Observational Study Sheds Light on Endovascular vs Surgical Options for Symptomatic PAD


Patients with symptomatic PAD have a lower risk of complications after endovascular intervention compared with lower-extremity bypass surgery but a higher likelihood of needing retreatment in subsequent years, according to a study published online September 11, 2015, ahead of print in Circulation

Take Home: Observational Study Sheds Light on Endovascular vs Surgical Options for Symptomatic PAD

Thomas T. Tsai, MD, MSc, of the University of Colorado (Denver, CO), and colleagues examined data on 1,858 symptomatic PAD patients who underwent endovascular therapy (n = 883) or surgical intervention (n = 975) at 2 large integrated healthcare delivery systems (59 total centers) in Colorado and California between 2005 and 2011.

Mean patient age was 69.6 years, and 59.4% were men. Comorbid hypertension (90.6%) and lipid disorders (84.6%) were common, while prior endovascular therapy (7.5%) and lower-extremity surgery (8.2%) were rare.

Approximately half of the cohort presented with claudication, and half with critical limb ischemia (CLI). Compared with claudication patients, those with CLI were older, had a higher comorbidity burden, and were more likely to be treated with surgery (68.5% vs 36.6%; P = .001).

Lesion and Limb Reintervention Higher

Patients undergoing surgery were more likely than those treated with endovascular therapy to experience complications in the first 30 days (37.1% vs 11.9%; P < .001).

However, at 1 and 3 years, the rates of both target lesion revascularization (table 1) and target limb revascularization (table 2)—the primary outcomes—were higher in the endovascular group compared with the surgery group in those presenting with claudication and those presenting with CLI.

Table 1. Target Lesion Revascularization


Table 2. Target Limb Revascularization

In a propensity-adjusted analysis, claudication patients treated with endovascular therapy were still more likely than those who received surgery to require target lesion revascularization (HR 2.49; 95% CI 1.62-3.81) and target limb revascularization (HR 2.59; 95% CI 1.79-3.74). The findings were similar in the CLI cohort.

Rates of major amputation at 1 and 3 years were similar for endovascular therapy compared with surgery, a finding that persisted after propensity adjustment (HR 0.95; 95% CI 0.71-1.29).

Propensity-adjusted analyses over the duration of follow-up indicated that the risk of death was lower with endovascular therapy for both claudication patients (HR 0.63; 95% CI 0.44-0.90) and CLI patients (HR 0.75; 95% CI 0.59-0.95). However, in sensitivity analyses, only the findings for the claudication cohort were significant.

Impact on Overall Health Important But Unknown

Amid the clinical uncertainty over the best approach to treating symptomatic PAD patients, the lack of large, randomized trials is a primary reason for turning to registry studies for guidance, Dr. Tsai and colleagues say. They note that the TLR rate seen here for endovascular therapy is comparable with that of the international RESILIENT trial, while the rate for surgery is better than that of at least 1 recent meta-analysis. The increased complication rate with surgery, the study authors say, also is consistent with prior literature and factors into the decision-making process when weighing 1 treatment against another.

“Perhaps risk prediction and decision-making tools can better quantify the risks vs benefits of [surgery] compared to [endovascular therapy] to help patients and clinicians make thoughtful decisions regarding the best course of treatment,” they write.

While the study did not look at health status after treatment, the researchers acknowledge that the extent to which each treatment impacts that metric—both in the short- and long-term—also is an important factor in the decision-making process.

“To date, most studies of revascularization have focused on patency, which does not necessarily correlate with patient-reported symptoms or measured exercise impairment,” they conclude. “Therefore, measurement of the impact of different revascularization strategies on health status is critical to support future comparative effectiveness studies of PAD treatment.”


Source: 
Tsai TT, Rehring TF, Rogers RK, et al. The contemporary safety and effectiveness of lower extremity bypass surgery and peripheral endovascular interventions in the treatment of symptomatic peripheral arterial disease. Circulation. 2015;Epub ahead of print. 

Disclosures:

  • Dr. Tsai reports no relevant conflicts of interest. 

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