Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease and severe calcification.1 Therefore, different vessel preparation devices have been developed to contribute to better peri- and postprocedural outcomes.2 Vessel preparation devices include mechanical atherectomy (MA: a composition of directional atherectomy, rotational atherectomy and orbital atherectomy), laser atherectomy (LA), scoring balloons and intravascular lithotripsy (IVL). This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug coated balloon (DCB) angioplasty with POBA or DCB alone in infrapopliteal arterial disease.

This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.3 Medline, EMBASE and Cochrane databases were searched for studies published between 2000 and 2021 assessing the value of adjunctive vessel preparation in infrapopliteal arterial disease. The Methodological Index for Non-Randomized Studies (MINORS) score was used to assess the quality of included studies.4 The primary outcomes were 12-month primary patency and limb salvage. In studies that provided Kaplan-Meier (KM) survival curves, original patient data reconstruction was used to calculate pooled survival estimates. These data were supplemented with absolute numbers from studies that didn't present outcomes in KM curves to construct forest plots for both vessel preparation and POBA results.

A total of 1685 patients with 1913 lesions were included in 11 POBA studies.5-15 Methodological quality was assessed as poor to moderate in these studies. Only one study with 80 patients with long infrapopliteal lesions assessed vessel preparation in conjunction with DCB angioplasty.16 Overall, chronic limb-threatening ischemia (CLTI) was present in 98.6% and DM in 69.1% of the patients. Lesions were located in the popliteal artery in 0.5% and were total occlusions in 58.7%. The DCB randomized trial was assessed as high quality and found no significant benefit of adjunctive atherectomy to DCB angioplasty. The pooled Kaplan-Meier estimates of 12-month primary patency (Figure 1A) and limb salvage (Figure 1B) were 67.8% and 80.9% for POBA, 62.1% and 86.4% for scoring balloons, 67.9% and 79.6% for mechanical atherectomy (MA) and 79.7% and 82.6% for laser atherectomy, respectively. Within the pooled data only scoring balloons (resp. RR 1.20; 95% CI 1.06 - 1.35; p = .003) and MA (RR 1.12; 95% CI 1.01 - 1.25; p = .026) demonstrated significantly improved 12-month limb salvage compared to POBA (Figure 2B).

Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and MA. However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.

1. Baumann F, Engelberger RP, Willenberg T, Do D. Infrapopliteal lesion morphology in patients with critical limb ischemia: implications for the development of anti-restenosis technologies. J Endovasc Ther 2013;20:149-56. 2. Tummala S, Amin A, Mehta A. Infrapopliteal artery occlusive disease: an overview of vessel preparation and treatment options. J Clin Med 2020;9:E3321. 3. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Biomed J 2009;339:b2535. 4. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological index for non-randomized studies (minors): development and validation of a new instrument. Anz J Surg 2003;73:712-6.