Antithrombotic Therapy in Patients with Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or with Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights from the AUGUSTUS Trial
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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Antithrombotic Therapy in Patients with Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or with Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention : Insights from the AUGUSTUS Trial. / Windecker, Stephan; Lopes, Renato D.; Massaro, Tyler; Jones-Burton, Charlotte; Granger, Christopher B.; Aronson, Ronald; Heizer, Gretchen; Goodman, Shaun G.; Darius, Harald; Jones, W. Schuyler; Aschermann, Michael; Brieger, David; Cura, Fernando; Engstrøm, Thomas; Fridrich, Viliam; Halvorsen, Sigrun; Huber, Kurt; Kang, Hyun Jae; Leiva-Pons, Jose L.; Lewis, Basil S.; Malaga, German; Meneveau, Nicolas; Merkely, Bela; Milicic, Davor; Morais, Joaõ; Potpara, Tatjana S.; Raev, Dimitar; Sabaté, Manel; De Waha-Thiele, Suzanne; Welsh, Robert C.; Xavier, Denis; Mehran, Roxana; Alexander, John H.; AUGUSTUS Investigators.
I: Circulation, Bind 140, Nr. 23, 12.2019, s. 1921-1932.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Antithrombotic Therapy in Patients with Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or with Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention
T2 - Insights from the AUGUSTUS Trial
AU - Windecker, Stephan
AU - Lopes, Renato D.
AU - Massaro, Tyler
AU - Jones-Burton, Charlotte
AU - Granger, Christopher B.
AU - Aronson, Ronald
AU - Heizer, Gretchen
AU - Goodman, Shaun G.
AU - Darius, Harald
AU - Jones, W. Schuyler
AU - Aschermann, Michael
AU - Brieger, David
AU - Cura, Fernando
AU - Engstrøm, Thomas
AU - Fridrich, Viliam
AU - Halvorsen, Sigrun
AU - Huber, Kurt
AU - Kang, Hyun Jae
AU - Leiva-Pons, Jose L.
AU - Lewis, Basil S.
AU - Malaga, German
AU - Meneveau, Nicolas
AU - Merkely, Bela
AU - Milicic, Davor
AU - Morais, Joaõ
AU - Potpara, Tatjana S.
AU - Raev, Dimitar
AU - Sabaté, Manel
AU - De Waha-Thiele, Suzanne
AU - Welsh, Robert C.
AU - Xavier, Denis
AU - Mehran, Roxana
AU - Alexander, John H.
AU - AUGUSTUS Investigators
PY - 2019/12
Y1 - 2019/12
N2 - Background: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. Methods: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: Patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction=0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; Pinteraction=0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction=0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=0.710). Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both.
AB - Background: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. Methods: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: Patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction=0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; Pinteraction=0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction=0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=0.710). Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both.
KW - acute coronary syndrome
KW - anticoagulants
KW - antithrombotic therapy
KW - aspirin
KW - atrial fibrillation
KW - hemorrhage
KW - percutaneous coronary intervention
KW - stroke
U2 - 10.1161/CIRCULATIONAHA.119.043308
DO - 10.1161/CIRCULATIONAHA.119.043308
M3 - Journal article
C2 - 31557056
AN - SCOPUS:85075526111
VL - 140
SP - 1921
EP - 1932
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 23
ER -
ID: 241042893