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Impact 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
- Source :
- American Heart Journal, 174, 95-102. Mosby Inc.
- Publication Year :
- 2016
-
Abstract
- Background Proton pump inhibitors (PPIs) are frequently prescribed in combination with clopidogrel, but conflicting data exist as to whether PPIs diminish the efficacy of clopidogrel. We assessed the association between PPI use and clinical outcomes for patients treated with percutaneous coronary intervention (PCI) and dual-antiplatelet therapy (DAPT) with clopidogrel plus aspirin. Methods and results In the PRODIGY trial, 1,970 patients were randomized to 6- or 24-month DAPT at 30 days from index procedure. Among them, 738 patients (37.5%) received PPI (mainly lansoprazole; 90.1%) at the time of randomization. Proton pump inhibitor users were older, were most likely to be woman, had a lower creatinine clearance, presented more frequently with acute coronary syndrome, and had a higher CRUSADE bleeding score. After adjustment, the primary efficacy end point (composite of all-cause death, myocardial infarction, and cerebrovascular accident) was similar between no PPI and PPI users (9.2% vs 11.5%, adjusted hazard ratio [HR] 1.051, 95% CI 0.788-1.400, P = .736). Bleeding rates did not differ between the 2 groups (Bleeding Academic Research Consortium type 2, 3, or 5: adjusted HR 0.996, 95% CI 0.672-1.474, P = .980). Net clinical adverse events were also similar in no PPI and PPI patients (12.9% vs 14.9%, adjusted HR 0.99, 95% CI 0.772-1.268, P = .93). Results remained consistent at sensitivity analysis when focusing on the 548 patients who remained on PPI for the whole study duration. Conclusions The current findings suggest that the concomitant use of PPIs, when clinically indicated, in patients receiving clopidogrel is not associated with adverse clinical outcome.
- Subjects :
- Male
Time Factors
medicine.medical_treatment
Administration, Oral
Aged
Aspirin
Coronary Vessels
Drug Therapy, Combination
Electrocardiography
Female
Follow-Up Studies
Graft Occlusion, Vascular
Humans
Hyperplasia
Middle Aged
Myocardial Infarction
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Proton Pump Inhibitors
Stents
Ticlopidine
Treatment Outcome
Tunica Intima
Medicine (all)
Cardiology and Cardiovascular Medicine
030204 cardiovascular system & hematology
law.invention
Graft Occlusion
0302 clinical medicine
Randomized controlled trial
law
030212 general & internal medicine
Myocardial infarction
610 Medicine & health
Hazard ratio
Clopidogrel
Administration
Combination
Platelet aggregation inhibitor
medicine.drug
Oral
medicine.medical_specialty
Acute coronary syndrome
NO
03 medical and health sciences
Drug Therapy
Vascular
Internal medicine
medicine
business.industry
Percutaneous coronary intervention
medicine.disease
Surgery
business
Subjects
Details
- Language :
- English
- ISSN :
- 00028703
- Database :
- OpenAIRE
- Journal :
- American Heart Journal, 174, 95-102. Mosby Inc.
- Accession number :
- edsair.doi.dedup.....6b6b62c64d5c2c370f72d683e62dc092