Design of the revascularization with open bypass vs angioplasty and stenting of the lower extremity trial (ROBUST): A randomized clinical trial

Mahmoud B. Malas, Umair Qazi, Natalia Glebova, Isibor Arhuidese, Thomas Reifsnyder, James Black, Bruce A. Perler, Julie A. Freischlag

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

IMPORTANCE To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments.

OBJECTIVES To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications.

DESIGN, SETTING, AND PARTICIPANTS ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus.

INTERVENTIONS Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire.

RESULTS The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%).

CONCLUSIONS AND RELEVANCE Providing level 1 evidence, ROBUSTmay help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs.

Original languageEnglish (US)
Pages (from-to)1289-1295
Number of pages7
JournalJAMA Surgery
Volume149
Issue number12
DOIs
StatePublished - Dec 1 2014
Externally publishedYes

Fingerprint

Angioplasty
Lower Extremity
Randomized Controlled Trials
Femoral Artery
Ischemia
Extremities
Quality of Life
Unnecessary Procedures
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ankle Brachial Index
Intermittent Claudication
Limb Salvage
Hospital Costs
Platelet Aggregation Inhibitors
Amputation
Health Care Costs
Wound Healing
Physical Examination
Cost-Benefit Analysis
Diabetes Mellitus

ASJC Scopus subject areas

  • Surgery
  • Medicine(all)

Cite this

Malas, M. B., Qazi, U., Glebova, N., Arhuidese, I., Reifsnyder, T., Black, J., ... Freischlag, J. A. (2014). Design of the revascularization with open bypass vs angioplasty and stenting of the lower extremity trial (ROBUST): A randomized clinical trial. JAMA Surgery, 149(12), 1289-1295. https://doi.org/10.1001/jamasurg.2014.369

Design of the revascularization with open bypass vs angioplasty and stenting of the lower extremity trial (ROBUST) : A randomized clinical trial. / Malas, Mahmoud B.; Qazi, Umair; Glebova, Natalia; Arhuidese, Isibor; Reifsnyder, Thomas; Black, James; Perler, Bruce A.; Freischlag, Julie A.

In: JAMA Surgery, Vol. 149, No. 12, 01.12.2014, p. 1289-1295.

Research output: Contribution to journalArticle

Malas, MB, Qazi, U, Glebova, N, Arhuidese, I, Reifsnyder, T, Black, J, Perler, BA & Freischlag, JA 2014, 'Design of the revascularization with open bypass vs angioplasty and stenting of the lower extremity trial (ROBUST): A randomized clinical trial', JAMA Surgery, vol. 149, no. 12, pp. 1289-1295. https://doi.org/10.1001/jamasurg.2014.369
Malas, Mahmoud B. ; Qazi, Umair ; Glebova, Natalia ; Arhuidese, Isibor ; Reifsnyder, Thomas ; Black, James ; Perler, Bruce A. ; Freischlag, Julie A. / Design of the revascularization with open bypass vs angioplasty and stenting of the lower extremity trial (ROBUST) : A randomized clinical trial. In: JAMA Surgery. 2014 ; Vol. 149, No. 12. pp. 1289-1295.
@article{1e3f691611034b0da4e1767941675bd8,
title = "Design of the revascularization with open bypass vs angioplasty and stenting of the lower extremity trial (ROBUST): A randomized clinical trial",
abstract = "IMPORTANCE To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments.OBJECTIVES To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications.DESIGN, SETTING, AND PARTICIPANTS ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus.INTERVENTIONS Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire.RESULTS The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60{\%}) and white (65{\%}).CONCLUSIONS AND RELEVANCE Providing level 1 evidence, ROBUSTmay help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs.",
author = "Malas, {Mahmoud B.} and Umair Qazi and Natalia Glebova and Isibor Arhuidese and Thomas Reifsnyder and James Black and Perler, {Bruce A.} and Freischlag, {Julie A.}",
year = "2014",
month = "12",
day = "1",
doi = "10.1001/jamasurg.2014.369",
language = "English (US)",
volume = "149",
pages = "1289--1295",
journal = "JAMA Surgery",
issn = "2168-6254",
publisher = "American Medical Association",
number = "12",

}

TY - JOUR

T1 - Design of the revascularization with open bypass vs angioplasty and stenting of the lower extremity trial (ROBUST)

T2 - A randomized clinical trial

AU - Malas, Mahmoud B.

AU - Qazi, Umair

AU - Glebova, Natalia

AU - Arhuidese, Isibor

AU - Reifsnyder, Thomas

AU - Black, James

AU - Perler, Bruce A.

AU - Freischlag, Julie A.

PY - 2014/12/1

Y1 - 2014/12/1

N2 - IMPORTANCE To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments.OBJECTIVES To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications.DESIGN, SETTING, AND PARTICIPANTS ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus.INTERVENTIONS Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire.RESULTS The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%).CONCLUSIONS AND RELEVANCE Providing level 1 evidence, ROBUSTmay help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs.

AB - IMPORTANCE To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments.OBJECTIVES To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications.DESIGN, SETTING, AND PARTICIPANTS ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus.INTERVENTIONS Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire.RESULTS The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%).CONCLUSIONS AND RELEVANCE Providing level 1 evidence, ROBUSTmay help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs.

UR - http://www.scopus.com/inward/record.url?scp=84919598589&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84919598589&partnerID=8YFLogxK

U2 - 10.1001/jamasurg.2014.369

DO - 10.1001/jamasurg.2014.369

M3 - Article

C2 - 25353642

AN - SCOPUS:84919598589

VL - 149

SP - 1289

EP - 1295

JO - JAMA Surgery

JF - JAMA Surgery

SN - 2168-6254

IS - 12

ER -