By Deborah Brauser
ORLANDO, Fla -- November 30, 2009 -- Proton pump inhibitors (PPIs) are associated with an increased risk of all-cause mortality after patients undergo percutaneous coronary intervention (PCI) with drug-eluting stents (DES), according to a study presented here at the American Heart Association (AHA) Scientific Sessions 2009.
In addition, the multivariable adjusted risk of mortality among patients taking omeprazole was 72% higher and 54% higher for those taking pantoprazole when compared with patients not taking any PPIs.
"We wanted to know: are PPIs safe or not safe?" said lead investigator Joseph Sweeny, MD, Mount Sinai Medical Center, New York, New York, during his podium presentation on November 16. "And if not, which ones are not safe? And what is the risk of mortality associated with PPI use?"
For the study, Dr. Sweeny and colleagues evaluated 8,311 consecutive patients who had PCI with DES between April 2003 and June 2007, with follow-up through mid-2008. A total of 17% of the patients were taking PPIs, which included esomeprazole (n = 312), lansoprazole (n = 469), omeprazole (n = 193), pantoprazole (n = 374), and others (n = 37).
The primary outcome was death from all causes, while 30-day stent thrombosis and lesion revascularisation after PCI were secondary.
At a median follow-up of 2.1 years, investigators found that 602 patients died, with death rates significantly higher for those taking PPIs compared with those not taking the drugs (53.5 vs 33.0 deaths per 1,000 person-years, respectively; P < .001). In addition, the hazard ratio was 1.53 for those taking PPIs vs those who did not and the overall multivariate adjusted hazard ratio was 1.37.
"This hazard ratio, or the increased mortality, was consistent among all subgroup analysis," reported Dr. Sweeny.
When comparing the specific PPIs, higher adjusted hazard ratios were found in patients taking omeprazole (1.72) or pantoprazole (1.54) versus those taking lansoprazole or esomeprazole (1.02 and 0.97, respectively). Neither lansoprazole nor esomeprazole-treated patients showed a significantly increased risk of death when compared with patients not taking PPIs.
Finally, there were 759 target lesion revascularisations and 14 cases of stent thrombosis, but neither was statistically significantly associated with PPI use.
"Overall, in this patient population, use of PPIs was associated with an increased risk of all-cause mortality and the high risk appears to be limited to omeprazole and pantoprazole," concluded Dr. Sweeny. "In my opinion, the findings were not unexpected given the profiles of the treatments involved."
[Presentation title: Mortality Associated With Proton Pump Inhibitors Following Percutaneous Coronary Interventions With Drug Eluting Stents. Abstract 4323]
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