TCT-867 Polymer-free sirolimus-eluting stents in an elderly and octogenarian all-comer population

Full text

Received: 9 October 2017
|
Revised: 6 November 2017
|
Accepted: 7 November 2017
DOI: 10.1111/joic.12472
CORONARY ARTERY DISEASE
9-month results of polymer-free sirolimus eluting stents
in young patients compared to a septuagenarian and
octogenarian all-comer population
Behrouz Kherad MD
1
|
Matthias Waliszewski PhD
1,2
|
Matthias Leschke MD
3
|
Muhammad Ali Kader MD
4
|
LiewHoungBangMD
5
|
Fernando Lozano Ruiz-Poveda MD
6
|
Burkert Pieske MD
1
|
Florian Krackhardt MD
1
1
Department of Internal Medicine and
Cardiology, Charité –Universitätsmedizin
Berlin, Campus Virchow Klinikum
2
Medical Scientific Affairs, B.Braun
Melsungen AG, Berlin, Germany
3
Klinik für Kardiologie, Angiologie und
Pneumologie, Klinikum Esslingen, Esslingen,
Germany
4
Department of Cardiology, Hospital Pulau
Pinang, Penang, Malaysia
5
Department of Cardiology, Hospital Queen
Elizabeth II, Kota Kinabalu, Malaysia
6
Servicio de Hemodinámica y Cardiología
Intervencionista, Hospital General
Universitario de Ciudad Real, Spain
Correspondence
Florian Krackhardt, MD, Department of Internal
Medicine and Cardiology, Charité −
Universitätsmedizin Berlin, Campus Virchow,
Augustenburger Platz 1D-13353 Berlin, Germany.
Email: florian.krackhardt@charite.de
Objectives: To evaluate the 9-month safety and efficacy of polymer-free sirolimus
eluting drug eluting stents in septuagenarians and octogenarians.
Methods: An all-comer, worldwide single armed trial (ClinicalTrials.gov Identifier
NCT02629575) was conducted to demonstrate the safety and efficacy of an ultra-thin
strut, polymer-free sirolimus eluting stent (PF-SES). The primary endpoint was the 9-month
target revascularization rate (TLR). Secondary endpoints included the rates of major adverse
cardiac events (MACE), stent thrombosis (ST) and bleeding (BARC) in septuagenarians
(≥70 years, <80 years), and in octogenarians (≥80 years) to be compared to the younger
patient group (<70 years).
Results: A total of 1607 patients were treated with PF-SES in the sub-70-year-old age
group, 694 in septuagenarians, and 371 in the octogenarian patient group. At 9 months,
the MACE rates were 7.2% in octogenarians, 5.3% in septuagenarians, and 3.0% in the
younger patient group (P= 0.001). These were mostly driven by all-cause mortality
(4.4% vs 1.9% vs 0.6%, P< 0.001) while the TLR rates were only numerically lower in
the younger age group (P= 0.080). BARC 1-5 bleeding events were more frequent in
the older age group (1.9% vs 2.7% vs 4.6%, P= 0.012) whereas the rates for ST were not
different (0.7% vs 0.6% vs 0.6%, P= 0.970).
Conclusions: In octogenarians treated with PF-SES, the rates for MACE, overall
mortality, and bleeding are higher as compared to the younger age groups. However,
the rates for TLR and ST were not significantly different across the investigated age
groups. PF-SES are safe and effective in octogenarians.
KEYWORDS
drug-eluting stent, octogenarian, sirolimus, ultra thin strut
1
|
INTRODUCTION
The very elderly age group (≥85 years) amounting to 6.5 million in
2015, will double between 2030 and 2035 according to the US census
(US census bureau, 2017).
1
It represents therefore the fastest growing
segment of patients with cardiovascular disease.
2
Octogenarians undergoing percutaneous coronary angioplasty
(PCI) are a very challenging treatment population which is characterized
Behrouz Kherad and Matthias Waliszewski contributed equally to this manuscript.
338
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© 2017, Wiley Periodicals, Inc. wileyonlinelibrary.com/journal/joic J Interven Cardiol. 2018;31:338–344.

by morphologically more difficultlesions and higher rates of targetlesion
revascularization (TLR) and mortality.
3
In particular peri-interventional
mortality in this octogenarian patient population can be in the 7-8%
range in case of acute coronary syndrome (ACS).
4
When treating older
patients, the interventionalistis plagued by balancing the risk-to-benefit
ratio of drug-eluting stent (DES) implantations which require dual
antiplatelet therapy (DAPT) between 6 and 12 months
5
depending on
and the increased risk of bleeding and stent thrombosis (ST).
3
To untie
this Gordian knot of choosing the proper revascularization strategy
while managing the risks of bleeding and ST, and to achieve acceptably
low TLR rates, may be facilitated with the new generation of polymer-
free DES. One potential candidate to resolve this dilemma is the use of
polymer-free sirolimus/probucol DES which was previously compared
to a zotarolimus-eluting stent in a large randomized trial
6
with a long-
term follow-up of 5 years
7
and subgroup analysis in diabetics
8
and
patients with ST elevation infarction.
9
We report the results of a previously published large all-comers
population
10
registry with a focus on septuagenarian and octogenarian
subgroups.
2
|
METHODS
2.1
|
Study population, end points, and definitions
On the basis of the international ISAR 2000 all-comers registry
population
10
(ClinicalTrials.gov Identifier NCT02629575) a post-hoc
subgroup analysis was conducted in three age groups, that is, <70 years,
septuagenarians (≥70 years, <80 years), and in octogenarians (≥80 years).
The primary end point was TLR at 9 months. Secondary end points
were the 9-month major adverse cardiac event (MACE) rate, the
in-hospital MACE rate, and the corresponding rates of myocardial
infarction (MI) and peri-procedural mortality. Furthermore, the acute/
subacute ST rate was determined as defined by the ARC criteria.
11
The
BARC scale was used in our assessment to determine the severity of
bleeding episodes.
12
A glomerular filtration rate (GFR) <30 mL/min/1.73 m
2
was the
limit to define end stage renal disease with a cut-off GFR rate for
mandatory dialysis of <15 mL/min/1.73 m.
2
Severely tortuous vessels
were defined with angulations >45°.
2.2
|
Inclusion and exclusion criteria
Due to the all-comers character of this study, patients ≥18 years of age
with stable angina and objective proof of ischemia or patients with ACS
had to meet the requirements for PCI.
13
De novo or restenotic lesions
with reference diameters from 2.0 to 4.0 mm could be treated in single
or multiple vessels.
2.3
|
Procedures and medication
Femoral or radial vascular access was admissible with recommended
introducer sheaths of at least five French. Either direct stenting or
pre-dilatation with a balloon catheter of any given preference were
allowed by the study protocol. According to the institutional guidelines
of the cardiac center, intravenous heparin (70 IU/kg) was given in all
patients and supplemented when required. Platelet aggregation
inhibitor loading was not mandatory, however, it was recommended
prior to the procedure. Post-procedural thienopyridines were not
restricted in choice, that is, clopidogrel 75 mg/d, prasugrel 10 mg/d,
or ticagrelor 2 × 90 mg/d. Acetylsalicylic acid 100-325 mg/d was
prescribed life long.
2.4
|
Materials
All patients were treated with PF-SES angioplasty (Coroflex© ISAR,
B.Braun Melsungen AG, Germany). Briefly, its cobalt-chromium bare
metal backbone has ultra-thin struts (50/60 µm) which are sand-
blasted to create a microporous, abluminal surface for the polymer-
free matrix consisting of sirolimus (1.2 μg/mm
2
stent surface), and
probucol as the excipient to modulate drug elution.
2.5
|
Data collection and ethics
An established data capture system with a proven track record
14
was
used which allowed for plausibility checks during all stages of data
entry. Data quality issues were handled on a national level through
dedicated contacts to the corresponding study nurses in each cardiac
center. Follow-up time windows were closely monitored and
automatic email alerts were sent to the corresponding study nurse.
All ethics votes prior to patient recruitment for both study cohorts
were obtained from relevant national or local ethics committees. This
non-interventional study was approved by national ethics committees
as mandated by local law. In France the Comité Consultative sur le
Traitement de l’Information en matière de Recherche dans le domaine de la
Santé (CCTIRS) and the Commission Nationale de l’informatique et des
Libertés (CNIL) approved this study prior to patient recruitment.
2.6
|
Statistics
The significance level αof 0.05 was used for all tests. The two-sided
Fisher's exact test or the Chi
2
statistic were used whenever applicable
for dichotomous variables, whereas continuous variables were
compared with the unpaired t-test or the Mann-Whitney U-test in
case the Shapiro-Wilk test revealed a strong deviation from a normal
distribution. Kaplan-Meier survival analyses were conducted based on
the log-rank test. SPSS version 24.0 (IBM, Munich, Germany) was used
for all statistical analyses whereas biometricestimates for the previously
conducted unselected patient cohorts were calculated with nQuery/
nTerim version 2.0 (Statistical Solutions Ltd. Cork, Ireland).
3
|
RESULTS
3.1
|
Patients
As reported elsewhere
10
a total of 2877 patients were recruited in
the Coroflex ISAR 2000 registry. Significant differences for male
KHERAD ET AL.
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339

gender (P<0.001), hypertension (P<0.001), and the rates of
STEMI/NSTEMI (P< 0.001) were observed across age groups
(Table 1). The rate of older patients was higher in Europe, for
example, octogenarian patients amounted to 15.1% of all patients
treated in Europe versus only 7.6% in Asia. In contrast, in patients
of less than 70 years of age the corresponding rates were 50.6%
versus 68.3% (P
group
< 0.001).
3.2
|
Lesions, procedures, and co-medication
The distributions of treated vessels are different across age groups.
Noteworthy is the higher rate of lesions in the left anterior descending
(LAD) coronary artery in octogenarians (P
group
= 0.009). In addition,
except for the rates of chronic total occlusions, bifurcations and the
rate of AHA/ACC type B2/C type lesions; all other lesion morphologi-
cal characteristics were significantly different across age groups
(Table 2). Pre-dilatation (Table 2) was more frequently done in older
patients (44.3% vs 37.7% vs 35.6%, P= 0.004) and higher inflation
pressures were applied in older patients as well (14.4 atm vs 14.1 atm
vs 13.8 atm, P= 0.003).
Preferred peri-procedural antiplatelet agents (Table 3) in octoge-
narians were primarily clopidogrel (59.8%) and prasugrel (15.3%). Oral
anti-coagulants were more frequently prescribed in octogenarians and
septuagenarians as compared to the age group <70 years (2.7% vs
2.9% vs 0.7%, P= 0.003). Dual anti-platelet therapy duration (Table 4)
was shortest in the octogenarian subgroup as compared to the
younger age groups (9.5 ± 3.2 months vs 9.8 ± 2.9 months vs 10.5 ± 2.5
months, P< 0.0001). Triple therapy (Table 3) was prescribed in 2.9%
(septuagenarians) and 2.7% (octogenarians) which was almost
threefold as high as the corresponding rate in the younger age group
(1.1%, P
group
= 0.003).
3.3
|
Clinical outcomes
The primary endpoint TLR (Table 5) at 9 months was 3.1%
(10/320) in octogenarians, 3.0% (24/789) in septuagenarians, and
1.7% (24/1404) in patients <70 years of age. Despite no
differences in terms of TLR across the age groups (P=0.080),
the 9-month accumulated MACE rate (Figure 1, log-rank
P< 0.001) was the highest in octogenarians 7.2% (23/320) mostly
driven by increased overall mortality 4.4% (14/320). Bleeding
occurred more frequently in octogenarians as compared to the
younger age groups (4.6% vs 2.7% vs 1.9%, P=0.012) whereas
there was no difference in the rates of ST (P=0.970). In
particular, BARC 2-5 bleeding episodes were more frequent in
octogenarians as compared to the younger age groups (2.7% vs
0.6% vs 0.6%, P<0.001).
In patients who were on triple therapy, we found a 2.0%
(1/50) 9-month MACE rate with six patients who had bleeding
complications (BARC 1: 4/6, BARC 2: 2/6). These were
numerically higher in the older age groups, that is, 28.6% (2/7
in octogenarians), 15.4% (4/26, septuagenarians), and 0.0%
(0/17, <70 years).
4
|
DISCUSSION
To our knowledge this is the largest study in an octogenarian all-comer
population treated with a polymer-free DES technology. Albeit the fact
that previously detected cardiovascular risk factors and lesion
morphological characteristics such as the previously reported higher
rates of LAD stenting in octogenarians
3
were confirmed in our series;
some outcomes of this study have not been reported to our
knowledge.
TABLE 1 Patient demographics
Variable <70 years 70-79 years ≥80 years P-value
Number of patients 1607 694 371 -
Number of lesions 1808 1024 422 -
Number of DES used 2115 1244 499 -
Age (years) 58.7 ± 7.5 74.6 ± 2.7 83.3 ± 2.8 -
Male gender 1310 (81.5%) 599 (66.6%) 217 (58.5%) <0.001
Diabetes 592 (36.8%) 355 (39.5%) 143 (38.5%) 0.407
Hypertension 1062 (66.1%) 735 (81.8%) 310 (83.6%) <0.001
Renal insufficiency 59 (3.7%) 54 (6.0%) 48 (12.9%) <0.001
Dialysis dependence 31 (1.9%) 9 (1.0%) 8 (2.2%) 0.162
Hemodialysis 18 (1.1%) 7 (0.8%) 6 (1.6%) 0.266
Peritoneal dialysis 13 (0.8%) 2 (0.2%) 2 (0.5%)
STEMI 315 (19.6%) 106 (11.8%) 51 (13.7%) <0.001
NSTEMI 337 (21.0%) 178 (19.8%) 97 (26.1%)
Region
Europe 1025 (63.8%) 694 (77.2%) 306 (82.5%) <0.001
Asia 582 (36.2%) 205 (22.8%) 65 (17.5%)
340
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KHERAD ET AL.

4.1
|
Target lesion revascularization
First of all, we could not detecta difference in TLR across our agegroups
(P= 0.080). Yazji et al
3
reported a 12-month TLR rate of 3.7%which was
higher as compared to patients <80 years of age (P= 0.005). Our
9-month TLR rate was in the same range (3.1%), however, this rate was
not different from the TLR rate in the 70-79 year age group (3.0%).This
finding may have been favored by a lack of power, nonetheless, the
accumulatedST rates were all quite similar (P= 0.970) across age groups,
that is, 0.7% (<70 years), 0.6% (septuagenarians), and 0.6% (octoge-
narians). This finding has to be evaluated together with the DAPT
duration which was significantly longer in the octogenarian subgroup.
Taken together, this may suggest that the polymer-free DES we used in
this study can be safely used with low ST rates and acceptably low TLR
and MACE rates. In addition, bleeding episodes were more frequent in
octogenarians which is in agreement with the current literature.
15
4.2
|
Cardiac mortality and stent thrombosis
A careful comparison to other studies such as the report by
Lopéz-Palop et al reveals that our all-cause death rate of 4.4% in
octogenarians appears to be substantially lower as those reported by
Lopéz-Palop et al
15
(18.0% in DES, 19.0% in BMS) whereas the
confirmed rates of ST are also higher (5.6% in DES, 3.5% in BMS) as
compared to our findings (0.7% in octogenarians). The outcomes of an
observational study conducted by Thomas et al
16
reported mortality
TABLE 2 Lesion characteristics and procedural data
Variable <70 years 70-79 years ≥80 years P-value
Number of lesions 1808 1024 422 -
Target vessel
LAD 771 (42.6%) 416 (40.6%) 187 (44.3%) 0.009
CX 496 (27.4%) 273 (26.7%) 97 (23.0%)
RCA 534 (29.5%) 319 (31.2%) 131 (31.0%)
Graft 7 (0.4%) 16 (1.6%) 7 (1.7%)
Multi-vessel disease
1-vessel 1589 (87.9%) 879 (85.9%) 362 (85.8%) 0.015
2-vessel 197 (10.7%) 136 (13.3%) 48 (11.4%)
3-vessel 25 (1.4%) 9 (0.9%) 12 (2.8%)
Thrombotic occlusion 225 (12.4%) 113 (11.0%) 35 (8.3%) 0.048
Chronic total occlusion 71 (3.9%) 46 (4.5%) 10 (2.4%) 0.166
Thrombus burden 293 (16.2%) 127 (12.4%) 42 (10.0%) 0.001
Diffuse vessel disease 757 (41.9%) 537 (52.4%) 226 (53.6%) <0.001
Calcification 454 (25.1%) 399 (39.0%) 167 (39.6%) <0.001
Ostial lesion 154 (8.5%) 110 (10.7%) 53 (12.6%) 0.018
Bifurcations 265 (14.7%) 132 (12.9%) 50 (11.8%) 0.204
In-stent restenosis 51 (2.8%) 36 (3.5%) 21 (5.0%) 0.077
Severe tortuosity 156 (8.6%) 127 (12.4%) 63 (14.9%) <0.001
Saphenous vein graft 9 (0.5%) 20 (2.0%) 8 (1.9%) 0.001
AHA/ACC type B2/C lesion 1009 (55.8%) 573 (56.0%) 237 (56.2%) 0.990
Reference diameter (mm) 2.85 ± 0.50 2.82 ± 0.52 2.79 ± ±0.50 0.126
Lesion length 18.5 ± 9.6 20.2 ± 13.2 20.4 ± 11.9 0.009
Degree of stenosis (%) 87.1 ± 11.0 87.1 ± 11.0 85.7 ± 11.4 0.070
Predilation 644 (35.6%) 386 (37.7%) 187 (44.3%) 0.004
DESs used 2115 1244 499 -
DES per patient 1.30 ± 0.70 1.38 ± 0.83 1.34 ± 0.79 0.039
DES diameter (mm) 2.85 ± 0.48 2.81 ± 0.50 2.81 ± 0.49 0.062
DES length (mm) 22.0 ± 9.7 21.6 ± 10.5 21.9 ± 9.7 0.547
DES inflation pressure (atm) 13.8 ± 3.0 14.1 ± 3.1 14.4 ± 3.0 0.003
Final result % stenosis 1.4 ± 4.7 1.9± 7.9 1.3 ± 4.4 0.094
Overall technical success per stent 2082 (98.4%) 1220 (98.1%) 488 (97.8%) 0.532
KHERAD ET AL.
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341

rates for patients 80 years and older in the 12-15% range which is also
substantially higher as compared to our outcomes. In this context one
needs to be prudent to draw quick conclusions since confirmed ST
events may be more difficult to obtain in older patients unless
revascularizations can be done in due time.
Most patients who passed away prematurely had BARC 1
bleeding episodes while severe bleeding (BARC ≥3) occurred in
relatively small subgroups. However, in octogenarians who passed
away, there were two BARC 3a episodes versus none in the younger
subgroups (14.3% vs 0.0% vs 0.0%). As previously mentioned, the
use of anti-coagulants was more frequent in older patients.
Therefore, it can be suspected that the higher bleeding rates are
more likely to be an outcome of the increased use of anti-coagulants
which is not primarily related to age.
4.3
|
Antiplatelet and triple therapy
We found that prasugrel usage amounted to 15.3% in the octogenarian
subgroup despite the fact that this thienopyridine has an age cut-off of
75 years. However, we suspect that prasugrel was given in 5 mg per
day dosages in some centers despite the established indications
specified by the drug manufacturer.
There were 54 patients who were on triple therapy. Of these,
there were 50 patients with 9-month follow-up. The corresponding
MACE rate was low (2.0%), nevertheless, older patients in this
subgroup had more bleeding events. In triple therapy patients older
than 70 years, the bleeding rate in this study was in the 15-28% range
versus 0.0% in the sub-septuagenarian age group. This, however, is
also in agreement with recent findings by Bavishi et al
17
who
conducted a meta-analysis of observational studies.
TABLE 3 Peri-procedural drug therapy
Drug type Drug <70 years 70-79 years ≥80 years P-value
Pre PCI
Antiplatelet therapy (APT) Clopidogrel 844 (52.5%) 463 (51.5%) 222 (59.8%) <0.001
Prasugrel 206 (12.8%) 99 (11.0%) 166 (15.3%)
Ticagrelor 228 (12.8%) 117 (13.0%) 23 (6.2%)
Ticlopidine 9 (0.6%) 5 (0.6%) 15 (1.3%)
Aspirin only 150 (9.3%) 124 (13.8%) 42 (11.3%)
No preloading 170 (10.6%) 91 (10.1%) 41 (11.1%)
Oral anti-coagulatives (OAC) All OAC 18 (1.1%) 26 (2.9%) 10 (2.7%) 0.003
Vitamin k antagonist (VKA) 12 (0.7%) 16 (1.8%) 5 (1.3%) 0.015
New oral anticoagulative (NOAC),
for example, rivaroxaban
6 (0.4%) 10 (1.1%) 5 (1.3%)
Post PCI
Antiplatelet therapy (APT) Clopidogrel 1040 (64.7%) 656 (73.0%) 314 (84.6%) <0.001
Prasugrel 231 (14.4%) 65 (7.2%) 4 (1.1%)
Ticagrelor 300 (18.7%) 158 (17.6%) 43 (11.6%)
Aspirin only 16 (1.0%) 7 (0.8%) 5 (1.3%)
Unknown 20 (1.2%) 13 (1.4%) 3 (1.3%)
TABLE 4 Recommended duration of dual antiplatelet therapy during follow-up
Variable < 70 years 70-79 years ≥80 years P-value
Number of patients 1607 694 371 -
DAPT duration in months 10.5 ± 2.5 9.8 ± 2.9 9.5 ± 3.2 <0.001
1 month 8 (0.5%) 9 (1.0%) 7 (1.9%) <0.001
1-3 months 13 (0.8%) 8 (0.9%) 13 (3.5%)
3-6 months 4 (0.2%) 6 (0.7%) 2 (0.5%)
6 months 223 (13.9%) 169 (21.8%) 84 (22.6%)
>6-12 months 164 (10.2%) 85 (9.5%) 33 (8.9%)
12 months 914 (56.9%) 443 (49.3%) 167 (45.0%)
>12 months 4 (0.2%) 0 (0.0%) 1 (0.3%)
Unknown status 277 (17.2%) 152 (16.9%) 64 (17.3%)
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4.4
|
Study limitations
The findings in this study provide guidance, however, the statistical
basis is descriptive in nature. Randomized controlled trials or
propensity score matching, even though desirable, would be
extremely challenging to conduct so that bias introducing factors
canbeeliminated.Moredataonother demographic risk factors
such as the smoking status would have been desirable as well but
were not assessed to facilitate data entry. Unfortunately, we did
not a priori assess the vascular access site (femoral vs radial) which
would have been very helpful to discuss bleeding events in the
BARC 2 category.
FIGURE 1 Kaplan-Meier curve freedom from MACE in various age groups
TABLE 5 Clinical outcomes
Variable < 70 years 70-79 years ≥80 years P-value
Number of patients 1603 899 371 -
Patients with clinical follow-up at 9 months or early event 1404 (87.4%) 789 (87.8%) 320 (86.3%) 0.762
Follow-up time (months) 8.7 ± 2.1 8.6 ± 2.1 8.3 ± 2.3 0.045
Time to discharge (days) 3.3 ± 11.8 4.0 ± 13.4 4.8 ± 20.0 0.127
In-hospital MACE 18 (1.3%) 13 (1.6%) 10 (3.1%) 0.063
In-hospital TLR 6 (0.4%) 4 (0.5%) 4 (1.3%) 0.198
In-hospital MI 15 (1.1%) 5 (0.6%) 5 (1.6%) 0.338
In-hospital cardiac death 5 (0.4%) 8 (1.0%) 4 (1.3%) 0.080
9-month MACE 42 (3.0%) 42 (5.3%) 23 (7.2%) 0.001
9-month TLR (Re-PCI, CABG) 24 (1.7%) 24 (3.0%) 10 (3.1%) 0.080
9-month MI 30 (2.1%) 17 (2.2%) 11 (3.4%) 0.354
9-month death all causes 9 (0.6%) 15 (1.9%) 14 (4.4%) <0.001
Bleeding complications
BARC 1-5 31 (1.9%) 24 (2.7%) 17 (4.6%) 0.012
BARC 2-5 13 (0.8%) 6 (0.7%) 11 (3.0%) <0.001
BARC 3-5 5 (0.3%) 3 (0.3%) 7 (1.9%) <0.001
Unknown BARC 1 (0.1%) 2 (0.2%) 1 (0.3%) 0.452
9-month accumulated definite/probable stent thrombosis 10 (0.7%) 5 (0.6%) 2 (0.6%) 0.970
Acute stent thrombosis, ≤24 6 (0.4%) 1 (0.1%) 2 (0.6%) 0.497
Subacute stent thrombosis,1-30 days 0 (0.0%) 1 (0.1%) 0 (0.0%)
Late stent thrombosis, ≥30 days 4 (0.3%) 3 (0.4%) 0 (0.0%)
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343

5
|
CONCLUSIONS
This is the first report on age groups and their clinical expectations
after polymer-free stenting with sirolimus-coated DES within the
framework of a large all-comer study. PF-SES seem safe and effective
in octogenarians with very favorable TLR and ST rates similar to those
in younger patient groups.
ACKNOWLEDGMENTS
We like to acknowledge Dr. Birgit Blaich (Klinikum Esslingen/
Germany), Hervé Faltot (Hôpital Albert Schweitzer, Colmar/France),
and Ms Ramona Kranefuss (Südharz Klinikum Nordhausen/Germany)
for their help in conducting this study. In addition, the regulatory and
logistic support to conduct this study would not have been possible
without the dedicated help of the following Medical Affairs Team
members: Denny Herberger (Germany), Dr. Ghislaine Martin and Ms.
Aude Michaud (France), Dr. Ricard Rosique (Spain), Ms. Zoey Hooi
(Malaysia), and Ms. Yoonmi Lee (South Korea).
6
|
CONFLICT OF INTEREST
Except for FK (lecturing fees) and MW (full time employment at
Medical Scientific Affairs, B.Braun Melsungen AG) there are no
conflicts of interest to declare.
ORCID
Behrouz Kherad http://orcid.org/0000-0003-1733-6646
Matthias Waliszewski http://orcid.org/0000-0002-8689-4505
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How to cite this article: Kherad B, Waliszewski M, Leschke
M, et al. 9-month results of polymer-free sirolimus eluting
stents in young patients compared to a septuagenarian and
octogenarian all-comer population. J Interven Cardiol.
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