Acute and Long-Term Results After Intra-arterial Thrombolysis of Occluded Lower Extremity Bypass Grafts Using Recombinant Tissue Plasminogen Activator for Acute Limb-Threatening Ischemia

Abstract

Occlusion of lower extremity vascular bypass grafts results in acute limb-threatening ischemia. The underlying cause of graft failure generally is distal anastomosis stenosis, and relief of culprit stenosis is a required to maintain long-term patency. Of the three thrombolytic agents used for prolonged infusion to accomplish fibrinolysis, streptokinase was the first to be used and is limited owing to the antigenicity that precludes repeated use. Urokinase had been the mainstay of thrombolytic therapy until it was withdrawn by the U.S. Food and Drug Administration in 1999 because of the potential of transmission of infectious agents during its manufacturing process. Recombinant tissue plasminogen activator (rt-PA) has not been studied adequately to assess safety and efficacy, and there are no standardized dosing guidelines. We report our experience with six patients presenting with acute limb-threatening ischemia attributable to thrombosis of synthetic lower extremity bypass grafts. After thrombolysis using rt-PA (mean bolus dose, 12.2 +/- 3.6 mg; range, 6-15 mg administered over 5 minutes followed by infusion at 2 mg/h for 15.6 +/- 6.4 hours; total dose, 51 +/- 16 mg), successful thrombolysis was achieved in 84% of the patients. The primary patency rate was 75% and the secondary patency rate 100% at 16 weeks. One patient underwent amputation owing to unsuccessful thrombolysis. No major bleeding or vascular complications occurred. We conclude that intra-arterial thrombolysis using rt-PA is a safe and effective therapy for patients with thrombotic occlusion of synthetic lower extremity bypass grafts presenting with acute limb-threatening ischemia and allows a high rate of secondary patency, avoiding amputation.

Is endovascular therapy effective in acute femoropopliteal bypass graft failure?

“…However, there is no consensus about the treatment approach of the FPBG failure (2,4,(8)(9)(10)(11)(12)(13)(14)(15)(16)(17). Previous studies indicated that initial success rates of EVT ranged from 70% to 90% and 85% to 95% in the thrombosed and stenosed grafts, respectively, which is consistent with our study (1,6,14,18,19). Some studies showed that the long term patency rate of EVT, was below the expectations in the thrombosed and stenosed grafts in spite of the high initial success rates (1,11,12,(20)(21)(22).…”

Effects of Delivering Recombinant Tissue Plasminogen Activator on a New Infusion System during Endovascular Intervention in Patients with Lower Limb Ischemia

“…4 Targeting these thrombi and reducing their burden prior to a more definitive treatment will result in more successful short-and long-term outcomes. 11 Several publications have reviewed the role of lytic therapy in the management of subacute/chronic thrombus in an occluded artery. 11,12 Thrombolysis is a nonsurgical therapy that reduces in the magnitude of interventions required and avoids emergent thrombectomy in medically compromised patients, potentially reduces high perioperative mortality, and morbidity.…”

“…11 Several publications have reviewed the role of lytic therapy in the management of subacute/chronic thrombus in an occluded artery. 11,12 Thrombolysis is a nonsurgical therapy that reduces in the magnitude of interventions required and avoids emergent thrombectomy in medically compromised patients, potentially reduces high perioperative mortality, and morbidity. 1,12,15 Lytic therapy offers several other advantages in locally dissolved thrombi being cleared with less risk of injuring the sensitive underlying endothelium and occurrence of re-thrombosis, visualizing the distal runoff vessels.…”

“…Considering the superior pharmacological properties of rt-PA, the concept of achieving maximum local lysis with minimal systemic lytic effect appears achievable, which is theoretically an advantage to PAD patients harboring large thrombus burden. 10,11 Rt-PA has the advantage of higher initial angiographic success and limb salvage over streptokinase. 11 Compared with urokinase, rt-PA has a shorter half-life (5 vs. 20 min), so lytic process tends to be more rapid.…”

“…CDT and PTA combination therapy in PAD is defined as thrombolysoangioplasty (thrombolysis followed by adjunctive angioplasty). 11 In China, the therapeutic indication of rt-PA does not include PAD, and the ideal dose for rt-PA infusion has not been established, so the purposes of this study has two sides: (1) to compare the effects of rt-PA in different dose using UNI*FUSE Infusion System during endovascular intervention procedure in treating recent-onset lower limb ischemia (< 6 months) to evaluate the feasibility and safety for establishing the dose guidelines and needs for adjunctive intervention and (2) to study the angiographic lysis degree, requirement and cost of adjunctive endovascular or surgical intervention, and evaluate the short-and long-term amputation-free survival after successful thrombolysoangioplasty treatment of the underlying lesion.…”