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Risk tools for AF inadequate in PCI population
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LAS VEGAS — Risk tools such as the CHA2DS2-VASc and HAS-BLED scores developed for patients with atrial fibrillation did not perform well in patients with AF undergoing PCI, according to new data from the AVIATOR-2 registry.
“Novel tools to accurately quantify risk and inform clinical decisions are needed in complex patients with AF requiring PCI,” Cardiology Today Next Gen Innovator Usman Baber, MD, MS, assistant professor of medicine at Icahn School of Medicine at Mount Sinai, said during a presentation at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
Patients with AF requiring PCI “present unique challenges given the number of potential antithrombotic strategies, treatment durations and overlap in ischemic and bleeding risk,” he said during the presentation. “Existing tools to estimate risk such as CHA2DS2-VASc and HAS-BLED were developed in AF cohorts that are distinct from PCI populations. Therapeutic approaches and factors influencing clinical decisions in a contemporary AF/PCI cohort are not well characterized.”
The researchers analyzed 514 patients (mean age, 73 years; 26% women) with AF who underwent PCI. The primary outcomes were MACCE and Bleeding Academic Research Consortium (BARC) grade 2 or higher, and the researchers assessed how well the CHA2DS2-VASc score, the HAS-BLED score and subjective physician assessment predicted those events.
Planned enrollment was 2,500, but funding was stopped after enrollment reached 514, Baber said during the presentation.
The mean CHA2DS2-VASc score was 4.23 and the mean HAS-BLED score was 2.99.
In a physician questionnaire, 84.8% said they used a risk score to help determine their patient’s antithrombotic therapy after PCI, 73.9% said they used CHA2DS2-VASc and 40.7% said they used HAS-BLED. In a patient questionnaire, 93% said they agreed mostly or completely that they were convinced about the importance of their therapy.
The physicians said safety and efficacy were the most important factors in the decision on antithrombotic therapy, and the patients said they were most worried about MI (63.4%), stroke (50.6%) and death (47.5%), according to the researchers.
Concordance between high CHA2DS2-VASc score and physician perception of high ischemic risk was 27%, whereas concordance between high HAS-BLED score and physician perception of high bleeding risk was 38.4%, Baber said.
Among the cohort, 338 were discharged on triple therapy consisting of an oral anticoagulant, a P2Y12 inhibitor and aspirin; 65 were discharged on dual therapy of an oral anticoagulant and a P2Y12 inhibitor and 105 were discharged on dual antiplatelet therapy. At 1 year, adherence was 82.9% in the DAPT group, 76.6% in the oral anticoagulant/P2Y12 inhibitor group and 31% in the triple therapy group, with antiplatelets being discontinued more often than anticoagulants, Baber said.
“We found that the intensity of antithrombotic therapy was primarily and inversely related to clinical perception of ischemic risk, which illustrates and is consistent with the risk-treatment paradox in such patients,” Baber said during the presentation.
At 1 year, 15.3% of patients had MACCE and 13.8% had major bleeding, according to the researchers.
Patients whom physicians had assessed as high or very high risk for MACCE had higher rates of MACCE than patients assessed as very low, low or intermediate risk (P for trend = .004), whereas patients with CHA2DS2-VASc score greater than 5 had very high rates of MACCE compared with patients with other scores (P for trend = .01), Baber said.
The C-statistics for MACCE were similar between physician perceived risk (0.594) and CHA2DS2-VASc score (0.591), he said.
Physician assessment of bleeding risk correlated with major bleeding events (P for trend = .02), but HAS-BLED score did not (P for trend = .35), according to the researchers. The C-statistic was lower for the HAS-BLED score (0.534) than for physician assessment (0.6).
“Existing tools, namely the CHA2DS2-VASc and HAS-BLED scores, to quantify ischemic and bleeding risk in AF populations, at least in our registry, performed quite poorly in these patients who also underwent PCI,” Baber said during the presentation.
He said the study was conducted at the Center of Interventional Cardiovascular Research at Icahn School of Medicine at Mount Sinai, with professor of medicine and Cardiology Today’s Intervention Associate Medical Editor Roxana Mehran, MD, serving as director of the academic research organization and study chair. – by Erik Swain
Reference:
Baber U, et al. Featured Clinical Research I. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 19-22, 2019; Las Vegas.
Disclosure: The registry was funded in part by Bristol-Myers Squibb and Pfizer. Baber reports he received honoraria from AstraZeneca and Boston Scientific.