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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 32, No 1, January/February 2021
30
AFRICA
in 10 patients. The average age was 74 years and 78.3% were
males. The majority of patients were dyslipidaemic (78.3%) and
hypertensive (74%); 30.4% were diabetic and 13% were smokers.
Seven patients (30.4%) had a prior coronary artery bypass graft.
The mean left ventricular ejection fraction was 52% and three
(13%) patients had severe aortic stenosis (two patients had prior
transcatheter aortic valve implantations and one had a prior
balloon aortic valvuloplasty).
Risk factors for bleeding included chronic renal failure (35%),
the use of oral anticoagulation (26%), atrial fibrillation (13%)
and peptic ulcer disease (35%). The mean haemoglobin level was
low, at 12.7 g/dl, and the mean creatinine level was raised, at 158
μ
mol/l, with an estimated glomerular filtration rate (eGFR) of
58 ml/kg/min. Mean total cholesterol was 4.4 mmol/l and the
low-density lipoprotein cholesterol was 2.4 mmol/l.
The majority of the procedures were performed via the
femoral route (87%) and 13% were performed radially. Cutting
balloon was used in 13% of calcified plaques. The 1.25-mm
burr was used in 61% of cases, followed by the 1.75-mm burr
(35%) and the 1.5-mm burr (27%). The average length of DEB
used was 37 mm. The DEB included SeQuent
®
Please (65%)
and IN.PACT Falcon (35%). After the procedure, six patients
received DAPT for a minimum of one month, 10 for six months,
four for 12 months and one for longer than 12 months, and for
two there were no follow up data. There were 15 patients who
had stents inserted in other lesions.
Procedural success was reported in all 23 patients. Twenty of
the 23 patients had follow-up information available at 24 months.
Six patients (26%) were not on DAPT beyond three months
and no patients had minor or major bleeding. Three patients
underwent repeat coronary angiography for angina and two
patients had evidence of target-vessel restenosis. Two patients
died but the cause of death was not known.
Discussion
The strategy of DEB following rotablation is a relatively new
concept. There were no published reports until the first study,
which showed the safety and efficacy of percutaneous coronary
intervention (PCI) using rotablation, followed by DEB in 2017.
2
The volume of published experience since then has been limited,
therefore our small cohort study from South Africa adds to the
global experience.
Our patients were elderly (mean age 74 years) and had
significant risk factors for bleeding, including chronic renal
failure (35%), the use of oral anticoaglation (26%) and peptic
ulcer disease (35%). More than three-quarters of the patients had
traditional risk factors such as hypertension and dyslipidaemia,
and one-third were diabetic. The patients were also high risk in
that a third had a prior coronary artery bypass graft. There were
no minor or major bleeding episodes. Although the femoral
approach was used in 87% of cases, the use of ultrasound
guidance for femoral puncture proved to be a safe alternative to
radial access.
The main findings from our retrospective patient review were
that the procedure is feasible, that DAPT could be stopped by
three months in a significant proportion (
>
25%) of patients, that
bleeding rates in this high-risk cohort over a 24-month period
were extremely low, and that restenosis rates were acceptable.
DEBs have been used in current daily practice for in-stent
restenosis (ISR), small-calibre vessels, bifurcation lesions, ostial
lesions and undilatable lesions.
10-13
The BELLO study (Balloon
Elution and Late Loss Optimization) was a randomised,
multicentre study of small coronary vessels (
<
2.8 mm),
which showed that apaclitaxel DEB was associated with less
angiographic late loss and similar rates of restenosis and
revascularisation as a paclitaxel-eluting stent,
12
but more evidence
is needed to compare DEB and newer-generation DES.
However, in a meta-analysis of over 5 000 patients looking at
the most appropriate coronary PCI strategy, including sirolimus-
and paclitaxel-eluting stents, DEBs, bare-metal stents and
balloon angioplasty, sirolimus-eluting stents yielded the most
favourable angiographic and clinical outcome for the treatment
of small coronary arteries.
14
In our study, the 2.5-mm DEB and
the 1.25-mm burr were used in 60.9% of patients in small-calibre
vessels.
Restenosis rates of 30 to 40% after rotablation alone or
following angioplasty alone were unacceptably high, which
decreased to 23 to 43% following bare-metal stents.
15-17
There is
a much more acceptable restenosis rate currently of one to 5%
in the DES era. However the increased bleeding risk of being on
DAPT suggests one should consider DEB.
Paclitaxel DEBs have been shown to be superior to balloon
angioplasty for ISR in terms of major adverse cardiovascular
events (MACE) and target-lesion revascularisation (TLR) for up
to 36 months in a multicentre, randomised study, which showed
that the multiple TLR was more frequent in the plain old balloon
angioplasty (POBA) group, compared to the DEB group (13.2
vs 1.4%,
p
=
0.021). The MACE rate was significantly reduced
in the DEB group compared to the POBA group (20.8 vs 52.6%,
p
=
0.001).
18
The disadvantages of stent complications such as
malapposition and under-expansion, delayed endothelialisation
and chronic inflammation are eliminated with no permanent
implant
4
and have led to new developments in the field of
interventional cardiology. In our study, two patients (8.7%) had
target-vessel restenosis. This restenosis rate was much lower than
the POBA rates of 23 to 43% but higher than the DES restenosis
rate of one to 5%.
Bioresorbable vascular scaffolds (BVS) have been developed
with the attractive concept of resorbable material, avoiding the
late complications of permanent metal scaffolds.
19
The BVS have
been shown to be efficacious but due to definite stent thrombosis
of 2.6% at 12 months, have not been shown to be superior to
DES.
20
Recently, novel drug-eluting metal absorbable scaffolds
consisting of absorbable magnesium scaffold backbones as an
alternative to polymeric scaffolds have showed a favourable
safety profile.
21
The polymer-free umirolimus stent has been
shown to be superior to bare-metal stents in primary safety
and primary endpoints in patients after one month of DAPT.
22
Further trials have also shown evidence to stop DAPT after
one month in patients with high bleeding risk with zotarolimus
stents.
23
The attractive concept of stentless PCI has gained interest
in the interventional cardiology community. Stentless PCI
has been reported recently from Japan, which suggests that
rotational atherectomy and DEB might be an alternative for
patients who may be unsuitable for DES implantation.
9
Case
reports of successful outcomes of patients with calcified diffuse
lesions, patients with severe thrombocytopaenia and those with