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Vascular and Interventional Radiology |
1 From the Department of Radiology, University of Pennsylvania Medical Center, 1 Silverstein, 3400 Spruce St, Philadelphia, PA 19010. From the 2001 RSNA scientific assembly. Received February 20, 2002; revision requested April 23; final revision received September 23; accepted October 14. Address correspondence to S.W.S. (e-mail: stav@rad.upenn.edu).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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MATERIALS AND METHODS: Abciximab was used in conjunction with recanalization techniques and angioplasty to treat stenoses or occlusions in 16 patients: 10 patients had high-grade stenoses or occlusions longer than 5 cm in the superficial femoral artery and popliteal artery, and six patients had stenoses or occlusions below the popliteal artery. All patients received a bolus of heparin after arterial access was achieved. Abciximab was administered by means of a weight-base nomogram that consisted of an initial bolus followed by an overnight infusion. Technical success was defined as a less than 30% residual stenosis after angioplasty. Patients were carefully followed up for possible postprocedural complications. Platelet counts were monitored for 24 hours.
RESULTS: Technical success was achieved in 15 (94%) of 16 patients. One occlusion of the superficial femoral artery could not be crossed. There was a mean postprocedural increase of 0.23 in the ankle-brachial index. There was no significant effect on platelet count. Two minor complications occurred. One major complication occurred; this was a groin hematoma, which required a blood transfusion.
CONCLUSION: The use of abciximab as an adjunct during complex infrainguinal arterial interventions appears promising, on the basis of initial experience.
© RSNA, 2003
Index terms: Arteries, femoral • Arteries, popliteal • Arteries, stenosis or obstruction, 922.721, 924.721 • Arteries, transluminal angioplasty, 922.1282, 924.1282
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Percutaneous transluminal angioplasty is an established therapeutic option for patients with infrainguinal peripheral vascular disease (10). As with angioplasty performed in other vascular beds, infrainguinal percutaneous transluminal angioplasty is associated with the risk of periprocedural thrombosis and distal embolus. This rationale led us to use abciximab during the treatment of selected patients with occlusive disease in the superficialfemoral artery (SFA), popliteal artery, or infrapopliteal artery who we believed, on the basis of clinical and angiographic severity, to be at high risk for acute thrombosis. The purpose of this study was to investigate the use of abciximab during infrainguinal angioplasty.
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MATERIALS AND METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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For an 18-month period starting in August 1999, abciximab (ReoPro; Centocor, Malvern, Pa) was used in a nonrandomized fashion during infrainguinal peripheral vascular interventions, at the discretion of the attending interventional radiologist (one of four possible) treating the patient (R.D.S.G., S.W.S., M.C.S., T.W.I.C.). Abciximab was administered to patients thought to be at high risk for a thrombotic or embolic complication. Abciximab was used prior to angioplasty in patients with long-segment (>5 cm) SFA and popliteal artery stenoses or occlusions (n = 10), as well as in patients with infrapopliteal artery stenoses or occlusions (n = 6). We did not give abciximab to patients with short-segment SFA disease unless a decision was made to treat concomitant infrapopliteal disease. We used abciximab in this manner on 14 men and two women, with a mean age of 64 years (range, 55–87 years).
Prior to the procedure, each patient provided a medical history and underwent a physical examination as part of the interventional radiology evaluation. Platelet counts were obtained before the procedure and were monitored once the patient was admitted to the hospital. Three of the patients were receiving a dosage of 75 mg of clopidogrel (Plavix; Sanofi, New York, NY) and aspirin per day prior to their interventional procedures. This medication was continued at the time of the procedure and for 4 weeks afterward.
Access to the artery was obtained with a single wall puncture. Angiography was performed with use of a nonionic contrast agent. Prior to administering any heparin or abciximab or attempting to cross a lesion, an activated clotting time (ACT) was obtained. If the ACT was less than 150 seconds, 70 U/kg heparin was administered to the patient. If the ACT was 150–199 seconds, 50 U/kg heparin was administered. If the ACT was greater than 200, no heparin was administered. During the procedure an additional 20 U/kg heparin was given to maintain an ACT of 200–300 seconds. No heparin was given after the procedure. Prior to crossing the lesion, abciximab was given as a bolus (0.25 mg/kg). After angioplasty was performed, each patient received an abciximab infusion of 0.125 µg/kg/min (up to a maximum dosage of 10 µg/min) for 12 hours.
Stenoses and occlusions were crossed with guide wires and angled catheters. Hydrophilic 0.035-inch and 0.018-inch guide wires were used as needed. Angioplasty was performed with angioplasty balloons sized to match the vessel lumen. No stents were used.
After angioplasty was performed, patients recovered in the radiology holding area and were then sent to the intensive care unit to be monitored overnight, during which time the abciximab infusion was continued for 12 hours (as discussed previously). In each patient, hemostasis was achieved with either a percutaneous closure device (n = 1) or, more typically, manual compression (n = 15). Manual compression was performed once the ACT had decreased to less than 180 seconds. After the procedure, oral antiplatelet medications were not routinely used.
Technical success was defined as no greater than 30% residual stenosis after angioplasty. Postprocedural complications were recorded and classified as major or minor according to the criteria of the Society of Interventional Radiology (formerly the Society of Cardiovascular and Interventional Radiology) (11). Ankle-brachial index (ABI) measurements were recorded before each patient was discharged from the hospital. A substantial increase in ABI was considered to be an increase of at least 0.10. In addition, ABI and Rutherford classifications were made prior to the procedure and (when possible) during 1-month follow-up clinic visits, according to the classification system adopted by the Society of Vascular Surgery, the International Society for Cardiovascular Surgery, and the Society of Interventional Radiology (12) (Table 1).
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RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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None of the treated patients experienced a significant change in platelet count in the 24 hours after the procedure. No intracranial hemorrhages occurred. No distal embolization events or acute occlusions occurred during any of the periprocedural periods.
A major complication occurred in one patient. A large groin hematoma developed in a patient who was undergoing chronic antiplatelet therapy with aspirin and a 75-mg daily dosage of clopidogrel. The subsequent decrease in the patient’s hemoglobin from 10.4 to 8.0 g/dL (104 to 80 g/L) was treated with a blood transfusion of 2 units. No surgical evacuation of the hematoma was required.
Minor complications occurred in two patients. In the first patient, there was an episode of gingival bleeding that required no therapy. In the second patient, extravasation was noted on the postangioplasty angiogram after recanalization of an SFA occlusion. This patient had already received heparin and abciximab boluses. The extravasation was treated with prolonged inflation of the angioplasty balloon (10 minutes). Following the prolonged balloon inflation, no extravasation was noted. The patient remained asymptomatic throughout the episode, and clinical examination demonstrated no evidence of a thigh hematoma. The patient received the remainder of the 12-hour abciximab infusion without further incident.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Although the role of abciximab in improving outcomes after percutaneous coronary interventions is becoming more defined, its use in peripheral vascular interventions has not been as well assessed. Direct extrapolation of data from studies on the coronary arteries to studies on the peripheral arteries is difficult, mainly because the end points for therapy are different. The end points in most coronary arterial studies focus on death, myocardial infarction, and urgent reintervention at 30 days, while end points in peripheral interventions focus on patency rates and limb salvage. Nevertheless, thrombosis caused by platelet aggregation remains problematic in both coronary and peripheral arterial percutaneous interventions. The potential exists for abciximab to decrease the incidence of acute and subacute thrombosis during complex peripheral interventions. Encouraging results with an acceptable safety profile have been reported in the use of abciximab as an adjunct during carotid artery angioplasty and stenting (7–9). In addition, work has been done in the use of abciximab in combination with lytic agents during peripheral arterial thrombolysis (16–19).
Our rationale for using abciximab during peripheral interventions was based on the literature on coronary interventions, which showed abciximab could decrease the risk of acute or subacute thrombosis and subsequent distal embolization (2–6,13–15). As a result of the added cost and possible additional risk associated with this drug, abciximab was used only in situations where the risks and consequences of arterial thrombosis were believed to be particularly high. These situations included cases of infrapopliteal angioplasty, long-segment SFA or popliteal stenoses or occlusions, or concomitant femoropopliteal or infrapopliteal disease, which have higher complication rates and lower success rates than iliac interventions (10,20–22). The risk of distal emboli and thrombosis is greatest in those patients with only one vessel runoff to the foot.
Additional studies are needed in a prospective, randomized (and preferably blinded) fashion to demonstrate conclusively the efficacy of using abciximab asan adjunct to angioplasty during complex infrainguinal arterial interventions. Moreover, future studies are needed to assess the effect of abciximab on long-term patency rates. The cost-effectiveness of using abciximab in this clinical setting remains to be established. Our preliminary experience with abciximab as an adjunct to angioplasty during complex infrainguinal percutaneous arterial interventions is promising and, we believe, warrants further investigation.
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FOOTNOTES |
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Author contributions: Guarantor of integrity of entire study, S.W.S.; study concepts and design, all authors; literature research, T.W.I.C., S.W.S., R.D.S.G.; clinical studies, all authors; data acquisition, S.W.S., J.A.S.; data analysis/interpretation, all authors; statistical analysis, S.W.S., J.A.S.; manuscript preparation and definition of intellectual content, R.S.G., S.W.S.; manuscript editing, J.A.S., S.W.S.; manuscript revision/review and final version approval, all authors.
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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