Abizaid, Alexandre

Abizaid, Andrea

Bbhat, Vinayak

Botelho, Roberto

Castro, Juliana P.

Chamié, Daniel

Costa, Jose d

Costa, Ricardo A.

John, Yan

Maeng, Michael

Morrison, Lynn

Ormiston, John A.

Schofer, Joachim

Toyloy, Sara

Verheye, Stefan

Witzenbichler, Bernhard

Elsevier - Publisher Connector 

J O U R N A L O F T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y , V O L . 6 6 , N O . 1 5 , S U P P L B , 2 0 1 5 B7TCT-16
Do overlapping scaffolds have an impact on clinical outcome? Analysis of
the ABSORB-EXTEND single arm study
Pieter C. Smits,1 Alexandre Abizaid2
1Maasstad Hospital Rotterdam, Rotterdam, Netherlands; 2Instituto
Dante Pazzanese de Cardiologia, São Paulo, Brazil
BACKGROUND Pre-clinical data show that overlapping scaffold seg-
ments show delayed healing and strut coverage compared to non-
overlapping scaffold segments. Little is known whether this may have
an impact on clinical outcome.
METHODS Within the ABSORB-EXTEND study of 812 patients with 1
year follow-up complete, patients with overlapping scaffolds (n¼115)
were compared to patients with non-overlapping scaffolds (n¼697).
RESULTS No differences in baseline patient and lesion characteristics
between both patient groups were noted, apart from the signiﬁcant
longer lesion length in the overlapping scaffold group (16.77.3 versus
11.64.4 mm, [p<0.0001; 95% CI: 3.7-6.4]) and subsequently less
lesion type B1 and more B2. Furthermore, more patients were treated
for stable angina in the overlapping scaffold group (72% versus 54%,
p¼0.0003). In the overlapping scaffold group 41/125 (33%) lesions
were > 20 mm long, compared to 33/734 (5%) lesions in the non-
overlapping group, p<0.0001. The 1 year clinical outcome is summa-
rized in the table below. Scaffold Thrombosis is reported according
ARC and Myocardial Infarction according protocol deﬁnitions.Overlapping Non-overlapping P valueCardiac death 0.9% 0.7% 0.6Myocardial Infarction (MI) 8.7% 2.4% 0.002- Q wave MI 1.7% 0.9% 0.3- non-Q wave MI 7.0% 1.6% 0.003Target Lesion Revascularization 0.9% 2.6% 0.5Def/Prob Scaffold Thrombosis (ST) 1.8% 0.9% 0.3- Early Def/Prob ST 1.7% 0.4% 0.1- Late Def/Prob ST 0.0% 0.4% 1.0CONCLUSIONS In the non to moderate complex lesion population of
ABSORB-EXTEND, patients with overlapping scaffolds showed only
signiﬁcantly more non-Q wave myocardial infarctions compared to
the non-overlapping scaffold group. This difference occurred mainly
in-hospital and was procedure related.
CATEGORIES CORONARY: Stents: Bioresorbable Vascular Scaffolds
KEYWORDS Bioabsorbable scaffolds, Long lesion treatment, PCI -
Percutanoeus Coronary Intervention
TCT-17
Prospective, Multi-Center Evaluation of the DESolve Novolimus-Eluting
Bioresorbable Coronary Scaffold: Imaging Outcomes and 3-Year Clinical
and Imaging Results
Stefan Verheye,1 Joachim Schofer,2 Michael Maeng,3
Bernhard Witzenbichler,4 Roberto Botelho,5 John A. Ormiston,6
Ricardo A. Costa,7 Jose d Costa, JR.,8 Daniel Chamié,9
Juliana P. Castro,10 Andrea Abizaid,8 Yan John,11 Vinayak Bbhat,11
Lynn Morrison,12 Sara Toyloy,11 Alexandre Abizaid13
1Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium,
Antwerp, Belgium; 2Medical Care Center Prof Mathey, Prof Schofer,
Hamburg University Cardiovascular Center, Hamburg, Germany;
3Aarhus University Hospital, Aarhus, Denmark; 4Helios Amper-
Klinikum Dachau, Berlin, Germany; 5Triangulo Heart Institute,
Uberlândia, Brazil; 6Professor, University of Auckland Medical School,
Auckland, New Zealand; 7INSTITUTO DANTE PAZZANESE DE
CARDIOLOGIA, SAO PAULO, Brazil; 8Instituto Dante Pazzanese de
Cardiologia, São Paulo, Brazil; 9Dante Pazzanese, São Paulo, Brazil;
10Cardiovascular Research Center, Sao Paulo, São Paulo; 11Elixir Medical
Corporation, Sunnyvale, CA; 12elixir medical corporation, Sunnyvale,
CA; 13Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
BACKGROUND The DESolve Novolimus Eluting Bioresorbable Cor-
onary Scaffold System (NEBCSS) is a drug-eluting bioresorbable scaf-
fold combining a PLLA-based scaffold coated with Novolimus, a
macrocyclic lactone mTOR inhibitor with potent anti-proliferative
properties. The drug dose is 5 mg per mm of scaffold length; the device
is available in multiple diameters (2.5 – 3.5 mm) and lengths (14, 18
and 28 mm). The DESolve Nx study is multi-center evaluation of the
safety and efﬁcacy of the DESolve NEBCSS in patients with single, de
novo, native coronary artery lesions.METHODS A total of 126 patients were enrolled in this prospective
registry. Patients receiving the study device were analyzed for mul-
tiple clinical endpoints including: device and procedure success;
Major Adverse Cardiac Events (MACE), a composite endpoint of car-
diac death, target vessel MI, or clinically-indicated target lesion
revascularization (CI-TLR); Target Vessel Revascularization, (CI-TVR)
and stent thrombosis assessed at 1, 6 and annually to 5 years. All
patients underwent angiographic assessment at 6 months and a sub-
set of patients underwent IVUS and OCT assessment also at 6 months
and imaging 12 months using multislice computed tomography
(MSCT). Additionally, at single centers, multi-modality imaging was
completed at 18 months and 3 years.
RESULTS Mean age at baseline was 62 years, 32% were females, and
21% diabetics. Lesion length was 11.2 mm, RVD was 3.06 mm, and
18.3% showed moderate-to-heavy calciﬁcation. Six-month QCA
demonstrated low mean in-scaffold late lumen loss (0.20 mm), 18.3%
DS and an MLD of 2.45 mm. Serial IVUS at baseline and 6 months
demonstrated a signiﬁcant increase in mean lumen (D 10.0%,
p ¼ < 0.001) and scaffold areas (D 15.7%, p ¼ < 0.001) and low %
volume obstruction (5.1%). Serial OCT demonstrated a signiﬁcant in-
crease in scaffold area (D 16.9 %, p ¼ < 0.001) with 98.8% neointimal
coverage of the scaffold at 6 months. Twelve-month MSCT results
demonstrated lumen dimension maintenance from 6 to 12 months.
QCA at 18 months shows minimal lumen change and 3 year OCT im-
aging reveals the “golden tube” indicating resorption of the scaffold.
Clinical events remained low (MACE ¼ 5.69% and 7.4% at 12 and
24 months respectively) with no reports of deﬁnite stent thrombosis.
CONCLUSIONS DESolve demonstrated safety and efﬁcacy with low late
lumen loss. Serial imaging assessments indicatedearlyvessel restorationat
6 months with good luminal patency at 12 months by MSCT. At 12 and 24
months, the clinical event rates remain low. Imaging endpoints at 18
months and 3 years and 3-year clinical results will be presented.
CATEGORIES CORONARY: Stents: Bioresorbable Vascular Scaffolds
KEYWORDS Bioabsorbable scaffolds, Drug-eluting stent, bioabsorbable,
NovolimusCOMPLEX AND HIGHER-RISK
INDICATED PATIENTS
Tuesday, October, 13, 2015, 2:00 PM-4:00 PM
Abstract nos: 18 - 25TCT-18
Impact of Incomplete Revascularization after Percutaneous Coronary
Intervention as Assessed by the SYNTAX Revascularization Index in
Complex Coronary Artery Disease: A SEEDS Substudy
Nicolas Bettinger,1 Changdong Guan,2 Yuejin Yang,3 Martin Leon,4
Bo Xu,2 Philippe Genereux5
1NewYork-Presbyterian Hospital/Columbia University Medical Center,
New York, NY; 2Fu Wai Hospital, National Center for Cardiovascular
Diseases, Beijing, China; 3Cardiovascular Institute and Fuwai Hospital,
National Center for Cardiovas, Beijing, China; 4Cardiovascular Research
Foundation, New York, United States; 5Columbia University Medical
Center, New York
BACKGROUND The SYNTAX revascularization index (SRI), representing
the percentage of revascularized myocardium, has been shown to be a
strong independent predictor of adverse ischemic events after percuta-
neous coronary intervention (PCI); however, its predictive capability
among patients with complex coronary artery disease (CAD) undergoing
PCI with second-generation everolimus-eluting stents (EES) remains un-
explored. We sought to evaluate the impact of incomplete revasculariza-
tion as assessed by the SRI on 2-year adverse ischemic events in a
population of patients with complex CAD undergoing EES-PCI.
METHODS Among 1900 patients enrolled in A Registry to Evaluate
Safety and Effectiveness of Everolimus Drug Eluting Stent for Coro-
nary Revascularization (SEEDS), SRI was available in 1851. Patients
were stratiﬁed into three groups (SRI¼100%, SRI 50 to 99%, and SRI
<50%), according to the proportion of revascularized myocardium.
Mortality and major adverse cardiac events (MACE) were compared
between groups.


TCT-17 Prospective, Multi-Center Evaluation of the DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold: Imaging Outcomes and 3-Year Clinical and Imaging Results 

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TCT-17 Prospective, Multi-Center Evaluation of the DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold: Imaging Outcomes and 3-Year Clinical and Imaging Results

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