SYNTHESIS N Engl J Med 2013
Background
In patients with ischemic stroke, endovascular treatment results in a higher rate of
recanalization of the affected cerebral artery than systemic intravenous thrombolytic
therapy. However, comparison of the clinical efficacy of the two approaches is
needed.
Methods
We randomly assigned 362 patients with acute ischemic stroke, within 4.5 hours
after onset, to endovascular therapy (intraarterial thrombolysis with recombinant
tissue plasminogen activator [t-PA], mechanical clot disruption or retrieval, or a
combination of these approaches) or intravenous t-PA. Treatments were to be given
as soon as possible after randomization. The primary outcome was survival free of
disability (defined as a modified Rankin score of 0 or 1 on a scale of 0 to 6, with
0 indicating no symptoms, 1 no clinically significant disability despite symptoms,
and 6 death) at 3 months.
Results
A total of 181 patients were assigned to receive endovascular therapy, and 181 intravenous
t-PA. The median time from stroke onset to the start of treatment was
3.75 hours for endovascular therapy and 2.75 hours for intravenous t-PA (P<0.001).
At 3 months, 55 patients in the endovascular-therapy group (30.4%) and 63 in the
intravenous t-PA group (34.8%) were alive without disability (odds ratio adjusted for
age, sex, stroke severity, and atrial fibrillation status at baseline, 0.71; 95% confidence
interval, 0.44 to 1.14; P = 0.16). Fatal or nonfatal symptomatic intracranial
hemorrhage within 7 days occurred in 6% of the patients in each group, and there
were no significant differences between groups in the rates of other serious adverse
events or the case fatality rate.
Conclusions
The results of this trial in patients with acute ischemic stroke indicate that endovascular
therapy is not superior to standard treatment with intravenous t-PA. (Funded
by the Italian Medicines Agency, ClinicalTrials.gov number, NCT00640367.)
In patients with ischemic stroke, endovascular treatment results in a higher rate of
recanalization of the affected cerebral artery than systemic intravenous thrombolytic
therapy. However, comparison of the clinical efficacy of the two approaches is
needed.
Methods
We randomly assigned 362 patients with acute ischemic stroke, within 4.5 hours
after onset, to endovascular therapy (intraarterial thrombolysis with recombinant
tissue plasminogen activator [t-PA], mechanical clot disruption or retrieval, or a
combination of these approaches) or intravenous t-PA. Treatments were to be given
as soon as possible after randomization. The primary outcome was survival free of
disability (defined as a modified Rankin score of 0 or 1 on a scale of 0 to 6, with
0 indicating no symptoms, 1 no clinically significant disability despite symptoms,
and 6 death) at 3 months.
Results
A total of 181 patients were assigned to receive endovascular therapy, and 181 intravenous
t-PA. The median time from stroke onset to the start of treatment was
3.75 hours for endovascular therapy and 2.75 hours for intravenous t-PA (P<0.001).
At 3 months, 55 patients in the endovascular-therapy group (30.4%) and 63 in the
intravenous t-PA group (34.8%) were alive without disability (odds ratio adjusted for
age, sex, stroke severity, and atrial fibrillation status at baseline, 0.71; 95% confidence
interval, 0.44 to 1.14; P = 0.16). Fatal or nonfatal symptomatic intracranial
hemorrhage within 7 days occurred in 6% of the patients in each group, and there
were no significant differences between groups in the rates of other serious adverse
events or the case fatality rate.
Conclusions
The results of this trial in patients with acute ischemic stroke indicate that endovascular
therapy is not superior to standard treatment with intravenous t-PA. (Funded
by the Italian Medicines Agency, ClinicalTrials.gov number, NCT00640367.)
Blogger comment-- endovascular v tpa does not represent real world since current protocol is patients get iv if eligible and both if iv does not work,and endovascular alone if not eligible for iv. Also hodgepodge of old interventional methods were used.
SYNTHESIS (Italian Study):
1) This study only randomized patients that arrived in < 4.5 hours and
were eligible candidates for IV tPA. For same reasons as above, this is a very
narrow scope of patients.
2) This study was a comparison of IV tPA versus IA tPA (additional devices
could be used). IA tPA is rarely used as an endovascular therapy now that we
have mechanical devices.
3) No CTA was allowed in this study. Only noncontrast head CT. 10% of
patients randomized to IA therapy had no occlusion on angiogram, and these
patients because the protocol dictated, were given IA tPA anyways even if they
had no occlusion!
4) In his presentation, Ciccone showed that the time-to-treatment was
significantly different: >60 minutes longer in the IA treatment arm of the
study.
5) It is not clear how many patients were screened to arrive at the final
enrollment of 362.
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