09/01/2025 | Press release | Distributed by Public on 09/01/2025 06:46
Key take-aways
Madrid, Spain - 1 September 2025: Compared with dual antiplatelet therapy (DAPT), a de-escalated DAPT strategy resulted in similar graft occlusion rates and reduced clinically relevant bleeding in patients who underwent coronary artery bypass grafting (CABG), according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.1
Saphenous vein grafts remain the most frequently used conduits in CABG; however, failure rates are high, with 3−12% occluding before hospital discharge and 8−25% failing at 1 year.2
"After CABG, decreased risk of saphenous vein graft failure has been observed with 12 months of DAPT (aspirin plus a P2Y12 inhibitor) but this was accompanied by an increased risk of bleeding,3" explained Investigator of the TOP-CABG trial, Doctor Xin Yuan from the State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing, China. "Rather than receiving DAPT for 12 months, a de-escalated strategy of DAPT for 1 or 3 months then aspirin monotherapy for 9 or 11 months is associated with similar ischemic benefits and better bleeding safety in patients after percutaneous coronary intervention (PCI). Mirroring PCI, the first 3 months after CABG surgery is a high-thrombotic-risk phase, but studies of de-escalated DAPT are lacking. Thus, we designed the TOP-CABG trial to compare the effects of de-escalated DAPT and DAPT on patency and bleeding events for 1 year after CABG."
TOP-CABG trial was a double-blind, parallel-controlled randomised trial conducted at 13 hospitals in China. Patients older than 18 and younger than 80 years old were recruited if they were undergoing planned CABG for the first time with at least one saphenous vein graft. Patients were randomised 1:1 to de-escalated DAPT (ticagrelor 90 mg twice daily plus aspirin 100 mg once daily for 3 months, then placebo twice daily plus aspirin 100 mg once daily for 9 months) or to DAPT (ticagrelor 90 mg twice daily plus aspirin 100 mg once daily for 1 year). The primary noninferior efficacy endpoint was 100% occlusion of the saphenous vein graft within 1 year after CABG at the per-graft level, with occlusion assessed by coronary computed tomography angiography or coronary angiography. The prespecified noninferiority margin was 3.5%. The primary superior safety endpoint was clinically relevant bleeding at the per-patient level (Bleeding Academic Research Consortium [BARC] classification ≥2) within 1 year.
The 2,290 patients included had a mean age of 61.5 years and 20.6% were female.
Noninferiority was demonstrated for the primary efficacy endpoint of graft occlusion, which occurred in 10.79% of patients' grafts in the de-escalated DAPT group and 11.19% in the DAPT group (difference −0.31%; 95% confidence interval [CI] −3.13 to 2.52; p=0.008). The primary safety endpoint of clinically relevant bleeding was less frequent with de-escalated DAPT vs. DAPT (8.26% vs. 13.19% of patients; HR 0.62; 95% CI 0.48 to 0.81; p<0.001).
There was no difference between the groups for secondary outcomes including graft failure, any graft stenosis, any graft occlusion or major adverse cardiac and cerebrovascular events.
Doctor Yuan concluded: "In the largest CABG trial to date, a de-escalation strategy offered a better balance between graft patency protection and bleeding risk than DAPT. These findings may help to inform future guidelines regarding the benefits of a shorter period of DAPT during the early phase after CABG."
ENDS