CardioVascular and Interventional Radiology

, Volume 36, Issue 3, pp 645–658

Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

  • Konstantinos Katsanos
  • Stavros Spiliopoulos
  • Athanasios Diamantopoulos
  • Dimitris Karnabatidis
  • Tarun Sabharwal
  • Dimitris Siablis
Clinical Investigation

DOI: 10.1007/s00270-013-0578-2

Cite this article as:
Katsanos, K., Spiliopoulos, S., Diamantopoulos, A. et al. Cardiovasc Intervent Radiol (2013) 36: 645. doi:10.1007/s00270-013-0578-2

Abstract

Introduction

Drug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.

Materials and Methods

PubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration’s tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford–Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel–Haenszel fixed effects model, and number-needed-to-treat values are reported.

Results

Three RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18–1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford–Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002–1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28–0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02–1.62, p = 0.04; NNT = 5.9), and better overall event-free survival (72.2 vs. 57.3 %; pooled RR = 1.26, 95 % CI = 1.10–1.44, p = 0.0006; NNT = 6.7).

Conclusion

DES for focal infrapopliteal lesions significantly inhibit vascular restenosis and thereby improve primary patency, decrease repeat procedures, improve wound healing, and prolong overall event-free survival.

Keywords

Meta-analysis Systematic review Infrapopliteal Below-the-knee Drug-eluting stents Restenosis Amputation Wound healing Event-free survival risk ratio Randomized controlled trial Sirolimus Everolimus Angioplasty 

Abbreviations

BTK

Below-the-knee

IC

Intermittent Ccaudication

CLI

Critical limb ischemia

TLR

Target lesion revascularization

MI

Myocardial infarction

DES

Drug eluting stents

BMS

Bare metal stents

ISR

In-stent restenosis

RCT

Randomized controlled trial

ITT

Intention-to-treat

CEC

Clinical-Events Committee

QVA

Quantitative vascular angiography

DUS

Color doppler ultrasonography

PSVR

Peak systolic velocity ratio

RR

Risk ratio

CI

Confidence interval

M–H

Mantel–Haenszel

D–L

DerSimonian and Lairdc

NNT

Number-needed-to-treat

PRISMA

Preferred reporting Items for systematic reviews and meta-analyses

Copyright information

© Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2013

Authors and Affiliations

  • Konstantinos Katsanos
    • 1
  • Stavros Spiliopoulos
    • 2
  • Athanasios Diamantopoulos
    • 1
  • Dimitris Karnabatidis
    • 2
  • Tarun Sabharwal
    • 1
  • Dimitris Siablis
    • 2
  1. 1.Department of Interventional Radiology, Guy’s and St. Thomas’ HospitalsNHS Foundation Trust, King’s Health PartnersLondonUK
  2. 2.Department of Interventional Radiology, School of MedicinePatras University HospitalRioGreece

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