Introduction: Statin dose guidelines for PAD patients are based on coronary artery disease and stroke data. The aim of our study was to determine the effect of statin dose (based on 2013 ACC/AHA guidelines) on PAD outcomes of amputation and mortality. Methods: Patients with PAD in the Veterans Affairs database were identified from 2003-2014. The exposure was highest statin dose usage (none, low-moderate and high intensity) around diagnosis of PAD (within 1 year). The outcomes were risk of incident amputation (below knee or above knee) and mortality at 1, 3 and 5 years. The effect of statin dose on the two outcomes was also analyzed using Cox proportional hazards modeling to adjust for covariates. Results: In 208,275 patients with PAD [Males: 98.1%; Mean age: 67.4 yrs (SD 9.9)], 17,643 amputations and 99,951 deaths occurred in a median follow up of 5.2 years. Almost a quarter (27.7%) of patients were not on a statin while 30.4% were on simvastatin 80 mg (no longer recommended due to drug toxicity). The risk of incident amputation declined significantly at the high intensity statin dose as seen in Table 1. In Cox models adjusting for age, gender, race, comorbidities, cholesterol levels and creatinine, the high intensity statins were associated with lower amputation risk and mortality as compared to no statin [HR 0.67; 95% CI (0.63, 0.72) and HR 0.71; 95% CI (0.68, 0.73), respectively]. Low-moderate-dose statins also had significant but smaller reductions in risk of amputation and mortality [HR amputation 0.78 (0.75, 0.82), HR death 0.78 (0.77, 0.80)]. Conclusion: This is one of the largest population based studies to examine the effect of statins on long-term PAD outcomes and the first to explore the dose-dependent effect of statins on amputation and mortality. High intensity statins are associated with a significant reduction in limb loss and mortality in PAD patients followed by a smaller risk reduction by low-moderate intensity statins as compared to no statin therapy.
Association of Statin Dose With Amputation and Survival in Patients With Peripheral Artery Disease
Background: Statin dose guidelines for patients with peripheral artery disease (PAD) are largely based on coronary artery disease and stroke data. The aim of this study is to determine the effect of statin intensity on PAD outcomes of amputation and mortality. Methods: Using an observational cohort study design and a validated algorithm, we identified patients with incident PAD (2003–2014) in the national Veterans Affairs data. Highest statin intensity exposure (high-intensity versus low-to-moderate–intensity versus antiplatelet therapy but no statin use) was determined within 1 year of diagnosis of PAD. Outcomes of interest were lower extremity amputations and death. The association of statin intensity with incident amputation and mortality was assessed with Kaplan-Meier plots, Cox proportional hazards modeling, propensity score–matched analysis, and sensitivity and subgroup analyses, as well, to reduce confounding. Results: In 155 647 patients with incident PAD, more than a quarter (28%) were not on statins. Use of high-intensity statins was lowest in patients with PAD only (6.4%) in comparison with comorbid coronary/carotid disease (18.4%). Incident amputation and mortality risk declined significantly with any statin use in comparison with the antiplatelet therapy–only group. In adjusted Cox models, the high-intensity statin users were associated with lower amputation risk and mortality in comparison with antiplatelet therapy–only users (hazard ratio, 0.67; 95% confidence interval, 0.61–0.74 and hazard ratio, 0.74; 95% confidence interval, 0.70–0.77, respectively). Low-to-moderate–intensity statins also had significant reductions in the risk of amputation and mortality (hazard ratio amputation, 0.81; 95% confidence interval, 0.75– 0.86; hazard ratio death, 0.83; 95% confidence interval, 0.81–0.86) in comparison with no statins (antiplatelet therapy only), but effect size was significantly weaker than the high-intensity statins ( P <0.001). The association of high-intensity statins with lower amputation and death risk remained significant and robust in propensity score–matched, sensitivity, and subgroup analyses. Conclusions: Statins, especially high-intensity formulations, are underused in patients with PAD. This is the first population-based study to show that high-intensity statin use at the time of PAD diagnosis is associated with a significant reduction in limb loss and mortality in comparison with low-to-moderate–intensity statin users, and patients treated only with antiplatelet medications but not with statins, as well.
Carotid Endarterectomy is Superior to Carotid Angioplasty and Stenting for Perioperative and Long-Term Results
Objective: Carotid angioplasty and stenting (CAS) has challenged carotid endarterectomy (CEA) as the therapy of choice for carotid disease. This meta-analysis aims at summarizing the most current body of evidence. Methods: All prospective, controlled clinical trials comparing CEA versus CAS were included. The outcome measures of interest were relative risk (RR) of 30-day stroke, 30-day stroke/death, long-term risk of stroke, and risk of restenosis. Results: The RR of 30-day stroke for CAS was 1.6 times that of CEA (RR 1.6; 95%CI 1.2-2.0, P = .001). The 30-day RR of stroke/death was 1.5 times higher for CAS (RR 1.5; 95%CI 1.1-2.1, P = .008). There was a higher risk of long-term stroke (RR 1.2; 95%CI 1.0-1.5, P = .043). The risk of restenosis was twice for CAS (RR 1.8; 95%CI 1.1-3.1, P = .04). Conclusion: The 30-day RR of stroke, stroke/death, long-term risk of stroke, and risk of restenosis are consistently higher for carotid artery stenting (CAS).