Dual antithrombic therapy with DOAC plus ticagrelor versus DOAC plus clopidogrel after PCI: results from the ReDUAL PCI real life registry-based randomized controlled trial.

BACKGROUND

Balancing thrombotic and bleeding risk in patients requiring direct oral anticoagulation (DOAC) after percutaneous coronary intervention (PCI) remains challenging. This study evaluated the safety of dual antithrombotic therapy with DOAC plus ticagrelor compared with DOAC plus clopidogrel in patients undergoing PCI for acute coronary syndrome or with high thrombotic risk.

METHODS

The ReDUAL PCI Real Life study was a Dutch, open-label, multicentre, registry-based randomized controlled trial within the Southeast Netherlands Heart Registry (ZON-HR), aiming to enrol 850 patients. Patients requiring DOAC were randomized 1:1 to DOAC plus ticagrelor or DOAC plus clopidogrel after PCI. The primary endpoint was any bleeding (BARC ≥2) at 1 year. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE), and net adverse clinical events (NACE: MACCE plus major bleeding). Outcomes were compared with a non-randomized ZON-HR cohort eligible for inclusion.

RESULTS

The study was terminated prematurely due to slow recruitment, with 109 patients randomized (53 ticagrelor, 56 clopidogrel). Overall bleeding rates were similar between ticagrelor and clopidogrel (13.2% vs 14.3%). Major bleeding (9.4% vs 1.8%), MACCE (13.2% vs 5.4%), and NACE (20.8% vs 7.1%) occurred more frequently with ticagrelor, without statistical significance. In 397 eligible non-randomized clopidogrel-treated patients, major bleeding rate was 3.4%, MACCE occurred in 12.5% and NACE in 14.5%.

CONCLUSIONS

In patients undergoing PCI requiring oral anticoagulation, DOAC plus ticagrelor showed similar overall bleeding but numerical increase in major bleeding without apparent ischemic benefit compared with DOAC plus clopidogrel. This prematurely terminated study was underpowered, limiting abilities to draw definitive conclusions.