A new study suggests a flexible approach to antiplatelet management may be considered for patients who have undergone coronary drug-eluting stent (DES) implantation and require non-cardiac surgery. The research, presented at the ESC Congress 2024, indicates that temporarily discontinuing antiplatelet therapy around the time of surgery is non-inferior to continuing aspirin monotherapy in terms of ischemic outcomes and major bleeding.
The ASSURE DES trial, an investigator-initiated, open-label randomized controlled trial, enrolled 926 patients from South Korea, India, and Turkey who had undergone percutaneous coronary intervention with DES more than one year prior and were scheduled for elective non-cardiac surgery. Patients were randomized 1:1 to either continue aspirin or discontinue all antiplatelet agents five days before surgery. Antiplatelet therapy was recommended to be resumed no later than 48 hours after surgery, unless contraindicated.
The primary outcome was a composite of death from any cause, myocardial infarction (MI), stent thrombosis, or stroke between five days before and 30 days after non-cardiac surgery. Secondary outcomes included the individual components of the primary outcome and major or minor bleeding according to the Thrombolysis in Myocardial Infarction definition.
The results showed no significant difference in the primary outcome between the groups. The composite outcome occurred in 0.6% of patients in the aspirin monotherapy group and 0.9% of patients in the no antiplatelet therapy group (absolute difference -0.2 percentage points; 95% confidence interval -1.3 to 0.9; p>0.99). Rates of the individual components of the primary outcome were low.
Major bleeding rates were similar between the groups: 6.5% in the aspirin monotherapy group and 5.2% in the no antiplatelet therapy group (p=0.39). Minor bleeding was more frequent in the aspirin monotherapy group (14.9% vs. 10.1%; p=0.027).
Clinical Implications
According to Dr. Jung-Min Ahn, the principal investigator from the Asan Medical Center, Seoul, South Korea, "Continuing aspirin monotherapy did not reduce ischaemic events, although it was associated with a modest increase in minor bleeding. Event rates were lower than expected, which may reflect the improved safety profile of contemporary DES. This low event rate led to the trial being underpowered and our overall findings should be interpreted with caution."
Dr. Ahn added, "In the meantime, it seems that a flexible approach to perioperative antiplatelet management may be considered, without compromising patient safety."
Considerations and Future Research
While the study suggests a potential for flexible antiplatelet management, the authors caution that further research is needed, particularly in higher-risk patients and surgeries. The relatively low event rates observed in the trial may limit the generalizability of the findings. A larger, adequately powered study is warranted to confirm these results and to explore the optimal antiplatelet strategy in various clinical scenarios.
