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AUGUSTUS: Dual therapy with apixaban, P2Y12 inhibitor safe, effective in AF, prior stroke

M. Cecilia Bahit

In patients with atrial fibrillation who had ACS or PCI, among those with prior stroke, transient ischemic attack or thromboembolism, those assigned a dual antithrombotic strategy of apixaban and a P2Y12 inhibitor had better outcomes than those assigned a vitamin K antagonist-based regimen, according to new data from the AUGUSTUS trial.

As Healio previously reported, in the main results of the AUGUSTUS trial, the dual antithrombotic regimen of a P2Y12 inhibitor and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), without aspirin, resulted in less bleeding and fewer hospitalizations and no difference in ischemic events at 6 months compared with other regimens that included a vitamin K antagonist, aspirin or both.

M. Cecilia Bahit, MD, chief of the cardiology department at INECO Neurociencias Oroño, Rosario, Argentina, presented an analysis at the International Stroke Conference in which 4,581 patients were grouped according to prior stroke, TIA or thromboembolism.

Compared with those without prior stroke/TIA/thromboembolism, those who had one were older (72 years vs. 70 years; P < .001), had higher CHADS2-VASc and HAS-BLED scores (P < .001 for both), were more likely to have prior bleeding (P < .001), HF (P = .014) and diabetes (P = .004), and were more likely to have previously taken an oral anticoagulant (P = .004), Bahit said during her presentation.

During the study period, regardless of randomization, patients with prior stroke/TIA/thromboembolism had statistically significant increased risk for International Society on Thrombosis and Haemostasis (ISTH) major and clinically relevant nonmajor bleeding events (7.1% vs. 13%; P = .019), death or hospitalization (30.6% vs 25.2%; P = .003), death or ischemic events (9.4% vs. 6.1%; P = .001) and ischemic stroke (1.6% vs. 0.5%; P = .002), compared with those without prior stroke, TIA or thromboembolism, she said.

There was no interaction between anticoagulant treatment and prior stroke, TIA or thrombolism on any outcomes. According to the researchers, the treatment effect favored the apixaban-based regimens compared with the vitamin K antagonist-based regimens regardless of prior stroke/TIA/thromboembolism for the outcomes of ISTH major or clinically relevant minor bleeding and death or hospitalization.

“However, we did find a significant interaction (P for interaction = .011) between the antiplatelet treatment (aspirin vs. placebo) and prior stroke/TIA/thromboembolism on ISTH major or clinically relevant nonmajor bleeding, demonstrating that aspirin increases the risk of bleeding more pronouncedly among patients without prior stroke, TIA or thromboembolism,” Bahit said.

“This study confirms that an antithrombotic strategy of clopidogrel plus apixaban, without aspirin, is safe and effective in patients with AF and ACS/PCI, regardless of the presence of prior stroke, TIA or thromboembolism,” she said. – by Erik Swain

Reference:

Bahit MC, et al. LB22. Presented at: International Stroke Conference; Feb. 19-21, 2020; Los Angeles.

Disclosures: The study was funded by Bristol-Myers Squibb and Pfizer. Bahit reports she received honoraria from CSL Behring, Merck Sharp & Dohme and Pfizer.

Editor’s Note: This article was updated on Feb. 26, 2020 to include additional data and other changes requested by Dr. Bahit.

M. Cecilia Bahit

In patients with atrial fibrillation who had ACS or PCI, among those with prior stroke, transient ischemic attack or thromboembolism, those assigned a dual antithrombotic strategy of apixaban and a P2Y12 inhibitor had better outcomes than those assigned a vitamin K antagonist-based regimen, according to new data from the AUGUSTUS trial.

As Healio previously reported, in the main results of the AUGUSTUS trial, the dual antithrombotic regimen of a P2Y12 inhibitor and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), without aspirin, resulted in less bleeding and fewer hospitalizations and no difference in ischemic events at 6 months compared with other regimens that included a vitamin K antagonist, aspirin or both.

M. Cecilia Bahit, MD, chief of the cardiology department at INECO Neurociencias Oroño, Rosario, Argentina, presented an analysis at the International Stroke Conference in which 4,581 patients were grouped according to prior stroke, TIA or thromboembolism.

Compared with those without prior stroke/TIA/thromboembolism, those who had one were older (72 years vs. 70 years; P < .001), had higher CHADS2-VASc and HAS-BLED scores (P < .001 for both), were more likely to have prior bleeding (P < .001), HF (P = .014) and diabetes (P = .004), and were more likely to have previously taken an oral anticoagulant (P = .004), Bahit said during her presentation.

During the study period, regardless of randomization, patients with prior stroke/TIA/thromboembolism had statistically significant increased risk for International Society on Thrombosis and Haemostasis (ISTH) major and clinically relevant nonmajor bleeding events (7.1% vs. 13%; P = .019), death or hospitalization (30.6% vs 25.2%; P = .003), death or ischemic events (9.4% vs. 6.1%; P = .001) and ischemic stroke (1.6% vs. 0.5%; P = .002), compared with those without prior stroke, TIA or thromboembolism, she said.

There was no interaction between anticoagulant treatment and prior stroke, TIA or thrombolism on any outcomes. According to the researchers, the treatment effect favored the apixaban-based regimens compared with the vitamin K antagonist-based regimens regardless of prior stroke/TIA/thromboembolism for the outcomes of ISTH major or clinically relevant minor bleeding and death or hospitalization.

“However, we did find a significant interaction (P for interaction = .011) between the antiplatelet treatment (aspirin vs. placebo) and prior stroke/TIA/thromboembolism on ISTH major or clinically relevant nonmajor bleeding, demonstrating that aspirin increases the risk of bleeding more pronouncedly among patients without prior stroke, TIA or thromboembolism,” Bahit said.

“This study confirms that an antithrombotic strategy of clopidogrel plus apixaban, without aspirin, is safe and effective in patients with AF and ACS/PCI, regardless of the presence of prior stroke, TIA or thromboembolism,” she said. – by Erik Swain

Reference:

Bahit MC, et al. LB22. Presented at: International Stroke Conference; Feb. 19-21, 2020; Los Angeles.

Disclosures: The study was funded by Bristol-Myers Squibb and Pfizer. Bahit reports she received honoraria from CSL Behring, Merck Sharp & Dohme and Pfizer.

Editor’s Note: This article was updated on Feb. 26, 2020 to include additional data and other changes requested by Dr. Bahit.

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