Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis

Abstract

Aims: Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy.

Methods and results: Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints.

Conclusion: Certain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.

Keywords: Atherectomy; Drug-coated balloon; Drug-eluting stent; Endovascular revascularization; Intermittent claudication; angioplasty.

Structured Graphical Abstract

Major findings from a random-effects meta-analysis investigating the efficacy and safety of endovascular revascularization strategies in the treatment of intermittent claudication at short- (<1 year), mid- (1–2 years), and long-term (≥2 years) follow-up. The forest plots display pooled odds ratios with associated 95% confidence intervals for the outcomes target-lesion revascularization (left) and primary patency (right) comparing drug-coated vs. uncoated balloon angioplasty, primary vs. provisional bare-metal stenting and drug-eluting vs. bare-metal stenting in femoropopliteal artery disease. BA, balloon angioplasty; BMS, bare-metal stents; CI, confidence interval; DCB, drug-coated balloons; DES, drug-eluting stents; OR, odds ratio; RCT, randomized controlled trial.

Figure 1

Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart describing study selection.

Figure 2

Effect estimates for primary patency comparing drug-coated balloon ± bare-metal stent vs. balloon angioplasty ± bare-metal stent in femoropopliteal lesions at (A) short-term follow-up; (B) mid-term follow-up; and (C) long-term follow-up. The summary estimates presented were calculated using random-effects models (D + L). The sizes of the data markers are proportional to the inverse of the variance of the odds ratio; the confidence intervals are represented by the bars.

Figure 3

Effect estimates for target-lesion revascularization comparing drug-coated balloon ± bare-metal stents vs. balloon angioplasty ± BMS in femoropopliteal lesions at (A) short-term follow-up; (B) mid-term follow-up; and (C) long-term follow-up. The summary estimates presented were calculated using random-effects models (D + L). The sizes of the data markers are proportional to the inverse of the variance of the odds ratio; the confidence intervals are represented by the bars.

Figure 4

Effect estimates for all-cause mortality comparing drug-coated balloon ± bare-metal stents vs. balloon angioplasty ± bare-metal stent in femoropopliteal lesions at (A) short-term follow-up; (B) mid-term follow-up; and (C) long-term follow-up The summary estimates presented were calculated using random-effects models (D + L). The sizes of the data markers are proportional to the inverse of the variance of the odds ratio; the confidence intervals are represented by the bars.

Figure 5

Effect estimates for primary patency comparing bare-metal stents vs. balloon angioplasty ± bare-metal stent in femoropopliteal lesions at (A) short-term follow-up; (B) mid-term follow-up; and (C) long-term follow-up. The summary estimates presented were calculated using random-effects models (D + L). The sizes of the data markers are proportional to the inverse of the variance of the odds ratio; the confidence intervals are represented by the bars.

Figure 6

Effect estimates for target-lesion revascularization comparing bare-metal stents vs. balloon angioplasty ± BMS in femoropopliteal lesions at (A) mid-term follow-up; (B) long-term follow-up. The summary estimates presented were calculated using random-effects models (D + L). The sizes of the data markers are proportional to the inverse of the variance of the odds ratio; the confidence intervals are represented by the bars.

Figure 7

Effect estimates for (A) mid-term primary patency and (B) mid-term target-lesion revascularization comparing drug-eluting stents vs. bare-metal stents in femoropopliteal lesions. The summary estimates presented were calculated using random-effects models (D + L). The sizes of the data markers are proportional to the inverse of the variance of the odds ratio; the confidence intervals are represented by the bars.