CardioVascular and Interventional Radiology

, Volume 36, Issue 3, pp 645–658 | Cite as

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

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



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.


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).


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.


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 





Intermittent Ccaudication


Critical limb ischemia


Target lesion revascularization


Myocardial infarction


Drug eluting stents


Bare metal stents


In-stent restenosis


Randomized controlled trial




Clinical-Events Committee


Quantitative vascular angiography


Color doppler ultrasonography


Peak systolic velocity ratio


Risk ratio


Confidence interval




DerSimonian and Lairdc




Preferred reporting Items for systematic reviews and meta-analyses


Conflict of interest



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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
    Email author
  • 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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