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Assessing Therapeutic Angiogenesis in a Murine Model of Hindlimb Ischemia
Published on: June 8, 2019
Nonrevascularization-based treatments in patients with severe or critical limb ischemia
Abd Moain Abu Dabrh1, Mark W Steffen2, Noor Asi3
1Division of Preventive, Occupational, and Aerospace Medicine, Mayo Clinic, Rochester, Minn; The Knowledge Synthesis Program, the Center for Science of Healthcare Delivery, Mayo Clinic, Rochester, Minn.
Insights
For severe or critical limb ischemia (CLI) patients ineligible for surgery, intermittent pneumatic compression and spinal cord stimulators may reduce amputation risk. Evidence for other nonrevascularization therapies is insufficient.
Area of Science:
- Vascular Medicine
- Regenerative Medicine
- Medical Devices
Background:
- Severe or critical limb ischemia (CLI) poses a significant risk of amputation for patients unsuitable for surgical revascularization.
- Nonrevascularization therapies offer alternative treatment strategies for this patient population.
Purpose of the Study:
- To systematically review and synthesize evidence on nonrevascularization therapies for severe or critical limb ischemia (CLI).
- To evaluate the efficacy of medical therapies and devices in preventing amputation and mortality in CLI patients.
Main Methods:
- Systematic search of multiple databases for randomized and nonrandomized studies up to November 2014.
- Meta-analysis of 19 studies involving 2779 patients, pooling data using a random effects model.
- Reported outcomes included mortality and amputation risk, with odds ratios (ORs) and 95% confidence intervals (CIs).
Main Results:
- No significant effect on mortality was observed for any nonrevascularization therapy.
- Intermittent pneumatic compression (OR, 0.14; 95% CI, 0.04-0.55) and spinal cord stimulators (OR, 0.53; 95% CI, 0.36-0.79) were associated with a reduced risk of amputation.
- Subgroup analyses did not yield statistically significant differences.
Conclusions:
- Very low-quality evidence suggests intermittent pneumatic compression and spinal cord stimulators may reduce amputation risk in CLI patients.
- The evidence is limited by imprecision and risk of bias.
- Insufficient evidence supports other medical therapies for CLI.
Objective:
The aim of this systematic review was to synthesize the existing evidence about various nonrevascularization-based therapies used to treat patients with severe or critical limb ischemia (CLI) who are not candidates for surgical revascularization.
Methods:
We systematically searched multiple databases through November 2014 for controlled randomized and nonrandomized studies comparing the effect of medical therapies (prostaglandin E1 and angiogenic growth factors) and devices (pumps and spinal cord stimulators). We report odds ratios (ORs) and 95% confidence intervals (CIs) of the outcomes of interest pooling data across studies using the random effects model.
Results:
We included 19 studies that enrolled 2779 patients. None of the nonrevascularization-based treatments were associated with a significant effect on mortality. Intermittent pneumatic compression (OR, 0.14; 95% CI, 0.04-0.55) and spinal cord stimulators (OR, 0.53; 95% CI, 0.36-0.79) were associated with reduced risk of amputation. A priori established subgroup analyses (combined vs single therapy; randomized vs nonrandomized) were not statistically significant.
Conclusions:
Very low-quality evidence, mainly due to imprecision and increased risk of bias, suggests that intermittent pneumatic compression and spinal cord stimulators may reduce the risk of amputations. Evidence supporting other medical therapies is insufficient.
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