Long-term Aspirin as Effective as Dual Therapy in Uncomplicated DES Patients

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In patients who receive drug-eluting stents (DES) and do not have major complications on dual antiplatelet therapy for 12 months, an additional 2 years of dual therapy is no more effective at reducing cardiovascular risk compared with aspirin alone. Results of the randomized trial appeared online October 4, 2013, ahead of print in Circulation.

The data were initially presented March 11, 2013, at the American College of Cardiology/i2 Scientific Session in San Francisco, CA.

For the prospective, randomized DES LATE trial, researchers led by Seung-Jung Park, MD, of Asan Medical Center (Seoul, South Korea), looked at 5,045 patients at 24 centers in South Korea who received DES and were free of MACE and major bleeding for at least 12 months after stent placement and who had been on dual therapy with clopidogrel and aspirin during that time. Patients were randomized to continue on clopidogrel and aspirin (n = 2,531) or aspirin alone (n = 2,514) for another 24 months.

At the end of the study period, the primary endpoint (cardiac death, MI, or stroke) was similar between the 2 groups, as were all secondary endpoints (table 1).

Table 1. Cumulative Outcomes at 24 Months

By the end of the follow-up period, the aspirin-alone group showed a lower rate of TIMI major bleeding than the dual-therapy group (HR 0.67; 95% CI 0.47-0.95; P = 0.026).

According to the study authors, aspirin monotherapy compared with dual antiplatelet therapy beyond 12 months did not reduce the risk of cardiac death, MI, or stroke. “However,” they note, “aspirin monotherapy was associated with lower risk of TIMI major bleeding during the follow-up period. These findings suggest that 2 antiplatelet strategies provide similar protection from ischemic events with less risk of bleeding in aspirin monotherapy.”

Dr. Park and colleagues add that in their study, there was no difference in the primary endpoint between 12 and more than 12 months of dual antiplatelet therapy after implantation of new-generation DES, “suggesting that prolonged dual antiplatelet therapy might not be needed. However, whether a longer duration of dual antiplatelet therapy is warranted in the current [DES] era will require further study.”

In an e-mail communication with TCTMD, Kishore J. Harjai, MD, of Geisinger Wyoming Valley (Wilkes-Barre, PA), indicated he was not surprised by the current results. “Prior observational studies and randomized trials have raised questions about the utility of continuing dual anti-platelet therapy beyond 12 months after PCI,” he said. “It is reassuring that these data are consistent with previous studies.”

Change in Practice Unlikely

But the results will not cause him to change practice, Dr. Harjai cautioned. “I typically discontinue dual antiplatelet therapy 12 months after PCI, except in very high-risk patients such as those with recurrent episodes of ACS, extensive stenting, significant residual disease, and those with stenting of the left main or diffusely diseased vein grafts,” he said.

 “With the advent of second-generation DES, there are some data that shorter-term duration of dual antiplatelet therapy may in fact be acceptable,” he said. “This is because the incidence of late stent thrombosis with second-generation DES is much lower than we had observed with the first-generation DES. Therefore, the more relevant question now is whether we can get away with shorter duration of DAP therapy, such as 6 months.”

Regardless, the current study signifies that antiplatelet therapy may be able to be simplified for some DES patients, Dr. Harjai said. “Based on this study and previous data, the majority of patients who have remained free of MACE in the first 12 months after DES implantation may be able to discontinue dual antiplatelet therapy and stay on aspirin alone,” he said. “Some high-risk patients may still need to stay on dual antiplatelet therapy and the clinician should exercise judgment in making this decision.”

 

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Source:
Lee CW, Ahn J-M, Park D-W, et al. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: A randomized controlled trial. Circulation. 2013;Epub ahead of print.

 

 

Related Stories:

• Aspirin Alone Just as Good as Dual Antiplatelet Therapy Beyond 12 Months
• After PCI, No Advantage to Continuing Dual-Antiplatelet Therapy Past 12 Months
• Findings Question Need for Antiplatelet Therapy Beyond 1 Year With DES