Effect of Platelet Inhibition by Cangrelor Among Obese Patients Undergoing Coronary Stenting: Insights From CHAMPION.

Benjamin E Peterson,Christian W Hamm,Deepak L Bhatt,Ph Gabriel Steg,Harvey D White,Gregg W Stone,Renato D Lopes,Robert A Harrington,C Michael Gibson,Kenneth W Mahaffey,Efthymios N Deliargyris,Jayne Prats,Matthew J Price,Sergio Leonardi

doi:10.1161/circinterventions.121.011069

Abstract

In randomized trials, cangrelor reduced periprocedural ischemic events related to percutaneous coronary intervention without increasing GUSTO severe bleeding. However, some antiplatelet agents have shown a differential treatment effect by body mass index (BMI). Patients from the 3 CHAMPION trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) who were randomized to cangrelor versus clopidogrel during percutaneous coronary intervention were stratified by BMI. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis within 48 hours. The principal safety outcome was GUSTO moderate or severe bleeding at 48 hours, although more sensitive bleeding measures such as Thrombolysis in Myocardial Infarction major bleeding were also assessed. We examined obese patients (defined as BMI≥30) versus nonobese patients. There were 24 893 patients, with 8979 (36.1%) having BMI of ≥30. There was no significant difference in the primary efficacy end point among obese versus nonobese patients (4.3% versus 4.2%; rate ratio, 1.01 [95% CI, 0.89-1.15]; P=0.82). There was a consistent benefit in the primary efficacy end point in patients who received cangrelor versus placebo who were obese (3.9% versus 4.7%, rate ratio, 0.83 [95% CI, 0.68-1.02]; P=0.07) and not obese (3.8% versus 4.7%; rate ratio, 0.81 [95% CI, 0.69-0.94]; P=0.0053); interaction P=0.77. There was no difference in GUSTO moderate or severe bleeding among patients who received cangrelor versus placebo who were obese (0.6% versus 0.6%; rate ratio, 0.99 [95% CI, 0.58-1.67]; P=0.96). Cangrelor at the time of percutaneous coronary intervention is effective and safe in obese and nonobese patients. There was no difference in short-term efficacy between obese and nonobese patients. Periprocedural cangrelor is an effective and safe antiplatelet agent, irrespective of BMI. URL: https://www. gov; Unique identifier: NCT01156571, NCT00385138, NCT00305162.

Highlights

In randomized trials, cangrelor reduced periprocedural ischemic events related to percutaneous coronary intervention without increasing GUSTO severe bleeding
We examined obese patients versus nonobese patients
There was no significant difference in the primary efficacy end point among obese versus nonobese patients (4.3% versus 4.2%; rate ratio, 1.01 [95% CI, 0.89–1.15]; P=0.82)

Summary

Methods

Patients from the 3 CHAMPION trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) who were randomized to cangrelor versus clopidogrel during percutaneous coronary intervention were stratified by BMI. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis within 48 hours. The study designs of the 3 prospective, double-blind, doubledummy CHAMPION trials have been published previously.[18,19] Patients ≥18 years of age requiring PCI for stable or acute coronary disease were randomly assigned to receive a cangrelor infusion (30 μg/kg bolus, followed by a 4 μg/kg per minute infusion for at least 2 hours, or the duration of PCI, whichever was longer) or clopidogrel. Subsequent to PCI, patients were treated with dual antiplatelet therapy with aspirin and clopidogrel at the direction of site investigators. Independent data safety and monitoring boards provided regular oversight of patient data at regular intervals

Results

Discussion

Conclusion