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Direct catheter-based thrombectomy is
as effective as bridging thrombolysis in
ischaemic stroke
Direct catheter-based thrombectomy is equally effective as thrombolysis in the treatment of acute
ischaemic stroke, according to results from the prospective, observational, pilot PRAGUE-16 registry
study.
P
etr Widimsky, MD, of Charles University, Prague, Czech
Republic, explained, “If left untreated, acute ischaemic
stroke caused by a major artery occlusion results in death
for up to half of patients and an additional 40% to 50% are left
permanently disabled. In other words, without treatment, only
a few patients with major ischaemic stroke survive without
severe sequelae.”
Functionally independent survival (defined as a modified
Rankin Scale score of 0–2) after these major strokes increases
to approximately 20% to 30% with thrombolytic treatment in
specialised stroke units. The majority of patients, however, still
die or remain permanently disabled.
In 2015 several randomised trials demonstrated that 45% to
50% of patients can survive and be functionally independent
with catheter-based (endovascular) mechanical thrombectomy.
If the intervention is performed very early (within 3 h of stroke
onset), results are even better – up to 70% of patients may
return to normal daily life. Thus, catheter-based mechanical
thrombectomy is now recommended for all patients with acute
ischaemic stroke caused by a major artery occlusion.
Many questions remain, however. Dr Widimsky and col-
leagues investigated two of them. First, they set out to deter-
mine whether direct (without thrombolysis) cathether-based
thrombectomy can achieve comparable results to thrombec-
tomy performed after intravenous (“bridging”) thrombolysis.
Second, they determined whether catheter-based thrombec-
tomy performed in interventional cardiology departments (when
no interventional neuroradiology department is available) can
achieve results comparable to neuroradiology settings.
Dr Widimsky said, “The study aim was to evaluate the
feasibility and safety of direct catheter-based thrombectomy
performed in close cooperation between cardiologists, neurolo-
gists, and radiologists – a true interdisciplinary approach.”
PRAGUE-16 included 103 patients who presented within
6 h from the onset of moderate to severe acute ischaemic stroke.
Patients had an occluded major cerebral artery but no large
ischaemia yet on a CT scan. The attending neurologist decided
whether patients received direct catheter-based thrombectomy
or bridging thrombolysis + catheter-based thrombectomy based
on the clinical picture and CT scan. The intervention was
performed within 60 minutes of the CT scan.
Approximately 73 patients received direct catheter-based
thrombectomy and 30, bridging thrombolysis + catheter-based
thrombectomy. Good functional outcome (defined as a modi-
fied Rankin Scale score of 0–2 after 90 days) was achieved
in 41% patients overall with similar results between the two
groups.
“In our study, 41% of patients who received direct catheter-
based thrombectomy had good functional recovery. This
compares to 48% of patients given this intervention in seven
randomised trials performed in expert neuroradiology units.
Our outcomes, however, were significantly better than trials in
which patients received medical therapy (intravenous throm-
bolysis) alone, of whom only 30% recovered,” Dr Widimsky
said.
“Our findings suggest that direct catheter-based thrombec-
tomy performed in a timely manner may be an alternative to
thrombectomy after bridging thrombolysis. Furthermore, in
regions with no (or limited) interventional neuroradiology
services, modern stroke treatment might be offered via inter-
ventional cardiology services in close cooperation with neurolo-
gists and radiologists. Both of these preliminary conclusions,
however, should be confirmed by larger multicentre studies or
large international registries.”
Given the level of risk of
cardiovascular disease attributed
to obstructive sleep apnoea in
previous observational studies,
wewere surprised not to find a
benefit fromCPAP treatment.
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Any intervention that reduces
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CPAP is shown to improve wellbeing but not cardiovascular outcomes
More than 3 years of nightly treatment with a continuous positive airway pressure (CPAP) machine did not reduce cardiovascular risk more than usual
care among patients with cardiovascular disease and obstructive sleep apnoea, reports the Sleep Apnea Cardiovascular Endpoints (SAVE) study.
D
oug McEvoy, MD, of Flinders University, Adelaide,
Australia, explained, “Given the level of risk of cardio-
vascular disease attributed to obstructive sleep apnoea
in previous observational studies, we were surprised not to find
a benefit from CPAP treatment.”
The SAVE study recruited sleep apnoea patients with
moderate-to- severe disease from 89 clinical centres in seven
countries. Participants were predominantly elderly (approxi-
mately 61 years), overweight, habitually snoring males, and all
had coronary artery or cerebrovascular disease.
Participants had to achieve a minimum 3 h of sham-CPAP
adherence per night in a 1-week run-in before the study started.
Usual care included concomitant cardiovascular risk manage-
ment, based on national guidelines, as well as advice on healthy
sleep habits and lifestyle changes to minimise obstructive sleep
apnoea. A total of 2717 individuals were randomised to receive
usual care alone or usual care plus CPAP.
Forty-two percent of patients assigned to CPAP achieved
good adherence (an average of 4 or more hours per night).
Mean apnoea–hypopnoea index (a measure of obstructive sleep
apnoea severity) decreased from 29.0 to 3.7 events per hour
when patients used CPAP, indicating good control of their
obstructive sleep apnoea.
After a mean of 3.7 years for 1341 usual care and 1346
CPAP patients included in the final analysis, however, no dif-
ference between groups was observed in the primary outcome,
a composite of death from any cardiovascular cause, myocardial
infarction or stroke, and hospitalisation for heart failure, acute
coronary syndrome, or transient ischaemic attack.
Specifically, 17.0% of patients in the CPAP group and 15.4%
in usual care experienced a serious cardiovascular event.
Dr McEvoy said, “It’s not clear why CPAP treatment did
not improve cardiovascular outcomes. It is possible that, even
though the average CPAP adherence of approximately 3.3 h
per night was as expected, and more than we estimated in
our power calculations, it was still insufficient to show the
hypothesised level of effect on cardiovascular outcomes.”
Importantly, however, CPAP did improve participant well-
being, defined by symptoms of daytime sleepiness, health-
related quality of life, mood (particularly depressive symptoms),
and attendance at work.
Dr McEvoy said, “While it is disappointing not to find a
reduction in cardiovascular events with CPAP, our results
showed that treatment of obstructive sleep apnoea in patients
with cardiovascular disease is nevertheless worthwhile. They
were much less sleepy and depressed, and their productivity
and quality of life was enhanced.”
He added, “More research is needed on how to reduce the
significant risk of cardiovascular events in people who suffer
from sleep apnoea. Given our finding of a possible reduction
in cerebrovascular events in patients who were able to use
CPAP for more than 4 h per night, and prior studies showing
a stronger association between obstructive sleep apnoea and
stroke than between obstructive sleep apnoea and coronary
artery disease, future trials should consider targeting patients
with obstructive sleep apnoea and stroke who can achieve a
high level of CPAP compliance.”
Future trials should consider targeting patients with
obstructive sleep apnoea and stroke who can
achieve a high level of CPAP compliance.
ESC 2016
VOL. 1 • No. 2 • 2016
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