PRAGUE-16: Direct Thrombectomy Safe, Effective in Stroke Patients

Marlene Busko

August 28, 2016

ROME, ITALY — In a registry study of 103 patients who presented to a hospital soon after having a major stroke, those who had catheter-based thrombectomy performed in a cardiology department without receiving prior thrombolytics had results as good as those who received thrombolytics[1]. Around 40% of patients in each treatment group had a good functional outcome at 90 days.

A neurosurgeon confirmed the indication for the thrombectomy, and it was carried out by an interventional cardiologist or an interventional radiologist.

Prof Petr Widimsky

This pilot study showed that "acute stroke intervention done in close cooperation of cardiologists, neurologists, and radiologists is feasible and safe," said Prof Petr Widimsky (Charles University, Prague, Czech Republic), presenting these findings from PRAGUE-16 in a press briefing prior to a session at the European Society of Cardiology (ESC) 2016 Congress.

"Direct catheter-based thrombectomy . . . may thus be considered in patients with contraindications for thrombolysis or in patients with very short CT-to-groin-puncture times," he continued. However, these are preliminary results that need to be confirmed in a randomized trial, he cautioned.

"Our question to solve was whether [catheter-based thrombectomy] can be done in the cardiology department if no neurologist is available . . . without thrombolytics," Widimsky clarified to heartwire from Medscape.

The procedure is not available everywhere in Europe or North America because of lack of expert neuroradiologists, he continued. Since there are many more interventional cardiologists than interventional neuroradiologists, "maybe if cardiologists could train a few months or a year in this procedure and then start to do it, this is faster than training a new neuroradiologist, which takes 7 years," he said.

This preliminary study suggests that "it's possible to do these kinds of interventions in the same settings as we already know from acute MI," ESC spokesperson Dr Christian Gerdes (Aarhus University Hospital, Denmark) told the press.

"Cardiologists have worked lots of years to optimize the logistics, cut away all the delaying factors; if the same process were applied to stroke patients, maybe the outcome would be better," he added to heartwire .

Thrombectomy in Severe Stroke

"There are five randomized trials—REVASCAT, SWIFT PRIME, MR CLEAN, ESCAPE, and EXTEND-IA—published in the New England Journal of Medicine that all showed the same direction," that thrombectomy is superior to thrombolysis alone in stroke, Widimsky said.

New international guidelines support "bridging" thrombolysis, but there are no data comparing thrombectomy with or without prior thrombolytics.

Using registry data, the researchers identified 73 stroke patients who received direct catheter-based thrombectomy and 30 stroke patients who received "bridging" with thrombolytics prior to going to the cath lab to have the clot removed.

All patients had moderate to severe (National Institutes of Health Stroke Scale [NIHSS] ≥6) acute ischemic stroke and a prestroke modified Rankin Scale (mRS) score of 0 to 1, indicating that they had no prior neurologic abnormality.

The patients arrived at the hospital within 6 hours of the stroke onset. Their admission CT scans did not show large ischemia but did show an occluded major artery. The attending neurologist determined whether the patient received catheter-based thrombectomy with or without prior thrombolytics, and the intervention was performed within an hour of the CT scan.

Because this was a registry study, it was not possible to directly compare the two groups, Widimsky told the press. However, the study did show that performing direct thrombectomy in this type of stroke patients was safe and feasible.

Outcomes in Stroke Patients, Direct Thrombectomy vs Thrombolysis Plus Thrombectomy

Outcome Direct CBT (n=73) Thrombolysis + CBT (n=30)
Good functional outcome (mRS 0–2 after 90 days), % 39 43
Symptomatic intracranial hemorrhage (NIHSS increase >3), % 12 10
Procedure-related complications (SAH, vessel perforation or dissection, symptomatic stent thrombosis within 24 hours, carotico-cavernous fistula, embolism to other territory), % 10 17
Angiographic success (TICI 2b–3 at the end of procedure), % 71 85
Mean time from symptom onset to CT, min 105 73
Mean time from CT scan to groin puncture, min 42 115
CBT=catheter-based thrombectomy
mRS=modified Rankin Scale
NIHSS=National Institutes of Health Stroke Scale
SAH=subarachnoid hemorrhage
TICI=Thrombolysis in Cerebral Infarction
CT=computed tomography

In the US, this intervention is mainly done by neurosurgeons as well as by radiologists, whereas in Europe it is done by radiologists in 90% to 95% of cases, and by a few cardiologists, neurologists, or neurosurgeons, Widimsky noted to heartwire .

"The main problem is we have this evidence from those five trials; this technique should be done for major ischemic stroke coming early to the hospital," but there are a lack of experts to do it, he said. The procedure is very effective, and the earlier the patient with a stroke goes to the hospital, the better.

"We have patients—about 29% in our study—where the patient was unconscious, hemiplegic, not moving, and we did the procedure and the patient opened their eyes and wanted to go home. Sometimes it is very dramatic, like a miracle," he said.

Widimsky has no relevant financial relationships.

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