BASIL-2 Trial
Details
BASIL-2 compared endovascular therapy with surgical bypass in patients with chronic limb-threatening ischaemia dominated by infrapopliteal disease. In contrast to BEST-CLI, it found endovascular therapy superior for the composite of death or major amputation — a difference driven by mortality rather than limb loss. (sources/PVD-AHA-2024, rating: very high)
Key Facts
- Population: CLTI with infrapopliteal-dominant disease. (sources/PVD-AHA-2024, rating: very high)
- Primary result: endovascular therapy superior to bypass for death or major amputation — 53% vs 63% (HR 1.35). (sources/PVD-AHA-2024, rating: very high)
- The difference was driven by fewer deaths in the endovascular group, not by fewer amputations. (sources/PVD-AHA-2024, rating: very high)
- The 2024 ACC/AHA PAD guideline cites BASIL-2, with BEST-CLI, as the basis for individualised CLTI revascularisation. (sources/PVD-AHA-2024, rating: very high)
Contradictions / Open Questions
- The result conflicts with BEST-CLI, where bypass was superior when a good vein was available. The most plausible reconciliation is anatomical and conduit-related: infrapopliteal disease has poorer bypass durability and higher surgical risk, whereas femoropopliteal disease with a single-segment saphenous vein does well with bypass. No trial has directly compared the two strategies within the same anatomical stratum. (sources/PVD-AHA-2024, rating: very high)
- A mortality-driven benefit is unusual for a revascularisation trial and raises the possibility that the surgical arm's risk (wound complications, cardiopulmonary events) rather than the endovascular arm's efficacy produced the difference; the source summary does not separate these mechanisms. (sources/PVD-AHA-2024, rating: very high)
- HR direction should be read carefully: the reported HR of 1.35 accompanies a higher event rate in the bypass arm; it is not evidence that endovascular therapy increases risk. (sources/PVD-AHA-2024, rating: very high)
Connections
- Related to concepts/CLTI — infrapopliteal revascularisation strategy
- Related to entities/BEST-CLI-Trial — the contrasting trial in surgical/endovascular candidates
- Related to entities/Peripheral-Artery-Disease — the broader disease spectrum
- Related to concepts/PAD-Medical-Therapy — adjunctive medical therapy