TCT-305 SeQuent Please Paclitaxel-Coated Balloon Angioplasty For De Novo Coronary Lesions: A Long-Term Follow-Up Study

Benezet, Javier; Sanchez-Perez, Ignacio; Lozano, Fernando; Pinilla, Natalia; Higuera, Felipe; Hessein, Yasser

doi:10.1016/j.jacc.2013.08.1042

Cited by 6 publications

(9 citation statements)

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“…Our results are concordant with the results of different single‐arm studies of DCB in small‐vessel CAD . In “The SeQuent Please Small Vessel ‘PCB only’ Registry study” which is the largest DCB study of de novo SVD, a low risk of TLR and MACE was reported at 9 months (4.7% and 3.6%, respectively) .…”

Section: Discussionsupporting

confidence: 89%

“…43 Therefore, the lack of predilation can theoretically be associ- Our results are concordant with the results of different singlearm studies of DCB in small-vessel CAD. 9,15,[44][45][46][47][48] In "The SeQuent Please Small Vessel 'PCB only' Registry study" which is the largest DCB study of de novo SVD, a low risk of TLR and MACE was reported at 9 months (4.7% and 3.6%, respectively). 49 16 However, their analysis included both ISR and de novo lesions and was not limited to SVD.…”

Section: Discussionmentioning

confidence: 99%

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Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Megaly

Rofael

Saad

et al. 2018

Cathet Cardio Intervent

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Background Percutaneous coronary intervention (PCI) of small‐vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug‐coated balloons (DCBs) in SVD has received limited study. Objectives To assess the outcomes of DCB in the treatment of SVD compared with the standard of care. Methods We performed a meta‐analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD. Results Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow‐up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug‐eluting stents (DES). During a mean follow‐up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04–0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08–0.37, P = <0.00001) compared with noncoated balloon angioplasty. Conclusion The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Megaly

Rofael

Saad

et al. 2018

Cathet Cardio Intervent

View full text Add to dashboard Cite

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“…Several factors might have contributed to these conflicting findings, including differences in bailout rate, predilatation, geographical mismatch, and the type of DEB used. For example, bailout proportion varied between 6% and 36%, and in most cases bailout stenting is associated with a less favorable outcome [37, 46, 47, 49]; however, several prospective registries using SeQuent Please DEB did not find a difference between DEB treatment with or without BMS implantation [35, 39, 41]. Geographical mismatch between the DEB-treated area and BMS implantation seems partly to account for the observed differences, where especially the stent edges are sites of restenosis, and thus geographical mismatch should be avoided, and a BMS only implanted as a part of a bailout strategy [21, 24, 28, 37, 49].…”

Section: Discussionmentioning

confidence: 99%

“…The authors speculated that this was due to a high-risk population [40]. A long-term follow-up registry was performed by Benezet et al, showing persistently low MACE and TLR rates after 36 months and no occurrence of vessel/stent thrombosis [41]. Twenty-five percent received bailout BMS implantation which was not associated with a less favorable outcome (MACE 7.1% with additional BMS and 9.5% without BMS) [41].…”

Section: Drug-eluting Balloonsmentioning

confidence: 99%

“…A long-term follow-up registry was performed by Benezet et al, showing persistently low MACE and TLR rates after 36 months and no occurrence of vessel/stent thrombosis [41]. Twenty-five percent received bailout BMS implantation which was not associated with a less favorable outcome (MACE 7.1% with additional BMS and 9.5% without BMS) [41]. The prospective Leipzig Registry evaluated the clinical outcome in 484 patients treated with a SeQuent Please DEB [42].…”

Section: Drug-eluting Balloonsmentioning

confidence: 99%

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Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review

2016

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Drug-eluting balloons (DEBs) have emerged as a new application in percutaneous coronary intervention. DEBs have proven successful in the treatment of in-stent restenosis, but their role in de novo lesions is less clear. This paper provides a review of the current studies where DEBs have been used in coronary de novo lesions, either as part of a DEB-only strategy or in combination with another device, mainly a bare metal stent (BMS). By searching Pubmed and Embase we were able to identify 52 relevant studies, differing in design, intervention, and clinical setting, including patients with small vessel disease, bifurcation lesions, complex long lesions, acute myocardial infarction, diabetes mellitus, and elderly. In 23 studies, a DEB was combined with a BMS, 25 studies used a DEB-only strategy with only provisional BMS implantation, and four studies combined a DEB with a drug-eluting stent (DES). In the vast majority of studies, DEB in combination with BMS does not seem to improve clinical or angiographic outcome compared with DES, whereas a DEB-only strategy seems promising, especially when predilatation and geographical mismatch are taken into account. A lower risk of recurrent thrombosis with DEB compared with DES is not evident from the current studies. In conclusion, the main indication for DEB seems to be small vessel disease, especially in clinical scenarios in which a contraindication to dual antiplatelet therapy exists. The main approach should be a DEB-only strategy with only provisional bailout stenting, which has shown interesting results in different clinical scenarios. In general, larger randomized controlled studies with prolonged follow-up comparing DEB with best in class DES are warranted. Technical developments of DEBs including the use of different drugs might potentially improve the efficacy of such treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-016-0064-4) contains supplementary material, which is available to authorized users.

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Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review

et al. 2018

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Percutaneous coronary intervention (PCI) with a drug coated balloon (DCB) is a novel treatment which seeks to acutely dilate a coronary stenosis and deliver an anti-proliferative drug to the vessel wall (reducing the risk of re-stenosis), without implanting a drug eluting stent (DES). In this study, we performed a systematic review of stentless DCB-only angioplasty in de novo coronary artery disease. We identified 41 studies examining the effects of DCB-only PCI in a variety of clinical scenarios including small vessels, bifurcations, calcified lesions, and primary PCI. DCB-only PCI appears to be associated with comparable clinical outcomes to DESs and superior angiographic outcomes to plain-old balloon angioplasty. Although current data are promising, there is still a need for further long-term randomized control trial data comparing a DCB-only approach specifically against a second- or third-generation DES. A 4-week period of dual antiplatelet therapy provides a real advantage for the DCB-only PCI approach, which is not possible with most DESs. Since rates of adverse clinical outcomes are very low for all PCI procedures attention should be turned to the development of robust endpoints with which to compare DCB-only PCI approaches to the standard treatment with a DES.Electronic supplementary materialThe online version of this article (10.1007/s40119-018-0121-2) contains supplementary material, which is available to authorized users.

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TCT-305 SeQuent Please Paclitaxel-Coated Balloon Angioplasty For De Novo Coronary Lesions: A Long-Term Follow-Up Study

Cited by 6 publications

References 0 publications

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review

Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review

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