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Comparison of Balloon Angioplasty and Stent Implantation for Femoropopliteal Disease According to Patient and Lesion Subgroup.

ABSTRACT: Background: Little is known about the superiority of balloon angioplasty vs. stent implantation for femoropopliteal (FP) lesions according to subgroup. Methods?and?Results: This study involved 1,018 de novo (balloon angioplasty, n=462; stent implantation, n=556) and 114 in-stent restenosis (ISR) FP lesions (balloon angioplasty, n=69; stent implantation, n=45) treated with endovascular therapy. For de novo FP lesions, the 3-year primary patency rate was significantly better with stent implantation than with balloon angioplasty (61% vs. 69%, log-rank P=0.001), but it was similar for ISR FP lesions (40% vs. 43%, log-rank P=0.83). For de novo FP lesions, stent implantation was favorable in all subgroups except for female sex (hazard ratio [HR], 0.92; 95% CI: 0.65-1.31, P=0.66), critical limb ischemia (CLI; HR, 0.70; 95% CI: 0.46-1.06, P=0.10), calcified lesion (HR, 0.81; 95% CI: 0.46-1.39, P=0.44), and poor tibial run-off (HR, 0.86; 95% CI: 0.59-1.25, P=0.42) subgroups. No difference was found between the 2 treatment strategies for ISR FP lesions in the majority of subgroups. Stent implantation, however, was favorable in totally occluded ISR FP lesions (HR, 0.45; 95% CI: 0.21-1.01, P=0.05). Conclusions: The primary patency rate in de novo FP lesions for the 2 treatment strategies was similar in the female, calcified lesion, CLI, and poor tibial run-off subgroups. Stent implantation was superior to balloon angioplasty for totally occluded ISR FP lesions.

SUBMITTER: Kobayashi N

PROVIDER: S-EPMC7890277 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Comparison of Balloon Angioplasty and Stent Implantation for Femoropopliteal Disease According to Patient and Lesion Subgroup.

Kobayashi Norihiro N Hirano Keisuke K Yamawaki Masahiro M Araki Motoharu M Sakai Tsuyoshi T Obokata Masaru M Sakamoto Yasunari Y Mori Shinsuke S Tsutsumi Masakazu M Nauchi Masahiro M Honda Yohsuke Y Makino Kenji K Shirai Shigemitsu S Sugizaki Yuta Y Fukagawa Tomoya T Kishida Toshihiko T Ito Yoshiaki Y

Circulation reports 20190201 2

Background: Little is known about the superiority of balloon angioplasty vs. stent implantation for femoropopliteal (FP) lesions according to subgroup. Methods and Results: This study involved 1,018 de novo (balloon angioplasty, n=462; stent implantation, n=556) and 114 in-stent restenosis (ISR) FP lesions (balloon angioplasty, n=69; stent implantation, n=45) treated with endovascular therapy. For de novo FP lesions, the 3-year primary patency rate was significantly ...[more]

PMID: 33693119

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Project description:The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal in-stent restenosis (ISR). Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) (all up to March 2019) were searched systematically. Trial sequential analysis (TSA) was conducted. 5 studies with 599 participants were included. Compared with PTA, DCB significantly increased the rate of patency (6 months: RR 1.65, 95% CI 1.30 to 2.09, P < 0.01; 12 months: RR 2.38, 95% CI 1.71 to 3.30, P < 0.01) and the rate freedom from target lesion revascularization (TLR) (6 months: RR 1.18, 95% CI 1.09 to 1.28, P < 0.01; 12 months: RR 1.56, 95% CI 1.33 to 1.82, P < 0.01) at 6 and 12 months follow-up, and the TSA results showed these outcomes were reliable. The rate of clinical improvement by ≥1 Rutherford category in the DCB group was higher than that in the PTA group (6 months: RR 1.35, 95% CI 1.03 to 1.75, P = 0.03; 12 months: RR 1.46, 95% CI 1.17 to 1.82, P < 0.01) at 6 and 12 months. There is no statistically difference of ABI, all-cause mortality, and incidence of amputation between DCB group and PTA group (MD 0.03, 95% CI -0.03 to 0.08, P = 0.40; RR 1.24, 95% CI 0.46 to 3.34, P = 0.67; RR 0.32, 95% CI 0.01 to 7.61, P = 0.48). Compared with PTA, the rate of patency and freedom from TLR in the laser atherectomy (LD) group was higher than that in the PTA group (patency: 6 months: RR 1.28, 95% CI 1.01 to 1.64, P < 0.05, 12 months: RR 2.25, 95% CI 1.14 to 4.44, P < 0.05; freedom from TLR: 6 months: RR 1.27, 95% CI 1.05 to 1.53, P = 0.01, 12 months: RR 1.59, 95% CI 1.12 to 2.25, P = 0.01) at 6 and 12 months follow-up. In conclusion, DCB and LD had superior clinical (freedom from TLR and clinical improvement) and angiographic outcomes (patency rate) compared with PTA for the treatment of femoropopliteal ISR. Moreover, DCB and LD had a low incidence of amputation and mortality and were relatively safe methods.

Project description:AimsIn-stent chronic total occlusion (IS-CTO) represents a unique challenge for percutaneous coronary intervention. Whether the optimal treatment for IS-CTO is angioplasty with paclitaxel-coated balloons (PCBs) or repeat stenting with drug-eluting stents (DESs) is unclear. We aimed to evaluate the long-term clinical outcome of PCB angioplasty and DES repeat stenting for DES IS-CTO.MethodsWe retrospectively included patients with DES IS-CTO who underwent successful PCB angioplasty or DES repeat stenting from January 2016 to December 2019. The primary endpoints were major adverse cardiac events (MACEs), including cardiac death, myocardial infarction, and target lesion revascularization (TLR). Cox proportional hazards model was performed to compare the risk of MACEs between PCB angioplasty and DES repeat stenting, and to further explore the prognostic factors of patients with DES IS-CTO.ResultsA total of 214 patients with DES IS-CTO were enrolled: 78 patients (36.4%) treated with PCB and 136 patients (63.6%) treated with DES respectively. The median follow-up was 1160 days, and MACEs were observed in 28.2% of patients with PCB angioplasty versus 26.5% of patients with DES repeat stenting (P = 0.784), mainly driven by TLR (21.8% vs. 19.9%, P = 0.735). There was no significant difference in the risk of MACEs between the PCB group and the DES group (hazard ratio [HR] 1.25, 95% confidence interval [CI] 0.64-2.46, P = 0.512). Multivariate Cox analysis revealed that chronic kidney disease and ≥ 3 stent layers in the lesion were independent predictors of MACEs, while switching to another antiproliferative drug was an independent protective factor (all P < 0.05).ConclusionsPCB angioplasty was an effective alternative treatment strategy for DES IS-CTO, which had similar long-term outcomes to DES repeat stenting in contemporary practice, but both were accompanied by a high rate of long-term MACEs. Improving the poor prognosis of patients with DES IS-CTO remains a challenge.

Project description:IntroductionThe combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease.MethodsPatients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed.ResultsFifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR.ConclusionsIn this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.

Dataset Information

Comparison of Balloon Angioplasty and Stent Implantation for Femoropopliteal Disease According to Patient and Lesion Subgroup.

Publications

Comparison of Balloon Angioplasty and Stent Implantation for Femoropopliteal Disease According to Patient and Lesion Subgroup.

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