Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries

Abstract

BACKGROUND

Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio.

AIM

To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs.

METHODS

The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model.

RESULTS

Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively].

CONCLUSION

Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.

Keywords: Infrapopliteal; Drug-eluting stent; Below-the-knee; Meta-analysis; Hazard ratio

Core Tip: The utility of drug-eluting stents (DESs) for infrapopliteal artery diseases was explored using traditional percutaneous transluminal angioplasty with or without bare stent implantation as control. The results suggest that the DES is superior on multiple outcomes. The hazard ratio, which is most appropriate for various outcomes categorized as time-to-event data by type, was adopted as the outcome measure, rather than the relative risk or the odds ratio.