RESUMEN
BACKGROUND: Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There are currently no long-term clinical data for this novel treatment for PAD. We present the 3-year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below-the-knee arteries. METHODS: The XTOSI pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation-free survival (AFS), overall survival, and ulcer-free status. RESULTS: At 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3%, and ulcer-free status in remaining survivors with intact limbs was 100%. For femoropopliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70%, and overall survival was 70%. For below-the-knee lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6%, and overall survival was 58.6%. CONCLUSIONS: SCB in the XTOSI pilot study showed promising clinical results sustained to 3 years, and no long-term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD.
Asunto(s)
Amputación Quirúrgica , Angioplastia de Balón , Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Arteria Femoral , Recuperación del Miembro , Enfermedad Arterial Periférica , Arteria Poplítea , Supervivencia sin Progresión , Sirolimus , Dispositivos de Acceso Vascular , Grado de Desobstrucción Vascular , Humanos , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Masculino , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Angioplastia de Balón/instrumentación , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Estudios Prospectivos , Anciano , Femenino , Proyectos Piloto , Factores de Tiempo , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Persona de Mediana Edad , Factores de Riesgo , Anciano de 80 o más Años , Resultado del TratamientoRESUMEN
PURPOSE: To evaluate the clinical effectiveness and safety of drug-coated balloons (DCBs) compared with those of percutaneous transluminal angioplasty (PTA) for arteriovenous fistula (AVF) stenosis via a review of systematic reviews (SRs) and an update of the current meta-analysis. MATERIALS AND METHODS: Literature was searched to retrieve SRs comparing DCBs and PTA for AVFs. A narrative review of SRs and pooled analysis were performed. RESULTS: Eleven SRs were included. DCBs demonstrated favorable outcomes at 6 and 12 months compared with PTA, with improved patency in 7 SRs and a trend toward favorable outcomes without statistical significance in 3 SRs. Target lesion revascularization (TLR) was reported in 3 SRs; 2 reviews reported a significantly lower incidence in the DCB group than in the PTA group, whereas 1 review reported no significant differences at 12 months. Four studies reporting all-cause mortality revealed no significant difference between the 2 treatments. In the updated meta-analysis including 23 studies, DCBs demonstrated improved primary patency at 6 months (risk ratio [RR], 1.27; 95% CI, 1.07-1.50) and 12 months (RR, 1.36; 95% CI, 1.19-1.55) and were associated with a lower incidence of TLR at 6 months (RR, 0.54; 95% CI, 0.41-0.73) and 12 months (RR, 0.78; 95% CI, 0.62-0.99). There was no difference in mortality between the 2 groups for 24 months. CONCLUSIONS: A review of SRs and meta-analysis update revealed the consistent benefits of DCBs over PTA in treating AVFs in terms of primary patency and TLR. Compared with PTA, DCBs do not increase mortality risk.
Asunto(s)
Angioplastia de Balón , Derivación Arteriovenosa Quirúrgica , Materiales Biocompatibles Revestidos , Grado de Desobstrucción Vascular , Humanos , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Resultado del Tratamiento , Derivación Arteriovenosa Quirúrgica/efectos adversos , Derivación Arteriovenosa Quirúrgica/mortalidad , Oclusión de Injerto Vascular/terapia , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/fisiopatología , Oclusión de Injerto Vascular/diagnóstico por imagen , Factores de Riesgo , Diálisis Renal , Dispositivos de Acceso Vascular , Diseño de Equipo , Factores de TiempoRESUMEN
BACKGROUND: Intracranial artery atherosclerotic stenosis (ICAS) is a major cause of stroke, especially in Asian countries. Current treatment options, including balloon-mounted stent (BMS) and balloon angioplasty (BA), lack sufficient evidence to determine a preferred approach. This systematic review and meta-analysis aimed to compare the efficacy and safety of BMS and BA in treating ICAS. METHODS: Following PRISMA 2020 guidelines, we conducted a comprehensive search in PubMed, Web of Science, and Scopus up to December 1, 2023. Eligible studies compared BMS with BA in patients diagnosed with ICAS. Primary outcomes included the success rate and occurrence of stroke (ischemic or hemorrhagic). Secondary outcomes were perforator occlusion, in-stent thrombosis, death, and restenosis. Statistical analysis was conducted using R software version 4.3.1, employing a random-effects model. RESULTS: Five high-quality studies involving 707 patients (515 males, 192 females) were included. BMS had a significantly higher success rate compared to BA (Risk Ratio [RR]: 1.13; CI: 1.03 to 1.24, p < 0.01; I2 = 14 %). The overall risk for stroke (ischemic and hemorrhagic) was significantly higher in BMS (RR: 2.97; CI: 1.32 to 6.67, p < 0.01; I2 = 0 %). However, no significant difference was found between BMS and BA regarding ischemic stroke (RR: 2.33; CI: 0.80 to 6.74, p = 0.12; I2 = 0 %). Additionally, no significant differences were observed in terms of perforator occlusion, in-stent thrombosis, dissection, minor and major strokes, and mortality rates. BMS was associated with a lower risk of restenosis (RR: 0.31; 95 % CI: 0.12 to 0.83, p = 0.02; I2 = 0 %). CONCLUSION: Our results indicate that BMS might be associated with higher success and lower restenosis rates than BA in the treatment of ICAS but with an increased overall risk of stroke. No significant differences were observed in ischemic stroke, perforator occlusion, in-stent thrombosis, dissection, minor and major strokes, and mortality rates. The choice of treatment should consider these findings, alongside the technical challenges and desired angiographic outcomes. Future randomized controlled trials are necessary to further elucidate these results.
Asunto(s)
Angioplastia de Balón , Arteriosclerosis Intracraneal , Stents , Humanos , Resultado del Tratamiento , Arteriosclerosis Intracraneal/terapia , Arteriosclerosis Intracraneal/mortalidad , Arteriosclerosis Intracraneal/diagnóstico por imagen , Factores de Riesgo , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Masculino , Femenino , Anciano , Persona de Mediana Edad , Medición de Riesgo , Accidente Cerebrovascular Isquémico/mortalidad , Accidente Cerebrovascular Isquémico/terapia , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/etiología , Diseño de Prótesis , Anciano de 80 o más Años , Accidente Cerebrovascular Hemorrágico/mortalidadRESUMEN
PURPOSE: To compare the efficacy and safety between paclitaxel coated balloon (PCB) angioplasty and conventional balloon (CB) angioplasty in the treatment of dysfunctional arteriovenous fistula (AVF). METHODS: We searched four major electronic databases (PubMed, EMBASE, Web of Science and the Cochrane Library) for randomized controlled trials (RCTs) published from inception through November 28, 2021. Outcomes of interest included target lesion primary patency (TLPP), technical success and all-cause mortality. The STATA package version 15.1 was utilized to undertake meta-analyses. RESULTS: Fourteen RCTs totaling 1535 patients were analyzed. The available data showed that there were no significant differences of TLPP rates at 3, 6, 9 and 12 months between the PCB group and the CB group (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93-1.07, p = 1.000, I2 = 33.5%, Cochrane Q test p = 0.185, fixed-effect model; RR 1.17, 95% CI 0.99-1.39, p = 0.065, I2 = 75.4%, Cochrane Q test p = 0.000, random-effect model; RR 0.81, 95% CI 0.35-1.89, p = 0.625, I2 = 62.8%, Cochrane Q test p = 0.045, random-effect model; RR 1.19, 95% CI 0.97-1.47, p = 0.096, I2 = 40.5%, Cochrane Q test p = 0.071, random-effect model). In addition, two groups had similar technical success rates (RR 1.00, 95% CI 0.97-1.03, p = 1.000, I2 = 0.0%, Cochrane Q test p = 0.596, fixed-effect model) and all-cause mortality rates (RR 1.00, 95% CI 0.54-1.84, p = 1.000, I2 = 0.0%, Cochrane Q test p = 0.599, fixed-effect model). CONCLUSIONS: PCB angioplasty did not appear to convey any obvious advantage over CB angioplasty in the treatment of dysfunctional AVF. However, further multi-center, large-scale and well-designed RCTs are needed to prove outcomes.
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Angioplastia de Balón/instrumentación , Fístula Arteriovenosa/terapia , Derivación Arteriovenosa Quirúrgica/efectos adversos , Paclitaxel/administración & dosificación , Diálisis Renal/efectos adversos , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Fístula Arteriovenosa/etiología , Derivación Arteriovenosa Quirúrgica/mortalidad , Materiales Biocompatibles Revestidos , Humanos , Paclitaxel/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Diálisis Renal/mortalidad , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality. METHODS: We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline). RESULTS: A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively. CONCLUSIONS: Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.
Asunto(s)
Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Arteria Femoral , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Sirolimus/administración & dosificación , Anciano , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Fármacos Cardiovasculares/efectos adversos , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Recuperación del Miembro , Masculino , Paclitaxel/efectos adversos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Placa Aterosclerótica , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Supervivencia sin Progresión , Sirolimus/efectos adversos , Factores de Tiempo , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Atherectomy is currently being used extensively for occlusive peripheral artery disease (PAD) interventions without proven benefits. This analysis examines the effects of atherectomy and other endovascular interventions on patient survival. OBJECTIVES: The aim of this study is to compare overall survival for patients undergoing PAD endovascular interventions, such as plain old balloon angioplasty (POBA), stent deployment and atherectomy. METHODS: Propensity score matched cohorts were constructed to conduct pairwise comparisons of overall survival in patients who underwent stenosis and occlusive PAD interventions between May 2011 and February 2020 using Vascular Quality Initiative (VQI) regional registry data. Inverse probability treatment weighting method was used to compare secondary outcomes of in-hospital mortality, length of stay, complications and major amputations. Comparative analysis was performed for POBA vs stenting, POBA vs atherectomy, and stenting vs atherectomy. RESULTS: A total number of 15281 eligible cases were identified. After propensity score matching, 6094, 4032, and 3312 cases were used to compare POBA versus stent deployment, POBA versus atherectomy and stent versus atherectomy, respectively. Stent deployment had significantly better overall survival compared with POBA and atherectomy (P < 0.001). Multivariable Cox proportional hazard models suggested stenting was associated with a reduction in mortality hazard by 30% compared with POBA (HR: 0.7; 95% CI: 0.6-0.82; P < 0.001) and a 40% mortality reduction compared with atherectomy (HR: 0.6; 95% CI: 0.48-0.75; P < 0.001). No significant difference was found between POBA and atherectomy. There was no statistical difference in other secondary outcomes which were comparable among all cohorts. CONCLUSIONS: Stent deployment was significantly superior to POBA and atherectomy in terms of overall survival with comparable complication and amputation rates. The natural history of PAD patients presenting with claudication is associated with an extremely low annual mortality risk. Therefore, further examinations of outcomes, especially in regards to mortality rates, both POBA and atherectomy on the management of PAD patients especially those presenting with claudication is warranted.
Asunto(s)
Angioplastia de Balón , Aterectomía , Enfermedad Arterial Periférica/terapia , Anciano , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Aterectomía/efectos adversos , Aterectomía/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Tiempo de Internación , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Puntaje de Propensión , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: A systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to determine the effectiveness and safety of drug coated balloon (DCB) angioplasty compared with uncoated plain balloon (PB) angioplasty in treating arteriovenous access stenosis. METHODS: MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched for RCTs comparing paclitaxel coated DCB and PB angioplasty for arteriovenous access stenosis. The last date of the literature search was 31 December 2020. Risk of bias of the retrieved studies was assessed with the Cochrane Collaboration tool for assessing risk of bias (RoB 2.0). The random effects model was used to estimate the risk of loss of target lesion patency (six and 12 months) and circuit patency (six and 12 months). Procedure related adverse events and mortality rate were also compared. Patency results were pooled using the time to event meta-analytical method and the quality of evidence was assessed according to the GRADE approach. RESULTS: Sixteen eligible trials, including 1 682 lesions, were included in the quantitative analysis for the efficacy and safety of paclitaxel coated DCBs. DCBs were associated with a lower risk of loss of target lesion patency at six months (HR 0.53, 95% CI 0.42 - 0.66) and 12 months (HR 0.60, 95% CI 0.47 - 0.76), and were also associated with improved six and 12 month circuit patency. Overall quality of evidence was moderate to low. Procedural complications were rare, and the risk of death up to 12 months was similar between the two groups (OR 1.03, 95% CI 0.68 - 1.56). CONCLUSION: Paclitaxel coated DCBs reduced the risk of loss of target lesion patency and circuit patency in arteriovenous access stenosis compared with PBs. Considering the heterogeneity of the included trials, there is a need to investigate optimal treatment regimens regarding drug dose and agent of the DCB and the treatment procedure.
Asunto(s)
Angioplastia de Balón/instrumentación , Derivación Arteriovenosa Quirúrgica/efectos adversos , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Oclusión de Injerto Vascular/terapia , Paclitaxel/administración & dosificación , Diálisis Renal , Dispositivos de Acceso Vascular , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Derivación Arteriovenosa Quirúrgica/mortalidad , Fármacos Cardiovasculares/efectos adversos , Femenino , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/mortalidad , Oclusión de Injerto Vascular/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Paclitaxel/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Drug-coated balloons (DCBs) have shown superiority in the endovascular treatment of short femoropopliteal artery disease. Few studies have focused on outcomes in long lesions. This study aimed to evaluate the safety and effectiveness of Orchid® DCBs in long lesions over 1 year of follow-up. METHODS: This study is a multicentre cohort and real-world study. The patients had lesions longer than or equal to 150 mm of the femoropopliteal artery and were revascularized with DCBs. The primary endpoints were primary patency, freedom from clinically driven target lesion revascularization (TLR) at 12 months and major adverse events (all-cause death and major target limb amputation). The secondary endpoints were the changes in Rutherford classification and the ankle brachial index (ABI). RESULTS: One hundred fifteen lesions in 109 patients (mean age 67 ± 11 years, male proportion 71.6%) were included in this study. The mean lesion length was 252.3 ± 55.4 mm, and 78.3% of the lesions were chronic total occlusion (CTO). Primary patency by Kaplan-Meier estimation was 98.1% at 6 months and 82.1% at 12 months. The rate of freedom from TLR by Kaplan-Meier estimation was 88.4% through 12 months. There were no procedure- or device-related deaths through 12 months. The rate of all-cause death was 2.8%. Cox regression analysis suggested that renal failure and critical limb ischaemia (CLI) were statistically significant predictors of the primary patency endpoint. CONCLUSION: In our real-world study, DCBs were safe and effective when used in long femoropopliteal lesions, and the primary patency rate at 12 months by Kaplan-Meier estimation was 82.1%.
Asunto(s)
Angioplastia de Balón/instrumentación , Materiales Biocompatibles Revestidos , Arteria Femoral , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Dispositivos de Acceso Vascular , Anciano , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Beijing , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX. METHODS: We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR. CONCLUSIONS: In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.
Asunto(s)
Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Isquemia/terapia , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Fármacos Cardiovasculares/efectos adversos , Enfermedad Crónica , Diseño de Equipo , Femenino , Humanos , Isquemia/diagnóstico , Isquemia/mortalidad , Isquemia/fisiopatología , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Paclitaxel/efectos adversos , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Supervivencia sin Progresión , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de TiempoRESUMEN
PURPOSE: Reporting outcomes with a new generation paclitaxel eluting balloon (Luminor®; iVascular, Vascular, S.L.U., Barcelona, Spain) in the popliteal district. Endovascular treatment of popliteal artery atherosclerotic disease is still debated without definitive evidences. METHODS: From January to June 2019, patients' data presenting popliteal artery atherosclerotic diseases and treated with the Luminor® (iVascular) drug eluting balloon (DEB) were prospectively collected. Critical limb ischemia (CLI) or severe claudication associated with popliteal artery stenosis >50% were the inclusion criteria. Measured outcomes were technical success, early and late results; including mortality, morbidity, symptoms recurrence, amputation, ankle-brachial index (ABI), survival, primary patency, secondary patency, freedom from restenosis. Median follow-up was 22.43 ± 4 (mean:21.58; IQR:20-24) months. RESULTS: Of the 33 included patients, 28 (85%) were diagnosed with CLI, with a mean preoperative run-off score of 5.39 (r:0-10; SD:3) and a chronic popliteal occlusion in 21 (64%). Technical success was achieved in all cases. Perioperative mortality was observed in 1 (3%) patient and perioperative complications in 2 (6%). During the follow-up were reported 2 symptoms recurrence; a significant ABI increase (0.57; IQR:0.41-0.47 vs. 0.69; IQR:0.50-0.67; P < 0.01); 1 (3%) major and 2 (6%) minor amputations. Estimated 24 months survival, primary patency, secondary patency, and freedom from restenosis were 97%, 96.9%, 100%, and 93.8% respectively. CONCLUSIONS: In this prospective study, the use of the Luminor® (iVascular) was safe and effective in addressing atherosclerotic popliteal artery lesions. Larger studies with longer term-outcomes are required to assess the durability of this device in the popliteal artery.
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Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Claudicación Intermitente/terapia , Isquemia/terapia , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Placa Aterosclerótica , Arteria Poplítea , Dispositivos de Acceso Vascular , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Fármacos Cardiovasculares/efectos adversos , Constricción Patológica , Enfermedad Crítica , Diseño de Equipo , Femenino , Humanos , Claudicación Intermitente/diagnóstico por imagen , Claudicación Intermitente/mortalidad , Claudicación Intermitente/fisiopatología , Isquemia/diagnóstico por imagen , Isquemia/mortalidad , Isquemia/fisiopatología , Recuperación del Miembro , Masculino , Paclitaxel/efectos adversos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Estudios Prospectivos , Recurrencia , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Drug-coated balloons (DCB) have shown promising results for the percutaneous treatment of de novo and restenotic lesions, involving both the coronary and femoropopliteal district. However, clinical outcomes data associated with the use of this devices are still unclear, with potential warnings on increased mortality being raised from initial studies. We aimed at performing an updated and comprehensive meta-analysis comparing DCB with conventional percutaneous revascularization strategies for the treatment of coronary (CAD) or peripheral artery disease (PAD). METHODS: Literature and main scientific session abstracts were searched for studies comparing DCB vs a standard percutaneous revascularization strategy, with or without stenting, for the treatment of CAD and PAD. The primary efficacy endpoint was mortality. Secondary endpoints were recurrent acute ischemic events (myocardial infarction or amputation) or target lesion revascularization (TLR). RESULTS: We included 45 randomized trials, (CAD: 27 studies, PAD: 18 studies) with an overall population of 7718 patients, (56.4%) randomized to a DCB strategy. At a mean follow-up of19.3 ± 15.2 months, death occurred in 5.8% of the patients, with no significant difference between DCB or conventionally treated patients (5.9% vs 5.7%, OR[95%CI] = 0.89[0.71,1.11], p = 0.31; phet = 0.43). We observed a non-significant reduction in recurrent acute ischemic events, whereas the use of DCB significantly reduced the rate of TLR, with larger benefits observed in patients with PAD and respect to balloon-only angioplasty, while being lower in comparison with stent implantation. No significant interaction was observed with de novo lesions or in-stent restenosis. CONCLUSIONS: Based on the current meta-analysis, the use of drug-coated balloons for the percutaneous treatment of CAD and PAD is associated to a comparable risk of mortality and recurrent acute ischemic events as compared to a conventional revascularization strategy, although offering larger benefits in terms of TLR, especially when compared with balloon-only angioplasty and in femoropopliteal disease.
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Síndrome Coronario Agudo/terapia , Angioplastia Coronaria con Balón/instrumentación , Angioplastia de Balón/instrumentación , Catéteres Cardíacos , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad Arterial Periférica/terapia , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/mortalidad , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/etiología , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/mortalidad , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
There have been concerns about the long-term risk of all-cause death with the use of paclitaxel-coated devices in the lower limbs. Results from a 2018 meta-analysis were corroborated by the US Food and Drug Administration and later confirmed by an individual patient data meta-analysis. However, population-based observational studies have produced contradictory results and often claimed a survival benefit with the use of paclitaxel. The recently published Swedish drug-elution trial in peripheral arterial disease did not confirm a significant mortality risk. In this review, the authors discuss the key elements of the identified mortality signal and stress important facts and figures that remain underrecognized and elusive. They also highlight the important types of epidemiological bias that pertain to the ongoing debate on paclitaxel.
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Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Extremidad Inferior/irrigación sanguínea , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Dispositivos de Acceso Vascular , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Fármacos Cardiovasculares/efectos adversos , Medicina Basada en la Evidencia , Humanos , Paclitaxel/efectos adversos , Seguridad del Paciente , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Diseño de Prótesis , Medición de Riesgo , Factores de Riesgo , Resultado del TratamientoRESUMEN
INTRODUCTION: Despite the BASIL-1 trial concluding that bypass surgery (BS) was superior to plain balloon angioplasty (PBA) in terms of longer-term amputation free (AFS) and overall survival (OS), CLTI patients are increasingly offered an endovascular-first revascularization strategy. This study investigates whether the results of BASIL-1 are still relevant to current practice by comparing femoro-popliteal (FP) BS with PBA in a series of CLTI patients treated in our unit 10 years after BASIL-1 (1999-2004). METHODS: We retrospectively analyzed prospectively gathered hospital data pertaining to 279 patients undergoing primary FP BS or PBA for CLTI in the period 2009 to 2014. We report baseline characteristics, 30-day morbidity and mortality, major adverse cardiovascular events (MACE) and long-term AFS, limb salvage (LS), OS, major adverse limb events (MALE), and freedom from re-intervention (FFR). RESULTS: 234 (84%) and 45 (16%) patients underwent PBA and BS respectively. PBA patients were significantly older (77 vs 71 years, P = 0.001) and more likely to be female (45% vs 28%, P = 0.026). Bollinger and GLASS anatomic scores were significantly more severe in the BS group. Technical success was better for BS (100% vs 87%, P = 0.007). Index hospital stay was shorter for PBA (9.1 vs 15.6 days, P = 0.035) but there was no difference in hospital days or admissions over the next 12 months. AFS (HR 1.00), LS (HR 1.44), OS (HR 0.81), MALE (HR 1.25) and FFR (HR = 1.00) were not significantly different between PBA and BS. CONCLUSION: Important clinical outcomes following FP BS and PBA for CLTI have not changed significantly in our unit in the 10 years following the BASIL-1 trial. BASIL-1 therefore remains relevant to our current practice and should inform our approach to the management of CLTI going forward.
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Angioplastia de Balón , Arteria Femoral/cirugía , Isquemia/terapia , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/cirugía , Injerto Vascular , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Enfermedad Crónica , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Isquemia/diagnóstico por imagen , Isquemia/fisiopatología , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Supervivencia sin Progresión , Estudios Retrospectivos , Factores de Tiempo , Injerto Vascular/efectos adversos , Injerto Vascular/mortalidadRESUMEN
We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.
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Angioplastia de Balón/mortalidad , Arteria Femoral , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Causas de Muerte , Materiales Biocompatibles Revestidos , Europa (Continente) , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Malasia , Masculino , Persona de Mediana Edad , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Estudios Prospectivos , Recurrencia , Resveratrol/administración & dosificación , Medición de Riesgo , Factores de Riesgo , Factores Sexuales , Factores de Tiempo , Resultado del Tratamiento , Dispositivos de Acceso Vascular , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Tandem carotid artery lesions that involve simultaneous internal carotid artery (ICA) and common carotid artery (CCA) stenoses present a complex clinical problem. Some studies have shown that the addition of a retrograde proximal intervention to treat a CCA lesion during a carotid endarterectomy (CEA) increases the risk of stroke and death. However, the stroke and death risks associated with a totally endovascular approach to tandem lesions is unknown and is the subject of this study. METHODS: Vascular Study Group of New England data for the years 2005 to 2020 were queried for carotid artery stenting (CAS) procedures. Emergent and bilateral procedures, procedures for indications other than atherosclerosis, patients with prior ipsilateral CAS, ICA lesions with stenosis of less than 50%, and transcarotid procedures were excluded. The cohort was divided into tandem and isolated lesion groups. The primary outcome was the composite of stroke and death. Predictors of stroke or death were determined with multivariable logistic regression. RESULTS: There were 2016 carotid arteries stented in 1950 patients-1881 (96%) with isolated lesions and 135 (4%) with tandem lesions. The mean patient age was 69.6 ± 9.0 years. Tandem lesions were more likely to be present in women (50.4% vs 33.0%; P < .001) and in patients with a prior carotid endarterectomy (45.9% vs 35.4%; P = .014). Other covariates were similar between the groups. Symptomatic lesions accounted for 42.3% of cases (isolated, 42.2% vs tandem, 43.0%; P = .86). Arteries in the tandem group more often required multiple stents to treat the ICA lesion (9.6% vs 5.2%; P = .027). ICA neuroprotection had similar outcomes in both groups (tandem: success 94.1%, failure 3.7%; isolated: success 96.3%, failure 1.8%; P = .29). The tandem group experienced a higher 30-day mortality (2.2% vs 0.6%; P = .039), more perioperative neurologic events (stroke or transient ischemic attack) (8.1% vs 2.0%; P < .001), and a higher incidence of stroke or death (5.9% vs 1.9%; P = .002). Predictors of the primary outcome in the multivariable model included treatment of tandem lesions (odds ratio [OR], 3.10; 95% confidence interval [CI], 1.39-6.89; P = .006), symptomatic lesions (OR, 2.24; 95% CI, 1.21-4.17; P = .010), chronic obstructive pulmonary disease (OR, 2.14; 95% CI, 1.17-3.92; P = .014), general anesthesia (OR, 3.34; 95% CI, 1.35-8.26; P = .009), and advancing age (OR, 1.05 per year; 95% CI, 1.01-1.09; P = .006). CONCLUSIONS: The addition of endovascular treatment of tandem CCA lesions with CAS is associated with a three-fold increase in perioperative stroke and death and should be avoided if possible.
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Angioplastia de Balón/efectos adversos , Arteria Carótida Común , Estenosis Carotídea/terapia , Accidente Cerebrovascular/etiología , Anciano , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Arteria Carótida Común/diagnóstico por imagen , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Stents , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: We evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD). METHODS: In this prospective, multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment. RESULTS: During the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period. CONCLUSIONS: We found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.
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Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Arteria Femoral , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Dispositivos de Acceso Vascular , Anciano , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , China , Diseño de Equipo , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Estudios Prospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population. MATERIALS AND METHODS: This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints. RESULTS: The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for ≥120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005). CONCLUSIONS: The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas.
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Angioplastia de Balón/instrumentación , Derivación Arteriovenosa Quirúrgica/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Oclusión de Injerto Vascular/terapia , Paclitaxel/administración & dosificación , Diálisis Renal , Dispositivos de Acceso Vascular , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Derivación Arteriovenosa Quirúrgica/mortalidad , Asia , Implantación de Prótesis Vascular/mortalidad , Europa (Continente) , Femenino , Oclusión de Injerto Vascular/diagnóstico por imagen , Oclusión de Injerto Vascular/mortalidad , Oclusión de Injerto Vascular/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Recurrencia , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
PURPOSE: To assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: This prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. RESULTS: LLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). CONCLUSIONS: Despite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.
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Angioplastia de Balón/instrumentación , Derivación Arteriovenosa Quirúrgica/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Oclusión de Injerto Vascular/terapia , Paclitaxel/administración & dosificación , Diálisis Renal , Dispositivos de Acceso Vascular , Anciano , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Derivación Arteriovenosa Quirúrgica/mortalidad , Implantación de Prótesis Vascular/mortalidad , Femenino , Oclusión de Injerto Vascular/diagnóstico por imagen , Oclusión de Injerto Vascular/mortalidad , Oclusión de Injerto Vascular/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Quebec , Recurrencia , Factores de Riesgo , Método Simple Ciego , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
OBJECTIVES: To compare the safety and efficiency of atherectomy plus drug-coated balloon with drug-coated balloon only for the treatment of femoropopliteal artery lesions. METHODS: This systematic review and meta-analysis was performed and reported following the requirement of the PRISMA. EMBASE, MEDLINE, and Cochrane library were queried from January 2000 to June 2020 to identify eligible literature. The modified Downs and Black checklist was used to assess the quality of included studies. Outcome measures included bail-out stenting, distal embolization, perforation, hematoma, primary patency at 12 months, target lesion revascularization at 12 months, leg amputation at 12 months, and mortality at 12 months. We used DerSimonian and Laird random-effects model to pool the dichotomous data on risk ratio (RR) with 95% confidence intervals (CIs) from each study to obtain an overall estimate for major outcomes. Subgroup analysis and sensitivity analyses were conducted. RESULTS: Six studies (two randomized controlled trials and four retrospective cohort studies) with 470 patients were included. Atherectomy plus drug-coated balloon group was associated with lower rates of bail-out stenting (RR: 0.49, 95%CI: 0.34-0.71, P < 0.001). There was no significant difference between two groups in terms of distal embolization (RR: 2.06, 95%CI: 0.51-8.38, P = 0.31), perforation (RR: 2.04, 95%CI: 0.43-9.71, P = 0.37), hematoma (RR: 1.75, 95%CI: 0.43-7.09, P = 0.43), primary patency at 12 months (1.09, 95%CI: 0.98-1.21, P = 0.12), target lesion revascularization at 12 months (RR: 0.68, 95%CI: 0.41-1.14, P = 0.15), leg amputations at 12 months (RR: 0.54, 95%CI: 0.13-2.23, P = 0.39), mortality at 12 months (RR: 2.18, 95%CI: 0.71-6.64, P = 0.17). Sensitivity analysis had no effect on our findings. CONCLUSIONS: The combination of atherectomy and drug-coated balloon was safe and effective in the treatment of femoropopliteal artery lesions, with lower incidence of bail-out stenting compared with drug-coated balloon only.
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Angioplastia de Balón/instrumentación , Aterectomía , Materiales Biocompatibles Revestidos , Arteria Femoral , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Dispositivos de Acceso Vascular , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Aterectomía/efectos adversos , Aterectomía/mortalidad , Diseño de Equipo , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Paclitaxel-coated devices have been shown to decrease restenosis when used in the femoropopliteal artery. Recent reports have suggested a possible risk of increased late mortality in patients treated with paclitaxel. It has been suggested that younger patients and those with limited comorbidities may be at higher risk. Our objective was to analyze long-term mortality based on patient age comparing treatment with paclitaxel to uncoated devices. METHODS: We performed a retrospective review of 1,170 consecutive patients who underwent femoropopliteal percutaneous intervention by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. Patients were grouped by age at the time of procedure: <60 years old (n = 244, 20.9%), 60-80 years old (n = 635, 54.3%), and >80 years old (n = 291, 24.9%). Within each group, patients were further divided by use of paclitaxel. The primary outcome measure was survival assessed by Kaplan-Meier analysis. Differences between the groups were analyzed with analysis of variance. Multivariable analysis was performed using Cox proportional hazard models. RESULTS: Of the 1,170 patients who underwent femoropopliteal percutaneous intervention, 654 (55.9%) received a paclitaxel-coated device during treatment and 516 (44.1%) did not. Mean age of the overall patient cohort was 70.4 ± 12.6 years and 663 (56.7%) were male. When comparing the groups by age we found an increase in age but a decrease in the proportion of patients who smoke. The use of paclitaxel-coated devices was similar across the groups (<60 years old, 56.2%; 60-80 years old, 57.0%; >80 years old, 52.6%; P = 0.45). Demographics and comorbidities were similar between the patients treated with and without paclitaxel within each age group except more males in the <60-year-old group treated without paclitaxel and more patients with chronic limb threatening ischemia in the >80-year-old group treated with paclitaxel. In patients <60 and 60-80 years old paclitaxel use was associated with increased survival at 4 years: <60 (80.7% vs. 64.4%; P = 0.04); 60-80 (63.2% vs. 55.1%; P = 0.04). Survival was similar in the >80-year-old group (46.6% vs. 32.8%; P = 0.65). CONCLUSIONS: Our data suggest that the use of paclitaxel-coated arterial devices is not associated with increased mortality. On the contrary, our data show that younger patients treated with paclitaxel show improved survival compared with those treated without paclitaxel. Paclitaxel-coated devices may be used with continued caution especially in patients at high risk for restenosis.