BEST-CLI trial on the homestretch
2019; Elsevier BV; Volume: 69; Issue: 2 Linguagem: Inglês
10.1016/j.jvs.2018.08.156
ISSN1097-6809
Autores Tópico(s)Acute Ischemic Stroke Management
ResumoPersistent, widespread clinical uncertainty about the best means by which to revascularize patients with chronic limb-threatening ischemia (CLTI, or critical limb ischemia [CLI]) and the striking paucity of comparative effectiveness data led to efforts by the authors in 2007 to design a randomized, controlled trial that would address these questions. There are huge variations in the clinical management of affected patients. The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial, funded by the National Heart, Lung, and Blood Institute, is a prospective, multicenter, multispecialty randomized controlled trial designed to compare treatment efficacy, functional outcomes, cost-effectiveness, and quality of life for 2100 patients suffering from CLI.1Menard M.T. Farber A. Assmann S.F. Choudhry N.K. Conte M.S. Creager M.A. et al.Design and rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) trial.J Am Heart Assoc. 2016; 5: e003219Crossref PubMed Scopus (148) Google Scholar The BEST-CLI trial enrollment has now crossed the halfway point, which places it firmly on the home stretch!2Farber A. Rosenfield K. Siami F.S. Strong M. Menard M. The BEST-CLI trial has crossed the halfway mark and promises to be worth the wait.J Vasc Surg. 2019; 69: 470-481Scopus (20) Google Scholar To place this in perspective, twice as many patients have been enrolled in this trial to date compared with the original Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial.3Bradbury A.W. Adam D.J. Bell J. Forbes J.F. Fowkes F.G. Gillespie I. et al.Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received.J Vasc Surg. 2010; 51: 18S-31SAbstract Full Text Full Text PDF PubMed Scopus (250) Google Scholar But efforts must not flag until the finish line has been crossed. Even though peripheral artery disease is the most common condition that vascular surgeons and allied vascular specialists treat, the evidence base supporting various forms of therapy is surprisingly weak. This statement is especially applicable to patients with its most severe presentation, CLTI. To date, only one randomized, prospective trial has compared endovascular therapy with open surgical bypass for this condition.3Bradbury A.W. Adam D.J. Bell J. Forbes J.F. Fowkes F.G. Gillespie I. et al.Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received.J Vasc Surg. 2010; 51: 18S-31SAbstract Full Text Full Text PDF PubMed Scopus (250) Google Scholar A recent high-energy BEST-CLI investigators meeting was followed by a large spike in enrollment. There has been excellent buy-in from the vascular community at large as well as from key interested parties, such as the National Institutes of Health, the Food and Drug Administration, and the Centers for Medicare and Medicaid Services. For many years, lower extremity bypass (LEB) with autogenous vein conduit was the unrivaled cornerstone of lower extremity revascularization, especially in patients with CLTI. However, with improved, lower profile devices and rapidly advancing endovascular techniques and expertise, percutaneous endovascular therapy is now performed quite frequently and in some units has become the therapy of first choice in such patients. Advocates of an endovascular-first approach note that it is less invasive, is associated with less morbidity and lower mortality, can be repeated if necessary, and allows more rapid recovery of the patient. Bypass-first proponents argue that vein bypass is more durable, results in greater and more lasting hemodynamic improvement, and is much less likely to require repetitive interventions for restenosis, especially for complex, long-segment disease. In truth, patients are often treated on the basis of the inherent biases of those vascular specialists to whom they are referred. The decision to proceed with LEB or endovascular therapy differs widely among institutions and practitioners. This variable state is strikingly illustrated in the authors' Fig 1 generated from Vascular Quality Initiative data, showing the range of infrainguinal LEB at various centers from 0% to 100%! Tremendous credit is owed to the BEST-CLI investigators to have devised and thus far carefully shepherded beyond the halfway point a multicenter, multinational trial at >150 sites. Multiple site visits have been performed by the investigators to encourage cooperation, to develop talking points about means of optimizing enrollment, and to support CLTI team building, setting aside the often deeply held, even emotionally charged biases about the optimal means of revascularization. Participating interventionalists include vascular surgeons, cardiologists, and interventional radiologists; 72% of sites are multidisciplinary. This process required individual investigators to generate and to build CLTI teams and to evaluate patients as a team. Sites have been encouraged to integrate the entire range of open and endovascular expertise in cases in which equipoise was highest. Patients who are believed by the team to be treatable by either open or endovascular means are randomized. For those randomized to bypass, there are two cohorts: those with available good-quality great saphenous vein (GSV) and those who would require the use of alternative conduits. The BEST-CLI trial is a herculean effort that may lead the way to answering relevant, unresolved questions in the realm of CLTI care. The principal question is how LEB with single-segment GSV compares with endovascular therapy. It should aid providers who treat CLTI patients in determining whether an endovascular-first approach is appropriate in patients who have a good autogenous vein. It will also guide treatment in patients who do not have an adequate single-segment GSV. In addition, BEST-CLI will compare the effectiveness of each treatment strategy to a greater degree than has ever been attempted. Clinical outcomes, cost, and quality of life will be comprehensively assessed across a wide range of demographic, clinical, anatomic, and procedural variables. The trial will also prospectively validate the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification in a group of patients undergoing revascularization as these data are collected for each enrolled patient.4Mills Sr., J.L. Conte M.S. Armstrong D.G. Pomposelli F.B. Schanzer A. Sidawy A.N. et al.Society for Vascular Surgery Lower Extremity Guidelines CommitteeThe Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI).J Vasc Surg. 2014; 59: 220-234Abstract Full Text Full Text PDF PubMed Scopus (812) Google Scholar, 5Darling J.D. McCallum J.C. Soden P.A. Meng Y. Wyers M.C. Hamdan A.D. et al.Predictive ability of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system following infrapopliteal endovascular interventions for critical limb ischemia.J Vssc Surg. 2016; 64: 616-622Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar The BEST-CLI trial will also analyze many relevant end points developed by the Society for Vascular Surgery objective performance goals working group.6Conte M.S. Geraghty P.J. Bradbury A.W. Hevelone N.D. Lipsitz S.R. Moneta G.L. et al.Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.J Vasc Surg. 2009; 50: 1462Abstract Full Text Full Text PDF PubMed Scopus (332) Google Scholar Finally, because the hemodynamics of CLTI are the subject of frequent debate and discussion, the trial will relate comparative hemodynamic outcomes of revascularization to corresponding clinical outcomes. In summary, the BEST-CLI trial has been well designed to compare the effectiveness of open and endovascular interventions for CLTI. Most important, it was designed to account for patients with and without available, good-quality vein conduit. It has also been stratified for key clinical issues, such as tissue loss vs ischemic rest pain, as well as for anatomic factors (below-the-knee disease) that are a known influence on outcome and includes a meaningful primary end point (major adverse limb events) that considers major reinterventions having an impact on patients.6Conte M.S. Geraghty P.J. Bradbury A.W. Hevelone N.D. Lipsitz S.R. Moneta G.L. et al.Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.J Vasc Surg. 2009; 50: 1462Abstract Full Text Full Text PDF PubMed Scopus (332) Google Scholar BEST-CLI is a remarkable individual and team effort. Its results will provide a broad perspective on the contemporary outcomes of revascularization for CLTI, inclusive of the full range of available interventional techniques, with quality of life and cost-effectiveness measures. It also serves to demonstrate the commitment of vascular surgeons to advance the care of CLTI patients and to establish a foundation for evidence-based practice. Regardless of the outcomes and the discussions to come about how the results are best to be interpreted, the most important legacy of the trial itself might be its efforts to lay biases aside and to form collaborative, multidisciplinary teams to care for complex patients with threatened limbs. Such patients deserve access to the best treatment and revascularization options available. The BEST-CLI trial is nearing the finish line and promises to be worth the waitJournal of Vascular SurgeryVol. 69Issue 2PreviewThere is significant variability and equipoise in the management of critical limb ischemia (CLI). The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial, funded by the National Heart, Lung, and Blood Institute, is a prospective, open label, multicenter, multispecialty randomized controlled trial designed to compare treatment efficacy, functional outcomes, cost-effectiveness, and quality of life for 2100 patients suffering from CLI. BEST-CLI is enrolling those patients who are determined to be candidates for open surgical or endovascular revascularization and is designed to be comprehensive, pragmatic, and balanced. Full-Text PDF Open Archive
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