The performance of ASpirin-FREE therapy after successful percutaneous coronary intervention for acute coronary syndrome: the ASFREE prospective pilot study.

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).