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Aspirin in Patients With DES Undergoing Noncardiac Surgery
Quick Takes
- Among patients undergoing noncardiac surgery >1 year after PCI with DES, there was no significant difference in the primary composite outcome of all-cause mortality, MI, definite stent thrombosis, and stroke at 30 days with continued aspirin monotherapy versus holding all antiplatelet therapy.
- Given the lower-than-expected event rates and the underpowered nature of the study, these findings should be interpreted with caution.
- At this time, maintaining aspirin therapy and abiding by current clinical practice guidelines should remain the approach of choice for most PCI patients undergoing noncardiac surgery until further high-quality data emerge.
Study Questions:
Is there a benefit to perioperative continuation of aspirin in patients with coronary drug-eluting stents (DES) undergoing noncardiac surgery?
Methods:
The ASSURE DES trial investigators randomly assigned patients who had received a DES >1 year previously and were undergoing elective noncardiac surgery either to continue aspirin or to discontinue all antiplatelet agents 5 days before noncardiac 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 5 days before and 30 days after noncardiac surgery. Regarding the primary outcome, the Fisher exact test was used to assess the superiority of aspirin monotherapy over no antiplatelet therapy.
Results:
A total of 1,010 patients underwent randomization. Among 926 patients in the modified intention-to-treat population (462 patients in the aspirin monotherapy group and 464 patients in the no antiplatelet therapy group), the primary composite outcome occurred in three patients (0.6%) in the aspirin monotherapy group and four patients (0.9%) in the no antiplatelet group (difference, −0.2 percentage points; 95% confidence interval, −1.3 to 0.9; p > 0.99). There was no stent thrombosis in either group. The incidence of major bleeding did not differ significantly between groups (6.5% vs. 5.2%; p = 0.39), whereas minor bleeding was significantly more frequent in the aspirin group (14.9% vs. 10.1%; p = 0.027).
Conclusions:
The authors report that among patients undergoing low-to-intermediate risk noncardiac surgery >1 year after stent implantation primarily with a DES, there was no benefit of perioperative aspirin monotherapy with respect to ischemic outcomes or major bleeding.
Perspective:
This study reports that among patients undergoing noncardiac surgery >1 year after percutaneous coronary intervention (PCI) with DES, there was no significant difference in the primary composite outcome of all-cause mortality, MI, definite stent thrombosis, and stroke at 30 days with continued aspirin monotherapy versus all antiplatelet therapy held 5 days before noncardiac surgery. While there was no significant difference in major bleeding, minor bleeding was more frequent in the aspirin group. Given the lower-than-expected event rates and the underpowered nature of the study, these findings should be interpreted with caution. Further research with a large-scale, adequately powered study is needed to confirm these results, especially in higher-risk patients and surgeries. At this time, maintaining aspirin therapy and abiding by current clinical practice guidelines should remain the approach of choice for most PCI patients undergoing noncardiac surgery until further high-quality data emerge.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention
Keywords: Aspirin, Drug-Eluting Stents, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
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