Author + information
- aDepartment of Medicine, Newton-Wellesley Hospital, Boston, Massachusetts
- bFireman Vascular Center and Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Michael R. Jaff, Newton-Wellesley Hospital, 2014 Washington Street, Newton, Massachusetts 02462.
With aging of the world population, and as cardiovascular risk factors become more prevalent among developing nations, peripheral artery disease has become a major health and financial burden globally (1). Although relatively uncommon, critical limb ischemia (CLI), the most severe form of peripheral artery disease, which includes ischemic rest pain, tissue loss, and gangrene, results in the greatest morbidity and risk of mortality to patients and the health care systems (2,3).
However, despite its immense health care impact, there are limited data to guide therapies for CLI patients. Furthermore, most studies examining best care for these patients have focused on intervention, and there are surprisingly few trials to guide optimal medical therapy.
Interventional options for CLI patients include either endovascular or open surgical revascularization. These are not mutually exclusive, as a patient may receive a hybrid procedure. Despite the fact that CLI care is provided by various specialists (i.e., vascular surgery, interventional radiology, and cardiology or vascular medicine), in modern practice, an endovascular-first approach has become the most widely used (4). Most data to support which therapy to choose relies on limited reports and on the only multicenter prospective randomized trial in the field (BASIL [Bypass versus Angioplasty in Severe Ischaemia of the Leg] trial), which only included uncoated percutanenous transluminal angioplasty as the endovascular option. This limitation prevents meaningful conclusions relevant to modern practice in which many technologies are being evaluated for the endovascular management of CLI (5). Thus, choosing between these options is for the most part reliant on operator skill and experience.
It is with this backdrop that in this issue of JACC: Cardiovascular Interventions, an interim analysis of CRITISCH (Registry of First-Line Treatments in Patients with Critical Limb Ischemia) is published by Bisdas et al. (6). This is a prospective, multicenter registry of 27 centers in Germany. Data regarding consecutive patients with CLI were collected and amputation and survival results at 12 months are reported. Importantly, although patient treatment allocation was left to the discretion of the treating clinicians, inclusion mandated that in each center both the endovascular and surgical revascularization options were available and that treatment decisions be made on the basis of a discussion between clinicians. The authors were able to compare 642 patients who underwent an endovascular-first approach to 284 patients who received open surgery as the initial first revascularization. At 12 months amputation and survival were similar in both groups and the authors concluded that noninferiority was met for the endovascular as compared to the open surgical approach.
The authors should be commended for many aspects of their trial. First, they mandated a multidisciplinary discussion regarding treatment allocation. This is reflective of the ideal modern treatment of CLI patients (the CLI team) and is targeted at avoiding the adverse effects of care fragmentation. Indeed, CLI teams are considered an aspirational goal for centers that manage these patients (7). Not surprisingly, and similar to the aforementioned real-world published data, most patients were allocated to the endovascular-first arm. Finally, the authors made an effort to collect data on many important variables that may affect outcomes, specifically including frailty, which is known to be a strong predictor of procedural success and post-procedure quality of life (8,9).
Unfortunately, this study also suffers from several design flaws and readers must exercise caution when attempting to extrapolate conclusions relevant to their CLI practice. First, there is missing information that is imperative when deciding how to treat a particular patient. Lesion-specific characteristics including lesion length, presence of calcification, and length of chronic total occlusions were not reported. The only medical therapy mentioned was the treatment of hypercholesterolemia with statins. Use of antiplatelet, antihypertensive, or diabetes medications was not reported. Furthermore, medication use was only reported at the time of discharge and not during follow-up, and attainment of treatment goals was not discussed.
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. With shared decision making emerging as important to health care delivery, appreciating the patient’s preference in the choice of revascularization strategy would have been helpful to appreciate in this manuscript. Finally, and perhaps most important, are the demographic differences between patients allocated to the treatment arms in Table 1. These differences suggest not only selection bias, but also probable unmeasured confounding variables. Indeed, the authors addressed known factors when analyzing outcomes with the use of multivariable Cox regression. Our conclusion of 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 patient.
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 make sound, evidence-based decisions regarding CLI management. The BEST-CLI (Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia) trial is a multicenter, multidisciplinary, prospective National Institutes of Health trial that is randomizing CLI patients who are eligible to either endovascular or open surgical revascularization. The BEST-CLI trial is evaluating outcomes including treatment efficacy, functional outcomes, quality of life, and cost (10). 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. 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.
↵∗ Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology.
Dr. Jaff has served as a noncompensated advisor for Abbott Vascular, Boston Scientific, Cordis, and Medtronic Vascular; has served as a compensated consultant for Cardinal Health and Volcano/Philips; has served as a compensated board member for VIVA Physicians; and owns equity interest in PQ Bypass, Primacea, and Vascular Therapies. Dr. Weinberg has reported that he has no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
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- Bisdas T.,
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- Torsello G.,
- for the CRITISCH collaborators
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- Giri J.,
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- Weinberg M.D.
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- Assmann S.F.,
- et al.