Taxan With Short Time for Contact for Reduction of Restenosis in Distal Arteries - THUNDER - Presented at TCT 2006
The goal of the trial was to evaluate treatment with uncoated balloon, uncoated balloon plus paclitaxel IA, or paclitaxel coated balloon among patients with peripheral artery disease (PAD).
Patients Enrolled: 154
Mean Follow Up: 6 months
Mean Patient Age: Mean age 68 years
Occlusion or stenosis ≥2 cm (mean grade stenosis ≥70%); SFA, APOP; PAD for >6 weeks without thrombolysis; successful guidewire passage; Rutherford 3-5; and age 18-95 years
Distal runoff <1 artery; creatinine >2.0; or PTA at the proximal origin
Late lumen loss at 6 months
Patients were randomized to uncoated balloon (n = 54), uncoated balloon plus paclitaxel IA (n = 52), or the Paccocath paclitaxel coated balloon (n = 48). The coated balloon contained 3 µg paclitaxel/mm2 of paclitaxel. After 6-month data were evaluated, a decision will be made on whether to continue following patients for a total of 24 months.
At baseline, mean degree of stenosis was 89% and occlusion was present in 20% of patients. The mean number of lesions treated was 1.7 per patient. The lesions were de novo in ~62% of patients. Procedure success rate was 100%. There was one subacute thrombosis 2 weeks after the procedure.
Follow-up at 6 months was available in 82% of patients. The primary endpoint of late lumen loss at 6 months was smallest in the paclitaxel coated balloon group (p < 0.01). Likewise, binary restenosis was lowest in the paclitaxel coated balloon group (17% vs. 45% for uncoated balloon). Target lesion revascularization was also lowest in the paclitaxel coated balloon group (6.3% vs. 29.6% for uncoated balloon and 25.0% for uncoated balloon plus paclitaxel IA; p < 0.01). There were five deaths in the trial.
Among patients with PAD, treatment with the paclitaxel coated balloon was associated with less late lumen loss, binary stenosis, and target lesion revascularization at 6 months compared with uncoated balloon.
Based on these data, patients will be followed for up to 2 years to evaluate if the benefit persists. Restenosis tends to occur later in the superficial femoral artery (SFA) than in the coronary arteries, highlighting the need for continued late follow-up. The Paccocath paclitaxel coated balloon was also evaluated in the setting of coronary in-stent restenosis in the PACCOCATH ISR trial.
Presented by Dr. Gunnar Tepe at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.
Keywords: Paclitaxel, Follow-Up Studies, Coronary Restenosis, Thrombosis, Femoral Artery, Peripheral Arterial Disease, Constriction, Pathologic, Stents
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