Comparison of Outcomes Following Infrapopliteal Plain Balloon Angioplasty in the BASIL Trial (1999-2004) and in a Contemporary Series (2009-2013)

Matthew A Popplewell, Huw O B Davies, Mary Renton, Gareth Bate, Smitaa Patel, Jonathan J Deeks, Andrew W Bradbury

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)


OBJECTIVES: To compare outcomes in patients randomized to infrapopliteal (IP) plain balloon angioplasty (PBA) for chronic limb-threatening ischemia within the Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL)-1 trial between 1999 and 2004 with outcomes in consecutive patients undergoing IP PBA at an academic vascular unit a decade later (2009-2013, Contemporary series [CS]).

METHODS: Individual patient data were obtained from prospective BASIL-1 (48 patients) and CS databases (73 patients). All had a minimum of 3-years of follow-up. Outcomes studied were amputation-free survival (AFS), overall survival (OS), major (above ankle) limb amputation, arterial reintervention, immediate technical success, and length of hospital stay for the index procedure and during the following 12-month period. Statistical analysis was performed using SAS version 9.4.

RESULTS: The BASIL and CS cohorts were well matched for gender, age, diabetes, previous stroke, myocardial infarction and arterial intervention, and presence of tissue loss. More patients in BASIL-1 underwent concomitant treatment of the superficial femoral (60% vs 37%, P = .01) and above knee popliteal (60% vs 34%, P = .005) arteries. Immediate technical success increased from 73% in BASIL-1 to 90% in the CS (P = .01). Between the two cohorts, there were no differences in AFS (hazard ratio [HR] = 1.00, 95% confidence interval [CI]: 0.65-1.54, P = 1.0), OS (HR = 1.04, 95% CI: 0.66-1.62, P = .9), major amputation (HR = 0.86, 95% CI: 0.37-1.97, P = .7), or reintervention (HR = 0.61, 95% CI: 0.29-1.27, P = .2). Contemporary series patients spent significantly fewer days in hospital following the index procedure (P = .02) and also over the following 12 months (P = .002).

CONCLUSIONS: Despite improvements in the immediate technical angiographic success of IP PBA between BASIL and the CS, there were no significant improvements in survival outcomes. Results from BASIL-2 and BEST-CLI are required in order to properly define the clinical and cost-effectiveness of endovascular treatment in such patients.

Original languageEnglish
Pages (from-to)141-146
Number of pages6
JournalVascular and Endovascular Surgery
Issue number2
Publication statusPublished - Feb 2020


  • Aged
  • Aged, 80 and over
  • Amputation
  • Angioplasty, Balloon/adverse effects
  • Chronic Disease
  • Databases, Factual
  • Female
  • Humans
  • Ischemia/diagnostic imaging
  • Length of Stay
  • Male
  • Peripheral Arterial Disease/diagnostic imaging
  • Popliteal Artery/diagnostic imaging
  • Progression-Free Survival
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Time Factors
  • Vascular Patency


Dive into the research topics of 'Comparison of Outcomes Following Infrapopliteal Plain Balloon Angioplasty in the BASIL Trial (1999-2004) and in a Contemporary Series (2009-2013)'. Together they form a unique fingerprint.

Cite this