Outcomes of Treatment With Paclitaxel-Coated Devices for Peripheral Arterial Disease

Abstract

Treatment of femoropopliteal peripheral artery disease using paclitaxel-coated devices (PCD) has been shown to improve patency in several randomized trials. However, a recent meta-analysis of trial data suggested an increased risk of mortality with the use of this technology. Although subsequent studies have found no association with mortality, real-world data are lacking. Thus, the aim of this study is to investigate real-world outcomes and causes of mortality of patients treated with PCD. Patients who underwent endovascular interventions for peripheral artery disease from 2013 to 2016 at a single institution were reviewed. Patients were stratified based on the use of PCD. The cumulative dose of paclitaxel over a 3-year period was calculated among patients who received multiple interventions. Causes of mortality were identified and compared between the two groups. There were 138 (37.7%) patients who received an endovascular intervention with a PCD and 228 (62.3%) who received an endovascular intervention without paclitaxel. Patients treated with PCD were less likely to have prior open surgery compared to patients treated without paclitaxel. There were no differences in indication, TransAtlantic Inter-Society Consensus classification, or 30-day outcomes between the two groups. After 3-year follow-up, there was no difference in primary patency, reintervention rate, mean number of reinterventions, amputation (5.1% vs 3.5%; P = .465), or mortality (15.9% vs 19.7%; P = .363) between the PCD and non-PCD groups (Table). There was also no overall difference in the causes of mortality with and without PCD use or in the Kaplan-Meier survival curves (Figure). Furthermore, the use of PCD was not associated with an increased risk of mortality in Cox regression analysis. The cumulative dose of paclitaxel in patients treated with PCD ranged from 383 to 49,259 μg with a median dose of 7561 μg. Comparison of patients treated with cumulative doses of paclitaxel in the upper 50th percentile compared to the lower 50th percentile showed no significant difference in mortality (13.0% vs 19.1%; P = .333). PCD use is safe and not associated with an increased risk of long-term mortality in this study. However, PCD use was not associated with improved LER outcomes. Continued monitoring of PCD is warranted to ensure safety and efficacy of this new technology in a real-world setting.TableDemographics, comorbidities, procedural characteristics, and outcomesNon-PCD paclitaxelPCDP valueDemographics and comorbidities No. of patients228138 Age (years)69.7 ± 11.469.7 ± 11.6.866 Male sex148 (64.9)89 (64.5).935 Race.693White171 (77.0)102 (77.7)African American33 (14.9)16 (12.2)Other18 (8.1)13 (9.9) Body mass index27.5 ± 5.929.2 ± 6.4.015 Diabetes120 (52.6)73 (52.9).960 Hypertension205 (89.9)133 (96.4).024 Coronary artery disease133 (58.3)75 (54.4).456 Chronic renal insufficiency31 (13.7)26 (18.8).192 Smoking.250Nonsmoker37 (16.4)30 (21.7)Former116 (51.3)73 (52.9)Current73 (32.3)35 (25.4) Prior endovascular revascularization53 (23.4)31 (22.5).846 Prior open revascularization30 (13.2)8 (5.8).025 Preoperative ABI0.7 ± 0.30.8 ± 0.3.290 Indication.195Asymptomatic5 (2.2)1 (0.7)Claudication131 (57.5)91 (65.9)Chronic limb-threatening ischemia92 (40.4)46 (33.3)Medications Antiplatelet192 (84.2)109 (79.0).205 Statin161 (70.6)99 (71.7).818Procedure characteristics TASC classification.227TASC A24 (26.1)22 (23.4)TASC B29 (31.5)22 (23.4)TASC C12 (13.0)9 (9.6)TASC D27 (29.4)41 (43.6)30-Day outcomes Return to operating room16 (7.3)9 (6.8).872 Any complication34 (14.9)17 (12.3).487 Mortality4 (1.75)0 (0.0).1183-Year outcomes Primary patency73 (52.4)45 (42.9).150 Ipsilateral reintervention67 (29.4)53 (38.4).075 Ipsilateral major amputation8 (3.5)7 (5.1).465 All-cause mortality45 (19.7)22 (15.9).363Deaths.807 No. of patients4522 Cause of deathCardiovascular12 (26.7)9 (40.9)Cancer5 (11.1)1 (4.5)Respiratory2 (4.4)2 (9.1)Neurologic1 (2.2)0 (0.0)Gastrointestinal2 (4.4)1 (4.6)Renal0 (0.0)0 (0.0)Infectious8 (17.8)3 (13.6)Other/unspecified15 (33.3)6 (27.3)ABI, Ankle-brachial index; PCS, paclitaxel-coated device; TASC II, Inter-Society Consensus of the Management of Peripheral Artery Disease.Values are mean ± standard deviation or number (%), unless otherwise indicated. Open table in a new tab