Optimal antiplatelet strategy in patients with advanced chronic kidney disease undergoing drug-eluting stent implantation: Design and rationale of the randomized ADAPT-CKD trial.

BACKGROUND: Although shortened dual antiplatelet therapy (DAPT) strategies have demonstrated favorable outcomes in the general percutaneous coronary intervention (PCI) population, patients with advanced chronic kidney disease (CKD) have been underrepresented in randomized clinical trials. The optimal duration of DAPT after PCI remains uncertain in patients with CKD, who are at increased risk for both ischemic and bleeding events.

METHODS: The ADAPT-CKD trial is an investigator-initiated, multicenter, open-label, randomized, superiority study designed to compare an abbreviated vs a standard DAPT strategy in patients with advanced CKD undergoing PCI with contemporary drug-eluting stents. A total of 900 patients with an estimated glomerular filtration rate <45 mL/min/1.73 m² will be randomly assigned in a 1:1 ratio to abbreviated DAPT (<3 months of DAPT after PCI) or standard DAPT (≥6 months). The primary endpoint is net adverse clinical events at 1 year, defined as a composite of all-cause death, myocardial infarction, stent thrombosis, stroke, or major bleeding according to the Bleeding Academic Research Consortium criteria. The primary hypothesis is that abbreviated DAPT is superior to standard DAPT in reducing net adverse clinical events at 1 year after randomization.

CONCLUSIONS: The ADAPT-CKD trial will provide randomized evidence on the efficacy and safety of an abbreviated DAPT strategy compared with a standard DAPT strategy in patients with advanced CKD undergoing PCI. The results are expected to inform clinical decision-making regarding optimal antiplatelet therapy in this high-risk population.

CLINICAL TRIAL REGISTRATION: https://www.

CLINICALTRIALS: gov. Unique identifier: NCT04708587.