What is the current best revascularization strategy to restore limb perfusion?

From the Guidelines

The current best revascularization strategy to restore limb perfusion is an endovascular-first approach, which typically involves balloon angioplasty with or without stenting, and should be performed emergently (within 6 hours) for marginally or immediately threatened limbs, and on an urgent basis (within 6–24 hours) for viable limbs. This approach is supported by the 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases 1, which recommend an endovascular-first approach for most patients with peripheral arterial disease (PAD) or critical limb ischemia (CLI). The choice between endovascular and surgical approaches should be individualized based on patient factors, including comorbidities, functional status, and anatomical considerations such as lesion complexity, length, and calcification.

Some key considerations for the revascularization strategy include:

• The presence of neurological deficits, which requires urgent revascularization 1
• The duration of ischemia, with prolonged duration (>6 to 8 hours) being a common factor in patients requiring amputation 1
• The localization of the ischemia, with different revascularization modalities being applied depending on the location of the occlusion 1
• The type of conduit (artery or graft) and therapy-related risks and outcomes 1

Prior to any intervention, optimal medical therapy should be initiated, including antiplatelet therapy (aspirin 75-100mg daily), statins (high-intensity such as atorvastatin 40-80mg daily), and risk factor modification. Following revascularization, dual antiplatelet therapy with aspirin and clopidogrel (75mg daily) is typically recommended for at least 1-3 months after endovascular interventions. The endovascular-first strategy is preferred because it offers lower procedural morbidity, shorter hospital stays, and faster recovery while preserving surgical options for future interventions if needed. However, for younger patients with long life expectancy or those with extensive, complex disease, surgical bypass may provide better long-term patency and limb salvage rates.

In cases where endovascular therapy is not available or feasible, surgical options such as thrombectomy, bypass, and/or arterial repair should be considered, as recommended by the 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease 1. The technique that will provide the most rapid restoration of arterial flow with the least risk to the patient should be selected, taking into account available facilities and clinical expertise.

From the FDA Drug Label

CLINICAL STUDIES Three clinical studies were performed in patients with improperly functioning central venous access devices (CVADs) A placebo‑controlled, double‑blind, randomized trial (Trial 1) and a larger open‑label trial (Trial 2) investigated the use of Alteplase in predominately adult patients who had an indwelling CVAD for administration of chemotherapy, total parenteral nutrition, or long‑term administration of antibiotics or other medications Both studies enrolled patients whose catheters were not functioning (defined as the inability to withdraw at least 3 mL of blood from the device) but had the ability to instill the necessary volume of study drug.

The current best revascularisation strategy to restore limb perfusion is not directly addressed in the provided drug labels, as they focus on the restoration of function in central venous access devices (CVADs) using Alteplase. Key points:

• The studies discussed in the drug labels are related to CVADs, not limb perfusion.
• There is no information in the drug labels that directly supports a revascularisation strategy for restoring limb perfusion. The FDA drug label does not answer the question.

From the Research

Revascularisation Strategies

The current best revascularisation strategy to restore limb perfusion is a topic of ongoing debate, with various studies suggesting different approaches.

• Endovascular therapy and surgical revascularization are the two main revascularization options for critical limb-threatening ischemia (CLTI) 2.
• A systematic review and meta-analysis found that surgery may be the preferred treatment option for CLTI patients, as it is associated with a lower risk of major adverse limb events (MALE) compared to endovascular therapy 2.
• However, endovascular therapy may be associated with a lower risk of major adverse cardiovascular events (MACE) and lower rates of bleeding, wound complications, readmission, unplanned reoperation, acute renal failure, and shorter hospital stays 2.

Patient Selection

Optimal patient selection is paramount for maximizing benefit with each technique.

• The expected outcomes for both endovascular and open surgery in critical limb ischemia (CLI) are strongly dependent on definable patient factors such as anatomic distribution of disease, vein quality, and comorbidities 3.
• A thoughtful approach to the complex decision of best strategy for revascularization is required, taking into account patient characteristics and anatomy 4.

Revascularisation Approaches

Different revascularisation approaches are available, including:

• Endovascular revascularization, which is an effective peripheral artery disease therapy for both above the knee and below the knee disease, and can safely and effectively treat both inflow and outflow disease 5.
• Open surgical bypass, which remains an important option for those with advanced disease 6.
• Hybrid approaches, which may be suitable for patients with multilevel disease 4.