Objective To compare the mortality rates of patients with claudication and de novo femoropopliteal lesions treated with and without paclitaxel coated devices (PCD). Background A recent meta-analysis, mostly including patients with claudication and de novo femoropopliteal lesions but also with recurrent stenoses and critical limb ischemia, has shown a significant excess mortality in patients treated with PCD. Methods Comparison of two historical cohorts of patients presenting with claudication and de novo femoropopliteal lesions treated with and without PCD between 2008 and 2018. Results After review of 5219 arteriograms in patients presenting with peripheral artery disease, 700 consecutive patients were included consisting in 72.6% of male (n = 508). Mean age was 68.1 ± 8.5 years. 45.7% of the patients (n = 320) had a treatment including a PCD. Mean femoropopliteal lesion length was 123 ± 91 mm including 44.6% of occlusions. Patients of the control group were censored at crossover to paclitaxel when applicable. Mortality rates at 1, 2 and 5 years were 4.6%, 7.5%, 19.4% and 1.6%, 6.2%, 16.6% in the non-PCD and PCD groups respectively. The relative risks of death when using PCD were 0.35 (p = 0.03), 0.83 (p = NS) and 0.86 (p = NS) at 1, 2 and 5 years respectively. Conclusion There was no excess mortality in patients with claudication and de novo femoropopliteal lesions treated with paclitaxel coated devices at 1, 2 and 5 years of follow-up in this cohort. The current study suggests that additional prospective randomized studies properly powered to study mortality are necessary.
Objective: To compare the mortality rates of patients with claudication and de novo femoropopliteal lesions treated with and without paclitaxel coated devices (PCD).Background: A recent meta-analysis, mostly including patients with claudication and de novo femoropopliteal lesions but also with recurrent stenoses and critical limb ischemia, has shown a significant excess mortality in patients treated with PCD.Methods: Comparison of two historical cohorts of patients presenting with claudication and de novo femoropopliteal lesions treated with and without PCD at our institution between 2008 and 2018.Results: After review of 5219 arteriograms in patients presenting with peripheral artery disease, 700 consecutive patients were included consisting in 72.6% of male (n=508). Mean age was 68.1±8.5 years. 45.7% of the patients (n=320) had a treatment including a PCD. Mean femoropopliteal lesion length was 123±91mm including 44.6% of occlusions. Patients of the control group were censored at crossover to paclitaxel when applicable. Mortality rates at 1, 2 and 5 years were 4.6%, 7.5%, 19.4% and 1.6%, 6.2%, 16.6% in the non-PCD and PCD groups respectively. The relative risks of death when using PCD were 0.35 (p=0.03), 0.83 (p= NS) and 0.86 (p= NS) at 1, 2 and 5 years respectively. Conclusion: There was no excess mortality in patients with claudication and de novo femoropopliteal lesions treated with paclitaxel coated devices at 1, 2 and 5 years of follow-up. The current study suggests that additional prospective randomized studies properly powered to study mortality are necessary.
Background: The Trans-Atlantic Inter-Society Consensus Document (TASC II) aims to comprehensively describe the case scenarios of aortoiliac and femoropopliteal lesions to suggest an endovascular or a surgical approach. Over time, it has become a guide for describing the gravity of arterial lesions. Purpose: To assess the revised TASC II system for classifying arterial lesions in a large database of patients presenting with claudication. Materials and Methods: This study was a retrospective review of the arteriograms of patients with intermittent claudication. Aortoiliac and femoropopliteal lesions were classified according to the TASC II. When no consensus was reached, the lesion was rated as unTASCable. Results: In total, 1454 patients were included (male: 62.1%, 66.8±9.3 years). There were 39% aortoiliac lesions (n=960/2462) and 61% femoropopliteal lesions (n=1502/2462); 33.6% of the patients (n=489/1454) were associated with aortoiliac and femoropopliteal lesions. In addition, 20% of the lesions (n=493/2462) were unTASCable, and 26.7% of the patients (n=388/1454) had at least 1 unTASCable lesion. There were 4 categories of unTASCable lesions: (1) association with a common femoral artery lesion in 53.1% (n=262/493); (2) iliac artery lesions in 23.1% (n=114/493); (3) femoropopliteal lesions whose lengths did not fit into any category in 16.6% (n=82/493); and (4) association with an aortic lesion in 7.1% (n=35/493). The interobserver agreement was 0.97 for anatomically describing the infrarenal arterial tree and 0.85 for TASCing, with the lesions lowering to 0.69 for aortoiliac lesions. Conclusion: Using the revised TASC II case scenario, 26.7% of the patients had at least 1 unTASCable lesion. Reporting peripheral artery disease using a comprehensive anatomical description of the infrarenal arterial tree showed better interobserver reproducibility.
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