Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter

Tepe, Gunnar; Gögebakan, Özlem; Redlich, Ulf; Tautenhahn, J.; Ricke, Jens; Halloul, Z.; Meyer, Dirk-Roelfs; Waliszewski, Matthias; Schnorr, Beatrix; Zeller, Thomas; Müller‐Hülsbeck, Stefan; Ott, Ilka; Albrecht, Thomas

doi:10.1007/s00270-017-1713-2

Cited by 47 publications

(44 citation statements)

References 17 publications

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“…We included a total of 22 RCTs. Seventeen trials compared DCB to POBA in FPD 4,5,9,[13][14][15][16][17][18][19][20][21][22][23][24][25][26] and five RCTs compared DCB to POBA in patients with ISR with a previous stent to FPD. [27][28][29][30][31]…”

Section: Data Extractionmentioning

confidence: 99%

Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Narayanan

Shah

Jelani

et al. 2019

Cathet Cardio Intervent

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Background Drug‐coated balloon (DCB) angioplasty has emerged as a mainstay of therapy for the treatment of peripheral arterial disease (PAD) involving the superficial femoral and popliteal arteries. We performed a meta‐analysis including all available randomized controlled trials (RCTs) to date which compare DCB to plain balloon angioplasty (POBA) in femoropopliteal disease (FPD). Methods Five databases were analyzed including EMBASE, PubMed, Cochrane, Scopus, and Web‐of‐Science from January 2000 to September 2018 for RCTs comparing DCB to POBA in patients with FPD. Heterogeneity was determined using Cochrane's Q‐statistics. Random effects model was used. Results Twenty‐two RCTs, including five trials of in‐stent restenosis (ISR) intervention, with 3,217 patients were included in the analysis. Mean follow‐up was approximately 21.6 ± 14.4 months. Overall, DCB use was associated with a 51% reduction in target vessel revascularization (TLR) when compared to POBA at follow‐up (relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.40–0.61, P < 0.0001). Rates of TLR were 45% lower in the DCB group when compared to POBA in patients with ISR (RR: 0.55, 95% CI: 0.37–0.81, P = 0.002). DCB was associated with lower rates of binary stenosis, late lumen loss and higher primary safety endpoints. Major amputation and mortality were not different between DCB and POBA. Conclusions Use of DCBs is associated with improved vessel patency and a lower risk of TLR when compared to POBA in patients with FPD, especially in the setting of ISR. There was no difference in mortality between DCB and POBA in our meta‐analysis. Extended follow‐up of the available RCT data will be essential to analyze long‐term device‐related mortality.

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Section: Data Extractionmentioning

confidence: 99%

Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Narayanan

Shah

Jelani

et al. 2019

Cathet Cardio Intervent

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“…The primary end point of in‐lesion late lumen loss (LLL) at 6 months and target lesion revascularization (TLR) at 12 months were superior in the DCB group: (LLL 0.35 mm vs 0.72 mm, P = 0.006), and (TLR 17.8 vs 37.7%, P = 0.008). There was also improved censored walking distance in DCB group in comparison to balloon angioplasty group …”

Section: Interventional Trials In Lower Extremity Padmentioning

confidence: 99%

“…There was also improved censored walking distance in DCB group in comparison to balloon angioplasty group. 7…”

mentioning

confidence: 99%

Peripheral vascular interventional advances in 2017

Devanabanda

Tummala

Galmer

et al. 2018

J Interven Cardiology

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“…Numerous randomized trials on femoropopliteal artery disease demonstrated that drug-coated balloon (DCB) angioplasty effectively decreased late lumen loss (LLL) [1][2][3][4][5][6][7][8][9] and increased primary patency [10][11][12][13][14]. However, heterogeneity among studies is substantial: The mean number of patients needed to treat within 1 year to prevent a single target lesion revascularization (TLR) ranges between 4 and 33 [15].…”

Section: Introductionmentioning

confidence: 99%

Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty

Mietz

Teichgräber

2020

Cardiovasc Intervent Radiol

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Purpose The post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty. Methods In the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months. Results A total of 171 patients (69 ± 8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI-0.04 to 1.3], p = 0.06 and-0.3 per 10 years [95% CI-0.5 to 0.01], p = 0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p = 0.01 and OR 0.1 [95% CI 0.01 to 0.6], p = 0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B:-0.1 per 10 mm [95% CI-0.1 to-0.03], p = 0.001 and-0.1 [95% CI-1.7 to-0.1], p = 0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04). Conclusion DCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.

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Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter

Abstract: The use of paclitaxel-resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates. ClinicalTrials.gov identifier NCT01970579.

Cited by 47 publications

References 17 publications

Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Peripheral vascular interventional advances in 2017

Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty

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