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Safety of clopidogrel and proton pump inhibitors in patients undergoing drug-eluting stent implantation

Rossini, Robertaa; Capodanno, Davideb; Musumeci, Giuseppea; Lettieri, Corradoc; Lortkipanidze, Nikoloza; Romano, Michelec; Nijaradze, Tamara; Tarantini, Giusepped; Cicorella, Nicolac; Sirbu, Vasilea; Guagliumi, Giulioa; Rosiello, Renatoc; Valsecchi, Orazioa; Gavazzi, Antonelloa

doi: 10.1097/MCA.0b013e328343b03a
Therapy and Prevention
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Objective A pharmacodynamic interaction between clopidogrel and proton pump inhibitors (PPIs) has been suggested, leading to reduced clopidogrel-induced platelet inhibitory effects. However, data from clinical studies are conflicting. The aim of this study was to evaluate the safety of long-term clopidogrel and PPI therapy.

Methods A total of 1328 consecutive patients (age 63±11 years; 81% male) undergoing drug-eluting stent implantation and 1-year follow-up were included. All patients were treated with a standard aspirin and clopidogrel treatment regimen for 12 months. The concomitant PPI therapy for the same duration was at the discretion of the clinical cardiologist. PPI therapy included lansoprazole (30 mg/day), pantoprazole (20 mg/day), or omeprazole (20 mg/day). At 1-year follow-up, major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), acute coronary syndrome leading to hospitalization and nonfatal stroke, were recorded. All cause death, any stent thrombosis (ST), and bleeding (Thrombolysis in MI major and minor) were also assessed.

Results Lansoprazole, pantoprazole, and omeprazole were administered to 855, 178, and 125 patients, whereas 170 were not prescribed any PPI therapy. Among patients treated with PPIs, those on pantoprazole had more often prior MI, multivessel coronary artery disease, and chronic kidney disease, whereas earlier peptic ulcer was more frequent among patients treated with omeprazole. The incidence of 1-year MACE was not statistically different between patients in the PPI and no-PPI groups (7.5 vs. 5.0%; P=0.26). Similarly, 1-year rates of all cause death, ST, and Thrombolysis in MI major and minor bleedings did not significantly differ. After statistical adjustment for potential confounders, the concomitant use of clopidogrel and PPIs was not associated with the risk of 1-year MACE [odds ratio (OR) 1.54, P=0.38], death (OR: 0.97, P=0.961), and ST (OR: 1.01, P=0.998). No differences across the three PPI types were found.

Conclusion The association of clopidogrel and PPIs after drug-eluting stent implantation, prescribed on clinical judgement, seems safe.

aCardiovascular Department, Ospedali Riuniti di Bergamo, Bergamo

bCardiovascular Department, Ferrarotto Hospital, University of Catania, Catania

cCardiology Division, Carlo Poma Hospital, Mantova

dDepartment of Cardiac, Thoracic and Vascular Sciences, Università di Padova, Padova, Italy

Correspondence to Roberta Rossini, MD, PhD, USC Cardiologia, Dipartimento Cardiovascolare, Ospedali Riuniti di Bergamo, Largo Barozzi 1, Bergamo 24122, Italy Tel: +39 035 266455; fax: +39 035 400491; e-mail: roberta_rossini@yahoo.it

Received October 13, 2010

Accepted December 13, 2010

© 2011 Lippincott Williams & Wilkins, Inc.