Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention

Wittig, Tim; Schmidt, Andrej; Kabelitz, Maria; Hukauf, Martin; Pflug, Toni; Scheinert, Dierk; Steiner, Sabine

doi:10.1016/j.ejvs.2022.08.004

Cited by 3 publications

(1 citation statement)

References 23 publications

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“…In case of repeated interventions (e.g., in both limbs), each patient was included only once for the first intervention during the study period. The key characteristics of this patient population have been described in a previous study focusing on the impact of drug-coated balloon angioplasty in this patient cohort [13]. The inclusion criteria were age > 18 years, symptomatic PAD defined by categories 2-6 according to Rutherford classification and a target lesion below the tibial plateau.…”

Section: Study Design and Patient Populationmentioning

confidence: 99%

Impact of Optimal Medical Therapy on Reintervention and Survival Rates after Endovascular Infrapopliteal Revascularization

Wittig

Pflug

Schmidt

et al. 2023

JCM

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Within this single-center cohort study, we investigated the impact of optimal medical therapy on all-cause mortality, major amputation-free survival and clinically driven target lesion revascularization (CD TLR) in 552 patients with peripheral arterial disease (PAD) undergoing endovascular infrapopliteal revascularization. From the overall cohort, 145 patients were treated for intermittent claudication (IC) and 407 were treated for critical limb ischemia (CLI). Optimal medical therapy (OMT) was defined as the presence of at least one antiplatelet agent, statin and ACE inhibitor or AT-2 antagonist based on guideline recommendations. About half (55.5%) of all patients were prescribed OMT at discharge, with a higher proportion in claudicants (62.1%) versus CLI patients (53.2%). Over three years of follow-up, survival was significantly better in patients with IC (80.6 ± 3.8% vs. 59.9 ± 2.9%; p < 0.001). There was a signal towards better survival in those patients receiving OMT (log-rank p = 0.09). Similarly, amputation-free survival (AFS) was significantly better in patients with IC (p = 0.004) and also in patients receiving OMT (78.8 ± 3.6%) compared to that in those without OMT (71.5 ± 4.2%; p = 0.046). Freedom from CD TLR within three years was significantly better in the IC group (p = 0.002), but there were no statistically significant differences for CD TLR dependent on the presence of OMT (p = 0.79). In conclusion, there is still an important underuse of OMT in patients undergoing infrapopliteal interventions, which is even more pronounced in CLI despite a signal for its benefit regarding all-cause mortality and major amputation-free survival.

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Section: Study Design and Patient Populationmentioning

confidence: 99%

Impact of Optimal Medical Therapy on Reintervention and Survival Rates after Endovascular Infrapopliteal Revascularization

Wittig

Pflug

Schmidt

et al. 2023

JCM

Self Cite

View full text Add to dashboard Cite

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Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Chronic Limb-Threatening Ischemia: Six-month Outcomes of PRIME-WIFI

Guo,

Ye,

Zhang

et al. 2023

J Endovasc Ther

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Purpose: To evaluate 6-month outcomes of drug-coated balloon (DCB) angioplasty of infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Methods: We analyzed 6-month follow-up data from the 10-center PRIME-WIFI prospective registry on 300 consecutive patients (33.000% female) with CLTI who underwent DCB angioplasty for infrapopliteal arterial lesions. The primary outcome was freedom from major adverse event (MAE), a composite of major amputation, all-cause death, and clinically-driven target limb reintervention (CD-TLR). Secondary outcomes included amputation-free survival (AFS), freedom from each primary outcome component, primary sustained clinical improvement, and quality of life (QOL) score. Independent risk factors of MAE were determined using Cox proportional hazards regression analysis. Results: A total of 409 infrapopliteal lesions in 312 limbs were treated with DCB, with 54.167% of the limbs being treated for isolated infrapopliteal lesions. By Kaplan-Meier analysis, at 6 months post- procedure (follow-up rate, 85.000%), freedom from MAE was 86.353%; AFS was 90.318%; and freedom from major amputation, all-cause death, and CD-TLR were 96.429%, 93.480%, and 95.079%, respectively. At 6-month follow-up, 83.590% of patients showed primary sustained clinical improvement, and QOL score (4.902±1.388) improved compared with that before procedure (2.327±1.109; p<0.001). Chronic renal insufficiency, chronic obstructive pulmonary disease, Rutherford grade, and postoperative infrapopliteal runoff score were independent risk factors for MAE within 6 months. Conclusion: In CLTI, DCB angioplasty of infrapopliteal lesions yields acceptable early efficacy and safety. Clinical Impact This study evaluated the 6-month outcomes of DCB angioplasty in infrapopliteal lesions in CLTI patients by analyzing multicenter prospective data, showing that infrapopliteal DCB angioplasty can be performed with acceptable freedom from MAE rate, amputation-free survival rate, freedom from major amputation rate, survival rate, and freedom from CD-TLR rate. No patient experienced DCB-related intraoperative distal embolism. Chronic renal insufficiency, chronic obstructive pulmonary disease, Rutherford grade and postoperative infrapopliteal runoff score were independent risk factors for MAE within 6 months. Comparative real-world studies are needed.

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Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population: A Multicenter Post-Market Surveillance Study

Choi,

Won,

Jae

et al. 2024

Korean J Radiol

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Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention

Cited by 3 publications

References 23 publications

Impact of Optimal Medical Therapy on Reintervention and Survival Rates after Endovascular Infrapopliteal Revascularization

Impact of Optimal Medical Therapy on Reintervention and Survival Rates after Endovascular Infrapopliteal Revascularization

Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions in Chronic Limb-Threatening Ischemia: Six-month Outcomes of PRIME-WIFI

Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population: A Multicenter Post-Market Surveillance Study

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