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Ticagrelor + Aspirin, Ticagrelor Alone, or Aspirin Alone on SVG Patency
Study Questions:
What is the effect of ticagrelor + aspirin or ticagrelor alone versus aspirin alone on saphenous vein graft (SVG) patency 1 year after coronary artery bypass grafting (CABG)?
Methods:
The investigators conducted a randomized, multicenter, open-label clinical trial among six tertiary hospitals in China. Eligible patients were aged 18-80 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, 1,256 patients were identified and 500 were enrolled. Follow-up was completed in January 2017. 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. The primary outcome was SVG patency 1 year after CABG adjudicated independently by a committee blinded to allocation. SVG patency was assessed by multislice computed tomographic angiography or coronary angiography. The generalized estimating equation model including terms for treatment was used to estimate between-group differences in SVG patency and 95% confidence intervals (CIs).
Results:
Among 500 randomized patients (mean age, 63.6 years; women, 91 [18.2%]), 461 (92.2%) completed the trial. SVG 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 versus aspirin alone was statistically significant (12.2% [95% CI, 5.2%-19.2%]; p < 0.001), whereas the difference between ticagrelor alone versus aspirin alone was not statistically significant (6.3% [95% CI, –1.1% to 13.7%]; p = 0.10). Five major bleeding episodes occurred during 1 year of follow-up (three with ticagrelor + aspirin; two with ticagrelor alone).
Conclusions:
The authors concluded that ticagrelor + aspirin significantly increased SVG patency after 1 year versus aspirin alone with no significant difference between ticagrelor alone and aspirin alone.
Perspective:
This study reports that ticagrelor + aspirin was superior to aspirin alone in maintaining SVG patency for up to 1 year after elective CABG surgery. However, bleeding episodes occurred more frequently in patients treated with combination therapy when compared with either aspirin alone or ticagrelor alone, which is consistent with previous studies of dual antiplatelet therapy in a variety of settings. Furthermore, this trial lacked sufficient statistical power to identify a significant effect on the incidence of major adverse cardiac events or other secondary and bleeding endpoints. Additional studies are needed to determine whether the significant benefit in graft patency translates into a meaningful improvement in hard clinical outcomes and further characterize the bleeding risk.
Keywords: Adenosine, Aspirin, Cardiac Surgical Procedures, Coronary Angiography, Coronary Artery Bypass, Hemorrhage, Multidetector Computed Tomography, Platelet Aggregation Inhibitors, Purinergic P2Y Receptor Antagonists, Saphenous Vein, Secondary Prevention, Tertiary Care Centers
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