Final results of the ReoPro readministration registry.

Because of its potential for antigenicity, theoretical concerns related to readministration of abciximab have been raised. We conducted the ReoPro Readministration Registry to assess the efficacy and safety of abciximab readministration. A total of 1,342 patients who underwent percutaneous coronary intervention and who received abciximab for at least a second time were recruited. Safety end points were hypersensitivity reactions, major bleeding, and thrombocytopenia (TCP). Human antichimeric antibody (HACA) titers were determined before and after readministration. Procedural success was 98% and was not influenced by the number of courses of abciximab or the presence of HACA. There were no cases of anaphylaxis. There were 5 minor allergic reactions, none of which required termination of the infusion. Clinically significant bleeding occurred in 31 patients (2.3%), including 1 (0.07%) with intracranial hemorrhage. TCP (<100 x 10(9)/L) developed in 5% of patients; profound TCP (<20 x 10(9)/L) occurred in 2%. In patients who received abciximab within 1 month of a previous treatment (n = 115), the risk of developing TCP and profound TCP was 16.5% and 12.2%, respectively. Having a positive HACA before readministration was not correlated with adverse clinical outcomes or bleeding, but was associated with TCP (14.1% vs 4.4%, p = 0.002) and profound TCP (5.6% vs 1.6%, p = 0.036). Readministration of abciximab can be accomplished without severe allergic responses and with a bleeding and efficacy profile similar to first-time administration. However, the rate of severe and profound TCP is increased relative to first-time administration, particularly when the time between treatments is <30 days or when HACA is present.

Cutting balloon angioplasty of the popliteal and infrapopliteal vessels for symptomatic limb ischemia.

Options for lower limb percutaneous revascularization are limited especially for complex vessel obstruction. Cutting balloon angioplasty (CBA) has been described in the coronary literature as effective for complex disease. We analyzed our peripheral vascular database and report procedural outcomes along with the clinical success at a mean of 1-year follow-up in 73 patients with symptomatic lower limb ischemia undergoing CBA. CBA was successfully completed in all 73 patients (93 vessels; 100%) with predilation necessary in 4% of vessels. Severe intimal dissection or inadequate hemodynamic result necessitated in adjunctive stenting in 20%. There were no incidents of vessel perforation or surgical target vessel revascularization. One patient (1.5%) died during the periprocedural period due to renal failure. After mean follow-up of 1 year (6-21 months), 89.5% of threatened limbs were salvaged. CBA is a safe and feasible option for the treatment of popliteal and infrapopliteal vessels.

Use of glycoprotein IIb/IIIa platelet inhibitors in peripheral vascular interventions.

With the expanding use of endovascular techniques for the treatment of peripheral vascular disease, consideration of glycoprotein IIb/IIIa receptor inhibitors to enhance the safety and efficacy of these procedures has increased. The scientific literature shows the benefits with the use of these agents in coronary vasculature interventions. However, data evaluating treatment with glycoprotein IIb/IIIa receptor inhibitors during peripheral vascular procedures is limited, with the vast majority of the trials investigating abciximab. With the varied vascular beds and end organs that may be affected by peripheral vascular intervention, the safety and efficacy may need to be studies for each area. The current literature ranging from carotid stenting to thrombolysis and mechanical thrombectomy for acute limb ischemia is reviewed, and recommendations are discussed on the use of these agents. The forthcoming results of controlled clinical trials should further clarify the clinical applications of these agents in peripheral vascular intervention.

Rheolytic thrombectomy in the management of limb ischemia: 30-day results from a multicenter registry.

PURPOSE: To evaluate the use of rheolytic thrombectomy (RT) with the AngioJet catheter for treatment of lower extremity ischemia due to arterial/graft thrombotic occlusion. METHODS: A retrospective multicenter review was performed of 99 consecutive patients (52 men; mean age 67 +/- 13 years, range 30-90) who underwent RT for thrombotic occlusions in native arteries (n=80) or bypass grafts (n=19). Pre- and postprocedural limb ischemia and in-hospital events were evaluated. Amputation and mortality rates at 30 days were determined. RESULTS: The majority of patients (78.8%) presented within 14 days of symptom onset. RT resulted in substantial to complete thrombus removal in 70 (70.7%) patients and partial in 22 (22.2%); there was no angiographic change in 7 (7.1%). Adjunctive post RT thrombolysis was used in 37 patients. Underlying stenoses found in 81 limbs were treated with one or more of the following procedures: balloon angioplasty (n=62), stenting (n=35), or nonemergent surgical revision (n=5). In-hospital complications included 2 major amputations, 5 cases of minor tissue loss, 7 rethromboses, and 3 cases of transient renal insufficiency. Four (4.0% patients died in-hospital; the 95 surviving patients all had viable limbs at discharge. Mortality and amputation rates at 30 days were 7.1% and 4.0%, respectively. CONCLUSIONS: Percutaneous treatment of thrombotic occlusions with RT, followed by definitive treatment of the underlying stenosis, is a promising therapeutic option for patients with limb-threatening ischemia.

Clinical results for the training-phase roll-in patients in the Intracoil femoralpopliteal stent trial.

The purpose of this study was to report the results of the roll-in patients for the multicenter IntraCoil trial in the femoropopliteal arteries at 9-month follow-up. Ninety-three roll-in patients (mean age, 67.8 +/- 10.5 years; 62.4% male gender) constituted the learning phase for the 22 clinical sites. Obstructive femoropopliteal artery disease up to 15 cm was treated with stenting. Clinical patency was measured over a 9-month period by clinical and hemodynamic data as well as the Rutherford scale. Diabetes mellitus was present in 35.5%. Twenty-nine percent of lesions treated were occlusions. The mean reference diameter for treated lesions was 4.27 +/- 1.11 mm, while the mean lesion length was 3.83 +/- 3.69 cm. Acute angiographic success by operator evaluation was obtained in 98.9% of patients. Major complications occurred in 3.2%. No patient experienced abrupt or subacute closure. There were two reports of failure to deliver assigned stent. In both incidences, the stent was removed without surgical intervention. There were also three reports of stent misplacement (moving during delivery), one report of stent migration, one report of delivery system failure. At 30-day and 9-month follow-up of successfully treated patients, 100%/77.9% remained free of major adverse clinical events (MACE) and 100%/81.8% target lesion revascularization (TLR), respectively. At 9-month follow-up, ankle-brachial index increased from 0.66 +/- 0.22 to 0.83 +/- 0.20 while mean maximum walking time increased form 4.47 +/- 3.02 to 5.91 +/- 3.97 min. The use of the IntraCoil stent appears to have a short learning curve. Excellent clinical and hemodynamic patency is seen at 9 months. The randomized comparison trial comparing the IntraCoil to angioplasty is pending.

Infrapopliteal Endovascular Techniques: Indications, Techniques, and Results.

The emerging field of endovascular therapy is opening up new therapeutic avenues for the treatment of peripheral vascular disease. The infrapopliteal arterial bed is a complex vascular bed. Treatment is usually restricted to patients with limb-threatening ischemia. Although education and medical therapy play a cornerstone role in long-term success, endovascular therapy offers a potentially easy low-risk treatment for early healing of damaged tissue. Surgical therapy remains the gold standard of treatment, but there remains significant associated morbidity and mortality. A clear understanding of the vascular anatomy, disease process, extent of tissue damage and comorbidities is necessary in forming the treatment plan for any particular patient. Close follow-up and possible retreatment is a key responsibility for the endovascular physician.