Introducing Anti-Vascular Endothelial Growth Factor Therapies for AMD Did Not Raise Risk of Myocardial Infarction, Stroke, and Death

Abstract

<div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d5032690e133">Purpose</h5> <p id="P2">To assess the effect of availability of anti-VEGF therapy on mortality and hospitalizations for stroke and acute myocardial infarction (AMI) over a 5-year follow-up period in US Medicare beneficiaries newly diagnosed with exudative age-related macular degeneration (AMD) in 2006 compared to control groups consisting of beneficiaries newly diagnosed with exudative AMD at a time when anti-VEGF therapy was not possible and with a control group of beneficiaries newly diagnosed with non-exudative AMD. </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d5032690e138">Design</h5> <p id="P3">Retrospective cohort study</p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d5032690e143">Participants</h5> <p id="P4">Medicare beneficiaries newly diagnosed with exudative and non-exudative AMD in 2000 and 2006 selected from a random longitudinal sample of Medicare 5% claims and enrollment files. </p> </div><div class="section"> <a class="named-anchor" id="S4"> <!-- named anchor --> </a> <h5 class="section-title" id="d5032690e148">Methods</h5> <p id="P5">Beneficiaries with a first diagnosis of exudative AMD in 2006 were the treatment group; beneficiaries newly diagnosed with exudative AMD in 2000 or non-exudative AMD in 2000 or 2006 were control groups. To deal with potential selection bias, we designed an intent-to-treat study. Intent-to-treat analysis controls for non-adherence to prescribed regimens. In our study, the treatment group consisted of patients with clinically appropriate characteristics to receive anti-VEGF injections given that the therapy is available, by-passing the need to monitor whether treatment was actually received. Control groups consisted of patients with clinically appropriate characteristics but first diagnosed at a time when the therapy was unavailable (2000) and similar patients but for whom the therapy is not clinically indicated (2000, 2006). We used a Cox proportional hazard model. </p> </div><div class="section"> <a class="named-anchor" id="S5"> <!-- named anchor --> </a> <h5 class="section-title" id="d5032690e153">Main Outcome Measures</h5> <p id="P6">All-cause mortality and hospitalization for stroke and AMI during follow-up.</p> </div><div class="section"> <a class="named-anchor" id="S6"> <!-- named anchor --> </a> <h5 class="section-title" id="d5032690e158">Results</h5> <p id="P7">No statistically significant changes in probabilities of death and hospitalizations for AMI and stroke within a 5-year follow-up period were identified in exudative AMD beneficiaries newly diagnosed in 2006, the beginning of widespread anti-VEGF use, compared to 2000. As an alternative to our main analysis, which excluded beneficiaries from non-exudative AMD group who received anti-VEGF therapies during follow-up, we performed a sensitivity analysis with this group of individuals re-included (11% of beneficiaries newly diagnosed with non-exudative AMD in 2006). Results were similar. </p> </div><div class="section"> <a class="named-anchor" id="S7"> <!-- named anchor --> </a> <h5 class="section-title" id="d5032690e163">Conclusions</h5> <p id="P8">Data from this study do not show that the introduction of anti-VEGF agents in 2006 for treating exudative AMD has posed a threat of increased risk of AMI, stroke, or all-cause mortality. </p> </div>