Revascularization Strategy for Peripheral Artery Disease/Chronic Limb-Threatening Ischemia: Endovascular, Open, Hybrid, Conduit, and Device Choice
Revascularization strategy in PAD and CLTI built on whether intervention is likely to produce meaningful limb benefit for this patient, in this limb, at this stage. The chapter frames the endovascular, open, hybrid, conduit, and device-choice decisions inside the Global Vascular Guidelines structure.
Definition and presentation
Chronic limb-threatening ischemia () defines an advanced stage of peripheral artery disease presenting with ischemic , tissue loss, or infection requiring intervention. Objective hemodynamic criteria support the diagnosis and drive the ischemia grade: with ischemic rest pain, an ankle pressure below 50 mmHg or a toe pressure below 30 mmHg; with tissue loss, an ankle pressure below 70 mmHg, a toe pressure below 50 mmHg, or a transcutaneous oxygen tension below 30 mmHg . Revascularization is pursued not merely to improve angiographic appearance, but to achieve durable perfusion sufficient to support wound healing, alleviate ischemic pain, and prevent major amputation. In diabetic patients, revascularization is coordinated alongside source control of infection, ulcer debridement, offloading, and cardiovascular risk management rather than executed as an isolated procedure .
Stratification and anatomic staging
Clinical stratification integrates patient operative risk, the severity of limb threat, and anatomic complexity. The Wound, Ischemia, and foot Infection (WIfI) classification stages the limb threat, clarifying the relative contributions of ischemia and infection. The Global Limb Anatomic Staging System () grades the complexity of the target arterial pathway . WIfI grades Wound, Ischemia, and foot Infection each from 0 to 3 and combines them into clinical stages 1 through 4 that estimate 1-year amputation risk and the expected benefit of revascularization. GLASS assigns a femoropopliteal grade and an infrapopliteal grade along the preferred target artery pathway to yield an overall stage I to III; stage III marks high anticipated immediate technical failure and under 50% limb-based patency at 1 year with an endovascular-first approach, tilting the decision toward bypass in a patient who can tolerate it. Preprocedural mapping is required to establish the presence and quality of an adequate single-segment great saphenous vein, which serves as a primary determinant for surgical bypass selection .
Treatment decision and revascularization strategy
All patients receive baseline medical therapy consisting of blood-pressure control, a statin, and smoking cessation, integrated with comprehensive diabetic foot care . The modality choice is subsequently governed by conduit availability, anatomic target, and surgical risk.
Acceptable surgical risk
- Key determinant
- Adequate single-segment great saphenous vein
- Preferred pathway
- Surgical bypass-first
CitationInfrapopliteal target
- Key determinant
- Individualize by anatomy, conduit, surgical risk, and expected limb benefit; BASIL-2 and the BEST-CLI tibial-intervention subgroup differed in populations and endpoints
- Preferred pathway
- Individualized bypass or endovascular strategy; target location alone does not mandate endovascular-first
CitationMultilevel disease
- Key determinant
- Distinct discrete inflow and outflow challenges
- Preferred pathway
- Hybrid revascularization
CitationProhibitive risk or limited benefit
- Key determinant
- Unsalvageable limb or severe frailty
- Preferred pathway
- Primary amputation or palliation (no revascularization)
CitationAcute infection or threatened limb
- Key determinant
- Sepsis or rapidly progressive tissue loss
- Preferred pathway
- Urgent source control, debridement, and tailored revascularization outside the elective framework
Citation
The post-hoc BEST-CLI subgroup of patients judged to have adequate single-segment great saphenous vein who underwent tibial-level intervention found fewer major adverse limb events and major amputations with bypass, without statistically significant differences in mortality or amputation-free survival; this does not establish equivalence or resolve the cross-trial disagreement .
The stepwise decision logic for intervention proceeds as follows:
- Establish the baseline medical and wound-care regimen, addressing acute infection via debridement and source control first.
- Determine whether the expected limb benefit justifies procedural intervention, reserving the no-intervention pathway for prohibitive operative risk or unsalvageable limbs.
- Assess conduit availability via vein mapping; an adequate single-segment great saphenous vein in a patient with acceptable risk favors an open bypass-first approach.
- Opt for an endovascular-first approach when usable vein is absent or operative risk is high; for infrapopliteal targets, individualize the choice using conduit, anatomy, surgical risk, and expected limb benefit rather than target location alone.
Conduit and device selection
Autologous, biological and biosynthetic bypass conduits
Map vein before selecting a substitute. Single-segment great saphenous vein remains the preferred conduit when suitable. Alternative autologous vein, including arm or spliced vein, deserves assessment before assuming that only a manufactured graft is available. The BEST-CLI conduit analysis was not randomized by graft type; its unfavorable distal prosthetic results and small alternative-vein/cryopreserved groups require careful interpretation .
- Material and role
- Patient’s own vein; preferred when suitable for the target reconstruction
- Evidence boundary
- Conduit quality, length and target are important; alternative autologous veins are not equivalent to cryopreserved allografts
PTFE or other synthetic conduit
- Material and role
- Manufactured prosthesis when vein is unsuitable and bypass still offers meaningful benefit
- Evidence boundary
- Distal CLTI outcomes are generally less favorable than with good-quality GSV; not automatically contraindicated at every below-knee target
Artegraft
- Material and role
- Bovine carotid biological graft, not a semisynthetic graft
- Evidence boundary
- A 124-graft retrospective lower-extremity series reported five-year primary patency of 67.5%; no randomized vein/PTFE comparator
Omniflow II
- Material and role
- Biosynthetic ovine collagen with polyester-mesh support
- Evidence boundary
- A prospective 83-patient CLTI registry reported two-year primary patency of 51% above knee and 60% below knee; no randomized comparator
Cryopreserved allograft
- Material and role
- Donor vascular tissue, distinct from bovine xenograft and biosynthetic material
- Evidence boundary
- Small, selected cohorts and unfavorable outcomes in the BEST-CLI analysis do not establish equivalence to autologous vein
The Artegraft manufacturer lists femoropopliteal use when suitable saphenous vein is absent or inadequate; this does not establish superiority at tibial or pedal targets. Omniflow II’s manufacturer states that it is not approved for sale in the United States. Clinical use therefore requires the applicable local indication and current instructions for use; dialysis-access results should not be substituted for lower-limb bypass evidence . In the femoropopliteal segment, drug-coated balloons confer a substantial patency advantage over standard percutaneous transluminal angioplasty.
| Treatment cohort | Device evaluated | 12-month primary patency | Citation |
|---|---|---|---|
| IN.PACT SFA | Paclitaxel-coated balloon | 82.2% (vs 52.4% standard , P < 0.001) | |
| LEVANT 2 | Paclitaxel-coated balloon | 65.2% (vs 52.6% standard PTA, P = 0.02) |
- Device evaluated
- Paclitaxel-coated balloon
- 12-month primary patency
- 82.2% (vs 52.4% standard , P < 0.001)
- Citation
- Device evaluated
- Paclitaxel-coated balloon
- 12-month primary patency
- 65.2% (vs 52.6% standard PTA, P = 0.02)
- Citation
Post-revascularization management and surveillance
Dual-pathway antithrombotic therapy is established for failure prevention following revascularization. Low-dose rivaroxaban (2.5 mg twice daily) combined with low-dose aspirin reduces the composite of acute limb ischemia, major amputation, myocardial infarction, ischemic stroke, or cardiovascular death at 3 years compared with aspirin alone (17.3% vs 19.9%), at the cost of higher TIMI major bleeding (2.65% vs 1.87%, HR 1.43) . This regimen is recommended following both surgical and endovascular lower-extremity revascularization when bleeding risk is acceptable .
Routine duplex surveillance is standard following vein bypass to identify graft-threatening lesions prior to . Surveillance pairs interval history, pulse and check, and duplex within the first postoperative month, then at 3, 6, and 12 months through the first year and annually thereafter . A graft-threatening high-grade (>70%) lesion is flagged by a focal peak systolic velocity above 300 cm/s with a velocity ratio over 3.5 across the , or by a uniformly low graft-flow velocity below 45 cm/s; either finding warrants preemptive revision before the graft thromboses. Early and 1-year graft event rates observed in the PREVENT III cohort serve as the baseline expectation for contemporary surveillance planning . Following endovascular procedures, reintervention is triggered by clinical failure, such as recurrent ischemic symptoms or a stalled wound-healing trajectory, rather than by asymptomatic restenosis alone.
Areas of controversy
The 2018 paclitaxel mortality signal remains historical context . The final SWEDEPAD 1 report, published in 2025, found no reduction in major amputation or mortality with coated devices in patients with CLTI . The trial SWEDEPAD 2 and the 2026 ESVS focused update address a different population and require separate consideration when selecting a device for intermittent claudication .
The optimal modality for isolated infrapopliteal disease is also actively debated. The lower composite risk of major adverse limb events or death with bypass in BEST-CLI Cohort 1 contrasts with the lower major amputation or death rate with endovascular-first treatment in BASIL-2; these are different endpoints, and BEST-CLI does not establish a separate survival advantage for bypass . In BEST-CLI Cohort 1 the composite of major adverse limb event or death was 42.6% with bypass-first versus 57.4% with endovascular-first, a 14.8 percentage-point difference (hazard ratio 0.68). BASIL-2 favored endovascular-first for amputation-free survival (adjusted hazard ratio 1.35, P=0.037). Retrospective registry data report lower 5-year mortality with bypass for below-knee targets, leaving the decision highly dependent on local center expertise and patient anatomy .
Finally, the routine use of distal embolic protection in complex endovascular cases is not uniformly standardized. Flow-controlled anti-embolic techniques using proximal antegrade flow arrest are described to reduce distal emboli, though broad comparative-effectiveness evidence against standard interventions remains limited .
Further reading
- Comparing the efficacy and safety of endovascular therapy versus surgical revascularization for critical limb-threatening ischemia: A systematic review and Meta-analysis. (2025). CLTI endovascular-versus-surgical comparative synthesis; account for heterogeneous populations, conduit and study design.
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