Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial

Kleber, Franz X.; Rittger, Harald; Ludwig, Josef; Schulz, Antonia; Mathey, D; Boxberger, Michael; Degenhardt, Ralf; Scheller, Bruno; Strasser, Ruth H.

doi:10.1007/s00392-015-0957-6

Cited by 81 publications

(62 citation statements)

References 34 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%

“…The trial showed that for bifurcations, DEB alone had a statistically significant reduction in LLL and binary restenosis (18). Whilst not having been directly compared to DES, the DEB-only approach is attractive for bifurcations owing to preservation of vessel patency and avoidance of carina shift-a phenomenon largely responsible for side branch occlusion following DES treatment (16,18). In addition, low rates of restenosis and TLR seen in the PEPCAD-BIF trial also suggested some promise for the DEB-only treatment of bifurcation lesions (18).…”

Section: Implications Of Deb-only Approachmentioning

confidence: 99%

“…There may also be other niche indications including high-risk restenotic lesions such as bifurcations, long lesions, diffuse disease in diabetic patients and small vessel disease (43). The PEPCAD-BIF trial was the first randomised controlled trial to explore DEB-only use in side branch and/or distal main branch lesions (18). The trial showed that for bifurcations, DEB alone had a statistically significant reduction in LLL and binary restenosis (18).…”

Section: Implications Of Deb-only Approachmentioning

confidence: 99%

“…Whilst not having been directly compared to DES, the DEB-only approach is attractive for bifurcations owing to preservation of vessel patency and avoidance of carina shift-a phenomenon largely responsible for side branch occlusion following DES treatment (16,18). In addition, low rates of restenosis and TLR seen in the PEPCAD-BIF trial also suggested some promise for the DEB-only treatment of bifurcation lesions (18). However, more randomised controlled trials comparing DES and DEB alone are needed to determine whether these theoretical benefits translate to better angiographic and clinical outcomes.…”

Section: Implications Of Deb-only Approachmentioning

confidence: 99%

“…The PEPCAD-BIF trial was the first randomised controlled trial to explore DEB-only use in side branch and/or distal main branch lesions (18). The trial showed that for bifurcations, DEB alone had a statistically significant reduction in LLL and binary restenosis (18). Whilst not having been directly compared to DES, the DEB-only approach is attractive for bifurcations owing to preservation of vessel patency and avoidance of carina shift-a phenomenon largely responsible for side branch occlusion following DES treatment (16,18).…”

Section: Implications Of Deb-only Approachmentioning

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: Implications Of Deb-only Approachmentioning

confidence: 99%

Section: Implications Of Deb-only Approachmentioning

confidence: 99%

Section: Implications Of Deb-only Approachmentioning

confidence: 99%

Section: Implications Of Deb-only Approachmentioning

confidence: 99%

See 3 more Smart Citations

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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Percutaneous coronary intervention with drug‐coated balloon‐only strategy in stable coronary artery disease and in acute coronary syndromes: An all‐comers registry study

Uskela

Kärkkäinen

Eränen

et al. 2018

Cathet Cardio Intervent

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Objectives The aim of this single center all‐comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug‐coated balloon (DCB) in de novo lesions including large proximal coronary arteries. Methods A total of 487 PCIs were performed using paclitaxel‐coated DCB in 562 de novo lesions with the possibility for bailout stenting in a patient population presenting with stable coronary artery disease (CAD) or acute coronary syndrome (ACS). Half of the patients had at least one risk factor for bleeding. All of the treated lesions were de novo and 60% of DCBs used were ≥ 3.0 mm in diameter. The median follow‐up time was 18 months for MACE and 60 months for survival. Results The total mortality after DBC only strategy was 2.3 and 9.3% at 12 months in stable CAD and ACS, respectively. The 12‐month MACE rate was 7.1 and 12% in stable CAD and ACS. The rate of ischemia‐driven target lesion revascularization was only 1.4% in stable CAD and 2.8% after ACS at 12 months. Median duration of DAPT was one month. The 12 month rate of significant bleeding (Bleeding Academic Research Consortium types 2–5) was 5.9%. Acute vessel closure occurred only in one case (0.2%) after DCB treatment. Bailout stenting was used in 12% of lesions. Conclusions PCI using DCB‐only strategy with the possibility for provisional stenting is a safe and efficient in de novo coronary artery lesions in both stable CAD and ACS. This strategy may be useful especially in patients with high bleeding risk.

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Ultrasound controlled paclitaxel releasing system—A novel method for improving the availability of coronary artery drug coated balloon

Song

Zhou

Zhang³

et al. 2019

Cathet Cardio Intervent

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Objectives: The aim of this study is to improve local-drug delivery efficiency and tissue absorption using the ultrasound (US)-responsible drug coating based on a newly developed US-controlled paclitaxel release balloon. Background: Low availability of the drug coating remains a major concern of the current drug coated balloon (DCB). The goal of this study is to develop a method to use an US-responsible paclitaxel-loaded microcapsules (PM) as the main content of balloon drug coating to enhance bioavailability of DCB. Methods: An US-controlled paclitaxel release balloon is designed and fabricated based on the US-responsible paclitaxel-loaded poly (lactic-co-glycolic acid) (PLGA) microcapsules. Rapid exchange percutaneous transluminal coronary angioplasty (PTCA) balloon catheters were coated with the PM. The deployment processes of the paclitaxel-loaded microcapsules coated balloons (PMCB) under US, PMCB without US and a homogenous matrix of paclitaxel and iopromide coated balloon (PICB) were then placed in healthy and stent implanted porcine coronary arteries. Results: In vitro release assay demonstrated an ability of US (1 MHz, 1.22 W/cm 2 , 1 minute) to affect the release kinetics of paclitaxel from PM by inducing a 76 ± 5.4% increase in the rate of release. The paclitaxel content in target vessels are 203 ± 37 μg/g for PMCB under US, 85 ± 23 μg/g for PMCB without US, and 107 ± 31 μg/g for PICB 1-hr post-surgery. The availability of the drug for the PMCB reaches 27% under US. Conclusions: The US-controlled paclitaxel release balloon significantly improved the drug content of the target vessels in the porcine model. K E Y W O R D S controlled drug release, drug coated balloon, paclitaxel, pharmacokinetics, PLGA microcapsules, US 1 | INTRODUCTION In recent decades, the outcomes of coronary heart disease (CHD) have markedly improved, which can be partly attributed to the evolution of percutaneous coronary intervention (PCI). From percutaneous transluminal coronary angioplasty to bare-metal stent and then to drugeluting stent, every step of PCI is attractive to interventional cardiologist, great progress has been made for patients with CHD. Drug eluting stent (DES) implantation is the first choice of treatment in PCI. The dramatic ability of DES to inhibit neointimal hyperplasia through

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Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial

Abstract: In bifurcation lesions that show only class A or B dissection and recoil not beyond 30 % the use of DCBs is a sound strategy.

Cited by 81 publications

References 34 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

Percutaneous coronary intervention with drug‐coated balloon‐only strategy in stable coronary artery disease and in acute coronary syndromes: An all‐comers registry study

Ultrasound controlled paclitaxel releasing system—A novel method for improving the availability of coronary artery drug coated balloon

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