Drug-eluting balloon in restenosis of drug-eluting stents: Medium term
follow-up
Scope of the work: Although the use of drug-eluting stents (DES) has dramatically reduced the incidence of
restenosis compared with bare-metal stent (BMS), in-stent restenosis (ISR) using DES is a phenomenon which still
exists, and becomes clinically relevant due to the prevalence of complex lesions. The optimal therapeutic strategy of
intra-DES ISR remains hotly debated.
Medicated drug eluting balloons (DEB) are a good treatment option, but little data are currently available on medium
term follow-up and potential of intra-DES ISR predictors.
Materials and methods: From May 2010 to July 2013, we retrospectively studied 70 patients who underwent 71
procedures using a medicated balloon (ELUTAX SV) for DES ISR.
The characteristics of the treated lesions were classified as intrastent, multifocal and DES stent marginal; focal
and diffuse proliferative lesions were therefore not included in our population. In all patients, we performed a
pre-dilatation with an appropriately gauged balloon.
The drug treatment plan provided for dual anti-platelet aggregation using acetyl salicylic acid + clopidogrel for three
months following treatment with DEB and only acetyl salicylic acid chronically.
All patients were provided with an instrumental clinical follow-up (cardiological examination with stress test and/or
myocardial scintigraphy) at 6 and 12 months, and further telephone follow-ups every six months.
Results:
Our population is characterised by a mean age of 67.6 years, with 42% diabetic patients, 70% dyslipidaemic patients,
30% patients with a family history of ischemic heart disease, 45% patients with previous myocardial infarction, 24%
patients with previous bypass, and 10% patients with chronic renal failure.
The 70 patients treated with DEB underwent our clinical observation for acute coronary syndrome (ACS) in 43% of
cases (30 patients), for stress angina in 30% of cases (21 patients), and for instrumental ischemia in 27% of cases (19
patients).
The treated vessels were divided as follows: 6 common trunk (CT), 25 anterior interventricular (AIV) 4 diagonal
branch (D1), 12 circumflex (CX), 6 marginal obtuse (MO) 1 CX posterior lateral (PLCX), 15 right coronary artery
(RCA), 1 DX posterior lateral (PLDX) and 1 vein graft.
The Intra-DES ISR were pre-treated in 65% of cases with non-compliant balloons, and 38% with cutting balloons; in
80% of cases the diameter of the pre-dilation balloon was greater than or equal to 0.25 mm, the stent restenosis
diameter.
The medicated balloon (ELUTAX SV) was chosen in the appropriate size to reach the vessel wall, the duration of
inflations with the medicated balloon was 60 seconds.
The average length of the treated lesions was 16.2 mm (standard deviation 3.1 mm) and the average
length of the medicated balloons was 18.8 mm (standard deviation 3.4 mm). There were no nonprocedural adverse events and in no case it was necessary to implant, post- DEB, any additional stent.
During the clinical and instrumental follow-up period (median 13.3 months), there were no deaths nor strokes, nor
intrastent thrombosis, nor hospitalisations for heart failure.
Sixteen patients underwent coronary angiography as a result of the following clinical presentations: 4 patients with
non-ST segment elevation myocardial infarction (NSTEMI), 8 as a result of unstable angina and 4 following stress
angina and instrumental ischemia.
MACE TABLE
Restenosis
(n=10)
Total Pop.
No restenosis
(n=70 pcs)
(n=60)
Death (%)
0
0
0
Myocardial
Infarction (%)
Re-PTCA (%)
4 (5.7 %)
1 (1.6%)
3 (30%)
p< 0.001
11 (15.7%)
5 (8.3%)
6 (60%)
p< 0.001
Stroke (%)
0
0
0
Cardiac
0
decompensation (%)
0
0
CABG (%)
/
1 (10%)
0
0
1 (1.4%)
Stent thrombosis (%) 0
P-Value
P< 0.008
The angiographic examination has highlighted restenosis during DEB in a total of 10 patients (14.2 % of the
population treated with DEB) which is broken down as follows: 3 NSTEMI, 5 unstable angina, and two residual
ischemia. The 10 patients with post-DEB restenosis were treated as follows: in 1 case, the patient was referred for
cardiac surgery, 6 patients underwent PCI with DES implantation (2nd layer), and one patient was treated with
medical therapy alone, and 2 patients were sent for shock wave therapy.
The case of NSTEMI patients without evidence of restenosis during DEB showed a progression of previously
untreated native vessel disease, and was sent for medical therapy. Of the other 5 patients without evidence of
restenosis during DEB, 2 were undergoing PCI with DES implantation on other vessels and 3 were left in medical
therapy.
Conclusions: Our "real world" group confirms the safety and efficacy of treatment of intra-DES restenosis via
medicated balloon (ELUTAX SV); in particular, in a high risk cardiology population such as ours, the post-DEB
restenosis rate in the medium term (median 15.4 months) stood at 14.2%, which appears very encouraging.
In turn the restenosis influences the outcome for patients, causing a higher incidence of acute coronary syndrome
(unstable angina and NSTEMI). On uni-variate analysis, the only distance predictor of restenosis is acute coronary
syndrome on presentation (80% vs 38%, p = 0.01).