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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 32, No 1, January/February 2021
28
AFRICA
Hybrid rotablation and drug-eluting balloon strategy
Ahmed Vachiat, Mpiko Ntsekhe, Farrel Hellig
Abstract
Aim:
The aim was to assess the safety and efficacy of rota-
tional atherectomy followed by drug-eluting balloon (DEB)
in patients with a high risk of bleeding.
Methods:
A retrospective review was carried out of hospital
records of consecutive patients who underwent the hybrid
procedure.
Results:
The average age of the 23 patients was 74 years.
Risk factors for bleeding included renal failure (35%), oral
anticoagulation use (26%) and peptic ulcer disease (35%). All
patients had procedural success. No bleeding was reported
over the 24-month follow-up period. Dual antiplatelet therapy
was stopped successfully in six patients (26%) at three months.
Two patients had confirmed target-lesion failure (restenosis).
Two patients died over the study period but the cause of death
was not known to be cardiovascular disease related.
Conclusion:
For patients at high risk of bleeding who require
rotablation, the use of a drug-eluting balloon may be a safe,
effective alternative.
Keywords:
rotablation, drug-eluting balloon, calcification
Submitted 16/6/20, accepted 6/10/20
Published online 12/11/20
Cardiovasc J Afr
2021;
32
: 28–32
www.cvja.co.zaDOI: 10.5830/CVJA-2020-050
The revascularisation strategy for dealing with calcified lesions
includes adequate lesion preparation to avoid complications
and improve clinical outcomes. The techniques to prepare
lesions include balloon angioplasty, using semi-compliant
and non-compliant balloons, cutting balloons, rotational
atherectomy and, recently, intravascular lithotripsy.
1
Post lesion
preparation, the current recommendations and practice are to
use drug-eluting stents (DES) requiring dual antiplatelet therapy
(DAPT), which includes P
2
Y
12
inhibitors (clopidogrel, ticagrelor
or prasugrel) for six to 12 months, and aspirin lifelong.
Hybrid rotablation and drug-eluting balloon strategy is a
new concept for calcified lesions and has a number of potential
benefits.
2
Most patients referred with calcified lesions are elderly
and have numerous co-morbidities and risk factors for bleeding,
including atrial fibrillation, oral anticoagulants, renal failure and
peptic ulcer disease.
2
The use of drug-eluting balloons (DEBs)
offers a strategy for reducing bleeding risk, as the post-procedure
addition of P
2
Y
12
inhibitors to aspirin for secondary prevention
is required for only one month, following which they can be
discontinued.
3
Patients with calcified lesions often have diffuse disease
and long lesions, potentially requiring long, small stents.
These are prone to under-expansion, malapposition, delayed
endothelialisation and chronic inflammation, stent fracture,
neo-atheroma and polymer reactions,
4
all of which place patients
at increased risk for early, late and very late stent thrombosis.
Therefore, by eliminating the need for any stent implantation,
DEBs may significantly reduce the risk of these stent-related
adverse events.
4
DEBs are designed to act as delivery vehicles to the target
lesion of chemotherapeutic agents (paclitaxel, sirolimus), which
have been coated on the balloon. The currently available DEBs
have different excipient/coating techniques (Table 1).
The main DEBs available for use in our practice were the
SeQuent
®
Please (B Braun) and IN.PACT Falcon (Medtronic).
The SeQuent
®
Please DEB uses iopromide (a contrast medium)
to act as the excipient to retain the drug on the balloon and
to facilitate delivery of the drug to the vessel wall due to its
lipophilicity. The dose of paclitaxel used is 3
μ
g/mm
3
. The
half-life of the drug is almost two months.
5
The IN.PACT
Falcon DEB uses urea as an excipient with the antiproliferative
agent paclitaxel (3.5
μ
g/mm
2
). Although sirolimus-coated DEBs
have recently been developed and used with promising clinical
outcomes in
de novo
lesions,
6
we did not use any DEBs containing
sirolimus in our cohort of patients.
Rotablation or rotational atherectomy has been practiced
worldwide and standard protocols have been developed to
improve the clinical outcomes of patients with calcified lesions.
The new concept of a hybrid approach that combines the use of
rotablation with a DEB adds to the pool of novel and beneficial
interventional therapies for patients with calcified lesions.
7
Although a strategy of hybrid rotational atherectomy and
Table 1. Drug-eluting balloons
Chemotherapeutic agent DEB type
Excipient/coating technique
Pactixacel
SeQuen
®
Please Lopromide matrix coating
Pantera Lux
BTHC matrix coating
IN.PACT Falcon FreePac matrix coating
DIOR
Shellac matrix coating
Elutax
No excipient
Lutonix
Polysorbate and sorbitol carriers
Danubio
BTHC excipient
Sirolimus
Magic touch
DEB, drug-eluting balloons; BTHC, butyryl-tri-hexyl citrate.
Division of Cardiology, University of Cape Town, Cape
Town, South Africa
Ahmed Vachiat, MB BCh (Wits), FCP (SA), MMed, Cert Cardiol
(SA), PhD,
ahmedvachiat@gmail.comMpiko Ntsekhe, MD, PhD, FACC, MASSAf
Farrel Hellig, BSc, MB BCh, FCP (SA), FSCAI
Sunninghill Hospital, Sunward Park Hospital,
Johannesburg, South Africa
Farrel Hellig, BSc, MB BCh, FCP (SA), FSCAI
Wits Donald Gordon Medical Centre, University of the
Witwatersrand, Milpark Hospital, Johannesburg, South Africa
Ahmed Vachiat, MB BCh (Wits), FCP (SA), MMed, Cert Cardiology
(SA), PhD