CLI Patients on Statins Show Improved Outcomes After Endovascular Treatment

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Periprocedural statin use appears to dramatically improve outcomes for patients with critical limb ischemia (CLI) undergoing endovascular treatment, according to an observational study published in the February 2012 issue of the Journal of Vascular Surgery. The benefits—ranging from better patency to higher rates of limb salvage and even survival—occur despite the fact that patients on statin therapy tend to be sicker than those not on the drugs.

Francesco A. Aiello, MD, of NewYork-Presbyterian Hospital (New York, NY), and colleagues assessed outcomes of 646 patients who underwent endovascular intervention for CLI at their institution between 2004 and 2009. Approximately half were receiving statins at the time of treatment (n = 319) and half were not (n = 327). Mean follow-up after treatment was 10.4 ± 11 months (range, 1-46 months).

At baseline, statin-treated patients were more likely to have diabetes, CAD, and congestive heart failure as well as histories of MI and CABG (P < 0.05 for all comparisons). Importantly, total cholesterol levels did not differ between statin-treated patients and controls (170 ± 39 mg/dL vs. 174 ± 46; P = 0.58), nor did LDL levels (94 ± 34 mg/dL vs. 95 ± 37 mg/dL; P = 0.95). Lesion characteristics also were similar.

At 24 months, the statin group had better outcomes for all measures including cumulative primary and secondary patency, limb salvage, and overall survival (table 1).

Table 1. Mean Clinical Outcomes at 24 Months

Multivariate Cox regression analysis found that statin use made patients less likely to lose primary patency (HR 0.77; 95% CI 0.65-0.92; P = 0.005) and more likely to retain their limbs (HR 2.55; 95% CI 1.77-3.67; P < 0.001).

Results Point to Pleiotropic Effects

In a telephone interview, Dr. Aiello told TCTMD that the NewYork-Presbyterian Hospital investigators did not initially plan on investigating the effects of statins.

“Where we work, we have a very high population of low socioeconomic patients who come in with advanced [peripheral arterial] disease,” he said, “and we wanted to see what we could do to help [them].” Statin use kept coming up in the database, Dr. Aiello explained, so the researchers decided to look deeper.

The fact that LDL and total cholesterol levels were equivalent regardless of statin use lends support to the idea that statins have pleiotropic effects, he said. According to the paper, “[s]tatins have decreased cholesterol content and size of lesions, increased plaque cap thickness, and decreased inflammatory cells and vascular calcium levels in altered animal models and in humans undergoing carotid endarterectomy and lower extremity angioplasty.”

Whereas “the lipid-lowering effects of statins can take weeks or months to occur,” Dr. Aiello noted, “the anti-inflammatory effects can happen within hours of drug administration.” He stressed that the current study only measured periprocedural statin use and did not account for the fact that many patients in the no-statin group likely began taking the drugs after treatment.

In an e-mail communication with TCTMD, Germano Di Sciascio, MD, of the University of Rome (Rome, Italy), reported being unsurprised by the findings. “I believe statins really matter. Although this is a nonrandomized study of patients presumably taking different types of statins for different periods of time, they are quite consistent with the findings derived from randomized studies on CAD. Diffuse cardiovascular disease, involving coronaries, carotids, brain, peripheral limbs, is indeed a manifestation of the same disease, ie atherosclerosis,” he said, adding that the mechanisms behind statins’ protective effect in the setting of PAD “may be essentially the same as [those] observed in ACS patients treated with PCI.”

Strong Endorsement for Statins

Generally speaking, fewer PAD patients are given statins compared to their counterparts suffering from CAD, Dr. Aiello noted. This may be because many peripheral interventions are performed by vascular surgeons, who he said are less likely to prescribe medications than cardiologists.

“The issue is that everyone’s always worried about side effects. And since [vascular surgeons] are not primary care physicians, we don’t follow patients regularly for these problems. In some cases we see them once every year, or every 2 years,” Dr. Aiello said, adding that surgeons may also be too busy to add medical management to their list of duties.

In recent years, however, vascular surgeons have been taking more initiative with statin use, he reported.

Dr. Aiello saw few contraindications. “Even in patients who have had a reaction to a statin, . . . the side effects of one do not necessarily correlate to those of another [type],” he said, adding that other groups shown to be at higher risk are the elderly, those on fibrates, and diabetics. “We just think that those patients need to be monitored closely. So instead of doing yearly exams on these patients you want to watch them every 3 to 6 months because the effects of statins—the dreaded rhabdomyolysis—can happen any time.”

According to Dr. Di Sciascio, the take-home message is clear: “Encourage early treatment with statins in patients with any of the manifestations of cardiovascular disease, ie at first medical contact in patients with stable or unstable CAD, cerebrovascular disease, and PVD. Continue such treatment, preferably at high dose, through revascularization procedures, and, if tolerated, continue at follow-up for the long-term. There are essentially minimal downsides [such as liver or muscle abnormalities, and if any occur,] they are evident early in the treatment, allowing the physician to act accordingly.”

 

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Source:
Aiello FA, Khan AA, Meltzer AJ, et al. Statin therapy is associated with superior clinical outcomes after endovascular treatment of critical limb ischemia. J Vasc Surg. 2012;55:371-380.

 

 

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