Dibra, Alban

Dibra, Laureta

Pavli, Elvis

Elsevier - Publisher Connector 

SATURDAY, SEPTEMBER 13, 2014, 5:00 PM–7:00 PM www.jacctctabstracts2014.comTCT-281
Meta-analysis of Randomized Trials Comparing Drug-Coated Balloon with
Drug-Eluting Stent for Treatment of Coronary in-Stent Restenosis
Alban Dibra1, Laureta Dibra1, Elvis Pavli1
1University Hospital Center, Tirana, Albania
Background: Drug-coated balloon (DCB) has been proposed as an alternative to
drug-eluting stent (DES) for treatment of coronary in-stent restenosis (ISR). Several
studies have examined the relative performance of these devices. However, their
statistical power regarding the evaluation of clinical endpoints has been limited due to
their small sample size. Therefore, we performed a meta-analysis of randomized trials
comparing DCB with DES in patients with ISR.
Methods: We searched for randomized trials comparing DCB with DES with no less
than 6 month follow-up. We excluded studies in which a BMS was used in conjunction
with DCB. Outcomes of interest were repeat revascularization, death, myocardial
infarction and the occurrence of major cardiac events (MACE). Odds ratios (ORs) with
95% conﬁdence intervals (CIs) were computed as summary statistics.
Results: Five studies were included in this meta-analysis. In all studies, the DCB
consisted of a paclitaxel-coated balloon while the DES was either a paclitaxel-eluting
or an everolimus-eluting stent. There were no differences regarding the two treatment
modalities regarding the odds of repeat revascularization [OR 0.92 (95% CI 0.63 to
1.33)], death [OR 0.81 (95% CI 0.32 to 2.05)] or myocardial infarction [OR 0.90 (95%
CI 0.36 to 2.21)]. Similarly, patients treated with DCB and DES had comparable odds
of suffering a MACE [OR 1.05 (95% CI 0.72 to 1.54)].
Conclusions: Among patients with coronary ISR, treatment with DCB is associated
with similar efﬁcacy and safety proﬁle compared to treatment with DES.
TCT-282
Systematic treatment of the side branch in a bifurcation lesion with a new drug
eluting balloon:the DEBSIDE study.
jacques berland1, PATRICE GUERIN2, Thierry Lefevre3, Jean Fajadet4
1clinique saint hilaire, rouen, France, 2HOPITAL GUILLAUME ET RENE
LAENNEC, NANTES, France, 3ICPS, Massy, France, 4CLINIQUE PASTEUR,
Toulouse, France
Background: The optimal treatment of the side branch(SB) in a bifurcation coronary
lesion is still a debate.Presently no study have evaluated the role of drug eluting balloon
SB infation after placement of a drug eluting stent in the main branch(MB). The DAN-
UBIO balloon integrates Speed Pax technology combining an excipient(BTHC)with
Paclitaxel(2.5mg/mm2) The DEBSIDE study is a prospective non randomized multi-
center study evaluating the DANUBIO balloon for the treatment of a SB(SB>2mm
diameter)after placement of a dedicated Paclitaxel stent(NILE Pax)in the MB.
Methods: From 8 French centers,50 patients(male 79%,Diabetic 26%,acute coronary
syndrome 22%) with bifurcation lesion were enrolled.After balloon pre-dilatation,
placement of the Nile Pax stent and kissing inﬂation(80%)without signiﬁcant residual
dissection, a DANUBIO balloon according to the SB size was inﬂated for 30s at 9.52.1
atm . Coronary angiography pre procedure before and after DANUBIO inﬂation and at 6
months were recorded and analysed by an independent core laboratory.Clinical follow up
was scheduled at 1,6 and 12 months. The primary endpoint involved 6 months late
loss(LL) of the ostiumof theSB and secondary endpointsMBLL,binary restenosis rate of
SB andMBand clinically driven revascularisation rates formain and secondary branches.
Results: Bifurcation lesions reached LAD/diag 74%,Circumﬂex/marginal 18% and
distal right coronary in 8%.Signiﬁcant SB lesion(Medina 111,101,011) was noted in
62% of the patients.Procedural success rate reached 100% after 3 additional stents in
the main branch .Per protocol no additional stent was placed in the SB. 2 patients
without cardiac events did not accept the angiographic control For the 48 others(96%)
at 6 month the minimal luminal diameter of the SB(1.580.34mm)was identical to the
post procedure one(1.530.3mm)resulting in a very low LL of 0.00650.4mm.
Accordingly the SB target lesion revascularisation(TLR) rate reached only 2%. For the
MB speciﬁcally the TLR reached 8% and 2 patients got non Target vessel angioplasty.
Conclusions: Combining the DANUBIO balloon with a dedicated bifurcation stent
seems to be a very effective strategy and needs to be conﬁrmed in a larger study.
TCT-283
Results Of Percutaneous Coronary Intervention With Sequent Please Paclitaxel
Eluting Balloon Catheter At A Very Long-Term Follow-Up.
Ignacio Sanchez-Perez1, Alfonso Jurado-Roman1, Manuel Marina-Breysse1,
Natalia Pinilla1, Maria T. Lopez-Lluva1, Jesus Piqueras-Flores1, Javier Benezet2,
Fernando Lozano1
1Hospital General Universitario de Ciudad Real, Ciudad Real, Spain, 2Hospital
Universitario de Jerez, Jerez de la Frontera, Cadiz
Background: Drug eluting balloons currently constitute one of the therapeutic tools
used in percutaneous coronary intervention (PCI) of both stent restenosis and de novo
coronary lesions, mainly in bifurcations and small vessels. Nowadays, their results at a
very long-term follow up are unclear. The main objective of this study was to evaluate
the efﬁcacy and safety of second-generation Sequent Please paclitaxel eluting
balloon (PEB) at 5 years.
Methods: We prospectively included 157 consecutive patients (6912 years, 71.3%
male) with 191 lesions (de novo or restenosis) treated with PEB between May 2009
and April 2013. We evaluated the presence of major cardiac events (MACE) after aB82 JACC Vol 64/11/Suppl B j September 13–17,prolonged clinical follow-up (median 36 months): death, nonfatal myocardial
infarction, target lesion revascularization (TLR ) and thrombosis.
Results: 40.8% of patients had stable coronary artery disease and 58.2% acute cor-
onary syndromes (46.6% Non-STEMI and 12.7% STEMI). 50.3% of patients were
diabetic and 24.3% of the lesions were bifurcations. Of the 191 lesions, 79 were de
novo lesions and 110 restenosis [77 restenosis of bare metal stent (BMS) and 33 of
drug-eluting stents (DES)]. 87.8% of the lesions were treated with PEB, 9.5% with
PEB and BMS and 2.6% with PEB and DES. There were no signiﬁcant differences
regarding baseline characteristics of these three groups neither in the MACE rate after
a long-term follow-up (p¼0.545). During follow-up, 10 patients died (2 cardiovas-
cular and 8 non-cardiovascular deaths) and a TLR rate of 2.6% was observed. No
cases of thrombosis were observed, immediately after the procedure nor during
follow-up. 20.1% of patients had an angiographic follow-up. We observed a higher
need for additional stent after dissection due to PEB in de novo lesions (p¼0.045) and
especially in diffuse lesions (p¼0.048) and bifurcations (p¼0.026).
Conclusions: Percutaneous coronary intervention of de novo coronary lesions and in-
stent restenosis (both of BMS and DES) with Sequent Please PEB provide very
favorable results at a very long-term follow up.
TCT-284
Synergy of Drug Coated Balloons plus Second-generation Drug Eluting Stents in
lesions with high risk for restenosis
Hiroyoshi Kawamoto1, Azeem Latib2, Katsumasa Sato1, Tadashi Miyazaki1,
Vasileios F. Panoulas2, Filippo Figini2, Alaide Chieffo2, Matteo Montorfano2,
Mauro Carlino2, Antonio Colombo1
1EMO GVM Centro Cuore Columbus/San Raffaele Scientiﬁc Institute, Milan, Italy,
2San Raffaele Scientiﬁc Institute, Milan, Italy
Background: Limited data are available as to whether the combination of drug coated
balloons (DCB) plus drug eluting stents (DES) would be more efﬁcacious than DES in
lesions or patients at high risk for restenosis. A combination of paclitaxel (present in
coated balloons) and a limus drug may exert a synergistic effect in preventing major
adverse cardiac events (MACE). We report the long-term follow-up data from a real-
world cohort.
Methods: Between 2009 and 2013, 68 patients (82 lesions) were treated with a
combination of DCB and implantation of a second-generation DES. The study end-
points were MACE, deﬁned as all-cause death, myocardial infarction (MI), and target
vessel revascularization (TVR). Furthermore, individual parameters, including cardiac
death, MI, TLR and TVR during the follow-up period, were evaluated. Cox regression
analysis was performed to determine the independent predictors of MACE.
Results: In our study cohort, baselines patient characteristics were severe. The cohort
had 31 lesions with in-stent restenosis (ISR) (37.8%), 18 lesions (22%) with multiple
ISR (more than 2 times) and 23 patients with diabetes mellitus (DM) (34.3%). The
mean lesion length was 25.8  13.7 mm, and 13% were CTO lesions. At median
follow-up of 19.8 months, (interquartile range [IQR]: 11.5–80.4), the MACE rates
were 9.2 and 27.4% at 1 and 2 years, respectively. The TLR and TVR rates at 1 year
were 5.9 and 13.5%, respectively. After 1-year, these rates increased to 24.7% and
32.5%. Very late stent thrombosis occurred in 1 patient on 1036 days after PCI. The
ﬁnal Cox regression model identiﬁed only insulin-dependent DM as the independent
predictor of MACE [HR 5.16, (95% CI, 1.04–25.6); P ¼ 0.05].
Conclusions: In our study, dual drugs with DCB and DES in lesions with high risk for
restenosis may be synergistic that may explain the favorable outcome. Insulin-
dependent DM was only the independent predictor of MACE. A large randomized
study is essential to evaluate the efﬁcacy of DCB plus DES combination in selected
high-risk lesions for restenosis.
TCT-285
Percutaneous Coronary Intervention With Drug Coated Balloons Only For
Coronary Bifurcation Lesions - Results Of The Randomized PEPCAD-BIF Trial
Franz X. Kleber1, Antonia Schulz2, Detlef Mathey3, Harald Rittger4, Bruno Scheller5,
Ralf Degenhardt6, Michael Boxberger7, Ruth H. Strasser8
1Cardio Centrum Berlin, Berlin, Germany, 2Charité University Medicine, Berlin,
Germany, 3University Cardiovascular Center Hamburg, Hamburg, Germany,
4Universitätsklinikum Erlangen, Medizinische Klinik 2, Erlangen, Germany,
5University of Saarland, Germany, Homburg, Germany, 6Clinical Research Institute,
Rotenburg a.d.F., Germany, 7BBraun Melsungen, Berlin, Germany, 8Technische
Universität Dresden, Herzzentrum Dresden, Universitätsklinik Dresden, Dresden,
Germany
Background: The standard treatment of bifurcation lesions is application of a drug
eluting stent to the main branch with provisional side branch stenting. While this
resulted in considerable improvement in overall MACE rate suboptimal side branch
results remained a problem. Given the good results of drug coated balloons (DCB) in
small vessels, we set out to explore the beneﬁt of distal main or side branch treatment
with a DCB and compared this to regular balloon angioplasty (POBA).
Methods: The study was performed from 2011 to 2013 in 6 German centers. All
patients planned for elective or deferred treatment of lesions involving bifurcations
were screened for participation in the trial. Native bifurcation lesions were included if
side branch vessel diameter was >2 mm and 3.5 mm and no proximal main branch
lesions was found. After successfull predilatation (TIMI III ﬂow, recoil 30 %,
dissection not beyond B according to NHLBI classiﬁcation) randomization was2014 j TCT Abstracts/Drug-Eluting Balloons and Local Drug Delivery


TCT-281 Meta-analysis of Randomized Trials Comparing Drug-Coated Balloon with Drug-Eluting Stent for Treatment of Coronary in-Stent Restenosis 

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TCT-281 Meta-analysis of Randomized Trials Comparing Drug-Coated Balloon with Drug-Eluting Stent for Treatment of Coronary in-Stent Restenosis

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