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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 32, No 1, January/February 2021
AFRICA
29
DEB is considered a viable alternative in patients with multiple
co-morbidities and high risk for bleeding, data on effectiveness
and safety are limited. There are no randomised, control trials
comparing this strategy to conventional approaches, and the
published observational experience consists predominantly of
small, retrospective, single-centre cohorts.
2,8,9
Given the paucity of available published data, we aimed to
add to the information on effectiveness and safety of a hybrid
approach to calcified lesions in a real-world setting by sharing
our recent experience from a different geography and population.
Important outcomes of interest included: (1) procedural success
[defined as thrombolysis in myocardial infarction (TIMI) III
flow with
<
30% recoil]; (2) proportion of people not on DAPT
beyond three months; (3) bleeding complications; (4) target-
vessel restenosis.
Methods
The study was conducted using anonymised patient data
from a high procedure-volume group cardiology practice in
Johannesburg, South Africa between June 2015 and December
2018. The percutaneous procedures of interest were performed
by one of two experienced interventional cardiologists.
This was a retrospective review of the patient records, files,
angiograms and other available relevant material. Parameters
included demographic, clinical (hypertension, diabetes and
dyslipidaemia) and laboratory data, medication and angiographic
data (Tables 2, 3). Consecutive adult patients who underwent a
hybrid percutaneous intervention, defined as the combination of
rotablation and DEB therapy for calcified lesions, in a minimum
of one lesion were included in the analysis. Patients who did not
have a complete set of procedural and follow-up date available
for review were excluded.
Patients were given clopidogrel either prior to or post
intervention. Ticagrelor and prasugrel were not used. Elective
patients were only given intravenous heparin during the
procedure to keep an activated clotting time level between 250
and 350 s. Enoxaparin 1 mg/kg bd subcutaneously was given
for acute coronary syndrome patients unless the patients were
on warfarin.
Rotablation was performed if the lesions were heavily calcified
or uncrossable with a balloon. It was performed using the
Rotablator (Boston Scientific, MN). The burr sizes ranged from
1.25 to 2.0 mm. The speed of the burr ranged between 170 000
and 180 000 rpm. Post rotablation, pre-dilatation of the lesion
was performed with a semi-compliant balloon, non-compliant
or cutting balloon for lesion optimisation and then followed
with a DEB, which was inflated for 60 to 90 seconds at nominal
pressures. The DEB was generally sized 1:1 per the vessel
diameter and at least 2 mm longer on both sides of the lesion.
The strategy in case of flow-limiting dissections (TIMI
<
3) or
significant recoil (
>
30%) was to then use a DES. No bare-metal
stents were used.
Results
There were 23 patients who had the rotablation and DEB
strategy. The indication for the hybrid procedure was non-ST-
segment myocardial infarction in 13 patients and unstable angina
Table 2. Baseline characteristics of patients
Characteristics
Number or mean
Percentage
Number of patients
23
100
Age
73.7
Male
18
78.3
Risk factors for CAD
Diabetes
7
30.4
Hypertension
7
30.4
Dyslipidaemia
16
70
Smoking
3
13
Family history of CAD
3
13
Risk factors for bleeding
Bleeding
3
13
Renal failure
8
35
Anticoagulation
6
26.1
Atrial fibrillation
3
13
Anaemia
12
52.2
Age
>
80 years
8
34.8
EF
<
50%
5
21.7
GFR
<
15 ml/kg/min
2
8.7
GFR 16–29 ml/kg/min
1
4.3
GFR 30–59 ml/kg/min
6
26.1
GFR
>
60 ml/kg/min
10
43.5
CAD, coronary artery disease; EF, ejection fraction; GFR, glomerular filtration
rate.
Table 3. Procedure-related characteristics
Characteristics
Number or mean Percentage
Access
Femoral
20
87.0
Radial
3
13.0
Coronary artery rotablation and DEB
Right coronary artery
6
26.1
Left anterior descending artery
10
43.5
Left circumflex artery
6
26.1
Ramus artery
3
13.0
Burr size (mm)
1.25
14
60.9
1.5
6
26.1
1.75
8
34.8
DEB
SeQuent
®
Please
15
65.2
IN.PACT
8
34.8
DEB diameter (mm)
2.25
2
8.7
2.5
14
60.9
2.75
4
17.4
3.0
3
13.0
3.5
4
17.4
DEB length (mm)
15
5
21.7
17
4
17.4
20
4
17.4
26
2
8.7
30
12
52.2
Cutting balloons
3
13.0
Stents in other vessels
15
65.2
DAPT
<
3 months
6
26.1
MACE
In-stent restenosis
2
8.7
Death
2
8.7
DEB, drug-eluting balloon; DAPT, dual antiplatelet therapy; MACE, major
adverse cardiovascular events.