Drug-Coated Balloons: Applications in Interventional Cardiology

230 Pages·2019·8.388 MB·English

by  Bernardo Cortese

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
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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
From Drug-Eluting Balloon to  1
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, consist-
ing of an angioplasty balloon with laser-made perforations around its circumfer-
ence. 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-p ressure
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 1
B. Cortese (ed.), Drug-Coated Balloons,
https://doi.org/10.1007/978-3-319-92600-1_1
2 P. W. Serruys and K. Takahashi
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 DRUG
SHAFT SPACE
BLOOD
FLOW
.023''
TIP
DRUG
INFLATION
INFUSION
COIL
INFUSION WIRE
OPENING LUMEN
INFLATION
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
1 From Drug-Eluting Balloon to Drug-Coated Balloon … to Eradication… 3
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 bal-
loon 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 bifurca-
tion, 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 lipophilic-
ity. 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 fea-
tures 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 pre-
cise 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 with-
out 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 perspec-
tives sketched in this remarkable monography by Bernardo Cortese.