Efficacy and Safety of Lansoprazole in Patients with Low to Moderate Bleeding Risk Undergoing Percutaneous Coronary Intervention

Background The routine use of prophylactic proton pump inhibitors (PPIs) in patients with coronary artery disease (CAD) receiving percutaneous coronary intervention (PCI) who are at low to moderate risk of bleeding and who are receiving a combination of aspirin and clopidogrel remains controversial. Aims This study aimed to investigate the gastrointestinal efficacy and cardiovascular safety of PPIs in CAD patients undergoing PCI on dual antiplatelet therapy (DAPT) with low to moderate bleeding risk. Methods In this investigator-initiated, open-label, randomized controlled trial, patients receiving DAPT were assigned to either the lansoprazole group (15 mg once daily) or the control group (no gastrointestinal medication) for an average of 185 days. The primary endpoint was a composite of upper gastrointestinal bleeding (GIB), ulcer-related perforation, or obstruction (ClinicalTrials.gov Identifier: NCT05820048 ; registered on April 6, 2023). Results Of the 300 patients screened, 274 were enrolled and randomized (134 to the lansoprazole group and 140 to the control group). The mean (± s.d.) follow-up duration was 185.0 ± 27.2 days in the lansoprazole group and 186.2 ± 19.0 days in the control group. Two patients (1.5%) in the lansoprazole group experienced GIB events, whereas no events occurred in the control group (P = 0.238; log-rank test, P = 0.150). Conclusions In patients with CAD undergoing PCI and receiving DAPT, prophylactic use of lansoprazole did not significantly reduce the incidence of upper GIB among those with low to moderate bleeding risk.