TY - JOUR
T1 - Endovascular Therapy Versus Bypass Surgery as First-Line Treatment Strategies for Critical Limb Ischemia: Results of the Interim Analysis of the CRITISCH Registry
AU - Bisdas, Theodosios
AU - Borowski, Matthias
AU - Stavroulakis, Konstantinos
AU - Torsello, Giovanni
AU - Adili, Farzin
AU - Balzer, Kai
AU - Billing, Arend
AU - Böckler, Dittmar
AU - Brixner, Daniel
AU - Debus, Sebastian E.
AU - Florek, Hans Joachim
AU - Gkremoutis, Asimakis
AU - Grundmann, Reinhardt
AU - Hupp, Thomas
AU - Keck, Tobias
AU - Gerß, Joachim
AU - Klonek, Wojciech
AU - Lang, Werner
AU - May, Björn
AU - Meyer, Alexander
AU - Mühling, Bernhard
AU - Oberhuber, Alexander
AU - Reinecke, Holger
AU - Reinhold, Christian
AU - Ritter, Ralf Gerhard
AU - Schelzig, Hubert
AU - Schlensack, Christian
AU - Schmitz-Rixen, Thomas
AU - Schulte, Karl Ludwig
AU - Spohn, Matthias
AU - Steinbauer, Markus
AU - Storck, Martin
AU - Trede, Matthias
AU - Uhl, Christian
AU - Weis-Müller, Barbara
AU - Wenk, Heiner
AU - Zeller, Thomas
AU - Zhorzel, Sven
AU - Zimmermann, Alexander
PY - 2016/12/26
Y1 - 2016/12/26
N2 - Objectives The most effective first-line treatment between endovascular therapy and bypass surgery for patients with critical limb ischemia (CLI) is still not well defined. The primary aim of the interim analysis of CRITISCH (Registry of First-Line Treatments in Patients With Critical Limb Ischemia) was to compare both treatment options in a prospective confirmatory manner. Background Only 1 randomized controlled trial between endovascular therapy and bypass surgery has been published yet. Several retrospective studies showed comparable outcomes between the 2 treatment strategies, but in the majority of them, current endovascular technologies have not been included. Methods Between January 2013 and September 2014, 1,200 CLI patients (Rutherford 4 to 6) from 27 vascular centers were enrolled. The selection of the first-line treatment was left completely to the discretion of the responsible physician. The primary composite endpoint was amputation-free survival (AFS), that is, time to major amputation and/or death from any cause. A pre-specified interim analysis aimed at showing noninferiority of the endovascular therapy versus bypass surgery as to the hazard ratio (HR) of AFS (noninferiority bound = 1.33; interim α = 0.0058). Time-to-event analyses of major amputation, death, and the composite endpoint of reintervention and/or above-ankle amputation were also conducted. Results Endovascular therapy was applied to 642 (54%) and bypass surgery to 284 (24%) patients. 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 1-sided (1 − 0.0058) confidence interval [CI]: 1.29; p = 0.003). An impact of the treatment strategy on time until death (HR: 1.14; 95% CI: 0.80 to 1.63; p = 0.453), major amputation (HR: 0.86; 95% CI:0.56 to 1.30; p = 0.463), and reintervention and/or above-ankle amputation (HR: 0.89; 95% CI: 0.70 to 1.14; p = 0.348) was not observed. Conclusions The interim analysis confirmed that when physicians are free to individualize therapy to CLI patients, the endovascular-first approach achieved a noninferior AFS rate compared with bypass surgery. (Registry of First-Line Treatments in Patients With Critical Limb Ischemia [CRITISCH]; NCT01877252)
AB - Objectives The most effective first-line treatment between endovascular therapy and bypass surgery for patients with critical limb ischemia (CLI) is still not well defined. The primary aim of the interim analysis of CRITISCH (Registry of First-Line Treatments in Patients With Critical Limb Ischemia) was to compare both treatment options in a prospective confirmatory manner. Background Only 1 randomized controlled trial between endovascular therapy and bypass surgery has been published yet. Several retrospective studies showed comparable outcomes between the 2 treatment strategies, but in the majority of them, current endovascular technologies have not been included. Methods Between January 2013 and September 2014, 1,200 CLI patients (Rutherford 4 to 6) from 27 vascular centers were enrolled. The selection of the first-line treatment was left completely to the discretion of the responsible physician. The primary composite endpoint was amputation-free survival (AFS), that is, time to major amputation and/or death from any cause. A pre-specified interim analysis aimed at showing noninferiority of the endovascular therapy versus bypass surgery as to the hazard ratio (HR) of AFS (noninferiority bound = 1.33; interim α = 0.0058). Time-to-event analyses of major amputation, death, and the composite endpoint of reintervention and/or above-ankle amputation were also conducted. Results Endovascular therapy was applied to 642 (54%) and bypass surgery to 284 (24%) patients. 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 1-sided (1 − 0.0058) confidence interval [CI]: 1.29; p = 0.003). An impact of the treatment strategy on time until death (HR: 1.14; 95% CI: 0.80 to 1.63; p = 0.453), major amputation (HR: 0.86; 95% CI:0.56 to 1.30; p = 0.463), and reintervention and/or above-ankle amputation (HR: 0.89; 95% CI: 0.70 to 1.14; p = 0.348) was not observed. Conclusions The interim analysis confirmed that when physicians are free to individualize therapy to CLI patients, the endovascular-first approach achieved a noninferior AFS rate compared with bypass surgery. (Registry of First-Line Treatments in Patients With Critical Limb Ischemia [CRITISCH]; NCT01877252)
UR - http://www.scopus.com/inward/record.url?scp=85006459297&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2016.09.039
DO - 10.1016/j.jcin.2016.09.039
M3 - Journal articles
C2 - 28007205
AN - SCOPUS:85006459297
SN - 1936-8798
VL - 9
SP - 2557
EP - 2565
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 24
ER -
