VEST IV

Long-term performance of an external stent for saphenous vein grafts: the VEST IV trial

Study design & primary objectives

NCT01415245 (clinicaltrials.gov reference #)

Trial period: Jun 2016 - Nov 2016

Sample size: N=21 (VEST I trial cohort)

Participating center:

  1. John Radcliffe, Oxford, UK
  2. Royal Brompton, London, UK
  3. Harefield, London, UK


Principal investigator:

Prof. David Taggart, Oxford, UK and Prof. Carlo Di Mario, Royal Brompton, London, UK.

Design:
The first reported long-term follow-up of a randomized controlled SVG cohort with and without external stents (VEST I cohort) which include angiographic and IVUS 4-5 years after CABG.
            

Primary Objective:
To obtain long term data on the effect of VEST on disease progression in SVG (Fitzgibbon I patency) and long-term prevention of intimal hyperplasia.

Results summary

At average follow up time of 4.5 years post CABG it was shown that there is a:

  1.  Significant higher rate of perfect patency rates (Fitzgibbon I) in the VEST supported group (80%) compared to the unsupported group (50%) (P<0.001).

  2.  Significant reduction (20%) of the intimal hyperplasia area and thickness in the VEST supported grafts compared to the unsupported grafts (P<0.001).

  3. Patency rates were similar to the VEST I trial. In the externally stented group, all grafts that were patent at the 1 year follow up, maintained their patency at the 4.5-5 year follow up. However, in the unsupported SVG group there was one additional graft occlusion between 1 and 4.5 years.

  4.  Intimal hyperplasia thickness was correlated with the distance of the external stent from the SVG lumen (P<0.001). Mildly constrictive external stents have significantly more effect compared to the loose-fitting stents.

Comparison to historical data

According to Fitzgibbon et al, who reported the largest-ever longitudinal follow up on 5,065 grafts, the progressive decline in perfect patency (Fitzgibbon I) rates of vein grafts over time reflects the disease progression over time:

At 2.5 years – perfect patency rate is 86%

At 5 years – perfect patency rate is 52% (compared to 50% in the control group at VEST IV trial and 80% in the VEST supported group at 4.5 years)

At 10 years – perfect patency rate is 23%

At 12.5 years – perfect patency rate is 14%

 FitzGibbon et al. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol 1996; 28:616-26

Main Conclusions

External stenting mitigates SVG remodeling and significantly reduces diffuse intimal hyperplasia and the development of lumen irregularities 4.5 years after coronary artery bypass surgery.

VEST IV Publications

Name

Link

Long-term performance of an external stent for saphenous vein grafts: the VEST IV trial

VEST IV