Paclitaxel-coated peripheral artery devices are not associated with increased mortality
| Autor: | Alexander H. King, Ravi N. Ambani, Jones P. Thomas, Jae S. Cho, Karem C. Harth, Jun Li, Virginia L. Wong, Mehdi H. Shishehbor, Norman H. Kumins, Vikram S. Kashyap, Saideep Bose |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Atherectomy Time Factors Paclitaxel medicine.medical_treatment 030204 cardiovascular system & hematology Prosthesis Design Revascularization Risk Assessment Peripheral Arterial Disease 03 medical and health sciences 0302 clinical medicine Coated Materials Biocompatible Restenosis Risk Factors Internal medicine Angioplasty Diabetes mellitus medicine Humans Popliteal Artery 030212 general & internal medicine Dialysis Survival analysis Aged Retrospective Studies Aged 80 and over business.industry Cardiovascular Agents Drug-Eluting Stents Middle Aged medicine.disease Femoral Artery Treatment Outcome Female Surgery Cardiology and Cardiovascular Medicine business Angioplasty Balloon Kidney disease |
| Zdroj: | Journal of Vascular Surgery. 72:968-976 |
| ISSN: | 0741-5214 |
| DOI: | 10.1016/j.jvs.2019.10.100 |
| Popis: | Objective Long-term safety concerns have been raised that the use of paclitaxel-coated balloons and stents is linked to excess mortality. Our objective was to compare outcomes in patients treated with paclitaxel vs uncoated devices and to analyze long-term mortality. Methods We conducted a retrospective single-institution review of 1170 consecutive patients who underwent femoropopliteal percutaneous revascularization by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. The primary outcome measure was all-cause mortality. Groups were divided into patients who received paclitaxel (n = 652) and those who did not (n = 518). Categorical variables were assessed using χ2 analysis and continuous variables with the Wilcoxon signed rank test. A multivariable analysis was performed using multivariable logistic regression models. Mortality was compared using Kaplan-Meier survival analysis. Results Demographics, risk factors, and Rutherford class were similar between the groups, except that the paclitaxel group was more likely to have diabetes (60.9% vs 55.0%; P = .04), was less likely to be on dialysis (10.7% vs 14.9%; P = .04), and had lower average creatinine concentration (1.6 ± 1.8 mg/dL vs 2.0 ± 2.3 mg/dL; P = .003). There were no differences in all-cause mortality through 2 years between paclitaxel and no-paclitaxel cohorts (25.5% vs 30.3%; log-rank, P = .098). At 3 years and 3.5 years, mortality was significantly lower in the paclitaxel group: year 3, 32.1% vs 39.4% (log-rank, P = .041); year 3.5, 35.2% vs 43.9% (log-rank, P = .027). Survival rates were not significantly different in examining subgroups by diabetes, chronic kidney disease, presence of chronic limb-threatening ischemia, or paclitaxel-coated balloon manufacturer. Multivariable analysis demonstrated that age, dialysis, chronic limb-threatening ischemia, chronic kidney disease, and congestive heart failure were independent risk factors for mortality, whereas paclitaxel use was associated with lower mortality. Conclusions The use of paclitaxel-coated balloons and stents does not increase mortality compared with uncoated devices out to 3.5 years. Paclitaxel-coated devices can be used with continued caution, especially in patients at increased risk of restenosis. Further long-term studies are needed to determine the risk of late mortality. |
| Databáze: | OpenAIRE |
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