The Effect Of Statins On Major Adverse Limb Effects After Infrainguinal Lower Extremity Revascularization
Vanessa Urhiafe, MPH, Khaled I. Alnahhal, MD, Mark D. Iafrati, MD, Meyyammai Narayanan, MPH, Alexander K. Friedman, MD, Payam Salehi, MD, PhD, Luis B. Suarez, MD.
Tufts Medical Center, Boston, MA, USA.
OBJECTIVES: Providing statins and antiplatelet agents to patients with peripheral arterial disease undergoing lower extremity revascularization (LER) is recommended, as secondary prevention, based on reductions in cardiovascular morbity and mortality on this population. However, little has been published on the effect of statins on limb-related outcomes. This study seeks to assess the role of statins on major adverse limb events (MALEs) after LER.
METHODS: A retrospective analysis of consecutive patients undergoing peripheral vascular intervention or infrainguinal bypass at our institution from January 2010 to December 2019 was carried out. The primary outcome examined was MALEs (major amputation, re-intervention, and death) within 2 years following the intervention. Risk factors were analyzed using univariable and multivariable Cox's proportional hazards regression models for MALEs.
RESULTS: A total of 512 patients were identified. 396 (77%) were taking statins while 116 (23%) were not. Statin patients more commonly received antiplatelet treatment (85.4% vs 49.1%; P < .001). In the infrainguinal bypass group, patients taking statins had improved major amputation rates compared to those that were not (3.3% vs. 11.4%; P = .0438). Multivariable Cox hazards model (Table I) showed statins significantly reduced risk of MALEs (aHR, 0.6; CI, 0.4 - 0.9), especially in the infrainguinal bypass group (aHR, 0.4; CI, 0.2 - 0.9). However, antiplatelets alone was not associated with decreased MALEs rates (aHR, 0.6; 95% CI, 0.3 - 1.1). Patients with diabetes and end-stage renal disease had significantly higher MALEs.
CONCLUSIONS: Our study findings highlight the benefits of statin use on MALEs reduction, especially in patients undergoing infrainguinal bypass. These benefits were particularly evident on the lower major amputation rates on this group. This benefit was independent to the use of antiplatelets. This adds to the well-known benefits of statins, not just for secondary prevention, but also as an adjunct to surgical intervention and is definitely best practice for PAD patients.
| Table I. Univariable (unadjusted) and multivariable (adjusted) Cox proportional hazards regression analysis of variables related to MALEs in patients underwent PVI or infrainguinal bypass. | ||||
| Covariate | Unadjusted analysis | Adjusted analysis | ||
| HR (95.0% CI) | P-value | aHR (95.0% CI) | P-value | |
| Demographics | ||||
| Age > 68 | 0.8 (0.6 - 1.1) | .141 | 1.3 (0.8 - 1.6) | .476 |
| Race (non-Hispanic white) | 1.1 (0.7 - 1.6) | .748 | 0.7 (0.4 - 1.1) | .122 |
| Gender (Male) | 0.9 (0.6 - 1.2) | .335 | 0.9 (0.6 - 1.2) | .350 |
| Comorbidities | ||||
| Smoking (current or prior) | 0.9 (0.6 - 1.2) | .426 | 1.1 (0.7 - 1.6) | .696 |
| Hypertension | 1.3 (0.9 - 1.9) | .167 | 1.2 (0.8 - 1.8) | .424 |
| Diabetes Miletus | 1.6 (1.2 - 2.2) | .001 | 1.6 (1.1 - 2.2) | .010 |
| CAD | 1.6 (1.2 - 2.2) | .003 | 1.2 (0.8 - 1.7) | .354 |
| CHF | 1.7 (1.2 - 2.6) | .005 | 1.5 (0.9 - 2.2) | .068 |
| COPD | 1.2 (0.8 - 1.7) | .321 | 1.2 (0.9 - 1.8) | .244 |
| ESRD | 3.4 (2.3 - 5.0) | <.001 | 3.4 (2.1 - 5.4) | <.001 |
| Medications | ||||
| Statins | 0.7 (0.5 - 1.2) | .202 | 0.6 (0.4 - 0.9) | .029 |
| Antiplatelet only | 0.8 (0.4 - 1.5) | .477 | 0.6 (0.3 - 1.1) | .092 |
| No medications | REF | REF | REF | REF |
MALEs, Major adverse limb events; PVI, Peripheral vascular intervention; aHR, Adjusted Hazards ratio; CI, Confidence interval; CAD, Coronary artery disease; CHF, Congestive heart failure; COPD, Chronic obstructive pulmonary disease; ESRD, End-stage renal disease.
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