Efficacy and safety of lansoprazole in patients with low-to-moderate bleeding risk undergoing percutaneous coronary intervention

Abstract Background The routine use of prophylactic proton pump inhibitors (PPIs) remains controversial in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) with low-to-moderate bleeding risk receiving dual antiplatelet therapy (DAPT). Aims This study investigated the gastrointestinal (GI) efficacy and cardiovascular safety of lansoprazole in CAD patients with low-to-moderate bleeding risk undergoing PCI on DAPT. Methods In this investigator-initiated, randomized controlled trial, 274 patients were assigned to either the lansoprazole group (15 mg once daily, n = 134) or the control group (no gastrointestinal medication, n = 140) for an average of 185 days. The primary endpoint was a composite of upper gastrointestinal bleeding (GIB), ulcer-related perforation, or obstruction. Results 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). The overall incidence of GI events was remarkably low in both groups. Conclusions In this study, routine prophylactic use of lansoprazole did not show additional preventive value against upper GIB in patients with low-to-moderate bleeding risk undergoing PCI with contemporary DAPT. These findings suggest that a PPI-free strategy may be considered for this specific population, although the study was underpowered due to a lower-than-expected event rate in the control group.