Systematic Review and Network Meta-analysis of Vessel Preparation Techniques With Plain Balloon Angioplasty, Atherectomy, or Intravascular Lithotripsy Before Application of a Drug Coated Balloon to Treat Atherosclerotic Femoropopliteal Disease.

OBJECTIVE

To compare one year outcomes after atherectomy, intravascular lithotripsy vs. plain balloon angioplasty before application of drug coated balloons for treating femoropopliteal atherosclerotic disease.

DATA SOURCES

MEDLINE, EMBASE, and Cochrane Library were screened until May 2023 for randomised controlled trials.

REVIEW METHODS

This was a systematic review and network meta-analysis. The inclusion criteria were patients with claudication and those with critical limb threatening ischaemia with lesion characteristics of all lengths, stenosis, calcification, and occlusions. The primary outcome was freedom from target lesion re-intervention at one year. Secondary outcomes were rate of bailout stenting, major amputation, and all cause mortality at one year. Pooled point estimates were calculated with a standard random effects model. Further sensitivity analyses were completed with a mixed treatment Bayesian model. Risk of bias was assessed by the Revised Cochrane Risk of Bias tool 2 (RoB2) and certainty of evidence assessed via the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework.

RESULTS

Four RCTs comprising 549 patients (two studies evaluating directional atherectomy, one evaluating rotational atherectomy, one evaluating intravascular lithotripsy against plain balloon angioplasty) were included. The weighted mean length of femoropopliteal lesions was 103.4 ± 6.67 mm. Results of the mixed treatment Bayesian analysis were consistent with pooled analysis for all outcomes. There were no significant differences in freedom from target lesion revascularisation (GRADE, high) (RoB2, low), major amputation (GRADE, low), or mortality (GRADE, moderate). Bailout stenting rates were significantly reduced with intravascular lithotripsy and atherectomy compared with plain balloon angioplasty (RR 0.25, 95% CI 0.07 - 0.89) (GRADE, moderate) (RoB2, low).

CONCLUSION

This review found that intravascular lithotripsy or atherectomy did not appear to incur a statistically significant advantage in freedom from target lesion revascularisation, major amputation, or mortality rate at one year. There was moderate certainty of evidence that bailout stenting is significantly reduced after vessel preparation with intravascular lithotripsy and atherectomy.