Sellers, Mary Ann

Abstract Whether initiation of statins could increase survival free of dementia and disability in adults aged ≥75 years is unknown. PREVENTABLE, a double‐blind, placebo‐controlled randomized pragmatic clinical trial, will compare high‐intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community‐dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia at baseline. Exclusion criteria include statin use in the prior year or for >5 years and inability to take a statin. Potential participants are identified using computable phenotypes derived from the electronic health record and local referrals from the community. Participants will undergo baseline cognitive testing, with physical testing and a blinded lipid panel if feasible. Cognitive testing and disability screening will be conducted annually. Multiple data sources will be queried for cardiovascular events, dementia, and disability; survival is site‐reported and supplemented by a National Death Index search. The primary outcome is survival free of new dementia or persisting disability. Co‐secondary outcomes are a composite of cardiovascular death, hospitalization for unstable angina or myocardial infarction, heart failure, stroke, or coronary revascularization; and a composite of mild cognitive impairment or dementia. Ancillary studies will offer mechanistic insights into the effects of statins on key outcomes. Biorepository samples are obtained and stored for future study. These results will inform the benefit of statins for increasing survival free of dementia and disability among older adults. This is a pioneering pragmatic study testing important questions with low participant burden to align with the needs of the growing population of older adults.

Background —Risks of coronary artery bypass graft surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA) may be different in the presence of peripheral vascular disease (PVD). Methods and Results —We analyzed outcomes of 550 patients with PVD enrolled in the Bypass Angioplasty Revascularization Investigation randomized trial and registry. Compared with 1770 patients without PVD, those with PVD were older and had a greater prevalence of medical comorbid conditions. No significant differences in coronary anatomy or PTCA success rates were found. The risk of any major complication (death, myocardial infarction, stroke, coma, or emergency revascularization) after PTCA was significantly higher among patients with PVD (11.7% versus 7.8%, P =0.027). In multivariate analysis, this represented a 50% increase in the odds of having any major complication (multivariate odds ratio, 1.5; P =0.032). Among patients undergoing CABG, the risk of major complications was found to be markedly higher for patients with PVD (12%) than those without (6.1%, P =0.003) even after controlling for baseline differences (multivariate odds ratio, 1.8; P =0.018). Major differences between the PTCA and CABG groups were related primarily to a higher risk of neurological complications in PVD patients who had CABG (multivariate odds ratio, 2.8; P <0.001). Conclusions —We conclude that patients with PVD are at high risk for periprocedural complications after myocardial revascularization, in particular neurological events.