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Background: The appropriate antithrombotic regimen for patients with chronic coronary syndrome who are at high atherothrombotic risk and receiving long-term oral anticoagulation remains unknown.
Methods: We conducted a multicenter, double-blind, randomized, placebo-controlled trial in France involving patients with chronic coronary syndrome who had undergone a previous stent implantation (>6 months before enrollment) and were at high atherothrombotic risk and currently receiving long-term oral anticoagulation. The patients were randomly assigned in a 1:1 ratio to receive aspirin (100 mg once daily) or placebo; all the patients continued to receive their current oral anticoagulation therapy. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia. The key safety outcome was major bleeding.
Results: A total of 872 patients underwent randomization; 433 were assigned to the aspirin group, and 439 to the placebo group. The trial was stopped early at the advice of the independent data and safety monitoring board after a median follow-up of 2.2 years because of an excess of deaths from any cause in the aspirin group. A primary efficacy outcome event occurred in 73 patients (16.9%) in the aspirin group and in 53 patients (12.1%) in the placebo group (adjusted hazard ratio, 1.53; 95% confidence interval [CI], 1.07 to 2.18; P = 0.02). Death from any cause occurred in 58 patients (13.4%) in the aspirin group and in 37 (8.4%) in the placebo group (adjusted hazard ratio, 1.72; 95% CI, 1.14 to 2.58; P = 0.01). Major bleeding occurred in 44 patients (10.2%) in the aspirin group and in 15 patients (3.4%) in the placebo group (adjusted hazard ratio, 3.35; 95% CI, 1.87 to 6.00; P<0.001). A total of 467 and 395 serious adverse events were reported in the aspirin group and placebo group, respectively.
Conclusions: Among patients with chronic coronary syndrome at high atherothrombotic risk who were receiving an oral anticoagulant, the addition of aspirin led to a higher risk of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia than placebo, as well as higher risks of death from any cause and major bleeding. (Funded by the French Ministry of Health and Bayer Healthcare; ClinicalTrials.gov number, NCT04217447.).
Guideline title Perioperative Management of Antithrombotic Therapy: An American College of Chest Physicians Clinical Practice Guideline
Release date November 2022
Developer and funding source American College of Chest Physicians
Target population Patients taking oral anticoagulation or antiplatelet therapy who are undergoing an elective surgery or procedure
Selected recommendations
For patients requiring aspirin therapy who are undergoing an elective noncardiac surgery, continuing aspirin through the surgery is suggested (conditional recommendation; moderate certainty of evidence [COE]).
For patients with atrial fibrillation taking vitamin K antagonists (VKAs) who are undergoing an elective surgery or procedure with low to moderate risk of thromboembolism, temporary use of therapeutic heparin doses during interruption of VKA (heparin bridging) is not recommended (strong recommendation; moderate COE).
For patients with a mechanical heart valve with low to moderate risk of thromboembolism who require VKA interruption for an elective surgery or procedure, heparin bridging is not suggested (conditional recommendation; very low COE).
For patients receiving a direct oral anticoagulant (DOAC) who will be undergoing an elective surgery or procedure, discontinuing DOAC therapy is suggested with the timing dependent on the specific DOAC and the bleeding risk of the procedure (conditional recommendation; very low COE).
The management of patients who are receiving an anticoagulant or antiplatelet drug and require surgery or an invasive procedure is a common clinical problem encountered by a broad spectrum of health care professionals. This review provides an evidence-based but practical approach to common clinical scenarios involving patients who require an elective surgery/procedure and are receiving either a vitamin K antagonist, a direct oral anticoagulant, or single or dual antiplatelet therapy. This review also addresses the role of perioperative heparin bridging and the management of patients who are receiving an anticoagulant drug and need urgent surgery.
