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evident
Original paper
2014NEJMSurgery/Perioperative

POISE-2

Aspirin in patients undergoing noncardiac surgery

RCTPerioperative medicine

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Overview

Perioperative aspirin and clonidine did not prevent death or MI; aspirin increased bleeding.

Clinical takeaway

POISE-2 is the companion perioperative caution trial to POISE: routine perioperative aspirin or clonidine initiation does not improve major ischemic outcomes and can cause harm.

Key result

Aspirin did not reduce death or nonfatal MI and increased major bleeding.

Practice impact

Avoid routine perioperative aspirin or clonidine solely to prevent MI in noncardiac surgery.

Evidence

Study design

Large randomized factorial perioperative trial.

Enrollment

10,010

Follow-up

30 days.

Geography

Multinational

Clinical question

Do aspirin or clonidine reduce death or nonfatal MI in patients undergoing noncardiac surgery?

Population

  • Patients undergoing noncardiac surgery at risk for vascular complications.

Intervention

Aspirin 200 mg just before surgery, then 100 mg daily for 30 days (initiation stratum) or 7 days (continuation stratum); clonidine was tested in the second factorial comparison.

Comparator

Placebo.

Primary outcome

Composite of death or nonfatal myocardial infarction at 30 days.

Perioperative aspirin did not reduce death or nonfatal MI and increased major bleeding.

Hazard ratio / 0.99 / 95% CI 0.86-1.15 / p=0.92

Key results

  • Aspirin did not reduce death or nonfatal MI: 7.0% vs 7.1% with placebo; HR 0.99 (95% CI 0.86-1.15; P=0.92).
  • Aspirin increased major bleeding: 4.6% vs 3.8%; HR 1.23 (95% CI 1.01-1.49; P=0.04).
  • Results were similar in the initiation stratum (5628 patients) and the continuation stratum (4382 patients).
  • Clonidine did not reduce death or nonfatal MI and increased clinically important hypotension (reported in the companion POISE-2 clonidine paper).

Harms

  • Aspirin increased major bleeding.
  • Clonidine increased clinically important hypotension and nonfatal cardiac arrest.

Clinical Use

Practice impact

  • Discouraged routine perioperative aspirin or clonidine initiation for ischemic prevention in noncardiac surgery.

Applicability

  • Adults undergoing noncardiac surgery where perioperative aspirin or clonidine is being considered for event prevention.

Limitations

  • Does not override separate indications for continuing aspirin in selected high-risk stent or vascular patients.
  • The card summarizes two linked POISE-2 randomized comparisons.

Common misinterpretations

  • Do not stop all chronic aspirin automatically; balance bleeding risk against the reason aspirin was prescribed.

Related evidence

POISE - Similar QuestionBRIDGE - ContextPOISE-3 - Later Trial

Citation

Devereaux PJ, Mrkobrada M, Sessler DI, et al. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014;370(16):1494-1503. doi:10.1056/NEJMoa1401105

Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding.