Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

Overview

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

Description

ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient perioperative atrial fibrillation and additional stroke factors after noncardiac surgery. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Eligibility

Inclusion Criteria:

1. noncardiac surgery in the past 35 days with at least one of the following:
   1. an overnight hospital admission after surgery;
   2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator
2. ≥1 episode of clinically important perioperative AF during or after their surgery;
3. sinus rhythm at the time of randomization; AND
4. any of the following high-risk criteria:
   1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
   2. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
   3. age ≥75 years.
5. provide written informed consent

Exclusion Criteria:

1. history of documented chronic AF prior to noncardiac surgery;
2. need for long-term systemic anticoagulation;
3. ongoing need for long-term dual antiplatelet treatment;
4. contraindication to oral anticoagulation;
5. severe renal insufficiency (CrCl <20 ml/min);
6. severe liver cirrhosis (i.e., Child-Pugh Class C)
7. acute stroke in the past 14 days;
8. underwent cardiac surgery in the past 35 days;
9. history of nontraumatic intracranial, intraocular, or spinal bleeding;
10. hemorrhagic disorder or bleeding diathesis;
11. expected to be non-compliant with follow-up and/or study medications;
12. known life expectancy less than 1 year due to concomitant disease;
13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
14. previously enrolled in the trial