawal of aspirin might lead to higher rates of stent thrombosis and ischemic events with dual therapy.

To help solve the dilemma, the study team conducted searches of PubMed, EMBASE, and the Cochrane Library from December 31, 2019, and ClinicalTrials.gov from January 7, 2020, without language restrictions. The focus was on randomized controlled trials that compared the effects of dual versus triple therapy on bleeding, mortality, and ischemic events in adults with AF after PCI.

Data was abstracted by two independent investigators who assessed the quality of evidence and rated the certainty of evidence. Ultimately, four trials involving 7,953 participants were included.

Results indicate that, at the median follow-up of one year, high-certainty evidence suggests that dual therapy was associated with reduced risk for major bleeding compared with triple therapy (risk difference [RD], -0.013 [95% CI, -0.025 to -0.002]). Low-certainty evidence showed inconclusive effects of dual versus triple therapy on risks for all-cause mortality (RD, 0.004 [CI, -0.010 to 0.017]), cardiovascular mortality (RD, 0.001 [CI, -0.011 to 0.013]), myocardial infarction (RD, 0.003 [CI, -0.010 to 0.017]), stent thrombosis (RD, 0.003 [CI, -0.005 to 0.010]), and stroke (RD, -0.003 [CI, -0.010 to 0.005]).

Researchers added, “The upper bounds of the [confidence intervals] for these effects were compatible with possible increased risks with dual therapy.”

Noting that their findings were limited by heterogeneity of study designs, dosages of DOACs, and types of P2Y12 inhibitors, the authors conclude, “In adults with AF after PCI, dual therapy reduces risk for bleeding compared with triple therapy, whereas its effects on risks for death and ischemic end points are still unclear.”

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