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ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease - RIO-Trial - Presented at ESC 2007
Description:
The goal of the trial was to evaluate the effect of abciximab administration compared with placebo among patients with interventional recanalization of chronic occlusions in the superficial femoral artery (SFA) and popliteal artery.
Study Design
Study Design:
Patients Enrolled: 423
Mean Follow Up: 3 years (6 months reported to date)
Mean Patient Age: Mean age, 68 years
Female: 42
Patient Populations:
Patients ages 18-90 years with a history of peripheral artery disease (for at least 6 weeks) with SFA or popliteal artery occlusion (>5 cm in length), which mandates PTA or stent administration as first treatment modality
Exclusions:
Acute limb ischemia; subacute ischemia which requires thrombolysis as first treatment modality; active bleeding or known bleeding diathesis; known severe hepatic or renal disorder; hyperthyreosis; diabetes mellitus treated with metformin; known heparin-induced thrombocytopenia; major surgery or trauma in past 6 weeks; history of stroke within the previous 2 years, or any stroke with a residual neurological deficit, or other central nervous system abnormality; gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks; administration of oral anticoagulants within the previous 7 days unless prothrombin time is <1.2; history of bleeding diathesis of platelet count <100,000/mm3; arteriovenous malformations or aneurysms; severe uncontrolled hypertension; hypertensive or diabetic retinopathy; vasculitis; known autoimmune disorders; aspirin intolerance; contraindication or known allergic reactions to abciximab or murine proteins; co-existent condition associated with a limited life expectancy; or previous use of a glycoprotein IIb/IIIa antagonist
Primary Endpoints:
Death, amputation, repeat target vessel intervention, or target vessel reocclusion within 30 days
Secondary Endpoints:
Restenosis at 6 months, target lesion revascularization, change in the clinical status, change of ankle-brachial index, hospital days
Drug/Procedures Used:
Patients undergoing interventional recanalization of chronic occlusions in the SFA or popliteal artery were randomized in a double-blind manner after wire passage to abciximab (n = 212) or placebo (n = 211). Doppler ultrasound was performed at 30 days, 6 months, and 12 months.
Concomitant Medications:
All patients were treated with aspirin and clopidogrel for 28 days following the intervention.
Principal Findings:
Median duration of symptoms at entry was 12 months. The average lesion length was 17 cm, and 14% of patients had recurrent lesions. Stents were used in 43% of patients.
There was no difference in the primary endpoint of death, amputation, repeat target vessel intervention, or target vessel reocclusion within 30 days for the abciximab group (5.1%) versus the placebo group (5.6%, p = NS). Distal embolization was lower in the abciximab group (6.1% vs. 12.3%, p = 0.02). Severe bleeding occurred more frequently in the abciximab arm (5.1% vs. 1.0%, p = 0.02), as did other bleeding events (8.1% vs. 1.5%, p = 0.004). There were no cases of intracranial hemorrhage or life-threatening bleeds in either arm.
At 6-month follow-up, target vessel reocclusion was lower in the abciximab group as compared with the placebo arm (22% vs. 39%, p < 0.001), as was binary restenosis (56% vs. 68%, p = 0.026). No significant differences were observed in the need for amputation (4.7% vs. 2.1%) or reintervention (18% vs. 23%).
Interpretation:
Among patients with interventional recanalization of chronic occlusions in the SFA and popliteal artery, treatment with abciximab as compared with placebo was not associated with a difference in the frequency of the composite of death, amputation, repeat target vessel intervention, or target vessel reocclusion within 30 days, but was associated with an increase in bleeding complications.
Previous studies have demonstrated a benefit with abciximab in patients undergoing percutaneous transluminal angioplasty (PTA) for subacute limb ischemia. Patients in the present study did not have subacute limb ischemia but rather had chronic occlusions, with symptoms for a median of 12 months. While some benefit was observed with a reduction in distal embolization and a reduction in reocclusion, these did not translate into a reduction in clinical events. Given the excess bleeding rate and the lack of efficacy in the abciximab group, routine use of abciximab during intervention does not appear to be a valid strategy in this population.
References:
Presented by Dr. Iris Baumgartner at the European Society of Cardiology Congress, September 2007, Vienna, Austria.
Keywords: Follow-Up Studies, Intracranial Hemorrhages, Platelet Aggregation Inhibitors, Femoral Artery, Ticlopidine, Immunoglobulin Fab Fragments, Popliteal Artery, Peripheral Vascular Diseases, Stents
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