DOI: 10.1161/CIRCULATIONAHA.114.009226
Primary PCI not Always the Best Reperfusion Strategy?
Running title: Sinnaeve et al.; Primary PCI not always best reperfusion strategy?
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
Peter R. Sinnaeve, MD, PhD1,2; Frans Van de Werf, MD, PhD1
1
Dept of Cardiovascular Sciences, KU Leuven, Leuven, Belgium; 2Dept of Cardiovascular
M dicine, University Hospitals
Me
Hospita
tals
ta
ls Leuven, Leuve
ven, Belgium
ve
Bel
elgi
g um
Medicine,
Leuven,
Address
Ad
ddr
dres
esss for
es
for Correspondence:
Corr
Co
rres
rr
espo
pon
ndencce:
nden
Frans
Fran
Fr
anss Van
an
Van de Werf,
Wer
erff, M
MD,
D, P
PhD
hD
Department
Depa
De
part
rtme
ment
nt ooff Ca
Card
Cardiovascular
rdio
iova
vasc
scul
ular
ar S
Sciences
cien
ci
ence
cess
KU Leuven
Herestraat 49
B-3000 Leuven, Belgium
Tel: +32 16 342111
Fax: +32 16 342100
E-mail: [email protected]
Journal Subject Code: Etiology:[4] Acute myocardial infarction
Key words: Editorial, reperfusion
1
DOI: 10.1161/CIRCULATIONAHA.114.009226
For patients with an ST-elevation myocardial infarction (STEMI), primary PCI is the preferred
reperfusion modality.1 Primary PCI, however, requires a catheterization lab and 24/7 availability of
an experienced team. Worldwide, only a minority of STEMI patients presents directly to a PCIcapable hospital. Most patients are first seen by an ambulance crew or at the emergence room of a
non-PCI-capable hospital. While in some regions almost all STEMI patients can be transferred to a
primary PCI center within guideline-recommended time, in many other regions across the world
timely transport remains a major issue because of distance, weather conditions, traffic and, very
often, a poor organization of the emergency medical system (EMS). The organization of regional
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
transfer can indeed be complex and costly. It requires close collaboration between ambulance
ystems, emergency departments and catheterization labs.2
systems,
Fibrinolytic therapy given before an already planned PCI in order to mitigate the delay
as
ssooci
ciat
ated
at
ed with
wit
ith primary
prim
pr
imary PCI does not improve out
im
utco
ut
co
ome.3 In most ooff thes
these
esse st
sstudies,
udies, no clopidogrel
associated
outcome.
was
w
ass gi
ggiven
ven upfr
upfront
fron
onnt an
andd an
anticoagulant
nti
tico
coag
co
agul
ag
ulan
antt th
an
ther
therapy
eraapy w
was
as oft
ooften
ften su
suboptimal.
ubo
bopt
ptim
pt
imaal. Se
Seve
Several
veeraal mo
more
re rrecent
ecent
ece
ent st
studies,
tud
udie
ies,,
ie
however,
coronary
and
performed
and
howe
ho
weve
we
ver,
ve
r,, ssuggest
ugge
ug
gest
stt tthat
hat co
hat
oro
rona
nary
ry aangiography
ngio
ng
iogr
io
grrap
phy an
nd PCI
PCI pe
perf
rffor
orme
medd between
me
betw
betw
twee
eeen 3 an
nd 24
2 hhours
ours
rss aafter
fter
ft
err
administration
on
n ooff th
thee ly
lytic,
yti
tic, iin
n ca
ccase
se ooff su
successful
ucc
c es
essf
sful
sf
ful
u rreperfusion,
eper
ep
erfu
er
f siion
fu
on,, re
rreduces
duce
du
c s th
thee ri
risk
sk ooff ne
new
w is
isch
ischemic
c emic
events.4-6 As now mentioned in the guidelines, if fibrinolysis is indicated, it needs to be followed
by an early coronary angiography. This strategy is often referred to as pharmaco-invasive therapy.
Due the absence of cross-linking of fibrin in the fresh occlusive clot, such a strategy is especially
effective in patients presenting early after symptom onset. In a post-hoc analysis of the CAPTIM
(Comparison of primary Angioplasty and Pre-hospital fibrinolysis In acute Myocardial infarction)
study, prehospital fibrinolysis in the subset of STEMI patients presenting within two hours of
symptom onset was associated with lower 30-day rates of both cardiogenic shock and death, as
compared to transfer for standard primary PCI.7 A combined analysis of CAPTIM and WEST
2
DOI: 10.1161/CIRCULATIONAHA.114.009226
(Which Early ST-elevation myocardial infarction Therapy), a comparable trial performed in
Canada, also suggests a beneficial effect at one year from a pharmaco-invasive therapy in patients
presenting early.8 After five years of follow-up in CAPTIM, this strategy was associated with
lower mortality compared to transfer for primary PCI among patients treated within two hours of
symptom onset.9
In the recent STREAM (Strategic Reperfusion Early After Myocardial Infarction) trial a
pharmaco-invasive strategy with tenecteplase (half dose in the elderly), clopidogrel and enoxaparin
and including angiography between 6 and 24 hours or rescue PCI, was compared with standard
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
primary PCI in almost 1900 early-presenting patients who could not undergo primary PCI within
one hour.10 Patients were randomized in the ambulance or the emergency room off a co
ccommunity
mmun
mm
unit
un
ityy
it
hospital. At 30 days, the pharmaco-invasive approach
h was associated with a 2% lower incidence of
death,
de
eat
ath,
h, sshock,
hock
ho
ck, cong
ck
congestive
ngeestive
ng
es
heart failure or reinfarcti
reinfarction
tion
ti
o when compar
on
compared
red
e too pr
prim
primary
imary PCI, which was
nnot
ot sstatistically
tatisticallyy si
ssignificant.
gniffic
i ant
nt. At oone-year
ne-y
ne
-yea
-y
e r follo
ea
ffollow-up,
o ow-up,, to
total
otall aand
nd ca
cardiac
ard
rdiiac mo
mor
mortality
rtalit
ityy rate
rrates
atess we
were
ere vvery
ery
ery
1
similar.
imila
milaar.11
In thi
this
is is
issu
issue
suue of Ci
C
Circulation,
rccul
ulat
a io
on, Da
D
Danchin
nchi
nc
hinn an
hi
andd co
coll
colleagues
l ea
ll
e guues rreport
epor
ep
ortt 5or
5-year
-ye
year
ar ssurvival
urvi
ur
v va
vi
vall ra
rate
rates
tess in the largee
te
FAST-MI (French registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction)
registry, in which a significant proportion of patients were managed similarly to the pharmacoinvasive arm of STREAM.12 The nationwide FAST-MI registry was set up almost a decade ago to
assess contemporary reperfusion practices in STEMI patients across France. Particular to the EMS
and network organization in France, two thirds of the patients received fibrinolysis in the prehospital setting and in most of them (84%) fibrinolysis was followed by a PCI. As already
reported, survival rates at one year after primary PCI and fibrinolysis with routine early coronary
angiography were similar: 91.8% vs 93.6%, respectively.13 In the present long-term follow-up
3
DOI: 10.1161/CIRCULATIONAHA.114.009226
analysis, the risk of death at 5-year follow-up tended to be lower in the total population receiving
fibrinolysis (given in community hospitals and ambulances) compared to primary PCI, although
the difference did not reach statistical significance (Hazard Ratio (HR) 0.73, 95% CI 0.50-1.06).
When compared to primary PCI, patients treated with fibrinolysis in the ambulance did have a
significantly lower risk of death after adjustment for baseline risk (HR 0.57, 0.36-0.88). However,
in a propensity score-adjusted matched analysis this difference did not remain significant.
Interestingly, the authors also looked at a subgroup of patients treated within time delays
similar to those of the STREAM trial. A time window of 90 minutes between initial call and start
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
of reperfusion was used as a proxy for the expected 60 minutes delay specifically required by the
significantly
STREAM protocol. In this “STREAM-like” cohort, five-year survival was signif
ficcan
ntl
t y lower
lowe
lo
werr after
we
af
fibrinolysis compared to primary PCI. As in the overall population, this benefit disappeared in the
propensity-matched
60-minute
was
required
pr
rop
open
en
nsi
sity
ty-m
ty
-maatch
-m
ch
hed cohort. While an expected 60
0-m
-minute delay wa
as re
equ
quiired
ir in STREAM, the
actual
between
medical
and
start
PCI
was
117
minutes,
within
ac
ctu
ual
a delay bet
etw
ween ffirst
ween
i st m
ir
ediical
ed
ical ccontact
ontact an
ont
nd star
rt ooff pprimary
riima
mary
ry
yP
CI w
as 11
17 mi
minu
nute
tees, sstill
till
ti
l w
ithhin
it
the
guideline-recommended
The
PCI-related
he gu
guid
i el
id
elin
in
nee-re
reccommen
mmende
d d maximal
de
maxi
maxi
xima
mall dela
ma
ddelay
elaay of
of ttwo
wo hhours.
our
urs. T
he ccalculated
alcu
al
cula
cu
late
la
tedd PCIP
CII-re
reela
l teed ttime
im
me ddelays
me
elaays
el
ays
minutes
were relatively
relativel
elyy short:
s or
sh
ort:
t 105
t:
105
0 minutes
min
nut
utes
es in
in FAST-MI
FA
AST
T-M
MI and
and 78
7 m
inut
in
utes
ut
es in
in STREAM
ST
TRE
REAM
AM ((Figure
Figu
Fi
gure
gu
re 11).
) These
).
time delays contrast with those of the DANAMI-2 study in which the delay times for both inhospital lytic therapy and primary PCI were longer on one hand and the PCI-related delays shorter
on the other hand thereby reducing the chance of finding a benefit of earlier reperfusion by giving
a lytic agent upfront.14
As the more neutral propensity score-adjusted results suggest, there is likely to be at least
some bias in the treatment strategy selected for the patients in FAST-MI. For instance, pharmacoinvasive patients tended to have less baseline co-morbidities and were less likely to be female,
although the overall GRACE risk score was similar in both groups. In addition, there were more
4
DOI: 10.1161/CIRCULATIONAHA.114.009226
patients in the pharmaco-invasive group who sought medical attention within 120 minutes of
symptom onset. Patients in the fibrinolysis group were also more likely to be transported by an
ambulance with a physician on board. On aggregate, pre-hospital fibrinolysis was probably more
likely given to early presenters with a clear diagnosis and no obvious comorbidity, features that
inevitably are associated with better long-term survival.
The recruitment of patients in FAST-MI started before the results of the “facilitated PCI”
trials were known. In these trials, PCI was performed immediately following fibrinolysis
(irrespective of its success), and was associated with a high rate of early thrombotic complications.
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
This negative outcome is likely due to the pro-coagulant effect of the lytic agent in the absence of
angiography
within
adequate antithrombotic co-therapy. In FAST-MI, only 23% of patients had an ang
ng
gio
iogr
g ap
aphy
hy w
ithin
ith
the
he 3 to 24 hour time window, the time window recommended by the current guidelines, while the
remainder
beyond
This
probably
ema
main
inde
in
derr of tthe
de
hee ppatients
at
atients
had a catheterization be
eyo
y nd 24 hours. T
h s pr
hi
prob
obab
ob
a ly reflects sustained
15, 166
reperfusion
epeerf
r usion because
beeca
caus
use of the
us
he routine
rou
outi
tine
ti
ne co-administration
co-a
o-adminiistrratio
on off cclopidogrel
lopi
lopi
pido
doogr
greel and
ndd eenoxaparin.
noxaapa
noxa
pari
rin.
n 15
n.
Almost
A
lmoostt 4
lm
ou
out
ut 100 ppatients
atie
at
ieent
ntss in
nF
FAST-MI
ASTAS
T--MI
M uunderwent
ndder
erwe
went
we
nt aan
n an
angi
angiography
iog
o ra
rapphy
phy wi
with
within
thin
th
in
n tthe
hee ffirst
irst
ir
s 3 hhours,
st
ourrs,
ou
rs, si
ssimilar
mila
mila
lar to
to tthe
he 336%
6%
6%
urgent cathete
catheterizations
teeri
r za
z ti
tion
onss pe
on
pperformed
rffor
orme
medd in S
me
STREAM.
TREA
TR
EAM.
EA
M A
M.
Att ppresent,
r seent
re
n , it rremains
emai
em
a ns uunclear
ncle
nc
lear
le
a w
ar
whether
heth
he
ther
th
er a routine
invasive procedure immediately following fibrinolysis should still be avoided if optimal
antithrombotic co-therapy is given upfront.
Are the long-term results from FAST-MI also representative for other EMS services across
the world? The pre-hospital medical system in France is well established and often includes
physicians. Remarkably, almost 66% of patients receiving fibrinolysis were treated in the prehospital setting, and 60 to 75% of patients in the FAST-MI registry were transferred by ambulance
or helicopter with a physician on board. Compared to primary PCI patients, more fibrinolysistreated patients were transported by a medical EMS as well. The presence of a physician during
5
DOI: 10.1161/CIRCULATIONAHA.114.009226
transport very likely affects the early management of STEMI patients by expediting start of
treatment and also diagnosis in case of atypical presentation. It remains uncertain whether the high
5-year survival rates can be obtained with other healthcare systems, especially those with
exclusively paramedical ambulance personnel. Physician-equipped emergency medical systems are
a rarity rather than the norm. In the ASSENT-3 Plus trial the outcome of pre-hospital fibrinolysis
was not affected by the presence or absence of a physician in the ambulance.17 Outside the setting
of a clinical trial, however, it remains unclear whether patients benefit from the presence of a
physician. Wireless ECG transfer to off-site cardiologists has become standard procedure in many
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
EMS and has certainly shortened treatment delays. However, the decision to give lytic therapy or
ransfer the patient for primary PCI is complex and does not exclusively depend oon
n th
he pr
pres
esen
es
ence
en
c of
ce
transfer
the
presence
ST-elevation in a 12-lead ECG.
IInn cconclusion,
onclus
on
usio
us
ionn, after 5 year follow-up, STE
io
EMI
MI patients treate
teed wi
ith a pre-hospital-initiated
STEMI
treated
with
ph
harma
arrm co-invas
asiv
ivee st
iv
str
rateegy ffare
aree ass ggood
ar
oodd aass tho
oo
hose ttransported
ho
ranspporrte
tedd for
for prim
pprimary
rimar
aryy PCI
PCI in
n tthe
he rreal
e l wo
ea
worl
rld
ld
pharmaco-invasive
strategy
those
world
FA
AST
ST-M
-MII re
regi
gist
strry.. In eearly
arrly ppresenters,
r seent
re
nter
ers,
er
s, a ppharmaco-invasive
harm
ha
rmac
rm
a o-iinv
ac
nvas
asiv
ivee th
iv
her
e ap
apyy wa
wass also
alsoo aassociated
ssoc
ss
occiaatedd with
with a
FAST-MI
registry.
therapy
urvival benefit
benef
effit
i ccompared
ompa
om
pare
pa
reed to a primary
prim
pr
imar
im
aryy PC
ar
PCII th
that
at w
as ddelayed
elay
el
ayed
ay
ed for
for more
morre th
than
an 990
0 mi
minu
nute
nu
tess after the
te
survival
was
minutes
initial call. The results are in line with the 30-day and 1-year results from STEMI patients
presenting early but unable to undergo primary PCI within 60 minutes in the STREAM trial. Taken
together, and awaiting long-term follow-up from STREAM, a contemporary pharmaco-invasive
management appears to be at least as good as primary PCI in STEMI patients presenting early after
symptom onset when a timely PCI is not an option.
Conflict of Interest Disclosures: Peter Sinnaeve received speaker’s and consultancy fees from
Boehringer Ingelheim. Frans Van de Werf received a research grant for performing the
STREAM trial and speaker’s and consultancy fees from Boehringer Ingelheim
6
DOI: 10.1161/CIRCULATIONAHA.114.009226
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en
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HR, Nielsen
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iels
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en K,
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ue n L, Kelbaek
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e baaek H,
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Ab
illdg
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aard
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AB,
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P
eddersen
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F, Ma
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8
DOI: 10.1161/CIRCULATIONAHA.114.009226
Figure Legend:
Figure 1. Important time delays with a pharmaco-invasive strategy versus primary PCI are
shown. PCI-related time delays in patients unable to undergo timely PCI in STREAM and
FAST-MI were 78 and 105 minutes, respectively. In both studies patients received either prehospital fibrinolysis followed by early rescue or planned coronary angiography (in case of
successful fibrinolysis) or were transported for primary PCI. A PCI-related delay in essence
indicates the time possibly gained by administering a lytic agent in the ambulance versus routine
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
transport for (delayed) primary PCI. As fibrinolytic therapy requires time to achieve clot
dissolution, the actual time difference
f
in obtaining reperfusion between the two stra
sstrategies
t ategi
gies
gi
es iiss
shorter
horter than the PCI-related delay. With a contemporary pharmaco-invasive management rescue
PCI
one third of the patientss while
PC
CI is needed
neeede
dedd inn around
around
ro
while a plannedd ccoronary
oron
onnar
aryy angiography (with
PCI
P
CII in
i most cases)
caasees)) can
can
n be
be performed
perf
pe
rfor
rf
orme
medd in
me
in the
the remaining
remaiini
ninng patients.
patie
atieentts.
s
9
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
Primary PCI Not Always the Best Reperfusion Strategy?
Peter R. Sinnaeve and Frans Van de Werf
Circulation. published online March 21, 2014;
Downloaded from http://circ.ahajournals.org/ by guest on July 12, 2017
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