Perioperative clopidogrel added to aspirin for critical limb ischemia surgery reduced platelet activation but did not significantly reduce troponin-positive events (16.0% vs 17.2%; RR 0.93; P=0.86).
RCT (n=108)
Double-blind
randomized
Does perioperative clopidogrel added to aspirin improve biomarkers of atherothrombosis without causing unacceptable bleeding in patients undergoing surgery for critical limb ischemia?
Perioperative dual antiplatelet therapy with clopidogrel and aspirin in patients undergoing surgery for critical limb ischemia reduces atherothrombotic biomarkers without increasing major bleeding, though it increases transfusion requirements.
Effect estimate: RR 0.93 (95% CI 0.39-2.17)
Absolute Event Rate: 16% vs 17.2%
p-value: p=0.86
In Brief Background and Objective: Patients with critical limb ischemia have a perioperative cardiovascular morbidity comparable to patients with acute coronary syndromes. We hypothesized that perioperative dual antiplatelet therapy would improve biomarkers of atherothrombosis without causing unacceptable bleeding in patients undergoing surgery for critical limb ischemia. Methods: In a double-blind randomized controlled trial, 108 patients undergoing infrainguinal revascularization or amputation for critical limb ischemia were maintained on aspirin (75 mg daily) and randomized to clopidogrel (600 mg prior to surgery, and 75 mg daily for 3 days; n = 50) or matched placebo (n = 58). Platelet activation and myocardial injury were assessed by flow cytometry and plasma troponin concentrations, respectively. Results: Clopidogrel reduced platelet-monocyte aggregation before surgery (38%–30%; P = 0.007). This was sustained in the postoperative period (P = 0.0019). There were 18 troponin-positive events (8 16.0% clopidogrel vs. 10 17.2% placebo; relative risk RR: 0.93, 95% confidence interval CI: 0.39–2.17; P = 0.86). Half of troponin-positive events occurred preoperatively with clopidogrel causing a greater decline in troponin concentrations (P < 0.001). There was no increase in major life-threatening bleeding (7 14% vs. 6 10%; RR: 1.4, 95% CI: 0.49–3.76; P = 0.56) or minor bleeding (17 34% vs. 12 21%; RR 1.64, 95% CI: 0.87–3.1; P = 0.12), although blood transfusions were increased (28% vs. 12.6%, RR: 2.3, 95% CI: 1.0–5.29; P = 0.037). Conclusions: In patients with critical limb ischemia, perioperative dual antiplatelet therapy reduces biomarkers of atherothrombosis without causing unacceptable bleeding. Large-scale randomized controlled trials are needed to establish whether dual antiplatelet therapy improves clinical outcome in high-risk patients undergoing vascular surgery. We hypothesized that dual antiplatelet therapy would improve atherothrombotic biomarkers without unacceptable bleeding in patients undergoing surgery for critical limb ischemia. In a double-blind RCT, patients on aspirin were randomized to clopidogrel (n = 50) or placebo (n = 58). Clopidogrel significantly reduced perioperative platelet-activation, and tended to reduce troponin release, without significantly increasing life-threatening bleeding. Supplemental digital content is available in the article.
Burdess et al. (Fri,) conducted a rct in critical limb ischemia (n=108). clopidogrel vs. matched placebo was evaluated on troponin-positive events (RR 0.93, 95% CI 0.39-2.17, p=0.86). Perioperative clopidogrel added to aspirin for critical limb ischemia surgery reduced platelet activation but did not significantly reduce troponin-positive events (16.0% vs 17.2%; RR 0.93; P=0.86).
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