Usefulness of off-label use of coronary drug-eluting stents as bailout for patients with critical limb ischemia and infrapopliteal arterial occlusive disease

Abstract

Background: Infrapopliteal arterial disease is the most common finding in patients presenting with critical limb-threatening ischemia (CLTI) majority of whom also present with tissue loss. Vein bypass has been the gold standard of treatment in these patients. Nowadays, because of high peri-operative mortality and morbidity in these high-risk patients, endovascular treatment is offered first. Vascular restenosis, caused by intimal hyperplasia due to vessel injury during percutaneous transluminal angioplasty (PTA), remains the main limitation of infrapopliteal PTA and bare metal stent with clinical relapse and reinterventions. Drug-eluting stents (DES) are considered a possible solution to the problem of restenosis by reducing neointimal hyperplasia, after promising results in coronary arteries. Materials and Methods: Coronary DES was used as a bail out in patients undergoing below the knee (BTK) angioplasty. Those who developed dissection or recoil were stented with coronary stents. Multiple stents were used in patients with a long segment recoil of the artery. None of the stents were placed 2 or 3 cm beyond the origin of the tibial artery. The primary patency at 6 and 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion based on clinical assessment and duplex scan, limb salvage and time taken to complete wound healing were assessed. Results: A total of 26 patients underwent drug-eluting stenting of the infra-popliteal vessels for CLTI during a period of 32 months. Technical success was possible in 92.3% patients (n = 24), however two patients had on table thrombosis of the stent. These two patients went on to have surgical bypass and their limbs could be salvaged. Wound healing was seen in 13 of 18 (72.2%) patients at 6 months and 11/12 (91.6%) patients at 1 year. Most patients took an average of 5 months to heal. Limb salvage was 11/12 (91.6%) at 1 year. Two patients underwent below-knee amputation for severe worsening sepsis due to uncontrollable foot infection. In both these patients' stents were patent at the time of amputation. Primary patency was 92.3% at 6 months and at 1 year. None of the patients required re-intervention. Mortality was 15.3% at 1 year. Conclusion: Off-label use of cardiac stents in the infra-popliteal segment seems a viable bailout option in patients undergoing revascularization. DES helps to achieve early technical success, longer patency, better wound healing, and improves limb salvage in these patients.