Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience.

Background: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel coated devices. To assess the long-term mortality after paclitaxel drug-coated (DCB) and uncoated balloon angioplasty (POBA) of femoropopliteal lesions in patients with ulcerations and gangrene in real world practice. Patients and methods: A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed. Results: Overall 624 patients with femoropopliteal lesions were included in this study. Of those, 197 patients were treated with POBA without crossover to a paclitaxel coated device during follow-up and 427 patients with DCB angioplasty. Mean follow-up time was 33.3 ± 25.4 months. Mortality incidence was 81.7% (95% confidence interval [95% CI]: 76.1-86.8) after POBA and 59.0% (95% CI: 54.6-63.9) after DCB (p < 0.001). Multivariate logistic regression analysis revealed type of treatment (POBA vs. DCB, (hazard ratio [HR]: 0.332, 95% CI: 0.215-0.514, p < 0.001), age per year (HR: 1.065, 95% CI: 1.046-1.087, p < 0.001), coronary heart disease (HR: 1.969, 95% CI: 1.323-2.930, p = 0.001), renal insufficiency (HR: 1.583, 95% CI: 1.079-2.323, p = 0.019), stroke (HR: 2.505, 95% CI: 1.431-4.384, p = 0.001) as predictors for all-cause mortality. In the subgroup excluding octogenarians, mortality predictors were type of treatment (HR: 0.463, 95% CI: 0.269-0.796, p = 0.005), age per year (HR: 1.035, 95% CI: 1.002-1.069, p = 0.038), coronary heart disease (HR: 2.082, 95% CI: 1.274-3.400, p = 0.003), stroke (HR: 2.203, 95% CI: 1.156-4.197, p = 0.016) and renal insufficiency (HR: 2.201, 95% CI: 1.357-3.571, p < 0.001). Conclusions: This monocentric retrospective analysis showed no survival disadvantage for patients in Rutherford-Becker stage 5 after treatment with paclitaxel-coated balloons.

[1]  J. Ioannidis,et al.  Mortality and Paclitaxel-Coated Devices , 2020, Circulation.

[2]  M. Waliszewski,et al.  Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons—A Pooled Analysis of Four Randomized Controlled Multicenter Trials , 2019, CardioVascular and Interventional Radiology.

[3]  L. Wann,et al.  ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and So , 2019, Journal of the American College of Cardiology.

[4]  S. Spiliopoulos,et al.  Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials , 2018, Journal of the American Heart Association.

[5]  K. Yamaji,et al.  Impact of Frailty on Clinical Outcomes in Patients With Critical Limb Ischemia , 2018, Circulation. Cardiovascular interventions.

[6]  S. Parikh,et al.  SCAI consensus guidelines for device selection in femoral‐popliteal arterial interventions , 2018, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[7]  I. Ott,et al.  Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound? , 2018, CardioVascular and Interventional Radiology.

[8]  F. Vermassen,et al.  Stellarex drug‐coated balloon for treatment of femoropopliteal arterial disease—The ILLUMENATE Global Study: 12‐Month results from a prospective, multicenter, single‐arm study , 2017, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[9]  K. Berger,et al.  Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence. , 2015, European heart journal.

[10]  D. Scheinert,et al.  Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease , 2015, Circulation.

[11]  Igor Rudan,et al.  Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis , 2013, The Lancet.

[12]  D Jackson,et al.  Meta‐analysis of contemporary short‐ and long‐term mortality rates in patients diagnosed with critical leg ischaemia , 2013, The British journal of surgery.

[13]  T. Albrecht,et al.  Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty: Evidence From the Randomized PACIFIER Trial , 2012, Circulation. Cardiovascular interventions.

[14]  V. Aboyans,et al.  Characteristics and outcome of patients hospitalised for lower extremity peripheral artery disease in France: the COPART Registry. , 2010, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[15]  C. Kalbaugh,et al.  Comparison of interventional outcomes according to preoperative indication: a single center analysis of 2,240 limb revascularizations. , 2009, Journal of the American College of Surgeons.

[16]  B. Hamm,et al.  Inhibition of Restenosis in Femoropopliteal Arteries: Paclitaxel-Coated Versus Uncoated Balloon: Femoral Paclitaxel Randomized Pilot Trial , 2008, Circulation.

[17]  R. Rutherford,et al.  Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. , 1991, Journal of vascular and interventional radiology : JVIR.

[18]  C. Claussen,et al.  Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. , 2015, JACC. Cardiovascular interventions.

[19]  D. Scheinert,et al.  The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. , 2014, JACC. Cardiovascular interventions.

[20]  L. Norgren,et al.  Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). , 2007, Journal of vascular surgery.