Treatment of Small Vessel Disease With the Paclitaxel Drug‐Eluting Balloon: 6‐Month Angiographic and 1‐Year Clinical Outcomes of the Spanish Multicenter Registry

Vaquerizo, Beatriz; Miranda-Guardiola, Faustino; Fidalgo, Eduardo; Rumoroso, José Ramón; Gómez-Hospital, Josep Antoni; Bossa, Francisco; Íñiguez, Andrés; Oategui, Inmanol; Serra, Antonio

doi:10.1111/joic.12227

Cited by 35 publications

(42 citation statements)

References 25 publications

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“…Only half of the patients underwent angiographic follow-up, revealing an LLL of 0.31 mm. As seen in other studies, bailout BMS implantation predicted both MACE and TLR [47]. …”

Section: Drug-eluting Balloonssupporting

confidence: 81%

“…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%

“…Bailout stenting was performed in 22.5% of patients and associated with a twofold clinical event rate [46]. The Spanish DIOR Registry was another observational real-world multicenter study reporting on outcomes following implantation of DIOR I or II DEB [47]. A total of 104 patients were included.…”

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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“…Only half of the patients underwent angiographic follow-up, revealing an LLL of 0.31 mm. As seen in other studies, bailout BMS implantation predicted both MACE and TLR [47]. …”

Section: Drug-eluting Balloonssupporting

confidence: 81%

Section: Discussionmentioning

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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“…The 2‐year TLF rate in the VSV cohort (6.3%) was slightly higher than that in the SVD cohort, once again underscoring that smaller vessel size may result in worse outcomes. The Spanish Registry published the results of the second‐generation DIOR in 103 patients with disease in vessels with a mean RVD of 1.95 ± 0.32 mm. The rate of MACE at 1 year (4.8%) was similar to that achieved with DCBs in our study.…”

Section: Discussionmentioning

confidence: 99%

Two‐year follow‐up of a randomized multicenter study comparing a drug‐coated balloon with a drug‐eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

Tian

Tang

Qiao

et al. 2020

Cathet Cardio Intervent

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Objectives To report the clinical outcomes of the RESTORE drug‐coated balloon (DCB; Cardionovum, Bonn, Germany) for treatment of de novo small vessel disease (SVD) beyond 1 year. Background Previous reports have demonstrated the noninferiority of the RESTORE DCB to the RESOLUTE Integrity drug‐eluting stent (DES; Medtronic, Minneapolis, Minnesota) in terms of 9‐month in‐segment percent diameter stenosis. Methods In the prospective, multicenter, noninferiority RESTORE SVD China trial, 230 patients with visually‐estimated reference vessel diameter (RVD) ≥2.25 and ≤2.75 mm were randomized to DCB or DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Furthermore, 32 patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel (VSV) registry. Clinical follow‐up were performed at 2 years to evaluate target lesion failure (TLF) in both groups and the VSV cohort. Results Overall, 256 (97.7%) patients (115 and 109 in the DCB and DES groups, respectively, and 32 in the VSV cohort) completed 2 years of follow‐up. There was no significant difference in TLF between the DCB and DES groups (5.2 vs. 3.7%, p = .75). Target lesion revascularization was acceptable at 1 month, 1 year, and 2 years, and did not differ significantly with DCB from that in the DES group (0.9 vs. 0%, p = 1.0, 4.4 vs. 2.6%, p = .72, 5.2 vs. 2.8%, p = .50, respectively). Conclusions Compared to the second‐generation DES, the RESTORE DCB did not increase the risk of clinical outcomes. Late catch‐up phenomen requiring revascularization was not significant in this study.

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“…The authors found that percutaneous intervention using the paclitaxel‐coated drug eluting balloons (DEB) in selected patients treated for small vessel coronary artery disease leads to excellent immediate results, maintained at 1‐year follow‐up, and we would like to congratulate the authors for their results …”

mentioning

confidence: 99%

“Treatment of Small Vessel Disease With the Paclitaxel Drug‐Eluting Balloon” Is the Target Lesion the Culprit One?

Blendea

Benedek

Chițu

2015

J Interven Cardiology

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Treatment of Small Vessel Disease With the Paclitaxel Drug‐Eluting Balloon: 6‐Month Angiographic and 1‐Year Clinical Outcomes of the Spanish Multicenter Registry

Abstract: The use of this PEB for the treatment of SMD provides excellent 1-year outcomes with only 4.8% MACE. The need for a bailout BMS was a strong predictor of MACE and TLR.

Cited by 35 publications

References 25 publications

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

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

Two‐year follow‐up of a randomized multicenter study comparing a drug‐coated balloon with a drug‐eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

“Treatment of Small Vessel Disease With the Paclitaxel Drug‐Eluting Balloon” Is the Target Lesion the Culprit One?

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