CRITISCH Registry Compares First-Line Treatments for CLI
December 20, 2016—Results from an interim analysis from the CRITISCH registry of first-line treatments in patients with critical limb ischemia (CLI) suggest that when physicians are free to individualize therapy to CLI patients, the endovascular-first approach achieved a noninferior amputation-free survival (AFS) rate compared to bypass surgery.
The CRITISCH analysis findings were published by Theodosios Bisdas, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2016;9:2557–2565).
The primary aim of the interim analysis of CRITISCH was to compare endovascular therapy and bypass surgery in a prospective confirmatory manner because the most effective of the two options is not well defined. The investigators noted that only one randomized controlled trial between endovascular therapy and bypass surgery has been published. Several retrospective studies showed comparable outcomes between the two treatment strategies, but in the majority, current endovascular technologies have not been included.
In an accompanying commentary in JACC: Cardiovascular Interventions, "How to Treat Critical Limb Ischemia: The Critical Need for High-Grade Evidence," Michael R. Jaff, DO, and Ido Weinberg, MD, acknowledged the efforts and insights of the CRITISCH registry, but found that the study was limited its general applicability. They stated, "Our conclusion of the CRITISCH registry is that endovascular care was noninferior to open surgery when implemented for the appropriate patients by physicians with the appropriate skills. Unfortunately, the study does not provide rich enough information to help clinicians decide which approach to implement for their particular patients." (2016;9:2666–2667).
As summarized in JACC: Cardiovascular Interventions, 1,200 CLI patients (Rutherford 4–6) from 27 vascular centers were enrolled in the registry between January 2013 and September 2014. The selection of the first-line treatment was left completely to the discretion of the responsible physician.
The primary composite endpoint was AFS, meaning time to major amputation and/or death from any cause. A prespecified interim analysis aimed to show noninferiority of the endovascular therapy versus bypass surgery as the hazard ratio (HR) of AFS (noninferiority bound = 1.33; interim α = .0058). Time-to-event analyses of major amputation, death, and the composite endpoint of reintervention and/or above-ankle amputation were also conducted.
The CRITISCH investigators reported that endovascular therapy was applied to 642 patients (54%) and bypass surgery to 284 patients (24%). Median follow-up time was 12 months in both groups. One-year AFS was 75% and 72%, respectively.
The noninferiority of endovascular therapy versus bypass surgery for AFS was confirmed (HR: 0.91; upper bound of one-sided (1−0.0058) confidence interval [CI], 1.29; P = .003). However, an impact of the treatment strategy on time until death (HR, 1.14; 95% CI, 0.8–1.63; P = .453), major amputation (HR: 0.86; 95% CI, 0.56–1.3; P = .463), and reintervention and/or above-ankle amputation (HR, 0.89; 95% CI, 0.7–1.14; P = .348) was not observed.
In their editorial, Dr. Jaff and Dr. Weinberg stated, "The CRITISCH registry represents another piece of information regarding the optimal management of CLI. We are still desperate for more high-quality evidence to emerge to aid clinicians on the frontlines to make sound, evidence-based decisions regarding CLI management." They advised that the National Institutes of Health multicenter, multidisciplinary, prospective BEST-CLI trial results are poised to offer the long anticipated and critically needed high-quality data that clinicians require when caring for CLI patients. "Until data become available, clinicians must rely on a team-based, experience-driven approach by seasoned vascular specialists such as those reporting the CRITISCH registry," concluded Dr. Jaff and Dr. Weinberg in JACC: Cardiovascular Interventions.