Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-month results of the multicenter BIOLUX-I study

Worthley, Stephen G.; Hendriks, Randall; Worthley, M.; Whelan, Alan; Walters, D.; Whitbourn, Robert; Meredith, Ian T.

doi:10.1016/j.carrev.2015.07.009

Cited by 53 publications

(35 citation statements)

References 15 publications

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“…PCB resulted in persistently lower rates of target lesion revascularization compared with uncoated balloons (2.4 % vs. 20.6 %) at 12 months [ 27 ]. Moreover, the efficacy and safety of PCB (with or without stent in the treated segment) has also been demonstrated in clinical studies for a variety of indications such as in-stent restenosis [ 13 , 28 – 31 ], de novo stenosis [ 32 – 34 ], stenosis of small vessels [ 35 , 36 ] and bifurcation stenosis [ 37 , 38 ].…”

Section: Discussionmentioning

confidence: 99%

Paclitaxel-Coated Balloons: Investigation of Drug Transfer in Healthy and Atherosclerotic Arteries – First Experimental Results in Rabbits at Low Inflation Pressure

Stolzenburg

Breinl

Bienek³

et al. 2016

Cardiovasc Drugs Ther

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PurposeBeyond antiproliferative properties, paclitaxel exhibits anti-inflammatory activity, which might be beneficial in the local treatment of nonocclusive coronary artery disease. Paclitaxel release and tissue concentrations after paclitaxel-coated balloon treatment using different pressures have not been investigated so far. The aim of the study was to investigate in an atherosclerotic rabbit model whether drug transfer from paclitaxel-coated balloons into the vessel wall is affected by the presence of atherosclerotic lesions and to which extent it depends on the inflation pressure used.MethodsPaclitaxel-coated balloons (3.5 μg/mm2 paclitaxel) were inflated with pressures of 1, 2, or 6 atm (60s) in healthy (n = 39) and atherosclerotic (n = 22) arteries of New Zealand White Rabbits. Paclitaxel content in arterial walls (10 min after interventions) and paclitaxel remaining on balloons after treatment were analyzed using high-performance liquid chromatography.ResultsMedian paclitaxel tissue concentrations were 829.3 μg/g (IQR 636.5–1487 μg/g) in healthy and 375.7 μg/g (IQR 169.8–771.6 μg/g) in atherosclerotic arteries (p = 0.0002). The paclitaxel tissue concentration was dependent on inflation pressure (1 atm vs. 2 atm vs. 6 atm) in atherosclerotic arteries (p = 0.0106) but not in healthy arteries (p ≥ 0.05).ConclusionsAtherosclerotic lesions impede the transfer of paclitaxel into arterial walls. Higher inflation pressures resulted in an increased paclitaxel transfer in atherosclerotic but not in healthy arteries. However, it is assumed that the tissue concentrations achieved with an inflation pressure of 2 atm are potentially effective in this model.

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Section: Discussionmentioning

confidence: 99%

Paclitaxel-Coated Balloons: Investigation of Drug Transfer in Healthy and Atherosclerotic Arteries – First Experimental Results in Rabbits at Low Inflation Pressure

Stolzenburg

Breinl

Bienek³

et al. 2016

Cardiovasc Drugs Ther

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“…[6,7] DCB was designed to achieve comparable efficacy in neointimal proliferation through local drug delivery without requiring foreign body implantation or prolonged dual antiplatelet therapy (DAPT). The advantages of DCB include homogeneous and high concentration's drug delivery to the entire vessel wall, absence of stent layer, and absence of the polymer that could lead to chronic inflammation.…”

Section: Introductionmentioning

confidence: 99%

Drug-coated balloon in combination with bare metal stent strategy for de novo coronary artery disease

Liu

Zhu²,

Han³

et al. 2017

Medicine

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Background:Studies examining the efficiency of drug-coated balloon (DCB) + bare metal stent (BMS) compared with stents alone for de novo lesions have reported inconsistent results. The present comprehensive meta-analysis of randomized controlled trials (RCTs) assessed and compared the clinical efficacy and safety of DCB + BMS with those of stents alone for de novo coronary artery disease.Methods:We formally searched electronic databases before September 2016 to identify potential studies. All RCTs were eligible for inclusion if they compared DCB + BMS with a control treatment (drug-eluting stent [DES] alone or BMS alone) in patients with de novo coronary artery disease.Results:Eleven RCTs with a total of 2196 patients met the inclusion criteria were included in our meta-analysis. Subgroup analysis indicated DCB plus BMS was associated with poorer outcomes when compared with DES alone in primary endpoint {(in-segment late lumen loss [LLL]: mean difference [MD], 0.19; 95% confidence interval [CI], 0.06–0.32; P = 0.0042) and (major adverse cardiovascular events [MACEs]: risk ratio [RR], 1.88; 95% CI, 1.44–2.45; P < 0.0001)}. However, DCB + BMS had nonsignificantly lower LLL than BMS alone (in-segment LLL: MD, −0.14; 95% CI, −0.33–0.04; P = 0.24), and was more advantageous in reducing MACE incidence, with borderline significance (MACEs: RR, 0.67; 95% CI, 0.45–0.99; P = 0.05).Conclusions:In summary, the present results do not favor the DCB + BMS strategy as an alternative therapeutic method to DES implantation for de novo coronary artery lesions in percutaneous coronary intervention (PCI). Additional well-designed large RCTs with long-follow-up periods are required to clarify the inconsistent results.

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“…The first is the observational (albeit prospective) nature of the study with a relatively small sample size. The small sample size itself is in keeping with other technical feasibility studies in the bifurcation field [39] , [40] . The purpose of this was to attain data and outcomes in an organized, systematic, prospective way regarding current practice of a technique with limited published findings, but with growing adoption.…”

Section: Discussionmentioning

confidence: 67%

The Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions

Peverill

Incani

Worthley

et al. 2020

IJC Heart & Vasculature

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Background The present study is a prospective observational single arm clinical investigation, with parallel bench test interrogation, aimed at investigating the technical feasibility, safety and clinical outcomes with the cone flare crush modified-T (CFCT) bifurcation stenting technique. Bifurcation percutaneous coronary intervention (PCI) remains an area of ongoing procedural evolution. More widely applicable and reproducible techniques are required. Methods From April 2018 until March 2019, 20 consecutive patients underwent bifurcation PCI using the CFCT technique with a Pt-Cr everolimus drug-eluting stent with a bioresorbable polymer. Exercise stress echocardiography was performed at 12-month follow-up. The primary outcome was a composite of cardiac related mortality, myocardial infarction, target lesion/vessel revascularization and stroke. Safety secondary endpoints included bleeding, all-cause mortality and stent thrombosis. Results All patients underwent a successful CFCT bifurcation procedure with no complications to 30-day follow-up. One patient met the primary endpoint requiring target lesion revascularization at 9 months for stable angina. There were no other primary or secondary outcome events in the cohort. There were no strokes, deaths, stent thrombosis or myocardial infarction during the follow-up period. The mean CCS score improved from 2.25 to 0.25 (p < 0.0001). Optical coherence tomography (OCT) and bench test findings indicated optimal side branch ostial coverage and minimal redundant strut material crowding the neo-carina. Conclusions The CFCT technique appears to be a safe, efficacious and feasible strategy for managing coronary artery bifurcation disease. Expanded and randomized datasets with longer term follow-up are required to further explore confirm this feasibility data. (ANZCTR ID: ACTRN12618001145291).

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Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-month results of the multicenter BIOLUX-I study

Abstract: The combination of an everolimus-eluting stent in the main branch and a paclitaxel-eluting balloon in the side branch appears to be a safe, effective and novel treatment option for bifurcation lesions.

Cited by 53 publications

References 15 publications

Paclitaxel-Coated Balloons: Investigation of Drug Transfer in Healthy and Atherosclerotic Arteries – First Experimental Results in Rabbits at Low Inflation Pressure

Paclitaxel-Coated Balloons: Investigation of Drug Transfer in Healthy and Atherosclerotic Arteries – First Experimental Results in Rabbits at Low Inflation Pressure

Drug-coated balloon in combination with bare metal stent strategy for de novo coronary artery disease

The Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions

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