Endovascular-first approach boosts amputation-free survival in patients with critical limb ischemia

Patients with critical limb ischemia might be better off if they opt for endovascular-first treatment over an open surgical bypass, a Circulation: Cardiovascular Quality and Outcomes study suggests.

Critical limb ischemia (CLI) is the most severe form of peripheral artery disease (PAD), Jonathan H. Lin, MD, and co-authors wrote in the journal, yet only one trial—conducted nearly a decade ago–has explored the question of whether one revascularization therapy is more effective than the other. The BEST-CLI trial (Best Endovascular vs. Best Open Surgical Therapy in Patients with Critical Limb Ischemia) will attempt to answer that question in the coming months, but right now it’s still in enrollment.

“While the trial will be able to inform us on the outcomes for those patients who meet the inclusion criteria and are subsequently treated by physicians with expertise in the management of infrainguinal disease, there will remain questions regarding what the outcomes are for all patients treated over a large variety of hospital settings,” Lin and colleagues wrote. “This study compares amputation-free survival (AFS), reintervention rates and overall mortality in patients treated with initial open surgical bypass or endovascular intervention for CLI across all non-federal hospitals in California.”

The authors linked non-federal hospital data to statewide death data in California, identifying all patients with lower extremity ulcers and a PAD diagnosis who underwent a revascularization procedure between 2005 and 2013. A total of 16,800 subjects were included in the study, 36% of whom underwent open surgical bypass and 64% of whom received endovascular intervention.

Endovascular-first patients were more likely than bypass patients to be younger and present with comorbid renal failure (36% vs. 24%, respectively). Lin et al. also found endovascular-first patients were more likely to have:

  • Coronary artery disease (34% vs. 32%)
  • Congestive heart failure (19% vs. 15%)
  • Diabetes mellitus (65% vs. 58%)

After inverse propensity weighting and adjustment for patients’ ability to manage their disease and their hospital revascularization experience, the researchers concluded open surgery first was associated with worse amputation-free survival, though they didn’t identify any difference in mortality rates. Endovascular-first treatment, on the other hand, was linked to higher rates of reintervention.

“Patients with CLI have multiple comorbidities, and choosing the initial treatment requires a customized therapeutic approach that balances patient factors with technical and anatomic limitations,” Lin and colleagues said. “Our work with this all-payer state-based data has shown that an initial open surgical bypass approach for patients with CLI was associated with worse AFS but decreased secondary procedures compared with an endovascular-first approach.”

The authors said endovascular therapy is more applicable to a wider patient population—especially those with multiple comorbidities. But it’s important to note that 38% of patients in the endovascular-first group and 34% of patients in the surgery group still required reintervention.

“As a vascular community, more work needs to focus on improved patency of surgical bypasses, as well,” Lin and co-authors wrote. “This is especially important as there are many patients who are not candidates for endovascular therapy due to anatomic limitations as well as many patients who do not have good single segment venous conduits.”