Key result
Endovascular revascularisation strategies including drug-coated balloons, bare metal stents, drug-coated stents, and atherectomy did not significantly reduce the risk of major amputation compared with plain balloon angioplasty in patients with chronic limb threatening ischaemia.
Why the study?
The study was conducted to compare the efficacy of different endovascular revascularisation procedures for treating chronic limb threatening ischaemia using network meta-analysis.
Does endovascular revascularisation with drug coated balloons, stents, or atherectomy reduce major amputation or death compared to plain balloon angioplasty in patients with chronic limb threatening ischaemia?
Network Meta-Analysis (n=2,655)
Does endovascular revascularisation with drug coated balloons, stents, or atherectomy reduce major amputation or death compared to plain balloon angioplasty in patients with chronic limb threatening ischaemia?
Current evidence from RCTs does not show that newer endovascular techniques (BMS, DCB, DCS, atherectomy) are superior to plain balloon angioplasty in preventing major amputation or death in patients with chronic limb threatening ischaemia.
No advanced endovascular technique outperforms plain balloon angioplasty for major amputation or death in CLTI; reinforces PBA as reference standard in RCTs.
OBJECTIVE: The aim of this study was to compare the efficacy of different endovascular revascularisation procedures for treating chronic limb threatening ischaemia (CLTI) using network meta-analysis (NMA). DATA SOURCES: The databases PubMed and Cochrane Central Register for Controlled Trials were searched on 14 March 2023. REVIEW METHODS: A NMA of randomised controlled trials (RCTs) reporting the efficacy of different endovascular revascularisation techniques for treating CLTI was performed according to PRISMA guidelines. The primary and secondary outcomes were major amputation and death, respectively. Random effects models were developed and the results were presented using surface under the cumulative ranking curve plots and forest plots. A p value of ≤ .050 was considered statistically significant. The Cochrane collaborative tool was used to assess risk of bias. RESULTS: A total of 2 655 participants of whom 94.8% had CLTI were included. Eleven trials compared plain balloon angioplasty (PBA) vs. drug coated balloon (DCB) angioplasty (n = 1 771), five trials compared bare metal stent (BMS) vs. drug coated stent (DCS) (n = 466), three trials compared atherectomy vs. DCB (n = 194), two trials compared PBA vs. BMS (n = 70), one trial compared PBA vs. atherectomy (n = 50), and one trial compared BMS vs. DCB (n = 104). None of the revascularisation strategies significantly reduced the risk of major amputation or death compared with PBA. Using the network estimates, GRADE certainty of evidence for improvement in major amputation outcomes for DCB was moderate, for atherectomy and BMS was low, and for DCS was very low compared with PBA. Risk of bias was low in 16 trials, of some concerns in six trials, and high in one trial, respectively. CONCLUSION: There is no current evidence from RCTs to reliably conclude that BMS, DCB, DCS, or atherectomy are superior to PBA in preventing major amputation and death in patients with CLTI. Larger comparative RCTs are needed to identify the best endovascular revascularisation strategy.
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Thanigaimani et al. (2024) conducted a network meta-analysis in Chronic limb threatening ischaemia (CLTI) (n=2,655). Endovascular revascularisation (drug-coated balloon, bare metal stent, drug-coated stent, atherectomy) vs. Plain balloon angioplasty (PBA) was evaluated on Major amputation. Endovascular revascularisation strategies including drug-coated balloons, bare metal stents, drug-coated stents, and atherectomy did not significantly reduce the risk of major amputation compared with plain balloon angioplasty in patients with chronic limb threatening ischaemia.
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