• Interventional Techniques & Devices
• Cardiology Clinical Trials
• Myocardial Infarction

• Interventional Techniques & Devices
• Cardiology Clinical Trials
• Cardiology & Cardiovascular Medicine
• Myocardial Infarction

Acetylsalicylic acid (aspirin) is ineffective in reducing perioperative heart attacks and death in noncardiac surgery, but increases the risk of bleeding. Results from the Perioperative Ischemic Evaluation-2 trial [POISE-2; Devereaux PJ et al. N Engl J Med 2014] were presented by Philip I. Devereaux, MD, PhD, McMaster University, Hamilton, Ontario, Canada.

Patients aged ≥45 years undergoing noncardiac surgery who were at risk of vascular complications were eligible for the Phase 3, randomized, controlled, POISE-2 trial. Exclusion criteria were recent stent implantation (bare-metal stent within 6 weeks or drug-eluting stent within 1 year) and use of aspirin within 72 hours prior to surgery. The primary outcome was a composite of death and nonfatal myocardial infarction (MI) within 30 days following surgery. Secondary composite outcomes were 1) death, MI, or stroke, and 2) death, MI, revascularization, pulmonary embolism (PE), or deep vein thrombosis (DVT). Tertiary outcomes were death, MI, peripheral arterial thrombosis, PE, DVT, and acute kidney injury requiring dialysis.

The study enrolled patients who had been taking aspirin daily before surgery (aspirin-chronic; n=4382) as well aspirin-naïve patients (n=5628). For those in the first group, aspirin use was stopped ≥72 hours before surgery. All patients received placebo or 200 mg aspirin just before surgery. Postoperatively, the aspirin-naïve patients received 100 mg aspirin or placebo daily for 30 days, while aspirin-chronic patients received 100 mg aspirin or placebo for 7 days before resuming their presurgery aspirin regimen.

Both groups were similar; mean patient age 68.6 years, 53% male, 32% had known vascular disease, and 4.7% had a history of percutaneous coronary intervention. Surgeries for both groups in descending order of frequency were orthopedic (38%), general (32%), urologic or gynecologic (16%), vascular (6%), and other (11%). Prophylactic anticoagulant was administered to 65% of patients

There were no significant differences in the rate of the primary, secondary, or tertiary outcomes among patients randomized to aspirin compared with those receiving placebo with the exception of a trend towards higher rates of acute kidney injury in those randomized to aspirin (Table 1). Primary and secondary outcomes were similar for the aspirin-chronic and -naïve patients.

Aspirin users were significantly more likely to experience a major retroperitoneal, intraspinal, or intraocular bleed requiring infusions of red blood cells. They also experienced more (statistically nonsignificant) episodes of life-threatening bleeding (Table 2).

Life-threatening or major bleeding was an independent predictor of perioperative MI (HR, 1.82; 95% CI, 1.40 to 2.36; p<0.001). The investigators hypothesized that this might explain the efficacy of aspirin in the non-operative setting, where the risk of bleeding is less frequent, compared with the more neutral effect of aspirin in the perioperative setting, where the risk of bleeding is greater.

• © 2014 MD Conference Express®