Off-site primary percutaneous coronary intervention in a new centre is safe: comparing clinical outcomes with a hospital with surgical backup
Neth Heart J
Off-site primary percutaneous coronary intervention in a new centre is safe: comparing clinical outcomes with a hospital with surgical backup
K. H. A. J. Koolen 0 1 2
K. A. Mol 0 1 2
B. M. Rahel 0 1 2
F. Eerens 0 1 2
S. Aydin 0 1 2
R. P. T. Troquay 0 1 2
L. Janssen 0 1 2
W. A. L. Tonino 0 1 2
J. G. Meeder 0 1 2
0 K. H. A. J. Koolen
1 Department of Cardiology, Catharina Hospital , Eindhoven , The Netherlands
2 Department of Cardiology, VieCuri Medical Centre , Venlo , The Netherlands
Objectives To evaluate the procedural and clinical outcomes of a new primary percutaneous coronary intervention (PPCI) centre without surgical back-up (off-site PCI) and to investigate whether these results are comparable with a high volume on-site PCI centre in the Netherlands. Background Controversy remains about the safety and efficacy of PPCI in off-site PCI centres. Methods We retrospectively analysed clinical and procedural data as well as 6-month follow-up of 226 patients diagnosed with ST-elevated myocardial infarction (STEMI) who underwent PPCI at VieCuri Medical Centre Venlo and 115 STEMI patients who underwent PPCI at Catharina Hospital Eindhoven. Results PPCI patients in VieCuri Medical Centre had similar procedural and clinical outcomes to those in Catharina Hospital. Overall there were no significant differences. The occurrence of procedural complications was low in both groups (8.4 % VieCuri vs. 12.3 % Catharina Hospital). In the VieCuri group there was one procedural-related death. No patients in either group needed emergency surgery. At 30 days, 17 (7.9 %) patients in the VieCuri group and 9 (8.1 %) in the Catharina Hospital group had a major adverse cardiac event. Conclusion Performing PPCI in an off-site PCI centre is safe and effective. The study results show that the proce-
Primary; Percutaneous coronary intervention; Off-site; Outcomes; Coronary disease
Primary percutaneous coronary intervention (PPCI) at
hospitals without surgical back-up (off-site PCI) has been
frequently investigated and debated. PPCI is an effective
treatment in acute coronary syndrome (ACS) and superior to
thrombolytic therapy [
]. The knowledge that a decrease
in time to reperfusion leads to decreased infarct size and
incidence of major adverse cardiac events (MACE),
contributed to the rise of off-site PCI centres [
Introduction of PCI at off-site hospitals has been a
gradual process in the Netherlands and implementation is
strictly regulated [
]. Numerous studies have reported no
difference in safety and effectiveness of PCI between
offsite PCI centres and medical centres with surgical
backup (on-site) [
], including two large Dutch studies
]. The need for bail-out surgery after on-site PCI
has dropped dramatically in the past decades, from 6.6 %
in the initial years to 0.3?0.6 % currently [
mortality rates for patients requiring emergency surgery are
the same in off-site and on-site PPCI centres [
European Society of Cardiology (ESC) recommends (Ib)
PPCI to be performed by experienced operators in a
24hour/7-day service [
]. No distinction is made between
onsite and off-site centres while, according to the American
College of Cardiology (ACC)/American Heart Association
(AHA) guidelines, PPCI at off-site centres is a class IIa
]. Both the ESC and ACC recommend that
operators performing PCI for ACS should have an annual
volume of at least 75 procedures at institutions performing
at least 400 PCIs per year [
The aim of this study is to investigate whether the results
at the VieCuri Medical Centre Venlo are comparable with
a high-volume on-site PCI centre, in this case Catharina
Hospital Eindhoven. We assume the procedural and clinical
outcomes are similar for off-site PPCI compared with
This study is a two-centre, retrospective cohort study. In
the period from 1 September 2012 to 1 September 2013,
122 patients in the VieCuri Medical Centre/Laurentius
Hospital Roermond area received PPCI in Catharina Hospital.
From September 2013, patients from Laurentius Hospital
and VieCuri were treated at VieCuri Medical Centre.
All STEMI patients who were signed up for PPCI were
included. Patients with an out-of-hospital cardiac arrest
were excluded. VieCuri is an intermediate-volume hospital
which started PPCI in September 2013. Laurentius
Hospital is an intermediate-volume hospital without PCI
facilities. Before September 2013 patients from VieCuri and
Laurentius Hospital who needed PPCI were transported to
PPCI is limited to the culprit vessel with the exception of
patients presenting with cardiogenic shock or persistent
ischaemia after PCI of the presumed culprit lesion [
choice for drug-eluting stent (DES) versus bare metal stent
and the use of an intra-aortic balloon pump or glycoprotein
IIb/IIIa inhibitors, was left to the discretion of the
Data collection and outcome measures
Patient characteristics, PCI characteristics, complications
and follow-up data were retrospectively found in the
medical records. Missing data from PPCI patients were
acquired by calling general practitioners. Foreign patients,
transferred to different countries for rehabilitation, were
considered as lost to follow-up.
The primary outcomes of this study were complications
during the procedure and the incidence of a major adverse
cardiac event (MACE) at 30 days and 6 months. Only
procedural complications were registered and no complications
as a result of the myocardial infarction itself. The combined
endpoint MACE consists of death, myocardial infarction
and revascularisation (target-lesion, target-vessel or
nontarget-vessel). Secondary outcomes are the incidence of
major adverse cardiovascular and cerebral events (MACCE)
and consist of death of any cause, myocardial infarction,
revascularisation (target-lesion, target-vessel or
non-targetvessel), emergency or semi-elective coronary artery bypass
graft (CABG), occurrence of cerebral vascular accidents,
probable or definite stent thrombosis, TIMI major and
minor bleeding [
] and the need for transfusion.
Emergency CABG was defined as CABG performed within
24 hours after PCI for a procedural complication.
Secondary outcomes were analysed with a maximum
followup period of 6 months.
Primary outcome registration was accomplished by
definitions from the Academic Research Consortium (ARC)
]. All deaths are considered cardiac unless an
unequivocal noncardiac cause could be established. Re-PCI was
defined following ARC definitions with target lesion
revascularisation, target vessel revascularisation and non-target
vessel revascularisation. Target lesion revascularisation
before 30 days is considered to be a safety endpoint, because
this time is too short for fibrointimal hyperplasia [
Stent thrombosis was classified as definite, probable and
possible and timing of the stent thrombosis as acute,
subacute or late .
Data were collected and analysed by an independent
investigator in SPSS version 22. Descriptive statistics were used
to calculate frequencies and means. The independent
sample T-test and the Mann-Whitney test were used to compare
means. Chi-square or Fisher?s exact test were used to
compare the VieCuri data with those of Catharina Hospital.
A total of 122 and 237 PPCIs in patients diagnosed with
STEMI were conducted in Catharina Hospital and VieCuri,
respectively. This consists of 115 and 226 patients. There
were 74 patients from Laurentius Hospital who underwent
PPCI in VieCuri Medical Centre. In the Catharina Hospital
group, 21 patients (18.3 %) were first admitted to VieCuri
before transportation to Catharina Hospital for PPCI.
Baseline characteristics and prescribed medication are
shown in Table 1. The patient groups were clinically well
balanced for all risk factors; however, there were
significantly more patients with Killip class II in the VieCuri
group and the TIMI risk score was significantly higher
compared with the Catharina Hospital group. There was
BMI body mass index, CAD coronary artery disease, MI myocardial infarction, PCI percutaneous coronary intervention, CABG coronary artery
bypass graft, TIA transient ischaemic attack, LVEF left ventricular ejection fraction, CK creatine kinase, ACE angiotensin-converting-enzyme,
DES drug-eluting stent
aPrescribed medication at discharge
a significant difference in the prescription of aspirin, beta
blockers, aldosterone antagonist and proton pump inhibitors
between VieCuri and Catharina Hospital. Several patients
did not have dual antiplatelet therapy because either no
stent had been placed or CABG was necessitated.
Fig. 1, 2, 3 and 4 show the PCI specifications. Most
patients had one-vessel disease (54.4 %) and the right
coronary artery was the most common culprit vessel (44.0 %),
which is shown in Fig. 1 and 2, respectively. Data from
Catharina Hospital show the same distribution. There was
a significant difference in the number of patients with one
lesion (Fig. 3), which was higher in the Catharina Hospital
group. In most patients, the diameter of the stenosis was
100 % (Fig. 4).
Table 2 shows the PCI specifications of both VieCuri and
Catharina Hospital. In 215 of the 237 PPCIs a stent was
placed in one of the coronary arteries. In 80.7 % this was
a DES. There were 22 procedures in which no stent was
inserted. In 6 cases stent placement was not successful. In
4 cases the operator decided, after spontaneous reperfusion,
not to place a stent due to multivessel disease or stenosis
of the left main coronary artery needing CABG. In both
groups only a few radial procedures were performed,
beFig. 3 Number of lesions. (VC VieCuri Medical Centre Venlo, CZE
Catharina Hospital Eindhoven)
Fig. 2 Culprit vessel. (VC VieCuri Medical Centre Venlo, CZE
Catharina Hospital Eindhoven, LM left main, LAD left anterior descending,
RCX right circumflex, RCA right coronary artery)
cause this was up-coming at that period. The time from
first medical contact to start of PCI (system delay) was
significantly longer in the Catharina Hospital group.
Procedural complications are also shown in Table 2.
Cardiac arrest was the most common complication (2.1 %)
followed by stent thrombosis (1.7 %). In 4 procedures (1.7 %)
coronary dissection occurred. One patient (0.4 %) had
coronary perforation with tamponade. One patient had
tamponade most likely due to a temporary pacemaker lead. Before
transport to Maastricht University Medical Centre for
emergency cardiac surgery, this patient died as a result of rupture
of the right ventricle. This was considered a
procedure-reFMC first medical contact, PCI percutaneous coronary intervention, CABG coronary artery bypass graft, DES drug-eluting stent, MI myocardial
infarction, CVA cerebrovascular accident, TIMI thrombolysis in myocardial infarction (bleeding as described by the TIMI bleeding criteria)
aIncluding all procedures
bThe number of patients with a pseudoaneurysm consists of patients treated with either surgery or if transfusion was necessitated
lated death. Procedural complications of patients receiving
PPCI at Catharina Hospital are also shown in Table 2. There
is no significant difference in procedural outcomes between
these two groups.
The follow-up period was 6 months. Ten patients were lost
to follow-up. These were all foreigners who were
transferred to a hospital in their home country for further
rehabilitation. The follow-up data are shown in Table 3. During
the first 30 days, 7 patients (3.2 %) died, of whom 5 (2.3 %)
suffered a cardiac death. Two patients died a few minutes
after the operator made the decision that continuing the
procedure was no longer helpful. One patient died as a result
of stent thrombosis after an elective multivessel PCI four
days earlier in another hospital. This patient was unsuitable
for CABG before the initial PCI. One patient died as a
result of persisting cardiogenic shock after re-PCI for stent
thrombosis. There was one procedure-related death as
discussed earlier. There were 7 re-PCIs, 5 (2.4 %) were in the
target vessel as a result of stent thrombosis.
During the total follow-up period of 6 months, 13
patients (6.1 %) died. All cardiac deaths occurred in the first
30 days after the PPCI procedure. During the follow-up
period of 6 months there was no significant difference in
primary and secondary outcomes in patients receiving PPCI
in VieCuri compared with Catharina Hospital.
This study presents procedural complications and clinical
outcomes of a new off-site PPCI centre in the Netherlands.
As shown in previous studies [
3, 8, 14
] our study confirms
PPCI in STEMI patients at an off-site PCI centre to be safe
and effective in the Netherlands. The percentage of
emergency surgery in our study was 0.0 % which corresponds
with the 0?1 % found in the literature. Patient
characteristics and procedural specifications were similar in VieCuri
MACE major adverse cardiac events, MI myocardial infarction, PCI percutaneous coronary interventions, CABG coronary artery bypass graft,
CVA cerebrovascular accident
aPatients with multiple procedures are counted as one
and Catharina Hospital, although in the VieCuri group there
were significantly more patients with Killip class II and the
TIMI risk score was significantly higher.
In the Catharina Hospital group the system delay was
significantly longer than in the VieCuri group. This is
mainly due to a longer travel time. Furthermore, there
were 21 patients who were first admitted to VieCuri before
undergoing PPCI in Catharina Hospital, which will affect
the time registration in a negative way. The occurrence of
procedural complications was low in both groups. There
was no significant difference in procedural complications
between the two groups.
The study period in VieCuri was shorter (9 months) than
in Catharina Hospital (12 months). Nevertheless, the
number of patients in the VieCuri group was higher. There are
a few explanations for this difference. First, part of this
difference can be explained by adding the number of patients
(n = 74) sent from non-PCI centres for PPCI in VieCuri.
The Catharina Hospital group included only patients from
VieCuri, and no patients from surrounding hospitals were
included. Despite this, the difference in the number of
patients remains high. Although the majority of STEMI
patients were sent to Catharina Hospital, it is possible that
some patients were sent to Maastricht University Medical
Centre when Catharina Hospital was already occupied.
There is a significant difference in aspirin prescription,
which can be corrected by the number of patients receiving
a vitamin K antagonist due to atrial fibrillation. When no
beta blocker was prescribed, a clear motivation was found
in medical records.
The percentage of 30-day MACE was low in both the
VieCuri and Catharina Hospital group at 7.9 and 8.1 %,
respectively. Despite a longer reperfusion time in the
Catharina Hospital group, there was no significant difference
between the occurrence of MACE. This might be due to a
reduced door-to-balloon time with a longer travel distance
]. Moreover, VieCuri is a new PPCI centre. All
cardiac deaths (2.3 %) occurred within 30 days for the VieCuri
group. In the literature the percentage of in-hospital deaths
of patients receiving PPCI in hospitals without surgical
back-up varies from 4 to 9.8 % [
]. In both trials
the number of in-hospital deaths was significantly higher
for the off-site PCI group. Occurrence of 30-day mortality
in the study by Tomassini et al.  was 7.1 %. For the
VieCuri group 30-day all-cause mortality was 3.2 %
compared with 1.8 % in the Catharina Hospital group, which is
not significant. In comparison with previously mentioned
studies this percentage of total deaths is low. The
occurrence of secondary outcomes is also very low in both study
There are several limitations in our study. First, this is
a retrospective study. Second, this study group is relatively
small and providing a larger dataset would be preferred
as this would stimulate the power of the study and gives
a higher possibility to catch rare events. In this study the
door-to-balloon time was not investigated, due to a
difference in definition between VieCuri and Catharina Hospital.
New studies should investigate whether, in geographically
isolated areas, performing PPCI in experienced off-site PCI
centres is superior to on-site PPCI due to a shorter
reperfusion time and therefore decreased infarct size. In this study
only STEMI patients were included. A study by IJkema
et al. [
] shows that not all ECGs of patients with a
transmural myocardial infarction have ST elevation. New studies
should investigate the time to reperfusion and occurrence
of MACE in this category too.
This study reports the procedural and clinical outcomes in
STEMI patients who underwent off-site PPCI at VieCuri
Medical Centre. Results were compared with the results of
STEMI patients who underwent on-site PPCI at Catharina
Hospital. In both study groups the occurrence of
procedural complications and MACE were low and no significant
differences were found. The study results therefore
confirm that the procedural and clinical outcomes of a new
offsite intermediate-volume PPCI centre are comparable with
those of an on-site high-volume PPCI centre.
Acknowledgements We acknowledge the support of the Department
of Cardiology of the Catharina Hospital Eindhoven and the Laurentius
Hospital Roermond. We would like to thank them for providing data
for this study.
Conflict of interest K.H.A.J. Koolen, K.A. Mol, B.M. Rahel,
F. Eerens, S. Aydin, R.P.T. Troquay, L. Janssen, W.A.L. Tonino and
J.G. Meeder state that they have no competing interest.
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