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Original Investigation
April 24, 2018

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

Author Affiliations
  • 1Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 2Changhai Hospital of Shanghai, Shanghai, China
  • 3Henan Provincial People's Hospital, Zhengzhou, China
  • 4Xinhua Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 5Nanjing First Hospital, Nanjing, China
  • 6Jiangsu Province Hospital, Nanjing, China
JAMA. 2018;319(16):1677-1686. doi:10.1001/jama.2018.3197
Key Points

Question  Does ticagrelor + aspirin or ticagrelor alone compared with aspirin alone improve saphenous vein graft patency in patients undergoing coronary artery bypass grafting (CABG)?

Findings  In this randomized trial that included 500 patients with 1460 saphenous vein grafts, the saphenous vein graft patency rate 1 year after CABG was 88.7% in patients treated with ticagrelor + aspirin, 82.8% in patients treated with ticagrelor alone, and 76.5% in patients treated with aspirin alone. The difference between ticagrelor + aspirin and aspirin alone was statistically significant, whereas that between ticagrelor alone and aspirin alone was not statistically significant.

Meaning  Ticagrelor + aspirin improved saphenous vein graft patency 1 year after CABG vs aspirin alone; there was no significant improvement with ticagrelor alone vs aspirin alone.

Abstract

Importance  The effect of ticagrelor with or without aspirin on saphenous vein graft patency in patients undergoing coronary artery bypass grafting (CABG) is unknown.

Objective  To compare the effect of ticagrelor + aspirin or ticagrelor alone vs aspirin alone on saphenous vein graft patency 1 year after CABG.

Design, Setting, and Participants  Randomized, multicenter, open-label, clinical trial among 6 tertiary hospitals in China. Eligible patients were aged 18 to 80 years with indications for elective CABG. Patients 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. From July 2014 until November 2015, 1256 patients were identified and 500 were enrolled. Follow-up was completed in January 2017.

Interventions  Patients were randomized (1:1:1) to start 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.

Main Outcomes and Measures  Primary outcome was saphenous vein graft patency 1 year after CABG (FitzGibbon grade A) adjudicated independently by a committee blinded to allocation. Saphenous vein graft patency was assessed by multislice computed tomographic angiography or coronary angiography.

Results  Among 500 randomized patients (mean age, 63.6 years; women, 91 [18.2%]), 461 (92.2%) completed the trial. Saphenous vein graft patency rates 1 year post-CABG 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. The difference between ticagrelor + aspirin vs aspirin alone was statistically significant (12.2% [95% CI, 5.2% to 19.2%]; P < .001), whereas the difference between ticagrelor alone vs aspirin alone was not statistically significant (6.3% [95% CI, –1.1% to 13.7%]; P = .10). Five major bleeding episodes occurred during 1 year of follow-up (3 with ticagrelor + aspirin; 2 with ticagrelor alone).

Conclusions and Relevance  Among patients undergoing elective CABG with saphenous vein grafting, ticagrelor + aspirin significantly increased graft patency after 1 year vs aspirin alone; there was no significant difference between ticagrelor alone and aspirin alone. Further research with more patients is needed to assess comparative bleeding risks.

Trial Registration  clinicaltrials.gov Identifier: NCT02201771

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