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Published on: March 15, 2022
The performance of ASpirin-FREE therapy after successful percutaneous coronary intervention for acute coronary
Donghyeon Joo1, Sungho Jo1, Jeong Tae Byoun1
1Department of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Korea.
Insights
An aspirin-free strategy using P2Y12 inhibitor monotherapy after PCI for acute coronary syndrome (ACS) showed feasibility. This approach demonstrated low rates of thrombotic and bleeding events in a pilot study.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Pharmacology
Background:
- Dual antiplatelet therapy (aspirin plus P2Y12 inhibitor) is standard post-percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS).
- Bleeding complications remain a significant concern in patients undergoing PCI for ACS.
- Investigating aspirin cessation strategies may reduce bleeding risk without compromising thrombotic safety.
Purpose of the Study:
- To evaluate the feasibility and safety of an aspirin-free strategy following PCI in ACS patients.
- To assess thrombotic and bleeding event rates with P2Y12 inhibitor monotherapy.
- To generate hypothesis for future randomized controlled trials.
Main Methods:
- The ASpirin-FREE therapy (ASFREE) study was a single-center, prospective, open-label pilot study.
- 228 patients with ACS undergoing PCI with drug-eluting stents were enrolled.
- Patients received a single aspirin dose, followed by ticagrelor or prasugrel monotherapy.
Main Results:
- Target vessel failure (TVF) occurred in 4.4% of patients at 12 months.
- Definite stent thrombosis was observed in only one patient (0.4%), with no early events.
- Major bleeding events (BARC type 3 or 5) occurred in 0.9% of patients.
Conclusions:
- An aspirin-free strategy with P2Y12 inhibitor monotherapy is feasible in ACS patients post-PCI.
- This approach was associated with low rates of both thrombotic and major bleeding events.
- Findings support further investigation in larger, randomized controlled trials.
Background:
Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is standard after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS); however, bleeding risk remains a major concern. Early discontinuation of aspirin due to potent P2Y12 inhibition may mitigate bleeding without increasing thrombotic events.
Methods:
The ASpirin-FREE therapy after successful percutaneous coronary intervention for acute coronary syndrome (ASFREE) study was an investigator-initiated, single-center, prospective, open-label, single-arm pilot study enrolling patients with ACS who underwent PCI with drug-eluting stents. All patients received a single loading dose of aspirin on the day of the PCI, followed by ticagrelor or prasugrel monotherapy. The primary efficacy endpoint was target vessel failure (TVF) at 12 months. The primary safety endpoint was definite stent thrombosis. Event rates are reported with 95% confidence intervals (CIs).
Results:
In total, 228 patients were enrolled. TVF occurred in 10 patients (4.4%; 95% CI, 2.1-7.9). Definite stent thrombosis was observed in one patient (0.4%; 95% CI, 0.01-2.4), with no acute or subacute events. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) occurred in two patients (0.9%; 95% CI, 0.1-3.1).
Conclusion:
An aspirin-free strategy following a single loading dose with continuation of potent P2Y12 inhibitor monotherapy was feasible in patients with ACS undergoing PCI and was associated with low rates of thrombotic and major bleeding events. These findings should be regarded as hypothesis-generating and supporting further evaluations in adequately powered randomized controlled trials (CRIS registration: KCT 0008182).
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