Comparison of Outcomes Following Infrapopliteal Plain Balloon Angioplasty in the BASIL Trial (1999-2004) and in a Contemporary Series (2009-2013)
Research output: Contribution to journal › Article › peer-review
Colleges, School and Institutes
- Heart of England NHS Foundation Trust
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.
|Number of pages||6|
|Journal||Vascular and Endovascular Surgery|
|Publication status||Published - 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