Clinical InvestigationImpact of proton pump inhibitors on clinical outcomes in patients treated with a 6- or 24-month dual-antiplatelet therapy duration: Insights from the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY trial
Section snippets
Methods
The design and main findings of the PRODIGY have been previously reported.1, 24 Briefly, all-comer PCI patients receiving a balanced mixture of stents with varying anti-intimal hyperplasia potency and belonging to both first- and second-generation drug-eluting stent (DES) at 3 Italian sites were randomly allocated at 30 days to either 6 or 24 months of DAPT. Selection criteria were broad, reflecting routine clinical practice. Randomization to 6- or 24-month DAPT was stratified by center,
Results
Among 1,970 patients randomized to 6- versus 24-month DAPT at 30 days from the PCI, 738 patients (37.5%) were receiving a PPI. Most of them were treated with lansoprazole (671 patients, 90.9%), whereas the others received pantoprazole (56 patients, 7.6%) and few patients received other PPI types (omeprazole, esomeprazole, and rabeprazole, 1.5%).
Baseline characteristics of population with PPI and without PPI are summarized in Table I, whereas Table II describes their characteristics in the
Discussion
The present post hoc analysis from the PRODIGY randomized trial investigated the impact of concomitant PPI use on clinical outcomes in all-comer patients undergoing PCI and receiving DAPT with clopidogrel as thienopyridine component.
Although, at univariate analysis, PPI use was associated with an increased risk of ischemic and bleeding events, after multivariate adjustment, PPI therapy was no longer related to different rates of ischemic events, bleeding, or NACE at 2 years irrespective of the
Limitations
This is a post hoc not randomized and not prespecified analysis of the PRODIGY trial, and the prescription of a PPI was left to the physician's discretion.
Rates of overall but not specifically GI bleeding were evaluated and available for this analysis, so potential benefits of PPI on reducing GI bleeding events could not be analyzed.
Although multivariate adjustment was performed, it cannot be excluded that unknown/unmeasured factors may have impacted findings.
Data on PPI dosage were not
Conclusion
Overall, PPI use was not associated with an increased risk of cardiovascular events in all-comer patients undergoing PCI and receiving DAPT. Our findings do not support the need to avoid concomitant use of PPIs and DAPT with aspirin plus clopidogrel, when clinically indicated.
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Cited by (52)
The High Bleeding Risk Patient with Coronary Artery Disease
2020, Cardiology ClinicsCitation Excerpt :In conclusion, the identification of HBR patients should prompt the selection of treatment strategies aiming at reducing the bleeding risk and optimizing the secondary prevention of ischemic events with lipid-lowering drugs.67 The most common bleeding events after PCI occur in the gastrointestinal tract,12 and the use of drugs, such as proton pump inhibitors, that can reduce these complications should be liberal.68,69 Patients at HBR represent a large proportion of the current population treated with PCI and undergoing DAPT.
Meta-Analysis of Efficacy and Safety of Proton Pump Inhibitors with Dual Antiplatelet Therapy for Coronary Artery Disease
2019, Cardiovascular Revascularization Medicine2023 ESC Guidelines for the management of acute coronary syndromes: Developed by the task force on the management of acute coronary syndromes of the European Society of Cardiology (ESC)
2024, European Heart Journal: Acute Cardiovascular CareIndividualization of Duration of Dual Antiplatelet Therapy after Coronary Stenting: A Comprehensive, Evidence-Based Review
2023, Journal of Clinical Medicine2023 ESC Guidelines for the management of acute coronary syndromes
2023, European Heart Journal
Clinical trial registration: RCT no. NCT00611286.