Effect of ticagrelor plus aspirin, ticagrelor alone, or aspirin alone on saphenous vein graft patency 1 year after coronary artery bypass grafting: A randomized clinical trial
JAMA Apr 30, 2018
Zhao Q, et al. - Researchers compared saphenous vein graft patency 1 year after coronary artery bypass grafting (CABG) in patients who received ticagrelor + aspirin or ticagrelor alone vs aspirin alone within 24 hours post-CABG. Compared with aspirin alone, ticagrelor + aspirin significantly increased graft patency after 1 year. No significant difference was seen between ticagrelor alone and aspirin alone.
Methods
- This randomized, multicenter, open-label, clinical trial was carried out among six tertiary hospitals in China, including patients aged 18 to 80 years with indications for elective CABG.
- Those requiring urgent revascularization, concomitant cardiac surgery, dual antiplatelet or vitamin K antagonist therapy post-CABG, and who were at risk of serious bleeding were excluded.
- Researchers identified 1,256 patients between July 2014 until November 2015, and ultimately enrolled 500.
- Follow-up was completed in January 2017.
- Patients were randomly assigned (1:1:1) to receive ticagrelor (90 mg twice daily) + aspirin (100 mg once daily) (n = 168), ticagrelor (90 mg twice daily) (n = 166), or aspirin (100 mg once daily) (n = 166) within 24 hours post-CABG.
- Neither patients nor treating physicians were blinded to allocation.
- Evaluated via multislice computed tomographic angiography or coronary angiography and adjudicated independently by a committee blinded to allocation, saphenous vein graft patency 1 year after CABG (FitzGibbon grade A) was the primary outcome.
Results
- A total of 461 (92.2%) of 500 randomized patients (mean age, 63.6 years; women, 91 [18.2%]) completed the trial.
- One year post-CABG, saphenous vein graft patency rates were 88.7% (432 of 487 vein grafts) with ticagrelor + aspirin, 82.8% (404 of 488 vein grafts) with ticagrelor alone, and 76.5% (371 of 485 vein grafts) with aspirin alone.
- A statistically significant difference was noted between ticagrelor + aspirin vs aspirin alone (12.2% [95% CI, 5.2% to 19.2%];P < .001), however no statistically significant difference was found between ticagrelor alone vs aspirin alone (6.3% [95% CI, –1.1% to 13.7%]; P=.10).
- During 1 year of follow-up, occurrence of 5 major bleeding episodes was reported (3 with ticagrelor + aspirin; 2 with ticagrelor alone).
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