Drug-Coated Balloons: Applications in Interventional Cardiology [1st ed.] 978-3-319-92599-8;978-3-319-92600-1

This book provides a comprehensive, up-to-date summary of drug-coated balloon (DCB) technology and the role of DCBs in t

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Drug-Coated Balloons: Applications in Interventional Cardiology [1st ed.]
 978-3-319-92599-8;978-3-319-92600-1

Table of contents :
Front Matter ....Pages i-viii
From Drug-Eluting Balloon to Drug-Coated Balloon … to Eradication of Intracoronary Metal, a New Ending Story (Patrick W. Serruys, Kuniaki Takahashi)....Pages 1-7
History of Drug-Coated Balloons (Dario Buccheri, Bernardo Cortese)....Pages 9-13
Previous Mistakes with DCB Technology, and How to Prevent Them in the Future (Dario Buccheri, Bernardo Cortese)....Pages 15-19
Local Drug Delivery to Prevent Restenosis of the Coronary and Peripheral Arteries (Carlo Zivelonghi, Pierfrancesco Agostoni, Freek Nijhoff)....Pages 21-34
Technical Insights on Drug-Coated Balloons (Marco Ferrone, Juan F. Granada)....Pages 35-43
Technical Insights on Drug-Coated Balloons II (Manish Doshi, Prakash Sojitra, Dinesh Shah, Sameer Dani, Alexandre Abizaid)....Pages 45-57
Design Parameters for Drug-Coated Balloons II (Manish Doshi, Dinesh Shah, Prakash Sojitra)....Pages 59-67
Potential Clinical Advantages of Drug-Coated Balloon in Specific Clinical Settings (Serdar Farhan, Birgit Vogel, Roxana Mehran)....Pages 69-79
The Use of Drug-Coated Balloons for Patients with In-Stent Restenosis (Fernando Alfonso, Javier Cuesta, Fernando Rivero, Marcos García Guimaraes, Teresa Bastante, Bernardo Cortese)....Pages 81-92
Drug-Coated Balloons in Native Coronary Artery Disease (Mostafa Elwany, Bernardo Cortese)....Pages 93-109
Drug-Eluting Balloons in Coronary Bifurcation Lesions (Anouar Belkacemi, Pieter R. Stella)....Pages 111-119
Dissection Management with Drug-Coated Balloons (Gaetano Di Palma, Bernardo Cortese)....Pages 121-128
The Role of Drug-Coated Balloons on Late Lumen Enlargement (U. Wickramarachchi, S. C. Eccleshall)....Pages 129-138
Sirolimus-Coated Balloon: Insights on a New Technology for Coronary Use (Gaetano Di Palma, Bernardo Cortese)....Pages 139-149
Drug-Coated Balloon in Superficial Femoral Artery In-Stent Restenosis (Donato Gerardi, Arturo Alfani, Giovanni Esposito, Eugenio Stabile)....Pages 151-158
Drug-Coated Balloons for Native Femoro-popliteal Disease (Dario Pellegrini, Bernardo Cortese)....Pages 159-180
The Role of Drug-Coated Balloon for the Treatment of Native Below-the-Knee Arteries (Roberto Nerla, Fausto Castriota, Alberto Cremonesi, Antonio Micari)....Pages 181-188
Drug-Coated Balloons: Lessons from the Real World (Damiano Regazzoli, Marco Bruno Ancona, Pier Pasquale Leone, Azeem Latib)....Pages 189-201
Stent Use After Drug-Coated Balloons (Satoru Mitomo, Richard J. Jabbour, Damiano Regazzoli, Azeem Latib, Antonio Colombo)....Pages 203-208
Drug-Coated Balloon and Antithrombotic Therapy (Arturo Alfani, Donato Gerardi, Giovanni Esposito, Eugenio Stabile)....Pages 209-218
Cost/Effectiveness and Reimbursement Policies with Drug-Coated Balloons in Europe (Dario Pellegrini, Gaetano Di Palma, Bernardo Cortese)....Pages 219-226
Current Technical Challenges and the Future of Drug-Coated Balloons (Marco Ferrone, Juan F. Granada)....Pages 227-234

Citation preview

Drug-Coated Balloons Applications in Interventional Cardiology Bernardo Cortese  Editor

123

Drug-Coated Balloons

Bernardo Cortese Editor

Drug-Coated Balloons Applications in Interventional Cardiology

Editor Bernardo Cortese Cardiac Department San Carlo Clinic Milano Italy

ISBN 978-3-319-92599-8    ISBN 978-3-319-92600-1 (eBook) https://doi.org/10.1007/978-3-319-92600-1 Library of Congress Control Number: 2018966141 © Springer Nature Switzerland AG 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Dedicated to my Granpa Gino, My mentor, my guidance, my pattern. Always

Contents

1 From Drug-Eluting Balloon to Drug-­Coated Balloon … to Eradication of Intracoronary Metal, a New Ending Story��������������������   1 Patrick W. Serruys and Kuniaki Takahashi 2 History of Drug-Coated Balloons ������������������������������������������������������������   9 Dario Buccheri and Bernardo Cortese 3 Previous Mistakes with DCB Technology, and How to Prevent Them in the Future��������������������������������������������������������  15 Dario Buccheri and Bernardo Cortese 4 Local Drug Delivery to Prevent Restenosis of the Coronary and Peripheral Arteries������������������������������������������������������������  21 Carlo Zivelonghi, Pierfrancesco Agostoni, and Freek Nijhoff 5 Technical Insights on Drug-Coated Balloons������������������������������������������  35 Marco Ferrone and Juan F. Granada 6 Technical Insights on Drug-Coated Balloons II��������������������������������������  45 Manish Doshi, Prakash Sojitra, Dinesh Shah, Sameer Dani, and Alexandre Abizaid 7 Design Parameters for Drug-Coated Balloons II������������������������������������  59 Manish Doshi, Dinesh Shah, and Prakash Sojitra 8 Potential Clinical Advantages of Drug-­Coated Balloon in Specific Clinical Settings������������������������������������������������������������������������������������������  69 Serdar Farhan, Birgit Vogel, and Roxana Mehran 9 The Use of Drug-Coated Balloons for Patients with In-Stent Restenosis������������������������������������������������������������������������������������  81 Fernando Alfonso, Javier Cuesta, Fernando Rivero, Marcos García Guimaraes, Teresa Bastante, and Bernardo Cortese 10 Drug-Coated Balloons in Native Coronary Artery Disease ������������������  93 Mostafa Elwany and Bernardo Cortese 11 Drug-Eluting Balloons in Coronary Bifurcation Lesions���������������������� 111 Anouar Belkacemi and Pieter R. Stella vii

viii

Preface

12 Dissection Management with Drug-­Coated Balloons ���������������������������� 121 Gaetano Di Palma and Bernardo Cortese 13 The Role of Drug-Coated Balloons on Late Lumen Enlargement�������� 129 U. Wickramarachchi and S. C. Eccleshall 14 Sirolimus-Coated Balloon: Insights on a New Technology for Coronary Use���������������������������������������������������������������������������������������� 139 Gaetano Di Palma and Bernardo Cortese 15 Drug-Coated Balloon in Superficial Femoral Artery In-Stent Restenosis������������������������������������������������������������������������������������ 151 Donato Gerardi, Arturo Alfani, Giovanni Esposito, and Eugenio Stabile 16 Drug-Coated Balloons for Native Femoro-popliteal Disease ���������������� 159 Dario Pellegrini and Bernardo Cortese 17 The Role of Drug-Coated Balloon for the Treatment of Native Below-the-Knee Arteries ���������������������������������������������������������� 181 Roberto Nerla, Fausto Castriota, Alberto Cremonesi, and Antonio Micari 18 Drug-Coated Balloons: Lessons from the Real World���������������������������� 189 Damiano Regazzoli, Marco Bruno Ancona, Pier Pasquale Leone, and Azeem Latib 19 Stent Use After Drug-Coated Balloons���������������������������������������������������� 203 Satoru Mitomo, Richard J. Jabbour, Damiano Regazzoli, Azeem Latib, and Antonio Colombo 20 Drug-Coated Balloon and Antithrombotic Therapy������������������������������ 209 Arturo Alfani, Donato Gerardi, Giovanni Esposito, and Eugenio Stabile 21 Cost/Effectiveness and Reimbursement Policies with Drug-Coated Balloons in Europe ���������������������������������������������������� 219 Dario Pellegrini, Gaetano Di Palma, and Bernardo Cortese 22 Current Technical Challenges and the Future of Drug-Coated Balloons ������������������������������������������������������������������������������ 227 Marco Ferrone and Juan F. Granada

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From Drug-Eluting Balloon to  Drug-­Coated Balloon … to Eradication of Intracoronary Metal, a New Ending Story Patrick W. Serruys and Kuniaki Takahashi

In October 1993, the team of the Thorax Center in Rotterdam transmitted three live cases to TCT in a 90-min session: the first one was a three-vessel disease treatment with three Palmaz-Schatz stents (not yet approved in the USA by the FDA) [1]; the second one was a recanalization of a CTO with a laser wire in a patient included in the TOTAL trial [2]; the third one was a drug-eluting balloon treatment (the Dispatch balloon) post balloon angioplasty [3]. Indeed, drug-eluting balloons have existed before drug-coated balloons. The first local drug delivery device for coronary application was the porous balloon, consisting of an angioplasty balloon with laser-made perforations around its circumference. This catheter, however, caused jet-stream lesions to the vessel wall because of the high local infusion pressure. Other infusion methods and a variety of infusion catheters were designed to overcome this limitation, such as controlled low-­pressure infusion, microporous balloon, dual balloon, multi-channel balloon, drug delivery sleeve, or iontophoretic balloon. However, all devices had the drawback of not allowing simultaneous distal arterial perfusion. The duration of infusion and the amount of drug administered were thereby limited. The potential hazards of local arterial damage and absence of coronary perfusion while the drug is being delivered confined the use of these devices to the animal experimental laboratory. A quarter of century ago (in 1995), a new local drug infusion catheter (Dispatch Soimed Systems Inc.) was designed to overcome these aforementioned limitations by combining infusion and perfusion characteristics. At that time, we used to administer 99mTc-labeled heparin through the drug-­ eluting balloon and during the live case (for the TCT) and as routine we used to push a gamma camera into the cath lab to visualize online, on the screen of the gamma

P. W. Serruys (*) Imperial College London, London, UK K. Takahashi Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands © Springer Nature Switzerland AG 2019 B. Cortese (ed.), Drug-Coated Balloons, https://doi.org/10.1007/978-3-319-92600-1_1

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camera, the increasing local radioactivity at the site of the balloon angioplasty [4] (see Figs. 1.1 and 1.2). Yes, indeed, more than 10 years before the use of drug-coated balloon we had a wave of research and hype with drug-coated balloons. Heparin was known as a powerful inhibitor of smooth muscle cells—in vitro, and for sure we were impacting the vessel wall with the drug, as demonstrated by the remnant radioactivity for 24 h (Fig. 1.2). Unfortunately, despite the scientifically documented administration of the drug into the vessel wall, it did not affect the neointimal hyperplasia. POLYURETHANE SHEATH 4.4 F DUAL LUMEN SHAFT

DRUG SPACE BLOOD FLOW

.023'' TIP INFLATION COIL INFUSION OPENING INFLATION LUMEN

DRUG INFUSION WIRE LUMEN

Fig. 1.1  Distal part of the local drug delivery catheter (Dispatch) showing the deployed 20-mm-­ long nondilatational coil balloon. The coil consists of six balloon loops wrapped in a nonporous polyurethane sheath. When the loops are inflated, a central conduit for blood perfusion was deployed, and five external blood-free compartments were created. Drug solution entered these compartments through isolated slits in the catheter shaft located between the inflated coils Fig. 1.2  Offline image reconstruction at four different periods during the acquisition: (1) last 15 min of infusion; (2) 15 min, (3) 3 h, and (4) 6 h after infusion and coil-balloon removal. A single image represents 15 min of acquisition

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I lost my interest in drug-eluting balloon and in 1997 Elisabeth Nabel from NHI tried to convince me that upregulation of P27 by a drug called Rapamycin would eliminate the exuberant neo-intimal hyperplasia induced by the baro-trauma of balloon angioplasty. In 1999, Robert Falotico drew my attention to the neo-intimal inhibition obtained from a pig model treated with a stent-eluting Rapamycin. The rest is history—with Eduardo de Sousa we ushered into the era of drug-eluting stents. There were two drugs: one cytostatic Sirolimus and one cytotoxic Paclitaxel. My preference went to Sirolimus although I tested Paclitaxel in TAXUS II and III trials [5–8]. What was not my astonishment when in 2006 I was asked to review for the NEJM a paper on prevention of neo-intimal hyperplasia in patients with in-stent restenosis treated by Paclitaxel drug-coated balloon. I could not detect any methodologic flaws in the paper and I accepted the paper of Bruno Scheller in the NEJM [9]. It was in itself the start of a new era, exploring drug-coated balloon versus BMS or DES in restenosis, in primary lesion, in large vessel, in small vessel, in bifurcation, and so on. Fortunately, drug-coated balloon does not have to face the specter of late or very late thrombosis. Paclitaxel was initially used because of its lipophilicity. In the early days of drug-eluting stent era, we used to say that “it sticks to the metal as benzene does.” A recent meta-analysis on the use of paclitaxel in the peripheral circulation has surprised some clinicians [10]. And, the saga about the correct report of the data is worrisome, but I have to remind the clinicians that animals, such as horses, chewing leaves of a Taxus hedge, may die—it is a powerful drug. But, as beautifully described in the monography of Bernardo Cortese, the technology has evolved. Limus are now used; biolimus A9, because of its lipophilic nature, could have a certain edge on the hydrophilic sirolimus. However, sirolimus encapsulated in lipidic microsphere would do the trick [11] (Figs. 1.3, 1.4, and 1.5) although nano-technology is luring around the corner to make its entry into the field. It seems like yesterday, but it was in 2013 that Pedro Lemos, Renu Virmani, and myself reported the preclinical work on that methodological approach. Figures 1.3, 1.4, and 1.5 describe the salient features of this technology, now widely applied in the clinical arena. The precise tailor-made use of the principle of drug-coated balloon is also described in detail in the monography. Nowadays, OCT imaging can provide precise dimensions of the vessel and guarantee correct fitting between the balloon dimension and the vessel size (Fig. 1.6). At some point, at least for stable angina the percutaneous treatment, even without implantation, will be challenged by powerful systemic pharmacological agents, such as monoclonal antibody against PCSK9, aiming at regression of coronary artery disease. Today, a reduction of 22% in revascularization rate has already been documented in the FOURIER trial [12]. Soon we will have to re-think our strategy of treatment and synergy of local and systemic treatment without permanent caging of the vessel with metal—a new Holy Grail! Since the first stent implantation in 1969 by Dotter [13, 14], it took us more than 50 years to learn how to properly cage a coronary vessel [15]. It may take us as long to abandon the metallic cage as the method of treatment. This is one of the perspectives sketched in this remarkable monography by Bernardo Cortese.

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Hydrophilic head

ient

1

20 - 200 nanometers

Excip

Lipophilic tail

Excipient 2

Fig. 1.3  Schematic illustration of the ultrastructure of the nanoparticle containing sirolimus (nucleus, in green), incorporating the combination of two excipient carriers to allow penetration and release of the active agent. Excipient 1 is a lipid-based component with a hydrophilic head and two lipophilic tails, which is the basic unit of a bilayer membrane that encapsulates the particle (note the detail in the right upper panel). Excipient 2 is integrated in the particle envelope, comprising ~5% of the coating mass. It is a calcium-phosphorus-based component with enhanced hemocompatibility that is readily absorbed into the vessel wall and releases the encapsulated drug on variation in pH

a

b

Fig. 1.4 (a) Scanning electron micrography of the nanocarrier drug-eluting stent formulation. From left to right: pre-crimped coated stent; balloon after removal of stent. (b) Scanning electron micrography of the nanocarrier drug-eluting balloon formulation (left panel). Right panel: high magnification microphotography of the nanocarrier coating

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Fig. 1.5  Temporal penetration of DTF-labeled sirolimus nanoparticles after drug-eluting balloon inflation, as assessed by confocal microscopy. The left panels show a diagrammatic representation and the mid- and right panels the actual cross-sectional images. At 1 h (upper panels), 60–70% of circumferential area was marked with DTF signal. No particle was seen below the internal elastic lamina. At 3 days (mid-panels), 30–40% of circumferential area presented DTF signal. The majority of particles were below the internal elastic lamina (some positive signals deeper in media). At 7 days (lower panels), 30–40% of circumferential area had DTF signal. Particles primarily in deep media, with rare extension into adventitia. A: adventitia; EEL: external elastic lamina; IEL: internal elastic lamina; L: lumen; M: media

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IVUS

3.0 mm

UltraSound

Vessel wall

Vessel wall

Light

Vessel wall

Vessel wall

Vessel wall

Vessel wall

QCA

3.2 mm

Pre-procedure Diameter/area assessment QCA < OCT = real value