Impact of Baseline and Postprocedural Intravascular Ultrasound Findings on 1-Year Primary Patency After Drug-Coated Balloon Treatment of Femoropopliteal Lesions

Iida

et al. 2023

JAHA

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Background Although clinical trials have reported favorable outcomes after drug‐coated balloon (DCB) therapy for femoropopliteal lesions, their real‐world performance and predictors have not been well evaluated. This study aimed to elucidate 1‐year freedom from restenosis and to explore the associated factors after a DCB for femoropopliteal lesions in clinical settings. Methods and Results This multicenter, prospective cohort registered 3165 de novo or restenotic femoropopliteallesions (mean lesion length, 13.5±9.3 cm; chronic total occlusion, 25.9%; severe calcification, 14.6%) that underwent successful DCB (Lutonix [24.2%] and IN.PACT Admiral [75.8%]) treatment between March 2018 and December 2019. Patency was assessed at 12±2 months. The primary outcome measure was 1‐year freedom from restenosis and its associated factors. Bailout stenting was performed in 3.5% of patients. The postprocedural slow flow phenomenon was observed in 3.9% of patients. During a median follow‐up of 14.2 months, 811 patients experienced restenosis. The Kaplan–Meier estimate of freedom from restenosis was 84.5% at 12 months (79.7% at 14 months). Focal, tandem, diffuse, and occlusive restenosis accounted for 37.4%, 9.8%, 18.9%, and 33.9%, respectively. Freedom from target lesion revascularization was 91.5% at 12 months. Risk factors independently associated with 1‐year restenosis were a history of revascularization, smaller distal reference vessel diameter, severe calcification, chronic total occlusion, low‐dose DCB, and residual stenosis. Conclusions The 1‐year clinical outcomes after DCB use for femoropopliteal lesions in real‐world practice was favorable. The additive risk factors were associated with a lower rate of freedom from restenosis.

Section: Discussionmentioning

confidence: 99%

Vessel Patency and Associated Factors of Drug‐Coated Balloon for Femoropopliteal Lesion

Soga

Iida

et al. 2023

JAHA

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“…Few large-scale studies have investigated whether postprocedural findings could be associated with restenosis risk after DCB treatment. The restenosis after DCB treatment has been reportedly affected by various factors, including vessel diameter, CTO, and severe calcification [13][14][15] . The MLA was expected to be highly dependent on baseline characteristics, and the present study successfully addressed those confounding influences by using the GPS method.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, IVUS-guided intervention has become a standard strategy in percutaneous revascularization of peripheral arteries as well as coronary intervention, especially in Japan [10][11][12][13] . A previous single-center registry showed that a larger IVUS-measured minimum lumen area (MLA) after DCB treatment was associated with a lower restenosis rate 14) . This association implies the effectiveness of larger lumen gain on primary patency after DCB treatment.…”

Section: Methodsmentioning

confidence: 99%

“…This association implies the effectiveness of larger lumen gain on primary patency after DCB treatment. However, the MLA can be dependent on several lesion characteristics such as vessel sizes and calcification, which are classical risk factors for restenosis after DCB treatment 13,14) . The MLA might be a marker of less severe lesion characteristics.…”

Section: Methodsmentioning

confidence: 99%

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Impact of Postoperative Lumen Gain on the Reduction of Restenosis Risk after Endovascular Treatment using Drug-coated Balloon for Femoropopliteal Lesions Assessed by Intravascular Ultrasound

Horie

Nakama³

et al. 2023

JAT

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Aim: This study aimed to reveal whether a larger postprocedural minimum lumen area (MLA) would reduce restenosis risk after endovascular therapy (EVT) using drug-coated balloons (DCBs) in femoropopliteal (FP) lesions. Methods: This retrospective, nonrandomized, single-arm, and multicenter registry analyzed patients with FP lesions undergoing intravascular ultrasound (IVUS)-guided EVT with DCB between 2017 and 2021. The primary outcome was restenosis 1 year after EVT. The association between IVUS-based MLA and restenosis risk was investigated using a generalized propensity score (GPS) method to address imbalance of baseline covariates. The dose-response function of IVUS-measured MLA for restenosis risk was developed using the GPS-adjusted Cox proportional hazards regression model. Results:This study enrolled consecutive 489 patients with 595 lesions undergoing DCB treatment. The median MLA (interquartile range) was 13.20 (9.90-16.91) mm 2 . Kaplan-Meier estimates showed that freedom from restenosis was 84.4% at 1 year. The GPS-adjusted dose-response function showed that MLA was inversely associated with restenosis risk. The upper limit of 95% confidence interval (CI) of the slope was lower than 0 between 10.6 and 17.0 mm 2 of MLAs. The 1-year cumulative incidence of restenosis was estimated to be 9.8% (95% CI, 5.8%-13.7%) for the 3rd quartile of MLA (16.91 mm 2 ) versus 18.5% (12.3%-24.1%) for the 1st quartile (9.90 mm 2 ), with a hazard ratio of 0.51 (95% CI, 0.39-0.67; p＜0.001). Conclusions:The present GPS analysis suggested that larger IVUS-measured MLA might be associated with lower risk of 1-year restenosis after DCB treatment for FP lesions.

“…Achievement of su cient luminal gain and less severe dissection are essential. Regarding the de nition of "su cient" luminal gain, Horie et al proposed a cutoff value of postprocedural IVUS-evaluated minimum luminal area (MLA) of 12.7 mm 2(Horie et al, 2022). Angiographic evaluation is the gold standard for the evaluation of dissection.…”

mentioning

confidence: 99%

Clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter EAGLE study

Hayakawa

Nakama³

et al. 2022

Preprint

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Background: Several studies have reported the efficacy of drug-coated balloons (DCB) for simple femoropopliteal (FP) lesions. However, the effectiveness of DCB for FP chronic total occlusive lesions (CTO) is controversial. The present study investigated the clinical outcomes of DCB for FP-CTO.Materials and methods: We retrospectively analyzed 359 limbs of 318 patients who underwent EVT with DCB for FP-CTO between July 2017 and February 2021 at seven cardiovascular centers. The primary endpoint was 12-month primary patency. The secondary endpoints were the 12-month rates of freedom from: (1) clinically-driven target lesion revascularization (CD-TLR), and (2) re-occlusion. The association of baseline characteristics with the 12-month restenosis risk was investigated using the Cox proportional hazards regression model.Results: The 12-month rate of primary patency was 79.8% (95% confidence interval [95%CI], 75.1% to 84.8%), whereas the corresponding rates of freedom from CD-TLR and re-occlusion were 86.4% (95%CI: 82.6% to 90.4%) and 88.5% (95%CI: 84.7% to 92.4%), respectively. The bailout stent rate was 8.9%. Independent risk factors for restenosis were hemodialysis (adjusted hazard ratio, 2.18 [1.39 to 3.45]; P=0.001), chronic limb-threatening ischemia (CLTI) (2.02 [1.33 to 3.07]; P=0.001), and restenosis lesion (2.02 [1.32 to 3.08]; P=0.001). Use of dual antiplatelet therapy (DAPT) was identified as a protective factor for restenosis (0.54 [0.35 to 0.82]; P=0.003).Conclusion: Despite the low rate of bailout stent, DCB treatment for FP-CTO was effective in real-world clinical practice. Hemodialysis, CLTI, and restenosis lesion were independent risk factors for 12-month restenosis, and the use of DAPT significantly attenuated the risk of 12-month restenosis.