Received: 18 December 2017 Revised: 2 May 2018 Accepted: 9 September 2018

DOI: 10.1002/ccd.27919

ORIGINAL STUDIES

Bioresorbable polymer-coated thin strut sirolimus-eluting stent

vs durable polymer-coated everolimus-eluting stent in daily
clinical practice: Propensity matched one-year results from
interventional cardiology network registry
Pawel Gasior MD, PhD1 | Marek Gierlotka MD, PhD2,3 |
Krzysztof Szczurek-Katanski MD, PhD4 | Marcin Osuch MD, PhD4 | Roman Gnot MD4 |
Michał Hawranek MD, PhD2 | Mariusz Gasior MD, PhD2 | Lech Polonski MD, PhD2

1
Department of Cardiology and Structural
Heart Diseases, Medical University of Silesia,
Katowice, Poland
2
3rd Department of Cardiology, School of
Medicine with the Division of Dentistry in
Zabrze, Medical University of Silesia,
Katowice, Silesian Centre for Heart Diseases,
Zabrze, Poland
3
Department of Cardiology, University
Hospital, Faculty of Natural Sciences and
Technology, University of Opole, Poland
4
Scanmed, Gliwice, Poland
Correspondence
Paweł Gąsior, MD, PhD, Division of Cardiology
and Structural Heart Diseases, Medical
University of Silesia, Ziolowa 47, 40-635
Katowice, Poland.
Email: p.m.gasior@gmail.com
Abstract
Objectives: We sought to determine the 1-year clinical follow-up in patients treated with the
thin strut (71 μm) bioabsorbable polymer-coated sirolimus-eluting stent (BP-SES) vs durable
coating everolimus eluting stent (DP-EES) in daily clinical routine.
Background: Presence of durable polymers may be associated with late/very late stent throm-
bosis occurrence and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers
may facilitate stent healing, thus enhancing clinical safety.
Methods: Interventional Cardiology Network Registry is a prospective, multicenter, observa-
tional registry of 21,400 consecutive patients treated with PCI since 2010. We analyzed 4,670
patients treated with either a BP-SES (ALEX, Balton, Poland) or DP-EES (XIENCE, Abbott, USA)
with available 1-year clinical follow-up using propensity-score matching. Outcomes included tar-
get vessel revascularization (TVR) as efficacy outcome and all cause death, myocardial infarction
(MI), and definite/probable stent thrombosis as safety outcomes.
Results: After propensity score matching, 1,649 patients treated with BP-SES and 1,649
patients treated with DP-EES were selected. Procedural and clinical characteristics were similar
between both groups. There was no significant difference between tested groups in in-hospital
mortality. One-year follow-up demonstrated comparable efficacy outcome, TVR (BP-SES 5.9%
vs DP-EES 4.6% P = 0.45), as well as comparable safety outcomes, all cause death, MI and defi-
nite/probable stent thrombosis.
Conclusions: In this multicenter registry, the BP-SES thin strut biodegradable polymer-coated
sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation
to the DP-EES. These data support the relative safety and efficacy of DP-SES in a broad range
of patients undergoing percutaneous coronary intervention.

KEYWORDS

Bioresorbable polymer, Drug-Eluting Stents, Percutaneous Coronary Intervention

1 | I N T RO D UC T I O N endothelialization.1,2 Second-generation DES maintained the low reste-

nosis rates of first-generation devices with reduced rates of ST.3–5 How-
Compared with bare-metal stents (BMS), first-generation drug eluting ever, very late ST and neoatherosclerosis have been recently observed
stents (DES) coated with durable polymer result in reduced rates of with second generation DES.6–8 Late DES failure was associated with
restenosis. However, they are associated with an increased risk of stent chronic inflammation and hypersensitivity reactions due to presence of
thrombosis (ST) due to delayed healing and prolonged re- durable polymer.9,10 In an attempt to overcome these unwanted late

Catheter Cardiovasc Interv. 2018;1–7. wileyonlinelibrary.com/journal/ccd © 2018 Wiley Periodicals, Inc. 1

2 GASIOR ET AL.

effects, new DES platforms that make use of biodegradable polymers 2.3 | Study population
have been developed. After complete release of the drug, the polymer
The demographic, clinical, and angiographic data of the patients were
gradually degrades into water and carbon dioxide molecules. In this
retrieved from prospective hospital records from the dedicated elec-
manner, biodegradable polymer DES were designed to provide polymer
tronic system. Follow-up data, including exact dates for deaths, myo-
and drug free surroundings at the treatment site after early “vulnerable”
cardial infarction (MI) and repeat revascularization, were obtained
restenotic period by transforming into a BMS once drug elution and
from the health insurer (National Health Fund) database. Detailed
polymer biodegradation are completed.11 Therefore, biodegradable
angiographic data for repeat revascularization were obtained from the
polymer DES could eliminate the potentially dangerous effects of persis-
medical centers that performed the procedures.
tent inflammatory stimulus and reduce the risk of adverse cardiac events
All patients underwent coronary angiography with following or
related to ST that may be related to durable polymer presence.12
postponed PCI using standard devices. All interventional strategies,
In our study, we sought to determine the 1-year clinical follow-up
including the use of stents, choice of stent type and periprocedural
in large cohort of patients treated with the thin strut bioabsorbable
antithrombin and antiplatelet therapy, were at the discretion of the
polymer-coated sirolimus-eluting stent (BP-SES) vs durable coating
attending physicians. Pharmacological treatments recommended by
everolimus eluting stent (DP-EES) in daily clinical routine.
the European Society of Cardiology were introduced before and after
the intervention unless contraindicated.

2 | METHODS
2.4 | Definitions and endpoints
2.1 | Study design The efficacy outcome was defined as target vessel revascularization
(TVR). The safety outcomes included separate endpoints of death, MI,
Interventional cardiology network registry is a prospective, observational
and definite or probable ST. MI was defined as an ischemic event that
registry which includes all patients treated with percutaneous coronary
fulfilled the European Society of Cardiology/American College of Cardi-
intervention (PCI) in four polish interventional cardiology centers in
ology criteria for MI and that was clinically distinct from the index event
Poland. A retrospective screening of unselected patients (n = 21,400)
at the time of first hospitalization.15 TVR was defined as any repeat
treated with PCI between 2010 and 2016 was undertaken. All consecu-
percutaneous intervention or surgical bypass of any segment of the tar-
tive patients that underwent single or multivessel revascularization with
get vessel. ST was considered as acute (0–24 hr), subacute (>24 hr to
either BP-SES (ALEX, Balton, Warsaw, Poland, n = 3,559) or DP-EES
30 days), or late (>31 days) and was defined as either definitive or
(XIENCE, Abbott Vascular, Santa Clara, CA, n = 3,979) during index pro-
probable according to the Academic Research Consortium.16
cedure were evaluated to be eligible for inclusion. As follow-up data
were not available for patients treated in years 2015 and 2016, for final
analysis, we selected only patients treated between 2010 and 2014. For 2.5 | Statistical analysis
these years, 1-year follow-up data were available for all patients. Categorical variables are presented as percentages and were com-
pared using the chi-square test, whereas continuous variables are dis-
2.2 | Stent system description played as means  SD and were compared using Student's t-test. A
propensity score method was used to match the BP-SES and DP-EES
The BP-SES is a CE-approved balloon expandable stent dedicated for
groups for all baseline clinical characteristics and angiographic param-
coronary atherosclerotic lesions. The stent platform is made of a laser-
eters listed in Tables 1 and 2. The area under curve for logistic model
cut cobalt-chromium alloy with a wall thickness of 71 mm. It has a
was 0.703, P < 0.0001. The greedy matching algorithm, available in
closed cell design for uniform drug distribution. The profile of the whole
NCSS, was used with the distance calculation option set to “Mahala-
implantation system, including stent, is 0.034 in. BP-SES is covered
nobis Distance within Propensity Score Calipers (no matching outside
with a fully biodegradable multilayer structure containing a copolymer
caliper)” and caliper to 0.2*Sigma. Cumulative event rates in 1-year
of poly-lactic and glycolic acid and sirolimus. The total mass of the poly-
follow-up were analyzed with the Kaplan–Meier method and com-
mer on a 3.0 × 15 mm stent does not exceed 360 μg. Experimental
pared with the log-rank test. All tests were two-tailed, and a P value
studies in the porcine in-stent restenosis model at 8 weeks showed
<0.05 was considered to indicate statistical significance. Statistics
nearly full polymer biodegradation and 95% drug release of initial drug
13 were calculated with STATISTICA 10 (Statsoft, Tulsa, Oklahoma, USA)
load. In the previously published study, BP-SES demonstrated favor-
and NCSS 11 Statistical Software (NCSS, LLC, Kaysville, Utah, USA).
able performance in complex coronary lesions of 424 patients in daily
clinical practice.14 BP-SES displayed high clinical device success
(98.5%), and acute gain (1.67  0.44 mm) together with low residual
3 | RE SU LT S
diameter stenosis (6.43  4.16%). In the current study, the thin strut
BP-SES was compared to an extensively used clinical practice balloon-
expandable cobalt-chromium DP-EES with strut thickness of 81 μm.
3.1 | Baseline demographic characteristics
Everolimus is blended in a nonerodable polymer coated over another A total of 2,004 BP-SES and 2,666 DP-EES patients were found to be
nonerodable polymer primer layer. The coating consists of acrylic and eligible for matching. Patients treated with BP-PES were older
fluoro polymers and everolimus is eluted up to 120 days. (66.25  10.37 vs 64.89  10.44; P < 0.001). There was a
GASIOR ET AL. 3

TABLE 1 Baseline characteristics

Unmatched Matched
BP-SES (n = 2,004) DP-EES (n = 2,666) P value BP-SES (n = 1,649) DP-EES (n = 1,649) P value
Age (years) 66.25  10.37 64.89  10.44 <0.001 65.65  10.30 65.62  10.62 0.94
Female (%) 38.3 35.5 0.046 37.0 37.8 0.63
Previous MI (%) 30.1 34.2 0.004 30.6 31.3 0.90
Previous PCI (%) 19.8 27.3 <0.001 21.8 22.1 0.87
Previous bypass surgery (%) 8.6 9.0 0.640 8.7 8.7 1.00
Previous stroke (%) 5.1 3.6 0.008 4.6 5.0 0.87
Hypertension (%) 79.9 79.2 0.550 80.1 79.8 0.67
Diabetes (%) 33.4 33.2 0.840 33.5 32.9 0.71
Hypercholesterolemia (%) 45.8 47.5 0.250 47.1 46.6 0.75
Smoking (%) 22.8 16.1 <0.001 20.3 19.5 0.57
Obesity (%) 31.1 35.2 0.250 32.4 32.9 0.71
Chronic heart failure (%) 22.3 20.6 0.160 21.2 21.4 0.29
Chronic renal failure (%) 8.1 9.2 0.170 8.0 7.9 0.90
Cardiogenic shock (%) 2.5 1.9 0.21 2.1 2.3 0.97
Indication for procedure (%)
STEMI 15.7 10.5 <0.001 13.5 13.2 0.80
NSTEMI 30.3 30.0 0.790 29.2 30.1 0.57
Unstable angina 33.9 37.1 0.022 35.5 34.9 0.72
Stable CAD 20.1 22.4 0.064 21.9 21.9 1.0

Abbreviations: MI, myocardial infarction; STEMI, ST-segment elevation myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction;
CAD, coronary artery disease.

significantly higher incidence of ST segment elevation MI in the BP- 37.1%; P = 0.022) than patients in the DP-EES group. Previous MI
SES group (15.7% vs 10.5%; P < 0.001) at hospital admission and and PCI procedures were less common in the BP-SES group (respec-
fewer BP-SES patients underwent PCI for unstable angina (33.9% vs tively: 30.1% vs 34.2%; P = 0.004, 19.8% vs 27.3%; P < 0.001).

TABLE 2 Angiographic and procedural characteristics

Unmatched Matched
BP-SES DP-EES P BP-SES DP-EES P
(n = 2,004) (n = 2,666) value (n = 1,649) (n = 1,649) value
Multivessel CAD (%) 49.6 50.1 0.75 49.6 49.4 0.63
LM CAD (%) 2.1 4.1 <0.01 3.4 4.1 0.27
Target vessel (%)
LM 1.4 5.2 <0.01 1.6 1.4 0.57
LAD 35.9 50.0 <0.01 46.5 46.3 0.75
Cx 20.3 19.3 0.42 30.5 30.3 0.79
RCA 34.8 27.9 <0.01 33.2 32.2 0.55
Bypass 3.1 2.6 0.30 3.1 3.3 0.69
Single vessel PCI (%) 85.3 79.1 <0.01 85.1 85.6 0.53
Bifurcation PCI (%) 7.8 16.9 <0.01 8.9 8.5 0.66
Stents used per patient (mean  SD) 1.41  0.76 1.43  0.75 0.39 1.39  0.72 1.39  0.72 0.90
Total length of stents (mean  SD) 25.81  15.96 29.99  18.09 <0.01 26.31  16.16 26.68  15.69 0.51
Maximal implantation pressure 14.56  2.23 14.55  2.61 0.86 14.57  2.22 14.46  2.67 0.34
(mean  SD)
Direct stent implantation (%) 43.0 37.9 <0.01 41.3 42.0 0.67
Post dilatation (%) 21.7 23.2 0.21 21.4 20.8 0.70
Thrombectomy (%) 6.7 6.8 0.20 6.4 6.4 0.94
Procedural glycoprotein IIb/IIIa inhibitor 6.3 7.4 0.14 6.7 8.2 0.18
(%)

Abbreviations: CAD, coronary artery disease; LM, left main; LAD, left anterior descending; Cx, circumflex; RCA, right coronary artery; PCI, percutaneous
coronary intervention.
4 GASIOR ET AL.
Previous stroke was present more often in BP-SES when compared to
DP-EES (5.1% vs 3.6%, P = 0.008).
Following propensity score analysis and matching, 1,649 pairs
were selected for further analysis with a mean age of 65.65  10.30
years in BP-SES group and 65.62  10.62 in DP-EES group. There
were no relevant differences found in the baseline characteristics fol-
lowing matching. The proportions of patients with ST-segment eleva-
tion MIs (BP-SES 13.5% vs DP-EES 13.2%), non-ST-segment elevation
MIs (BP-SES 29.2% vs DP-EES 30.1%), unstable (BP-SES 35.5% vs
DP-EES 34.9%), and stable angina (BP-SES 21.9% vs DP-EES 21.9%)
were comparable between matched groups. An overview of the
unmatched and matched baseline characteristics is shown in Table 1.
3.2 | Patients angiographic and procedural
characteristics
In general cohorts, there were significant differences between BP-SES
and DP-EES in angiographic and procedural characteristics. Left main
coronary artery disease was significantly less frequently seen in the
BP-SES group compared to the DP-SES group (2.1% vs 4.1% respec-
tively, P < 0.01). There were also significant differences in targeted
vessels between both investigated groups. Single vessel PCI was per-
formed more often in BP-SES compared to DP-EES (respectively:
85.3% vs 79.1%, P < 0.01). Bifurcation PCI was performed less often
and direct stenting was more frequent in BP-SES group (respectively:
BP-SES 7.8% vs DP-EES16.9%, P < 0.01; BP-SES 43.0% vs 37.9%,
P < 0.01). The number of stents per patient and maximal implantation
pressures were similar between the groups. However, total length of
stents was significantly lower in BP-SES vs DP-EES (respectively:
25.81  15.96 vs 29.99  18.09, P < 0.01).
After propensity score matching, angiographic and procedural
characteristics such as multivessel CAD, left main CAD, and targeted
vessels were comparable between studied groups. There was no dif-
ference in multivessel (BP-SES 14.9% vs DP-EES 14.4%; P = 0.53) and
bifurcation (BP-SES 8.9% vs DP-EES 8.5%; P = 0.53) intervention
rates. On average, the number and length of stents implanted per
patient were similar. Also, there was no difference in maximal implan-
tation pressure (BP-SES 14.57  2.22 atm. vs DP-EES 14.46  2.67
atm.; P = 0.34). Direct implantation was performed in 41.3% of cases
in BP-SES group and 42.0% in DP-EES group (P = 0.67). Angiographic
and procedural characteristics before and after propensity score
matching are summarized in Table 2.
3.3 | Clinical outcomes in matched cohorts
There was no difference in in-hospital (BP-SES 2.2% vs DP-EES 1.9%;
P = 0.62) and 30-day mortality (BP-SES 2.7% vs DP-EES 2.0%;
P = 0.17) in the matched groups. In general, there were no relevant
differences found in the clinical outcomes after 1 year. At 12 months,
the efficacy outcome of TVR rates was comparable between BP-SES
and DP-EES (respectively: 5.9% vs 4.6%, P = 0.10). There was also no
difference in safety endpoints between the matched groups in terms
of death, MI, and definite/probable ST (Figure 1). All cause death at
1 year was 6.0% in BP-SES and 5.4% in DP-EES (P = 0.45). Myocardial
infarction rates were similar in both groups (BP-SES 5.3% vs DP-EES
5.0%; P = 0.75). The cumulative rates of definite/probable ST were
low with no significant difference between the matched groups (BP-
SES 1.46% vs DP-SES 1.21%; P = 0.55). There was also no difference
in acute (BP-SES 0.06% vs DP-SES 0.06%; P = 0.48), subacute (BP-
SES 0.85% vs DP-SES 0.49%; P = 0.20), and late (BP-SES 0.67% vs
DP-SES 0.55%; P = 0.65) definite/probable ST. Details of the follow-
up results are presented in Table 3.
4 | DI SCU SSION
The present analysis is the first to describe a direct comparison of the
clinical outcomes of thin strut biodegradable polymer coated
sirolimus-eluting stent against benchmark nonerodable polymer
coated everolimus eluting stent. The major finding of this investigation
in a large propensity matched cohort of patients undergoing DES
implantation in a routine clinical practice, is comparable to 1-year clini-
cal outcomes for the BP-SES when compared with DP-EES, with rea-
sonable event rates, demonstrating similar safety and efficacy of the
devices in a real-world setting.
BP-DES was initially developed to overcome the risk of delayed
healing process attributed to the inflammatory reaction induced by
the durable polymer. The use of biodegradable polymers, as opposed
to durable polymers, in coronary stent technology has the advantages
of complete drug elution and degradation of polymer, which may
result in a reduced inflammatory response. Recent reports demon-
strated similar clinical outcomes after implantation of BP-DES when
compared to durable polymer coated stents despite their theoretical
advantages. In large meta-analysis, treatment with BP-DES signifi-
cantly reduced late lumen loss and late ST rates, without clear benefits
on harder endpoints compared to durable polymer DP-DES.17 How-
ever, high-risk population like STEMI patients could benefit from BP-
DES.18,19 In 497 patients with STEMI at 4 years, major adverse cardiac
events were significantly reduced following treatment with BP-DES
(hazard ratio [HR] 0.59, 95% CI 0.39–0.90; P = 0.01). Similar conclu-
sions were drawn from pooled individual patient-level data from three
randomized clinical trials.20
Nonetheless, several studies have shown that polymers requiring
active bioresorption are associated with higher rates of inflammation
than DP BP-DES.21,22 This inflammatory process seen with biodegra-
dation could possibly explain the attenuated benefit of BP-DES. In
fact, several meta-analyses have demonstrated worse outcomes with
BP-DES compared with DP-DES. Indeed, Bangalore et al. found that
BP-DES were associated with higher mortality compared with cobalt
chromium everolimus-eluting stents beyond 1 year of follow-up (RR:
1.52, 95% CI: 1.02–2.22).23 However, in up-to-date largest meta-
analysis comparing BP-DES to the second-generation DP-DES dem-
onstrated similar safety and efficacy profiles in both types of
devices.24
In our study, BP-SES demonstrated similar efficacy as DP-EES
described by comparable TVR rates in both studied groups (respec-
tively: 5.9% vs 4.6%, P = 0.10). Also, we showed that treatment with
BP-SES was not associated with increased mortality (respectively:
6.0% vs 5.4%; P = 0.45) and MI rates (respectively: 5.3% vs 5.0%;
P = 0.75) when compared to DP-EES. Furthermore, no significant
GASIOR ET AL. 5

FIGURE 1 One-year Kaplan–Meier event rates. The Kaplan–Meier curves show the cumulative incidence of (A) target vessel revascularization;
(B) myocardial infarction; (C) all-cause death; and (D) the definite/probable stent thrombosis [Color figure can be viewed at wileyonlinelibrary.com]

differences were found in terms of definite and probable ST (BP-SES highlight that this difference might be attributed to more challenging
1.46% vs DP-SES 1.21%; P = 0.55). The 12-month rates of ST found population included in our study with higher rate of acute coronary
in our study are slightly higher than in randomized trials comparing syndrome patients (~80%) than in most of the randomized trials. How-
biodegradable and durable polymer coated DES.25 It is important to ever, in the randomized study with a slightly lower proportion of

TABLE 3 Clinical outcomes at 30 days, 6 months, and 12 months in propensity matched cohort

BP-SES (n = 1,649) DP-EES (n = 1,649) P value

30 days
TVR (n) 14 (0.85%) 18 (1.09%) 0.48
Myocardial infarction (n) 19 (1.15%) 22 (1.33%) 0.64
All cause death (n) 45 (2.73%) 33 (2.00%) 0.17
6 months
TVR (n) 72 (4.37%) 51 (3.09%) 0.055
Myocardial infarction (n) 63 (3.82%) 52 (3.15%) 0.30
All cause death (n) 80 (4.49%) 68 (4.12%) 0.60
12 months
TVR (n) 97 (5.88%) 76 (4.61%) 0.10
Myocardial infarction (n) 87 (5.28%) 83 (5.03%) 0.75
All cause death (n) 99 (6.00%) 89 (5.40%) 0.45
Definite/probable stent thrombosis (n) 24 (1.46%) 20 (1.21%) 0.54
Acute (0–1 days, n) 1 (0.06%) 1 (0.06%) 0.48
Subacute (2–30 days, n) 14 (0.85%) 8 (0.49%) 0.20
Late (31–365 days, n) 9 (0.55%) 11 (0.67%) 0.65

Abbreviation: TVR: target vessel revascularization.

6 GASIOR ET AL.
patients with acute coronary syndromes (~70%) comparing two BP-
DES with different biodegradable polymer coatings to the durable
polymer stent demonstrated lower rates of ST (<1%) in all tested
devices.18
It has been previously postulated that longer follow up is required
to demonstrate the risk reduction of adverse events in favor of BP-
DES compared with DP-DES.20 For example, the 5-year results in the
LEADERS trial showed that BP-DES was associated with a significant
reduction in very late (>1 year) definite ST.26 Therefore, follow-up
beyond 1 year is required to clarify the potential benefit of BP-SES
over DP-EES on clinical outcomes.
The drug release profile is a key element governing the overall
performance of DES. Moreover, the optimal rates of drug elution for
DES are still unknown. Compared to the DP-EES, the BP-SES used in
this study has faster drug release profile. Preclinical pharmacokinetic
evaluation of BP-SES demonstrated nearly full polymer biodegrada-
tion and 95% drug release of initial drug load at 8 weeks, where in
DP-EES drug elution took up to 120 days. The more rapid rates of
drug elution may allow for accelerated and more complete healing to
occur within the first several months after stent implantation, a critical
period for vascular restoration to prevent later complications.27 His-
torically, fast-release zotarolimus-eluting stent (Endeavor, Medtronic)
has shown a significant risk reduction in late and very late ST, cardiac
death, and MI when compared to paclitaxel-eluting stent.28,29 How-
ever, excellent safety profile did not translate into efficacy at long-
term follow up with higher rates of target vessel failure when com-
pared to first generation DES.30 Nevertheless, recently published
results of PANDA III trial comparing target lesion failure (composite of
cardiac death, target vessel MI, or ischemia-driven target lesion revas-
cularization) rates at 1 year following implantation of slow release vs
fast release BP-DES demonstrated that device with more rapid drug
elution is noninferior slow release BP-DES.31
Acute thrombogenicity and long-term vascular healing in DES has
been attributed, not only to drug pharmacokinetics, durable polymer
biocompatibility, composition distribution, and, in case of BP-DES,
duration of bioresorption, but also to the platform material and stent
strut thickness.30–32 Indeed, compared with the thicker struts, thinner
strut platforms have been shown to reduce platelet aggregation and
inflammatory cell adhesion.33,34 The BP-EES evaluated in this study
was designed to facilitate stent vascular healing using a thinner strut
profile (71 μm) when compared to DP-EES (81 μm).
Taking into consideration above observations in a large
propensity-matched cohort, we are of the opinion, that the BP-SES
included in the present study displays similar efficacy profile as the
benchmark DP-EES, without compromising safety, which is of the
utmost importance among patients treated in routine clinical practice.
4.1 | Study limitations
First, our study is limited by its observational nature and patients were
not enrolled in a randomized fashion. Thus, any findings should be
confirmed by prospective and sufficiently powered clinical trial. Any-
way, more challenging patients are often excluded from randomized
controlled trials. For such reasons, observational studies can be used
35
as complementary forms of research in the real-world population . diol 2012;59:2051-2057.
We attempted to minimize the selection bias whether to implant BP-
SES or DP-EES by using a propensity score matching for a wide range
of variables. However, not all possible differences between the groups
can be removed in this way.
Second, no routine angiographic surveillance was scheduled, and
thus no conclusions regarding potential restenosis can be made. Also,
no intravascular imaging data were collected. Adequate DAPT is one
of the most important factors that prevent ST. However, we do not
have the data on antiplatelet drug compliance during follow-up.
Third, our study is limited to 1-year follow-up, while theoretical
differential clinical outcome between the compared technologies
might be observed during long-term follow-up.
5 | CONC LU SIONS
This is the first competitive evaluation of BP-SES vs DP-EES in a large,
relevant and broad population. It provides evidence for the safety and
efficacy of the BP-SES. The 12-month rates of TVR, death, MI, and ST
for the BP-SES were similar to the DP-EES. These findings should be
verified in a prospective, randomized trial.
CONFLIC T OF INT E RE ST
Nothing to report.
ORCID
Pawel Gasior http://orcid.org/0000-0001-8564-7257
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How to cite this article: Gasior P, Gierlotka M, Szczurek-
Katanski K, et al. Bioresorbable polymer-coated thin strut
sirolimus-eluting stent vs durable polymer-coated everolimus-
eluting stent in daily clinical practice: Propensity matched one-
year results from interventional cardiology network registry.
Catheter Cardiovasc Interv. 2018;1–7. https://doi.org/10.
1002/ccd.27919