Advice

Summary

Summary

The Gore PROPATEN heparin‑bonded vascular graft is a synthetic graft used to treat peripheral arterial disease by bypassing damaged blood vessels. The graft is made from expanded polytetrafluoroethylene (ePTFE) that has a layer of heparin anticoagulant bonded to its inner surface, which is designed to reduce graft occlusion. Relevant evidence was limited and consisted of 1 randomised controlled trial and 5 cohort studies, with either artificial graft or autologous vein graft comparators. The reports indicate that the PROPATEN graft is either equivalent or inferior to autologous vein grafts in maintaining patency (that is, remaining open and functional over time). In scenarios where vein grafts could not be used, PROPATEN performed at least as well or better than other types of artificial graft. The manufacturer declined to provide the cost of a PROPATEN graft. Based on similar products, and expert advice, the likely cost of a PROPATEN graft is estimated to be between £600 and £1000, excluding VAT.

Product summary and likely place in therapy

  • The Gore PROPATEN heparin‑bonded vascular graft is a synthetic graft used to treat peripheral arterial disease.

  • It would be used as an alternative to currently available synthetic peripheral vascular grafts to maintain effective blood flow to the lower limbs. Current practice varies in the choice of artificial grafts, which are typically used only when an autologous graft is unavailable.

Effectiveness and safety

  • The evidence is of limited quality and based on 6 studies, including approximately 1124 patients who had PROPATEN grafts.

  • Patency rates were used as a surrogate end point in all studies, with some studies also reporting more relevant clinical outcomes. In addition, patency rates are known to vary depending on whether the bypass extends beyond the knee, so study findings, which did not generally distinguish between above‑ and below‑knee procedures, may not be directly comparable.

  • The PROPATEN graft was reported to have lower primary patency than autologous saphenous vein (ASV) grafts in 1 cohort study, and 2 cohort studies reported no statistically significant differences.

  • The PROPATEN graft showed a better primary patency rate than other prosthetic grafts in 1 randomised controlled trial, but 3 cohort studies found no differences.

  • Safety issues were not consistently reported.

Technical and patient factors

  • The PROPATEN graft has a layer of heparin anticoagulant bonded to its inner surface, designed to reduce graft occlusion.

  • The PROPATEN graft would be used in secondary care by suitably qualified clinicians, experienced in peripheral vascular bypass graft procedures.

  • The PROPATEN graft is available in a range of configurations which vary in length, internal diameter and structural features such as wall thickness and presence or absence of reinforcing rings.

Cost and resource use

  • The manufacturer declined to provide the cost of a PROPATEN graft. Based on similar products, and expert advice, the likely cost of a PROPATEN graft is estimated to be between £600 and £1000 excluding VAT.

  • One cohort study described longer procedure lengths using the PROPATEN graft with a distal vein patch when compared with a pre‑cuffed prosthetic graft. The randomised trial reported no differences in procedure lengths between using the PROPATEN graft and a standard PTFE graft.

  • Two cohort studies reported that post‑procedure hospital stays were longer with the PROPATEN graft compared with ASV grafts (p<0.001) and another artificial graft (no statistical comparison reported).

  • Any graft that reduces the need for repeated interventional procedures could reduce long‑term treatment costs.