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Drug-eluting balloons: The path is made by walking
Balão eluidor de fármaco: o caminho faz-se caminhando
António Leitão Marques
Serviço de Cardiologia, Hospital Geral, Centro Hospitalar Universidade de Coimbra, Coimbra, Portugal
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"en" "Traduccion" => array:1 [ "pt" => array:9 [ "pii" => "S0870255112003332" "doi" => "10.1016/j.repc.2012.09.006" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "pt" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255112003332?idApp=UINPBA00004E" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204913000871?idApp=UINPBA00004E" "url" => "/21742049/0000003200000005/v1_201308021409/S2174204913000871/v1_201308021409/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Editorial comment</span>" "titulo" => "Drug-eluting balloons: The path is made by walking" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "371" "paginaFinal" => "372" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "António Leitão Marques" "autores" => array:1 [ 0 => array:3 [ "nombre" => "António" "apellidos" => "Leitão Marques" "email" => array:1 [ 0 => "almarques@mail.telepac.pt" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Serviço de Cardiologia, Hospital Geral, Centro Hospitalar Universidade de Coimbra, Coimbra, Portugal" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Balão eluidor de fármaco: o caminho faz-se caminhando" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The concept behind drug-eluting balloons (DEB) is local vascular release of an antiproliferative drug without the need for a metal structure or a polymer, which is certainly an attractive idea and an important innovation in interventional cardiology.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Their use in the treatment of coronary artery disease is relatively recent, but DEB angioplasty has grown rapidly, in fact outstripping the evidence in this area. The history of interventional cardiology is full of such examples of action ahead of large trials and the guidelines based on them.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The development of this alternative was prompted by the fact that the use of stents is not advisable in certain situations or is likely to achieve less favorable results.</p><p id="par0020" class="elsevierStylePara elsevierViewall">DEB angioplasty has been shown to be most useful for the treatment of in-stent restenosis, bifurcations and small vessel disease, particularly in patients with diabetes. All these situations are a challenge for interventional cardiology for which there is as yet no standard treatment, unlike conventional lesions for which stenting has become universally accepted.</p><p id="par0025" class="elsevierStylePara elsevierViewall">A return to simple balloon angioplasty but with DEBs to reduce the risk of restenosis appears to be a path worth exploring and for which it is important to gather more evidence.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The multicenter series presented in the article by Calé et al. in this issue of the <span class="elsevierStyleItalic">Journal</span> provides interesting information on the use of DEBs, particularly in patients with small vessel disease, on whom there have been few large-scale studies.</p><p id="par0035" class="elsevierStylePara elsevierViewall">Based on a prospective registry from two centers, the authors analyzed 156 consecutive patients in whom 184 lesions were treated, with a 12-month follow-up. The indications for DEB angioplasty were divided between in-stent restenosis and small vessel disease. The study analyzed major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI) and need for target lesion revascularization (TLR).</p><p id="par0040" class="elsevierStylePara elsevierViewall">One important result was 98% device success, confirming the excellent navigability of the system, even in small vessels, in most cases with distal lesions.</p><p id="par0045" class="elsevierStylePara elsevierViewall">The apparently high rate of MACE, particularly at 30 days, with two cardiovascular deaths, four MI and two TLR, may be explained by the population studied, which included a higher than usual percentage of diabetic patients, and most of whom had significant coronary disease previously treated by angioplasty or bypass surgery.</p><p id="par0050" class="elsevierStylePara elsevierViewall">It could be questioned whether analysis of clinical events is the best method to evaluate DEB angioplasty outcomes, since the rate of restenosis and need for TLR are of greater interest.</p><p id="par0055" class="elsevierStylePara elsevierViewall">Clinical manifestations are not always typical in patients with in-stent restenosis or in diabetic patients with small vessel disease, as formation of collateral circulation is frequent in the former due to the gradual process of restenosis, and the percentage of patients with silent ischemia is high among the latter.</p><p id="par0060" class="elsevierStylePara elsevierViewall">It would be interesting to see more studies on DEB angioplasty with angiographic assessment so as to obtain a better idea of its true efficacy. While there is an appreciable amount of evidence on its use for the treatment of in-stent restenosis,<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1,2</span></a> an indication that is included in the latest European Society of Cardiology guidelines on myocardial revascularization, the results of studies on treatment of small vessel disease have been controversial or even negative.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Although the study by Calé et al. found no significant difference in the occurrence of MACE between patients being treated for in-stent restenosis and those for small vessel disease, it is difficult to draw any conclusion as to whether DEB angioplasty was equally effective since the two situations are completely different.</p><p id="par0070" class="elsevierStylePara elsevierViewall">One aspect that could have benefited from more detailed analysis was treatment of small vessel disease, since there have been few studies on this patient group, in whom balloon angioplasty is sometimes the only option. The definition of “small vessel” is not the same in all studies. The article states that the median DEB diameter was 2.5 mm, but it would be relevant to know the caliber of vessels in this group, particularly the proportion of patients with vessels of ≤2 mm, which present more of a challenge.</p><p id="par0075" class="elsevierStylePara elsevierViewall">However, the study has the merit of pointing out other facts, including that the best predictors of vascular events are patient characteristics rather than the type of balloon employed or its length.</p><p id="par0080" class="elsevierStylePara elsevierViewall">For all these reasons, the publication of registries such as this one is to be commended, especially in areas where information is sparse and off-label use is common in clinical practice.</p><p id="par0085" class="elsevierStylePara elsevierViewall">While DEB angioplasty is beginning to gain wider acceptance for the treatment of in-stent restenosis, there is still little information on the actual results of the technique in cases of small vessel lesions, particularly when diffuse.</p><p id="par0090" class="elsevierStylePara elsevierViewall">A final word on the path chosen by the authors, which seems likely to bring benefits; sharing information, establishing multicenter registries, and developing joint projects is without doubt the best way to obtain results and to raise the profile of Portuguese interventional cardiology.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0095" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Leitão Marques A, Balão eluidor de fármaco: o caminho faz-se caminando. Rev Port Cardiol 2013. <span class="elsevierStyleInterRef" id="intr0005" href="doi:10.1016/j.repc.2013.03.003">http://dx.doi.org/10.1016/j.repc.2013.03.003</span>.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:3 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "B. Scheller" 1 => "C. Hehrlein" 2 => "W. Bocksch" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1056/NEJMoa061254" "Revista" => array:6 [ "tituloSerie" => "N Engl J Med" "fecha" => "2006" "volumen" => "355" "paginaInicial" => "2113" "paginaFinal" => "2124" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/17101615" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Paclitaxel-coated balloon catheter versus paclitaxel coated stent for the treatment of coronary in-stent restenosis" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "M. Unverborben" 1 => "C. Vallbracht" 2 => "B. Cremers" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1161/CIRCULATIONAHA.108.839282" "Revista" => array:6 [ "tituloSerie" => "Circulation" "fecha" => "2009" "volumen" => "119" "paginaInicial" => "2986" "paginaFinal" => "2994" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19487593" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised trial. The PICCOLETO study" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "B. Cortese" 1 => "A. Michelli" 2 => "A. Picchi" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/hrt.2010.195057" "Revista" => array:6 [ "tituloSerie" => "Heart" "fecha" => "2010" "volumen" => "96" "paginaInicial" => "1291" "paginaFinal" => "1296" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/20659948" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/21742049/0000003200000005/v1_201308021409/S2174204913000834/v1_201308021409/en/main.assets" "Apartado" => array:4 [ "identificador" => "9917" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Original Articles" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/21742049/0000003200000005/v1_201308021409/S2174204913000834/v1_201308021409/en/main.pdf?idApp=UINPBA00004E&text.app=https://revportcardiol.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204913000834?idApp=UINPBA00004E" ]
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| 2021 November | 29 | 35 | 64 |
| 2021 October | 43 | 48 | 91 |
| 2021 September | 20 | 28 | 48 |
| 2021 August | 32 | 26 | 58 |
| 2021 July | 21 | 28 | 49 |
| 2021 June | 35 | 18 | 53 |
| 2021 May | 27 | 34 | 61 |
| 2021 April | 55 | 41 | 96 |
| 2021 March | 48 | 28 | 76 |
| 2021 February | 50 | 19 | 69 |
| 2021 January | 34 | 17 | 51 |
| 2020 December | 38 | 6 | 44 |
| 2020 November | 27 | 13 | 40 |
| 2020 October | 21 | 17 | 38 |
| 2020 September | 53 | 25 | 78 |
| 2020 August | 43 | 9 | 52 |
| 2020 July | 32 | 9 | 41 |
| 2020 June | 31 | 5 | 36 |
| 2020 May | 30 | 3 | 33 |
| 2020 April | 28 | 7 | 35 |
| 2020 March | 32 | 8 | 40 |
| 2020 February | 37 | 18 | 55 |
| 2020 January | 28 | 3 | 31 |
| 2019 December | 26 | 5 | 31 |
| 2019 November | 21 | 3 | 24 |
| 2019 October | 25 | 6 | 31 |
| 2019 September | 21 | 9 | 30 |
| 2019 August | 14 | 6 | 20 |
| 2019 July | 28 | 5 | 33 |
| 2019 June | 26 | 9 | 35 |
| 2019 May | 36 | 6 | 42 |
| 2019 April | 14 | 8 | 22 |
| 2019 March | 26 | 10 | 36 |
| 2019 February | 33 | 7 | 40 |
| 2019 January | 23 | 10 | 33 |
| 2018 December | 42 | 15 | 57 |
| 2018 November | 45 | 8 | 53 |
| 2018 October | 69 | 17 | 86 |
| 2018 September | 29 | 11 | 40 |
| 2018 August | 35 | 8 | 43 |
| 2018 July | 25 | 4 | 29 |
| 2018 June | 35 | 6 | 41 |
| 2018 May | 31 | 11 | 42 |
| 2018 April | 38 | 3 | 41 |
| 2018 March | 56 | 8 | 64 |
| 2018 February | 22 | 9 | 31 |
| 2018 January | 35 | 11 | 46 |
| 2017 December | 47 | 7 | 54 |
| 2017 November | 29 | 10 | 39 |
| 2017 October | 34 | 9 | 43 |
| 2017 September | 33 | 8 | 41 |
| 2017 August | 36 | 21 | 57 |
| 2017 July | 29 | 9 | 38 |
| 2017 June | 35 | 12 | 47 |
| 2017 May | 26 | 5 | 31 |
| 2017 April | 36 | 0 | 36 |
| 2017 March | 20 | 74 | 94 |
| 2017 February | 17 | 5 | 22 |
| 2017 January | 13 | 1 | 14 |
| 2016 December | 28 | 6 | 34 |
| 2016 November | 11 | 5 | 16 |
| 2016 October | 30 | 7 | 37 |
| 2016 September | 16 | 3 | 19 |
| 2016 August | 7 | 2 | 9 |
| 2016 July | 14 | 3 | 17 |
| 2016 June | 10 | 5 | 15 |
| 2016 May | 14 | 6 | 20 |
| 2016 April | 23 | 2 | 25 |
| 2016 March | 29 | 22 | 51 |
| 2016 February | 50 | 30 | 80 |
| 2016 January | 45 | 19 | 64 |
| 2015 December | 47 | 19 | 66 |
| 2015 November | 40 | 15 | 55 |
| 2015 October | 38 | 16 | 54 |
| 2015 September | 50 | 8 | 58 |
| 2015 August | 36 | 11 | 47 |
| 2015 July | 32 | 9 | 41 |
| 2015 June | 25 | 0 | 25 |
| 2015 May | 35 | 7 | 42 |
| 2015 April | 33 | 7 | 40 |
| 2015 March | 40 | 7 | 47 |
| 2015 February | 40 | 6 | 46 |
| 2015 January | 28 | 9 | 37 |
| 2014 December | 47 | 15 | 62 |
| 2014 November | 27 | 6 | 33 |
| 2014 October | 39 | 8 | 47 |
| 2014 September | 41 | 7 | 48 |
| 2014 August | 31 | 9 | 40 |
| 2014 July | 37 | 11 | 48 |
| 2014 June | 33 | 6 | 39 |
| 2014 May | 43 | 9 | 52 |
| 2014 April | 29 | 7 | 36 |
| 2014 March | 39 | 15 | 54 |
| 2014 February | 38 | 19 | 57 |
| 2014 January | 63 | 16 | 79 |
| 2013 December | 42 | 14 | 56 |
| 2013 November | 61 | 18 | 79 |
| 2013 October | 58 | 15 | 73 |
| 2013 September | 62 | 20 | 82 |
| 2013 August | 55 | 28 | 83 |
| 2013 July | 83 | 23 | 106 |
| 2013 June | 12 | 4 | 16 |
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