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Endovascular therapies for critical limb ischemia (CLI) were non-inferior to bypass surgery in 12-month data from the Registry of First-Line Treatments in Patients with Critical Limb Ischemia (CRITISCH), investigators showed.

Amputation-free survival at 1 year was non-inferior for patients who had endovascular therapy (75% versus 72% for bypass surgery recipients, P=0.003 for non-inferiority), according to , of St. Franziskus Hospital in Germany, and collaborators.

The interim analysis of their non-randomized study, published online in, revealed that the two groups performed similarly on other metrics as well over a median follow-up of 12 months:

• Time until death (HR 1.14, 95% CI 0.80-1.63)
• Time to major amputation (HR 0.86, 95% CI 0.56-1.30)
• Rates of re-intervention and/or above-ankle amputation (HR 0.89, 95% CI 0.70-1.14)

"The interim analysis confirmed that when physicians are free to individualize therapy to CLI patients, the endovascular-first approach achieved a non-inferior amputation-free survival rate compared with bypass surgery," the authors concluded.

For the study, they enrolled 1,200 CLI patients in 2013 and 2014 who had visited one of 27 vascular centers. Physicians made the decision to direct their patients to endovascular therapy (54%) or bypass surgery (24%). Not included in the analysis were those who had femoral artery pathplasty, conservative management, or primary major amputation instead.

Within the endovascular therapy arm, bare metal stents were most commonly implanted (41% of cases); half as many patients received drug-coated balloons in the superficial femoral and popliteal arteries.

Patients getting stents and drug-coated balloons tended to be older (median age 75 versus 73 for patients in the surgery arm, P<0.001); frailer (modified PREVENT III risk score 5 versus 4, P<0.001); and more frequently had chronic kidney disease (49% versus 35%, P<0.001).

"We chose amputation-free survival as the primary endpoint to be in accordance with previous studies as to CLI," Bisdas and colleagues reasoned. "However, this can be criticized considering that a major adverse limb event, meanwhile, has been described as a superior outcome."

"We are not able to provide a number of details as to the type of previous interventions, the exact endovascular products and their manufacturers, the primary or secondary patency of the treated lesions or implanted bypass grafts, the time to wound healing, and the exact reason of death."

Additionally, "we are not able to report on the exact selection criteria for each patient separately. These can be extrapolated only by comparing the baseline characteristics between the groups," the authors acknowledged, noting that their multivariate Cox regression model was used to minimize the effect of confounders in the non-randomized study.

Writing in an accompanying , , of Newton-Wellesley Hospital, and , of Massachusetts General Hospital, both in Boston, however, sounded a note of caution: "Unfortunately, the study does not provide rich enough information to help clinicians decide which approach to implement for their particular patient," they said, pointing especially to certain missing information in the study that they said would have been imperative to include: lesion-specific characteristics (lesion length, presence of calcification, and length of chronic total occlusions) and a fuller picture of medical therapy (use of antiplatelet, antihypertensive, or diabetes medications).

"Furthermore, medication use was only reported at the time of discharge and not during follow-up, and attainment of treatment goals was not discussed," Jaff and Weinberg continued.

"When treating CLI patients, the goal is to achieve symptomatic relief, wound healing, or at the worst, limit the extent and level of amputation. Thus, we agree with the authors that their choice of lower extremity outcome may have been more useful if it had been major adverse limb events and not amputation alone."

To provide more answers, the editorial cited the ongoing Best Endovascular Versus Best Surgical Therapy for Patients with Critical Limb Ischemia () trial, which is randomizing CLI patients to endovascular therapy or surgical revascularization. The outcomes to be evaluated will include treatment efficacy, functional outcomes, quality of life, and cost.

"Results of the BEST-CLI trial are poised to offer the long-anticipated and critically needed high-quality data that clinicians require when caring for CLI patients," Jaff and Weinberg concluded.