A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results

Mínguez, José Ramón López; Asensio, Juan Manuel Nogales; Vecino, Luis Javier Doncel; Sandoval, Jorge; Romany, Sebastián; Romero, Pedro Martinez; Díaz, José; Portales, Javier Fernández; González-Fernández, Reyes; Caceres, Gines Martinez; Herrera, Antonio Merchán; Manterola, Fernando Alfonso

doi:10.4244/eijv10i1a10

Cited by 88 publications

(39 citation statements)

References 24 publications

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“…Following screening for replicates, 405 remained; and after screening abstracts for relevance, a further 371 studies were removed. Finally, full text of the remaining 34 studies were screened, of which 17 randomised controlled trials (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34) fulfilled the inclusion criteria and were qualitatively and quantitatively analysed.…”

Section: Resultsmentioning

confidence: 99%

“…Finally, some studies were susceptible to industry bias owing to author involvement in relevant device companies such as B. Braun, Boston Scientific Medtronic and Eurocor GmbH (18,21,22,28,29,31,33). Similarly, conflicts of interest may have arisen due to these companies funding studies which investigated their own products (18,21,26,28,30,31,33,34).…”

Section: Limitationsmentioning

confidence: 99%

“…disease compared to BMS (37,38). DEB, advocated for their ability to reduce DAPT and promote homogeneous drug transfer have been proposed as an alternative to DES (39).…”

Section: Figurementioning

confidence: 99%

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Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Patel

Svermova

Burke-Gaffney

et al. 2018

Cardiovasc. Diagn. Ther.

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Background: Efficacy of drug-eluting balloons (DEB) for treatment of de novo coronary lesions remains controversial. The present systematic review and meta-analysis of randomised controlled trials assessed DEB with bare-metal stents (BMS) and also DEB with provisional bail-out stents ('DEB-only' strategy), to other conventional options: plain-old balloon angioplasty (POBA), BMS and drug-eluting stents (DES). Conclusions:The results of this meta-analysis showed that whilst DEB with BMS is superior to BMS alone, the combination is inferior to DES for treatment of de novo coronary lesions. Thus, DEB + BMS should not be applied in de novo lesions unless in patients who have absolute contraindications to DES. DEB alone, however, should be considered for relative contraindications to DES such as small vessel disease and bifurcation lesions.

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Section: Resultsmentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

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Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Patel

Svermova

Burke-Gaffney

et al. 2018

Cardiovasc. Diagn. Ther.

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“…The use of PEB to treat the entire bifurcation lesion was examined by the BABILON Trial and the PEPCAD V Bifurcation Study [15,16]. In the PEB arm of the former study, both MV and SB were pre-treated by PEB, followed by BMS implantation to the MV.…”

mentioning

confidence: 99%

Six month angiographic result of supplementary paclitaxel-eluting balloon deployment to treat side branch ostium narrowing (SARPEDON)

Jim

Lee

Fung

et al. 2015

International Journal of Cardiology

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“…Therefore, DEB without stent treatment mostly focuses on high-risk restenotic lesions, such as small vessels, bifurcations, or ISR [4]. Several clinical trials have confirmed the safety of paclitaxel-coated balloon in patients with de novo lesions in small coronary arteries or in bifurcation lesions [12,13,23,24,25,26,27,28]. However, information on DEB treatment of non-small coronary artery lesions is limited.…”

Section: Discussionmentioning

confidence: 99%

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Ding²,

Tian³

et al. 2016

Cardiology

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Background: The drug-eluting balloon (DEB) is a promising tool to prevent restenosis after coronary angioplasty. However, data on the outcomes of DEB in de novo lesions are scarce. Vessel recoil and constrictive remodeling are the dominant causes of restenosis after angioplasty. The use of cutting balloons (CB) may effectively reduce elastic recoil after balloon dilation. In this study, we evaluate the efficacy and safety of DEB in treating de novo coronary artery lesions, using a predilation strategy with cutting balloon (CB) dilation before DEB angioplasty. Methods/Design: We present the design of a prospective, single-center, open-label, randomized, 2-arm clinical trial aiming to assess whether or not the strategy of CB dilation before DEB angioplasty reduces the primary end point of late lumen loss (LLL) compared with drug-eluting stent (DES) implantation alone for de novo coronary artery lesions. A total of 120 patients will be randomly enrolled into the DEB or DES group (1:1 ratio). The primary end point is insegment LLL at 12 months as measured by optical coherence tomography (OCT). Secondary end points include procedural success, such as angiographic success and device success, and clinical outcomes including all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. Discussion: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEB after CB dilation compared with DES for the treatment of de novo coronary artery lesions guided by OCT.

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A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results

Abstract: pDEB bifurcation pretreatment with BMS implantation in MB showed greater LLL (ns) and increased incidence of MACE compared to everolimus DES. Both strategies showed similar results in the SB.

Cited by 88 publications

References 24 publications

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Six month angiographic result of supplementary paclitaxel-eluting balloon deployment to treat side branch ostium narrowing (SARPEDON)

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

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