Groundbreaking study-High-risk patients may not require long-term aspirin after PCI

High-risk patients undergoing coronary stent procedures may not require long-term aspirin use after stent placement reveals international clinical trial 'TWILIGHT. The results of the study could change the standard of care for high-risk cases.

Current practice is to combine aspirin with an anti-clotting medication, such as ticagrelor, to lower the risk of a heart attack after stenting. However, this treatment also increases bleeding complications, and therefore identifying therapies that lower bleeding without increasing heart attack risk has emerged as a clinical priority.

The results of the groundbreaking study TWILIGHT suggest that doctors treat high-risk cardiac patients following percutaneous coronary intervention (PCI) by withdrawing aspirin and using ticagrelor alone. This implies that Ticagrelor monotherapy may provide anticoagulation with a lowered risk of bleeding compared to ticagrelor plus aspirin in high-risk patients who underwent percutaneous coronary intervention (PCI) and completed 3 months of dual antiplatelet therapy. The findings were published in the September 26 issue of The New England Journal of Medicine and presented as a late-breaking trial at the 31^st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific conference of the Cardiovascular Research Foundation.

Aspirin in combination with ticagrelor (anti-clotting medicine, that lowers the risk of a heart attack) is the current standard of care for such patients. But this standard practice is also associated with bleeding complications that raise the need for identifying therapies that lower the bleeding risk without increasing the risk of a heart attack.

Roxana Mehran, Director of the Center for Interventional Cardiovascular Research and Clinical Trials at Mount Sinai Heart, and colleagues examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI.

The researchers enrolled 9,006 high-risk patients at 187 sites across 11 countries in the US, Canada, Europe, and Asia. All patients had undergone a successful PCI with at least one drug-eluting stent (DES) and were discharged on dual antiplatelet therapy with aspirin+ticagrelor for a duration of 3 months. On completion of a three-month course of dual-antiplatelet therapy, patients without adverse events were randomized to receive either aspirin (81 to 100 mg daily) or placebo, and all patients continued with ticagrelor (90 mg twice daily) for 12 months. The occurrence of any clinically relevant bleeding or adverse events such as death, heart attack, and stroke was being tracked by the investigators.

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Key findings include:

• For patients who took ticagrelor and no aspirin (placebo), bleeding was reduced by 44 percent, compared to patients on ticagrelor combined with aspirin.


• There were no differences in the risk for heart attack, death, or stroke between the groups, which suggests that aspirin withdrawal does not compromise safety.


• These results were consistent in both men and women and in patients older and younger than 65 and those with diabetes (patients over 65 and diabetics are often at higher risk of bleeding and ischemic complications after stenting).

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"Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke," concluded the authors.

To read the complete study log on to DOI: 10.1056/NEJMoa1908419