Uninterrupted Direct-Acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures: The DOAC-NOSTOP.

BACKGROUND

Patients receiving direct oral anticoagulation (DOAC) often require coronary angiography with or without percutaneous coronary intervention (PCI). Guidelines recommend DOAC withdrawal 12-24 h before the procedure based on experts' opinion. Therefore, the aim of this study was to assess the safety of an uninterrupted DOAC strategy during trans-radial coronary procedures.

METHODS

prospective, single-arm, pilot study conducted across six European centers. Enrolled patients underwent coronary angiography or PCI with intended transradial access without DOACs interruption. A safety stopping rule based on the occurrence of more than three Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events was prespecified. Primary outcome was BARC 2, 3, or 5 bleeding events at 30-day follow-up, which was compared against a prespecified objective performance criterion (OPC). The study is registered at ClinicalTrials.gov (NCT05292846).

RESULTS

A total of 200 patients were included. Median age was 75 years (IQR 69-80) and 29.0% were women. One in four (51, 25.5%) patients underwent PCI. At 30-days, two BARC type 2 and two BARC type three bleeding events were reported. The uninterrupted DOAC strategy resulted in a rate of BARC types 2, 3, or 5 bleeding events of 2%, with the 1-sided upper 95% confidence limit (4.5%) being lower than the OPC of 4.6% (p = 0.045).

CONCLUSIONS

DOAC-NOSTOP is the first prospective study assessing the risk of periprocedural bleeding with uninterrupted DOAC in patients undergoing transradial coronary procedures. The uninterrupted DOAC strategy was shown to be safe and met the pre-specified OPC, with low rates of clinically relevant or major bleeding at 30 days.