Nonsteroidal antiinflammatory drug use and cardiovascular risks after coronary stent implantation.
ABSTRACT To determine whether use of nonselective nonsteroidal antiinflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2)-selective inhibitors in patients with coronary stents increased the 3-year rate of major adverse cardiovascular events (MACE).
Population-based cohort study.
The Danish National Patient Registry, the Western Denmark Heart Registry, the Danish Nationwide Prescription Database, the Danish Civil Registration System, and the National Registry of Causes of Deaths.
A total of 13,001 patients who underwent first-ever percutaneous coronary intervention with stent implantation between January 1, 2002, and June 30, 2005.
All patients were followed for 3 years after stent implantation for MACE, defined as the first occurrence of myocardial infarction, stent thrombosis, target-lesion revascularization, or cardiac death. Patients' comorbidities were identified from the hospital registries; time-varying use of NSAIDs and concomitant drugs was determined from the Danish Nationwide Prescription Database. For each clinical outcome (MACE), the 3-year risk was computed. We used Cox proportional-hazards regression analysis to compute hazard ratios (HRs) as a measure of relative risk, controlling for potential confounders. During the follow-up period, 5407 patients (41.6%) redeemed at least one NSAID prescription. There were 686 hospitalizations for myocardial infarction (5.3% of patients), 146 for stent thrombosis (1.1%), and 1091 for target-lesion revascularization (8.4%). A total of 1220 patients (9.4%) died during the follow-up period; 637 (4.9%) died of cardiac causes. Compared with no NSAID use, the adjusted HR for MACE was 1.04 (95% confidence interval [CI] 0.83-1.31) for nonselective NSAID use and 1.00 (95% CI 0.81-1.25) for COX-2 inhibitor use.
Use of nonselective NSAIDs or COX-2 inhibitors was not associated with an increased rate of MACE in patients with coronary stents. However, we cannot rule out small risks associated with individual NSAIDs.
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ABSTRACT: In early 2012, a number of serious events in the implant area raised public awareness and started a discussion on safety issues and monitoring medical devices in academics and politics. Apparently, there is a lack in the surveillance of medical devices. Therefore, the objective of this work is to detect and classify implant registries in Europe. A systematic search of literature was carried out to identify the different types of registries. Furthermore, to characterize the implant registries by different criteria a medical device classification system was established. One hundred and one European registries were found. Most registries exist in the field of cardiac implants and arthroplasty (38 and 29) and their distribution showed variation within Europe. For a lot of implant categories, none or very few registries could be identified. Some countries run more registries than others. There are a lot of differences in aim and structure among the registries. There is only a limited number of reviews on registries and a centralized monitoring system in Europe is missing. Our results reveal a lack of transparency concerning number, aim, structure and quality of registries. This is crucial, as registries work as early warning systems for identifying and notifying patients at risk.Health Policy 09/2013; 113(1-2). DOI:10.1016/j.healthpol.2013.08.008 · 1.73 Impact Factor
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