Spine Treatment Appraisal Report (STAR): Tranexamic Acid in Patients Undergoing Noncardiac Surgery: The POISE-3 Trial

Citation: Devereaux PJ, Marcucci M, Painter TW, et al; POISE-3 Investigators. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2022 May 26;386(21):1986-1997.

Visual Abstract

Why is This Study an Important Topic?

In non-cardiac surgeries, perioperative bleeding can lead to serious complications including death. Tranexamic acid is used to reduce bleeding during non-cardiac surgery. However, there is limited evidence of its effectiveness and safety in non-cardiac surgery such as spinal and orthopedic procedures. This study aimed to determine whether tranexamic acid can provide a reduction in bleeding events with a level of safety that is non-inferior to placebo in patients undergoing non-cardiac surgery.

What are the Primary Clinical Questions?

In patients undergoing non-cardiac surgery who are at risk for bleeding and cardiovascular events, does tranexamic acid result in a lower incidence of life-threatening bleeding, major bleeding, or bleeding into a critical organ than placebo, and is it non-inferior to placebo with respect to the incidence of major cardiovascular complications within 30 days?

Study Characteristics

Population:

Male (56%) and female (44%) adults, mean age 69years following non-cardiac surgery and at risk for bleeding or cardiovascular complications.

Excluded: Cardiac surgery, intracranial neurosurgery, planned systemic tranexamic acid during surgery, creatine clearance <30ml/min, long-term dialysis.

Intervention:

Tranexamic acid, 1-g intravenous bolus at the start and end of surgery.

Control:

Placebo administration at the start and end of surgery.

Outcomes:

Primary efficacy: A composite bleeding outcome (life-threatening bleeding, major bleeding, or bleeding into a critical organ).

Primary safety: A composite cardiovascular outcome (myocardial injury, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism).

Time:

Within 30days

Results

Result 1. Percent of an Event (A) and Kaplan-Meier Estimates (B) of Primary Efficacy Outcome (Composite Bleeding)

Result 2. Percent of an Event (A) and Kaplan-Meier Estimates (B) of Primary Safety Outcome (Composite Cardiovascular)

How Will This affect the Care of My Patients?

Among patients undergoing non-cardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid compared with placebo (absolute difference, −2.6 percentage points; 95% CI, −3.8 to −1.4). Although the difference between groups in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established (absolute difference, .3 percentage points; 95% CI, −1.1 to 1.7). Health care providers and patients will have to weigh the beneficial reduction in the incidence of composite bleeding outcome events against the low probability of a small increase in the incidence of composite cardiovascular outcome events.