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Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia

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Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. / Belch, Jill (Lead / Corresponding author); Hiatt, William R.; Baumgartner, Iris; Driver, I. Vickie; Nikol, Sigrid; Norgren, Lars; Van Belle, Eric; TAMARIS Comm Investigators.

In: Lancet, Vol. 377, No. 9781, 04.06.2011, p. 1929-1937.

Research output: Contribution to journalArticle

Harvard

Belch, J, Hiatt, WR, Baumgartner, I, Driver, IV, Nikol, S, Norgren, L, Van Belle, E & TAMARIS Comm Investigators 2011, 'Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia' Lancet, vol 377, no. 9781, pp. 1929-1937.

APA

Belch, J., Hiatt, W. R., Baumgartner, I., Driver, I. V., Nikol, S., Norgren, L., Van Belle, E., & TAMARIS Comm Investigators (2011). Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet, 377(9781), 1929-1937doi: 10.1016/S0140-6736(11)60394-2

Vancouver

Belch J, Hiatt WR, Baumgartner I, Driver IV, Nikol S, Norgren L et al. Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011 Jun 4;377(9781):1929-1937.

Author

Belch, Jill (Lead / Corresponding author); Hiatt, William R.; Baumgartner, Iris; Driver, I. Vickie; Nikol, Sigrid; Norgren, Lars; Van Belle, Eric; TAMARIS Comm Investigators / Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia.

In: Lancet, Vol. 377, No. 9781, 04.06.2011, p. 1929-1937.

Research output: Contribution to journalArticle

Bibtex - Download

@article{50d2b65c2c43420398a3246ecb1a991d,
title = "Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia",
author = "Jill Belch and Hiatt, {William R.} and Iris Baumgartner and Driver, {I. Vickie} and Sigrid Nikol and Lars Norgren and {Van Belle}, Eric and {TAMARIS Comm Investigators}",
year = "2011",
volume = "377",
number = "9781",
pages = "1929--1937",
journal = "Lancet",
issn = "0140-6736",

}

RIS (suitable for import to EndNote) - Download

TY - JOUR

T1 - Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia

A1 - Belch,Jill

A1 - Hiatt,William R.

A1 - Baumgartner,Iris

A1 - Driver,I. Vickie

A1 - Nikol,Sigrid

A1 - Norgren,Lars

A1 - Van Belle,Eric

A1 - TAMARIS Comm Investigators

AU - Belch,Jill

AU - Hiatt,William R.

AU - Baumgartner,Iris

AU - Driver,I. Vickie

AU - Nikol,Sigrid

AU - Norgren,Lars

AU - Van Belle,Eric

AU - TAMARIS Comm Investigators

PY - 2011/6/4

Y1 - 2011/6/4

N2 - <p>Background Patients with critical limb ischaemia have a high rate of amputation and mortality. We tested the hypothesis that non-viral 1 fibroblast growth factor (NV1FGF) would improve amputation-free survival.</p><p>Methods In this phase 3 trial (EFC6145/TAMARIS), 525 patients with critical limb ischaemia unsuitable for revascularisation were enrolled from 171 sites in 30 countries. All had ischaemic ulcer in legs or minor skin gangrene and met haemodynamic criteria (ankle pressure &lt;70 mm Hg or a toe pressure &lt;50 mm Hg, or both, or a transcutaneous oxygen pressure &lt;30 mm Hg on the treated leg). Patients were randomly assigned to either NV1FGF at 0.2 mg/mL or matching placebo (visually identical) in a 1:1 ratio. Randomisation was done with a central interactive voice response system by block size 4 and was stratified by diabetes status and country. Investigators, patients, and study teams were masked to treatment. Patients received eight intramuscular injections of their assigned treatment in the index leg on days 1, 15, 29, and 43. The primary endpoint was time to major amputation or death at 1 year analysed by intention to treat with a log-rank test using a multivariate Cox proportional hazard model. This trial is registered with ClinicalTrials.gov, number NCT00566657.</p><p>Findings 259 patients were assigned to NV1FGF and 266 to placebo. All 525 patients were analysed. The mean age was 70 years (range 50-92), 365 (70%) were men, 280 (53%) had diabetes, and 248 (47%) had a history of coronary artery disease. The primary endpoint or components of the primary did not differ between treatment groups, with major amputation or death in 86 patients (33%) in the placebo group, and 96 (36%) in the active group (hazard ratio 1.11, 95% CI 0.83-1.49; p=0.48). No significant safety issues were recorded.</p><p>Interpretation TAMARIS provided no evidence that NV1FGF is effective in reduction of amputation or death in patients with critical limb ischaemia. Thus, this group of patients remains a major therapeutic challenge for the clinician.</p>

AB - <p>Background Patients with critical limb ischaemia have a high rate of amputation and mortality. We tested the hypothesis that non-viral 1 fibroblast growth factor (NV1FGF) would improve amputation-free survival.</p><p>Methods In this phase 3 trial (EFC6145/TAMARIS), 525 patients with critical limb ischaemia unsuitable for revascularisation were enrolled from 171 sites in 30 countries. All had ischaemic ulcer in legs or minor skin gangrene and met haemodynamic criteria (ankle pressure &lt;70 mm Hg or a toe pressure &lt;50 mm Hg, or both, or a transcutaneous oxygen pressure &lt;30 mm Hg on the treated leg). Patients were randomly assigned to either NV1FGF at 0.2 mg/mL or matching placebo (visually identical) in a 1:1 ratio. Randomisation was done with a central interactive voice response system by block size 4 and was stratified by diabetes status and country. Investigators, patients, and study teams were masked to treatment. Patients received eight intramuscular injections of their assigned treatment in the index leg on days 1, 15, 29, and 43. The primary endpoint was time to major amputation or death at 1 year analysed by intention to treat with a log-rank test using a multivariate Cox proportional hazard model. This trial is registered with ClinicalTrials.gov, number NCT00566657.</p><p>Findings 259 patients were assigned to NV1FGF and 266 to placebo. All 525 patients were analysed. The mean age was 70 years (range 50-92), 365 (70%) were men, 280 (53%) had diabetes, and 248 (47%) had a history of coronary artery disease. The primary endpoint or components of the primary did not differ between treatment groups, with major amputation or death in 86 patients (33%) in the placebo group, and 96 (36%) in the active group (hazard ratio 1.11, 95% CI 0.83-1.49; p=0.48). No significant safety issues were recorded.</p><p>Interpretation TAMARIS provided no evidence that NV1FGF is effective in reduction of amputation or death in patients with critical limb ischaemia. Thus, this group of patients remains a major therapeutic challenge for the clinician.</p>

KW - PERIPHERAL ARTERIAL-DISEASE

KW - QUALITY-OF-LIFE

KW - VASCULAR-DISEASE

KW - PLASMID DNA

KW - ANGIOGENESIS

KW - METAANALYSIS

KW - MANAGEMENT

U2 - 10.1016/S0140-6736(11)60394-2

DO - 10.1016/S0140-6736(11)60394-2

M1 - Article

JO - Lancet

JF - Lancet

SN - 0140-6736

IS - 9781

VL - 377

SP - 1929

EP - 1937

ER -

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