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Bridging antiplatelet therapy with cangrelor in patients undergoing cardiac surgery: a randomized controlled trial
Dominick J Angiolillo1, Michael S Firstenberg, Matthew J Price
1Department of Cardiology, University of Florida, Jacksonville, USA.
Insights
Cangrelor effectively maintained platelet inhibition in patients undergoing coronary artery bypass grafting (CABG) surgery after stopping thienopyridines. This intravenous therapy provided a safe bridging option, showing no significant increase in major bleeding events.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Thienopyridines are commonly prescribed but pose challenges when surgery is needed.
- Guidelines advise discontinuing thienopyridines 5-7 days before surgery to mitigate bleeding risks, despite increased thrombosis risk.
Purpose of the Study:
- To assess cangrelor, an IV reversible P2Y12 inhibitor, as a bridge therapy for patients on thienopyridines awaiting coronary artery bypass grafting (CABG).
Main Methods:
- A prospective, randomized, double-blind, placebo-controlled, multicenter trial involving 210 patients undergoing or awaiting CABG.
- Patients received either cangrelor or placebo after thienopyridine cessation, with treatment discontinued 1-6 hours before surgery.
Main Results:
- Cangrelor significantly increased the proportion of patients achieving low platelet reactivity (PRU <240) compared to placebo (98.8% vs 19.0%).
- Excessive bleeding rates were similar between groups (11.8% for cangrelor vs 10.4% for placebo), with no significant difference in major bleeding.
- Minor bleeding episodes were numerically higher with cangrelor, but not statistically significant.
Conclusions:
- Cangrelor effectively maintains platelet inhibition in patients discontinuing thienopyridine therapy before cardiac surgery.
- It serves as a viable bridging strategy, demonstrating comparable safety regarding major bleeding to placebo in the context of CABG.
Context:
Thienopyridines are among the most widely prescribed medications, but their use can be complicated by the unanticipated need for surgery. Despite increased risk of thrombosis, guidelines recommend discontinuing thienopyridines 5 to 7 days prior to surgery to minimize bleeding.
Objective:
To evaluate the use of cangrelor, an intravenous, reversible P2Y(12) platelet inhibitor for bridging thienopyridine-treated patients to coronary artery bypass grafting (CABG) surgery.
Design, Setting, And Patients:
Prospective, randomized, double-blind, placebo-controlled, multicenter trial, involving 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent and receiving a thienopyridine awaiting CABG surgery to receive either cangrelor or placebo after an initial open-label, dose-finding phase (n = 11) conducted between January 2009 and April 2011. Interventions Thienopyridines were stopped and patients were administered cangrelor or placebo for at least 48 hours, which was discontinued 1 to 6 hours before CABG surgery.
Main Outcome Measures:
The primary efficacy end point was platelet reactivity (measured in P2Y(12) reaction units [PRUs]), assessed daily. The main safety end point was excessive CABG surgery-related bleeding.
Results:
The dose of cangrelor determined in 10 patients in the open-label stage was 0.75 μg/kg per minute. In the randomized phase, a greater proportion of patients treated with cangrelor had low levels of platelet reactivity throughout the entire treatment period compared with placebo (primary end point, PRU <240; 98.8% (83 of 84) vs 19.0% (16 of 84); relative risk [RR], 5.2 [95% CI, 3.3-8.1] P < .001). Excessive CABG surgery-related bleeding occurred in 11.8% (12 of 102) vs 10.4% (10 of 96) in the cangrelor and placebo groups, respectively (RR, 1.1 [95% CI, 0.5-2.5] P = .763). There were no significant differences in major bleeding prior to CABG surgery, although minor bleeding episodes were numerically higher with cangrelor.
Conclusions:
Among patients who discontinue thienopyridine therapy prior to cardiac surgery, the use of cangrelor compared with placebo resulted in a higher rate of maintenance of platelet inhibition.
Trial Registration:
clinicaltrials.gov Identifier: NCT00767507.
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