Treatment of Peripherical Vascular Atherosclerotic Disease with Local Delivery of Paclitaxel after balloon angioplasty
Treatment of Peripherical Vascular Atherosclerotic Disease with Local Delivery of Paclitaxel after balloon angioplasty
Authors: Roberto. J. Fernandez Vina1,2,3,4, R. F. Fernandez Viña1, O. Andrin1, F. Vrsalovick4, P. Andres1, L. Camozzi9,
Affiliations 1San Nicolas ClinicSA, 2Fernandez Viña Foundation, San Nicolas (Buenos Aires), ARGENTINA, 3Universidad National de Rosario, Rosario, ARGENTINA, 4Universidad Maimonides Buenos Aires, Buenos Aires.
Background:
Percutaneous Tranluminal Angioplasty (PTA) and Percutaneous Tranluminal Coronary Angioplasty (PTCA) are established, proven methods for re-opening stenotic or occluded arteries in a minimally invasive way. The balloon is placed in the stenotic segment of the artery and then expanded until the lumen reaches its original diameter. To this end, very high pressure is applied, which unavoidably causes vessel wall injury. Hyperproliferation resulting in lumen narrowing is the natural reaction to this injury A single short contact of tissue with a small dose of Paclitaxel has been shown to efficaciously inhibit local cell proliferation Antiproliferative Taxanes such as Paclitaxel seem to be suitable due to their high lipophilicity and tight binding to various cell constituents, resulting in effective local retention at the site of delivery. Paclitaxel as a hydrophobic compound possesses preferential tissue binding.
Method:
23 patients, All subjects between 65 and 86 years of age with symptomatic claudication (Rutherford category 1-6) with TASC II type A, B, or C lesions in lower limbs will be invited to participate in this study under signed informed consent. The vascular pheripherical suboclusions were localized in FSA, 16 lesions, Popliteal Arteries 9 lesions, Anterior Tibial Artery, 6 lesions, Posterior Tibial Artery, 12 lesions, Peroneal artery 2 lesions. All suboclusions were treated with classic Balloon Angioplasty (PTA) with adequate diameter balloon for each arterial diameter, after successfully procedure Paclitaxel mixed with the contrast medium was administered intra-arterially through the guiding catheter to treat segment of treated artery, the balloon used for PTA was introduce distally to the treated plaques and inflated with low atmospheres with the objective to stagnate the flow during 3 minutes. Dosing used was based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3 . All the procedure were finished with out complications and no collateral effects of the drug were seem, not acute thrombosis were reported, all the patients return home after 24 hours with aspirin 100mg and clopidogrel 75mg.
Evolution:
Patients were followed with pheripherical vascular echo duplex during 1 year and the treated plaques didn’t show more decrement of the initial diameter obtained than 18% (Lumen loss), all patients improve the walking more than 800 meters and only 14 pts. accepted to be submitted to new control angiography, in this studies the lesions treated were maintained opened with minimal re-stenosis ( 12%).
Conclusion:
Local delivery of Paclitaxel resulted in reduced neointimal re-stenosis using low doses to avoid collaterals effects with stagnation of flow during the procedure, and it would be new form to treat lower limbs arterial occlusions.
Authors: Roberto. J. Fernandez Vina1,2,3,4, R. F. Fernandez Viña1, O. Andrin1, F. Vrsalovick4, P. Andres1, L. Camozzi9,
Affiliations 1San Nicolas ClinicSA, 2Fernandez Viña Foundation, San Nicolas (Buenos Aires), ARGENTINA, 3Universidad National de Rosario, Rosario, ARGENTINA, 4Universidad Maimonides Buenos Aires, Buenos Aires.
Background:
Percutaneous Tranluminal Angioplasty (PTA) and Percutaneous Tranluminal Coronary Angioplasty (PTCA) are established, proven methods for re-opening stenotic or occluded arteries in a minimally invasive way. The balloon is placed in the stenotic segment of the artery and then expanded until the lumen reaches its original diameter. To this end, very high pressure is applied, which unavoidably causes vessel wall injury. Hyperproliferation resulting in lumen narrowing is the natural reaction to this injury A single short contact of tissue with a small dose of Paclitaxel has been shown to efficaciously inhibit local cell proliferation Antiproliferative Taxanes such as Paclitaxel seem to be suitable due to their high lipophilicity and tight binding to various cell constituents, resulting in effective local retention at the site of delivery. Paclitaxel as a hydrophobic compound possesses preferential tissue binding.
Method:
23 patients, All subjects between 65 and 86 years of age with symptomatic claudication (Rutherford category 1-6) with TASC II type A, B, or C lesions in lower limbs will be invited to participate in this study under signed informed consent. The vascular pheripherical suboclusions were localized in FSA, 16 lesions, Popliteal Arteries 9 lesions, Anterior Tibial Artery, 6 lesions, Posterior Tibial Artery, 12 lesions, Peroneal artery 2 lesions. All suboclusions were treated with classic Balloon Angioplasty (PTA) with adequate diameter balloon for each arterial diameter, after successfully procedure Paclitaxel mixed with the contrast medium was administered intra-arterially through the guiding catheter to treat segment of treated artery, the balloon used for PTA was introduce distally to the treated plaques and inflated with low atmospheres with the objective to stagnate the flow during 3 minutes. Dosing used was based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3 . All the procedure were finished with out complications and no collateral effects of the drug were seem, not acute thrombosis were reported, all the patients return home after 24 hours with aspirin 100mg and clopidogrel 75mg.
Evolution:
Patients were followed with pheripherical vascular echo duplex during 1 year and the treated plaques didn’t show more decrement of the initial diameter obtained than 18% (Lumen loss), all patients improve the walking more than 800 meters and only 14 pts. accepted to be submitted to new control angiography, in this studies the lesions treated were maintained opened with minimal re-stenosis ( 12%).
Conclusion:
Local delivery of Paclitaxel resulted in reduced neointimal re-stenosis using low doses to avoid collaterals effects with stagnation of flow during the procedure, and it would be new form to treat lower limbs arterial occlusions.
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