Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease: A weighted meta-analysis of seven randomised controlled trials including 5577 patients
Neth Heart J
Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease: A weighted meta-analysis of seven randomised controlled trials including 5577 patients
J. Elias 0
I. M. van Dongen 0
R. P. Kraak 0
R. Y. G. Tijssen 0
B. E. P. M. Claessen 0
J. G. P. Tijssen 0
R. J. de Winter 0
J. J Piek 0
J. J. Wykrzykowska 0
J. P. S. Henriques 0
0 AMC Heartcenter, Academic Medical Center, University of Amsterdam , Amsterdam , The Netherlands
Aims Mid- and long-term safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) have been studied in randomised trials; however, most were not individually powered for clinical endpoints. We performed a weighted meta-analysis comparing mid- and long-term outcomes in patients treated with the BVS compared with the Xience metallic stent. Methods and results Randomised trials comparing the BVS and Xience were identified by searching MEDLINE, EMBASE and conference abstracts. Seven trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1-3 years. The primary outcome of target lesion failure occurred more frequently in BVS compared with Xience [OR 1.34; 95% CI 1.11-1.62, p = 0.003]. Overall definite or probable device thrombosis occurred more frequently with the BVS [OR 2.86; 95% CI 1.88-4.36, p < 0.001] and this extended beyond 1 year of follow-up [OR 4.13; 95% CI 1.99-8.57, p < 0.001]. Clinically indicated or ischaemia driven target lesion revascularisation [OR 1.43; 95% CI 1.11-1.83, p = 0.005] and myocardial infarction (all MI) [OR 1.64; 95% CI 1.20-2.23, p = 0.002] were more frequently seen in the BVS compared with Xience. Rates of target vessel failure [OR 1.15; 95% CI 0.91-1.46, p = 0.25]
Coronary artery disease; Percutaneous coronary intervention; Bioresorbable vascular scaffold; Stent; Device thrombosis; Meta-analysis
J. Elias and I.M. van Dongen contributed equally to this paper.
and cardiac death [OR 0.91; 95% CI 0.57–1.46, p = 0.71]
were not significantly different between BVS and Xience.
Conclusion This meta-analysis shows a higher rate of target
lesion failure and an almost threefold higher rate of device
thrombosis in BVS compared with Xience, which extends
beyond the first year. Device thrombosis did not lead to an
overall increased (cardiac) mortality.
Bioresorbable scaffolds may theoretically overcome some
limitations of current generation drug-eluting stents [
Absorb (Abbott Vascular, Santa Clara, California, USA)
bioresorbable vascular scaffold (BVS) is the most widely
used bioresorbable device. Clinical trials enrolling patients
with strict inclusion and exclusion criteria showed that the
use of the BVS was safe and feasible with acceptable
shortand mid-term clinical outcomes [
]. However, registries
performed in more complex patients and lesions reported
higher rates of early and late scaffold thrombosis [
In the ABSORB II trial, an ongoing risk of scaffold
thrombosis up to 3 years of follow-up was observed . The
ABSORB III trial showed significantly higher 2-year
target lesion failure in the BVS compared with Xience [
leading to an US Food and Drug Administration (FDA)
]. The AIDA trial included a patient population
reflecting routine clinical practice, and reported data earlier
due to safety concerns. In AIDA, treatment with the BVS
compared with Xience was associated with an increased
incidence of device thrombosis throughout a median
followup of 2 years [
]. A previous meta-analysis of randomised
controlled trials comparing the BVS with Xience showed
higher rates of scaffold thrombosis, mainly in the acute
and subacute phase [
]. More recently, various trials also
raised concerns on the use of the BVS with a longer
followup, with a higher incidence of late and very late scaffold
11, 12, 14, 16–20
]. Sorrentino et al. performed
a meta-analysis of randomised clinical trials with longer
follow-up and raised the same concerns regarding the
Absorb BVS; however, they did not perform an analysis on
the events occurring beyond 1 year . We performed
a weighted meta-analysis on the available randomised
controlled trials comparing mid- and long-term outcome
(>12month follow-up), together with a landmark analysis
beyond 1 year of follow-up, in BVS compared with Xience
Search strategy and study selection
We searched PubMed, MEDLINE, and EMBASE for
randomised studies on the BVS compared with Xience from
inception to March 29th 2017. There were no language or
other restrictions, and the results were only filtered on
Records iden fied in
MEDLINE (n = 313)
Records iden fied in
EMBASE (n = 336)
Records a er duplicates removed
(n = 422)
Full-text ar cles assessed
(n = 10)
comprising 7RCTs, for
quan ta ve synthesis
(n = 14)
Fig. 1 Search Flow Diagram
(n = 412)
Addi onal trial conference
(n = 4)
man studies. The search consisted of the following search
terms including keywords and MESH terms for
‘Bioabsorbable’, ‘ABSORB’, ‘Bioresorbable stent’, ‘Everolimus’,
‘Controlled Clinical trial’ and ‘Randomized controlled trial’
(see the online Electronic Supplementary Material (ESM)
for the complete MEDLINE search).
All retrieved studies were first screened independently
by two of the investigators (JE and ID) at the title and/or
abstract level. The remaining applicable studies were then
reviewed in detail according to the following predefined
inclusion and exclusion criteria. Inclusion criteria were
randomised design, ≥50 enrolled patients and performance of
an intention-to-treat analysis. Exclusion criteria were
nonhuman studies or another comparison than of BVS versus
Xience. If there were no published trial data on
followup beyond 1 year, we searched for additional conference
proceedings on long-term follow-up data of the particular
Risk of bias assessment and data extraction
Risk of bias in the included trials was assessed using the
Cochrane risk of bias assessment tool in Review
Manager (Version 5.3. Copenhagen, the Cochrane
Collaboration, 2014), and data of the included trials were extracted
by two of the investigators (JE and ID) [
]. Data were
extracted from design papers, main papers, follow-up
papers, conference proceedings and/or presentation slides, and
combined in an Excel spreadsheet for further calculations
The primary efficacy outcome was target lesion failure
(TLF), a combined endpoint of cardiac death, target vessel
myocardial infarction (TV-MI) and target lesion
revascularisation (TLR). The primary safety outcome was
definite or probable device thrombosis. Secondary outcomes
were clinically indicated or ischaemia driven target lesion
revascularisation (ID-TLR), the device oriented combined
endpoint target vessel failure (TVF) consisting of cardiac
death, target vessel MI (TV-MI) and target vessel
revascularisation (TVR), as well as the occurrence of target
vessel MI, all MI, all-cause death and cardiac death. All
endpoints were defined according to the definitions of the
original trials, and assessed according to the
intention-totreat analysis at the longest follow-up available. To assess
long-term efficacy and safety we performed a landmark
analysis after 1 year of follow-up comparing the rates
of target lesion failure and device thrombosis occurring
beyond 1 year of follow-up. For this landmark analysis
patients were included in the denominator if they were
free of the event of interest at 1-year follow-up. Patients
Overall baseline patient and lesion characteristics per included trial. Data are presented as number (%) and continuous data as mean (±SD).
ACS acute coronary syndrome, STEMI ST-elevated myocardial infarction, NSTEMI non-ST-elevated myocardial infarction, UAP unstable angina
pectoris, DAPT dual anti-platelet therapy, RVD reference vessel diameter
who withdrew informed consent, were lost-to-follow-up
or died before 1-year follow-up were excluded from the
Continuous variables are reported as mean (±SD),
categorical variables are expressed as n/N (%). The meta-analysis
and statistical analysis for pooled odds ratios (ORs) was
performed using the Peto fixed-effects model for categorical
variables. Pooled ORs were calculated and are reported with
95% confidence intervals, a p-value <0.05 was considered
statistically significant. Statistical heterogeneity was tested
using the χ2 test and the I2 test. I2 < 25% was considered
to be low, 25–50% moderate, and >50% high
heterogeneity. If no events occurred, the trial could not be added to
the pooled ORs. All meta-analyses were performed on
intention-to-treat basis and were performed with the Review
Manager. To assess for publication bias, funnel plots were
constructed for the primary outcomes. Additionally, we
performed an influence analysis by omitting one trial at a time,
and we carried out the Egger’s asymmetry test [
The search identified 422 publications. In total, seven
eligible randomised controlled trials comparing BVS and
Xience were identified after screening [
11, 12, 14, 16–19
For four trials the 2-year outcomes were only available as
conference proceedings [
]. Fig. 1 depicts the flow
diagram of the search; the MEDLINE search strategy and
risk of bias assessment of the included trials are shown in
the online ESM files. One trial had a third group of patients
receiving a Biolimus-eluting stent; results from this patient
group were excluded . The ABSORB II trial started
enrolment in 2011 and is depicted as ‘ABSORB II (2011)’ and
so on. The primary objective of the original trials differed:
three trials investigated clinical outcomes, three trials
investigated late lumen loss on follow-up angiography and one
trial investigated the optimal frequency domain
imagingderived healing score at 6 months. Follow-up duration also
differed: one trial described a 3-year follow-up, five trials
described 2-year follow-up and one trial reported a median
follow-up duration of two years [Q1-Q3: 507-895 days].
Definitions of target lesion failure, target lesion failure, and
SBOA (1320 rsobA 025 .)(969 .28± .04 .412±a.33 .31± .04 .812± .24 ,ac216 )(36 .33± .40 AN
.6 .8 A 8 e
1 3 N 9 d
X 9 N N 3 1 1 2 3 N N N N N e
1 ra e
Fig. 2 Meta-analyses of the
primary efficacy endpoint of
target lesion failure and the
primary safety endpoint of device
thrombosis at longest follow-up
Cases of definite or probable stent/scaffold thrombosis (ST) divided over early, late and very late time points after the index procedure. ST scaffold
or stent thrombosis
aspirin and dual antiplatelet therapy (DAPT) prescriptions
differed between some of the trials. Table 1 of the online
ESM shows all the relevant trial characteristics. The degree
of bias within included trials was small (ESM Table 2).
Patient and lesion characteristics
The seven trials included 5577 patients, randomised to
either BVS (n = 3258) or Xience (n = 2319). The pooled
mean age was 63 ± 10 years, with 66.7% of patients being
male and 25.2% diabetic, of which 32% insulin-dependent.
In total, 12.0% of patients presented with non-ST-elevated
myocardial infarction (STEMI) on admission, 7.3%
nonSTEMI and 20.6% unstable angina pectoris.
Periprocedural DAPT was administered in 98.9%. Table 1 shows the
baseline characteristics of the patients and lesions included
in the trials.
In total, 6406 lesions were included in the trials of which
58% were randomised to BVS implantation. Pre-dilatation
was performed in 97.7% of BVS, and in 93.5% of
Xiencetreated lesions. Post-dilatation was performed in 66.7% of
BVS, and in 50.3% of Xience-treated patients. Device
success, reported in six trials, was achieved in 96.3% of BVS,
and in 99.4% of Xience patients. Table 2 depicts all
available device implantation characteristics.
Primary and secondary endpoints
The primary outcome of target lesion failure occurred
significantly more often with the BVS [OR 1.34; 95% CI
1.11–1.62, p = 0.003]. Definite or probable stent
thrombosis occurred significantly more frequently in patients treated
with the BVS (crude rates; BVS 2.4%, Xience 0.7% [OR
2.86; 95% CI 1.88–4.36, p < 0.001]) (Fig. 2). Timing of
scaffold and stent thrombosis events differed between the
two devices. Early device thrombosis occurred in 34 of BVS
and in 11 of Xience-treated patients, late device thrombosis
in 17 of BVS and in 2 of Xience-treated patients, and very
late in 26 of BVS and 3 of Xience-treated patients
(Table 3). ESM Fig. 3 depicts the funnel plots of both primary
endpoints. Visual estimation of the funnel plots did not
suggest any important influence of small studies on the primary
study outcomes, nor did the Egger’s asymmetry tests for
target lesion failure (intercept 0.117 [95% CI –1.539–1.772],
two-sided p-value of 0.863) and definite/probable device
thrombosis (intercept 0.322 [95% CI –0.936–1.580],
twosided p-value of 0.539). The influence analysis showed that
by omitting every trial, the total ORs did not alter direction
(ESM Tables 3 and 4).
Secondary outcomes showed that clinically indicated or
ischaemia driven target lesion revascularisation, all MI and
target vessel MI occurred significantly more frequently with
the BVS. The rate of target vessel failure was not
significantly different between BVS and Xience. All-cause death
[OR 0.70; 95% CI 0.48–1.03, p = 0.07] and cardiac death
[OR 0.91; 95% CI 0.57–1.46, p = 0.71] were also
non-significantly different between the BVS and Xience (Fig. 3).
Heterogeneity was low for all outcomes (0–7%).
In ESM Figs. 1 and 2, forest plots of the primary and
secondary endpoints at 1 year (for EVERBIO II at 9-month
follow-up and for TROFI II at 6-month follow-up) are
depicted. At 1-year follow-up, definite or probable device
thrombosis, all MI and target vessel MI occurred
significantly more frequently with the BVS: OR 2.43 [95% CI
1.45–4.04, p < 0.001], OR 1.39 [95% CI 1.06–1.82, p =
Fig. 3 (continued)
Meta-analyses of all secondary endpoints
at longest follow-up available
0.02] and OR 1.48 [95% CI 1.09–2.01, p = 0.01]
respectively. All other endpoints at 1-year follow-up were not
significantly different between the two treatment groups.
Fig. 4 shows the number of the primary outcome events
and associated odds ratios beyond 1 year of follow-up
(for EVERBIO II beyond 9 months of follow-up and for
TROFI II beyond 6 months of follow-up). Occurrence of
target lesion failure events after 1 year occurred
significantly more frequently in the BVS patients [OR 1.55;
95% CI 1.12–2.14, p = 0.008] and device thrombosis after
1-year follow-up occurred in 27 patients treated with the
BVS and in 3 patients treated with Xience [OR 4.13; 95%
CI 1.99–8.57, p < 0.001]. During all time periods (early,
late and very late) device thrombosis rates were higher in
the BVS group (Fig. 5).
Considering 4 of the 7 randomised trials did not publish
their long-term data, we also performed a meta-analysis of
the primary endpoint using only the published trials (n =
3). However, excluding these trials did not lead to a major
difference in primary outcomes (target lesion failure: OR
1.34; 95% CI 1.02–1.76, p = 0.03; definite or probable
device thrombosis: OR 3.17; 95% CI 1.87–5.38, p < 0.001)
(ESM Fig. 4).
This meta-analysis showed a higher target lesion failure in
BVS compared with the Xience. Also, in BVS, a highly
significantly increased risk for definite and probable device
thrombosis was observed compared with Xience. The
incidence of all-cause mortality and cardiac death was not
significantly different between the two groups.
Our meta-analysis demonstrates an ongoing higher risk
of device thrombosis throughout the follow-up. Acute and
subacute scaffold thrombosis has been attributed to
inadFig. 4 Meta-analyses of the
primary efficacy and safety
endpoints beyond one year
equate DAPT and suboptimal implantation techniques of
the BVS. One of the most intriguing findings of this
metaanalysis is the ongoing and increased risk for definite or
probable device thrombosis beyond 1 year of follow-up.
These late and very-late scaffold thromboses are probably
associated with different mechanisms and may be
associated with resorption-related scaffold discontinuity and
dismantling. Factors affecting flow conditions, such as
(lateacquired) malapposed and uncovered struts due to
heterogeneous endothelialisation of the scaffold, have also been
suggested as potential causes [
A specific BVS implantation protocol has been proposed
to reduce the rates of scaffold thrombosis. This protocol
consists of adequate pre-dilatation, correct sizing and
postdilatation (PSP) [
]. While this suggests that improved
implantation techniques can prevent early device
thrombosis, the effect of implantation techniques on long-term
outcomes is less clear. Nevertheless, it is important to point
out that post-dilatation was only performed in about 50%
of the patients included in previous studies with infrequent
use of intracoronary imaging [
]. In the studies included
in this meta-analysis post-dilatation was only performed in
65–80% of the patients. Furthermore in a separate analysis
performed by Stone pooling of previous ABSORB studies
only 60.1% received predilatation and just 12.4% of
patients received adequate high-pressure postdilatation with a
noncompliant balloon [
The duration of DAPT is potentially associated with the
occurrence of late scaffold thrombosis. The AIDA trial
investigators very recently recommended continuation of
DAPT for all BVS patients until 3 years post index PCI
]. This recommendation is supported by the results from
the DAPT trial: treatment with metallic drug-eluting stents
and DAPT beyond 1 year compared with aspirin alone was
associated with a significantly reduced risk of stent
thrombosis and cardiovascular events [
]. Optimal DAPT
duration for patients treated with BVS is unknown and might
be challenging to determine given the variation in
resorption time in every patient and lesion type. Furthermore, it
is currently unknown if prolongation of DAPT will prevent
late and very-late scaffold thrombosis.
Although the early and late thrombotic events in
patients treated with the BVS are associated with worse
outcome, these events did not translate into an overall higher
mortality when compared with Xience. The bioresorbable
technology holds great theoretical benefits, which can be
expected to occur several years after implantation of the
scaffold when the scaffold is completely dissolved.
However, the BVS failed to demonstrate superiority in terms of
vasomotion and did not meet non-inferiority in terms of late
lumen loss [
]. Therefore the suggested advantages of
the BVS still need to be established. However, with current
safety issues completing the ongoing future trials,
COMPARE ABSORB and ABSORB IV might be challenging;
nevertheless, long-term follow-up of these trials will shed
additional light on the use of the first-generation BVS in
Our study has several limitations: most of the trials
included in this meta-analysis enrolled highly selected,
mainly stable patients with non-complex lesions. Therefore
generalising the results to all-comer populations should be
done with caution. Also, our meta-analysis only included
studies comparing the Absorb BVS to the Xience stent,
therefore the results do not apply to other ‘bioresorbable
stents’. None of the randomised trials were adequately
powered for differences in individual clinical endpoints or
for relatively rare endpoints. Furthermore, all the included
trials used different event definitions and no patient-level
data were available to examine predictors of worse
outcome. There was only one study that reported a 3 year
follow-up, other trials had a follow-up of 2 years or less,
one trial reported median follow-up of 2 years. Since the
resorption process of the scaffold is probably not
completed at that time, extended follow-up is needed to fully
assess the possible effect of the dissolving BVS on clinical
In conclusion, this meta-analysis shows a significantly
higher rate of target lesion failure and an almost threefold
higher rate of device thrombosis in BVS compared with
Xience metallic stent. This led to an increased incidence
of MI, but not to an overall increased mortality. Further
extension of follow-up will be essential to determine very
long term clinical effects after full resorption of the first
generation coronary bioresorbable scaffold.
Conflict of interest Dr. J.P.S. Henriques reports grants from Abbott
Vascular, grants from Abiomed Inc, grants from B-Braun, outside the
submitted work; Dr. J.J. Wykrzykowska receives consultancy fees from
Xience and a research grant from Abbott Vascular. Dr. J.J. Piek
reports grants and personal fees from Member MAB Abbott Vascular,
grants and personal fees from Consultant Philips/Volcano, grants and
personal fees from Previous consultant Miracor, outside the submitted
work. Dr. R.J. de Winter reports grants from Abbott Vascular, outside
the submitted work. J. Elias, I.M. van Dongen, R.P. Kraak, R.Y.G.
Tijssen, B.E.P.M. Claessen and J.G.P. Tijssen declare that they have no
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