In the Journals

Apixaban plus aspirin may be beneficial after MitraClip implantation

Patients with maintained sinus rhythm experienced a lower adverse event rate with apixaban plus aspirin vs. single or dual antiplatelet therapy at 30 days after percutaneous repair of severe mitral regurgitation, according to a research letter published in JACC: Cardiovascular Interventions.

“The adequate anticoagulation or antiplatelet strategy following structural heart procedures is an important issue. Although MitraClip has been performed in more than 60,000 patients to date, anticoagulation strategy is still unclear. First, when working in the left atrium, there is an unknown risk of endothelial damage. Second, there are published case reports on thrombus formation on the device,” Julia Seeger, MD, from the University of Ulm, Ulm, Germany, wrote in an email to Cardiology Today’s Intervention. “Anticoagulation after MitraClip procedure even in sinus rhythm patients in the first periprocedural period might adequately address this issue.”

In a prospective, observational registry study, Seeger and colleagues assessed the safety and efficacy of dual antithrombotic therapy using apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) plus aspirin vs. antiplatelet therapy alone in patients with maintained sinus rhythm at 30 days and 12 months after undergoing percutaneous mitral valve repair with the MitraClip device (Abbott).

Of the 254 patients enrolled in the study, 53.5% received apixaban plus aspirin for 4 weeks after the procedure followed by antiplatelet therapy alone and 46.5% received antiplatelet therapy only after MitraClip implantation. Of the 118 patients on antiplatelet therapy, 72.1% were on single antiplatelet therapy and 27.9% were on DAPT with clopidogrel plus aspirin after previous PCI.

All patients were taking aspirin before the procedure, and treatment with apixaban was initiated 24 hours after device implantation in patients with sinus rhythm.

At 30 days, patients on apixaban plus aspirin had a lower rate of the combined endpoint of all-cause mortality, all stroke and rehospitalization for congestive HF or MI than those on antiplatelet therapy only (1.4% vs. 7.6%; P = .02). The stroke rate was also lower in the apixaban plus aspirin group, but the difference was not statistically significant (0% vs. 0.9%; P = .28). Neither group experienced major bleeding at 30 days.

In multivariate analysis, the only independent predictor of the combined endpoint at 30 days was antithrombotic regimen (OR = 0.18; 95% CI, 0.038-0.867), whereas other factors, such as age, sex, NYHA functional class, Society of Thoracic Surgeons score, left ventricular function or etiology of mitral regurgitation, did not appear to be predictive of the combined endpoint.

In a landmark analysis after the 30 days, there were no statistically significant differences in the combined endpoint between patients who received apixaban plus aspirin and those who received antiplatelet therapy only.

Seeger and colleagues noted, however, that these study results are hypothesis-generating due to the number of patients and low event rates.

“This is a first exploratory finding that needs to be addressed in large randomized controlled trials. As more and more patients are treated with MitraClip and recent randomized controlled trials have demonstrated a benefit not only in quality of life but also regarding mortality, post-procedural anticoagulation/antiplatelet strategy is a question that needs to be addressed to allow clear recommendations in the guidelines,” Seeger said.

“With the rapidly evolving field of structural heart interventions post-procedural anticoagulation strategy is an important issue to keep in mind. These first exploratory findings on anticoagulation after MitraClip in sinus rhythm patients, should trigger the initiation of larger randomized controlled trials.” – by Melissa Foster

For more information:

Julia Seeger, MD, can be reached at julia.seeger@t-online.de.

Disclosures: The authors report no relevant financial disclosures.

Patients with maintained sinus rhythm experienced a lower adverse event rate with apixaban plus aspirin vs. single or dual antiplatelet therapy at 30 days after percutaneous repair of severe mitral regurgitation, according to a research letter published in JACC: Cardiovascular Interventions.

“The adequate anticoagulation or antiplatelet strategy following structural heart procedures is an important issue. Although MitraClip has been performed in more than 60,000 patients to date, anticoagulation strategy is still unclear. First, when working in the left atrium, there is an unknown risk of endothelial damage. Second, there are published case reports on thrombus formation on the device,” Julia Seeger, MD, from the University of Ulm, Ulm, Germany, wrote in an email to Cardiology Today’s Intervention. “Anticoagulation after MitraClip procedure even in sinus rhythm patients in the first periprocedural period might adequately address this issue.”

In a prospective, observational registry study, Seeger and colleagues assessed the safety and efficacy of dual antithrombotic therapy using apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) plus aspirin vs. antiplatelet therapy alone in patients with maintained sinus rhythm at 30 days and 12 months after undergoing percutaneous mitral valve repair with the MitraClip device (Abbott).

Of the 254 patients enrolled in the study, 53.5% received apixaban plus aspirin for 4 weeks after the procedure followed by antiplatelet therapy alone and 46.5% received antiplatelet therapy only after MitraClip implantation. Of the 118 patients on antiplatelet therapy, 72.1% were on single antiplatelet therapy and 27.9% were on DAPT with clopidogrel plus aspirin after previous PCI.

All patients were taking aspirin before the procedure, and treatment with apixaban was initiated 24 hours after device implantation in patients with sinus rhythm.

At 30 days, patients on apixaban plus aspirin had a lower rate of the combined endpoint of all-cause mortality, all stroke and rehospitalization for congestive HF or MI than those on antiplatelet therapy only (1.4% vs. 7.6%; P = .02). The stroke rate was also lower in the apixaban plus aspirin group, but the difference was not statistically significant (0% vs. 0.9%; P = .28). Neither group experienced major bleeding at 30 days.

In multivariate analysis, the only independent predictor of the combined endpoint at 30 days was antithrombotic regimen (OR = 0.18; 95% CI, 0.038-0.867), whereas other factors, such as age, sex, NYHA functional class, Society of Thoracic Surgeons score, left ventricular function or etiology of mitral regurgitation, did not appear to be predictive of the combined endpoint.

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In a landmark analysis after the 30 days, there were no statistically significant differences in the combined endpoint between patients who received apixaban plus aspirin and those who received antiplatelet therapy only.

Seeger and colleagues noted, however, that these study results are hypothesis-generating due to the number of patients and low event rates.

“This is a first exploratory finding that needs to be addressed in large randomized controlled trials. As more and more patients are treated with MitraClip and recent randomized controlled trials have demonstrated a benefit not only in quality of life but also regarding mortality, post-procedural anticoagulation/antiplatelet strategy is a question that needs to be addressed to allow clear recommendations in the guidelines,” Seeger said.

“With the rapidly evolving field of structural heart interventions post-procedural anticoagulation strategy is an important issue to keep in mind. These first exploratory findings on anticoagulation after MitraClip in sinus rhythm patients, should trigger the initiation of larger randomized controlled trials.” – by Melissa Foster

For more information:

Julia Seeger, MD, can be reached at julia.seeger@t-online.de.

Disclosures: The authors report no relevant financial disclosures.