Rome, Italy - 27 Aug 2016: Direct catheter-based thrombectomy is equally effective to bridging thrombolysis in the treatment of acute ischaemic stroke, according to results from the observational PRAGUE-16 registry study presented at ESC Congress 2016 today.1
"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," said principal investigator Professor Petr Widimsky, head of the Third Faculty of Medicine, Charles University, Prague, Czech Republic. "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 Scale2 score of 0-2) after these major strokes increases to approximately 20% to 30% with thrombolytic treatment in specialised stroke units. But the majority of patients 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 three hours from stroke onset), the 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.3
However, many questions remain, of which two were investigated in this pilot study. First, whether direct (without thrombolysis) cathether-based thrombectomy (d-CBT) can achieve comparable results to thrombectomy performed after intravenous ("bridging") thrombolysis. And second, whether catheter-based thrombectomy performed in interventional cardiology departments (when no interventional neuroradiology department is available) can achieve results comparable to neuroradiology settings.
Professor Widimsky said: "The study aim was to evaluate the feasibility and safety of d-CBT performed in close cooperation between cardiologists, neurologists and radiologists - a true interdisciplinary approach."
PRAGUE-164 was a prospective, observational pilot registry study. It included 103 patients who presented within six hours from the onset of moderate to severe acute ischaemic stroke. Patients had an occluded major cerebral artery but no large ischaemia yet on a computed tomography (CT) scan. The attending neurologist decided whether patients received d-CBT or bridging thrombolysis plus CBT based on the clinical picture and CT scan. The intervention was performed within 60 minutes of the CT scan.
Some 73 patients received d-CBT and 30 had bridging thrombolysis plus CBT. Good functional outcome (defined as a modified Rankin Scale score of 0-2 after 90 days) was achieved in 41% patients overall with similar results between the two groups (table 1).
Professor Widimsky said: "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 trials5 performed in expert neuroradiology units. However, our outcomes are significantly better than patients in the trials who received medical therapy (intravenous thrombolysis) alone, of whom only 30% recovered."
He concluded: "Our findings suggest that direct catheter-based thrombectomy 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 interventional cardiology services in close cooperation with neurologists and radiologists. However, both of these preliminary conclusions should be confirmed by larger multicentre studies or large international registries."
|Direct CBT (n=73)||Bridging thrombolysis + CBT (n=30)|
|Good functional outcome (mRS 0-2 after 90 days)||39%||43%|
|Symptomatic intracranial haemorrhage (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||105 minutes||73 minutes|
|Mean time from CT to groin puncture||42 minutes||115 minutes|
Table 1. Outcomes after direct CBT and bridging thrombolysis plus CBT Abbreviations: CBT (cathether-based thrombectomy); mRS (modified Rankin Scale); NIHSS (National Institutes of Health Stroke Scale); SAH (subarachnoid haemorrhage); TICI (Thrombolysis in Cerebral Infarction); CT (computed tomography)
Notes to editors
Sources of funding: The administrative costs were covered by the Charles University Cardiovascular Research Program P35. The interventional procedures are routinely covered by the health insurance in the Czech Republic.
References and notes
1Professor Petr Widimsky will present the abstract "Feasibility and safety of direct catheter-based thrombectomy in the treatment of acute ischemic stroke. Prospective registry PRAGUE-16" during:
- The press conference "Stroke and Arrhythmia: Life or Death" on 27 August at 15:00 to 16:00
- The session "Registries coronary artery disease, stroke and intervention" on 29 August at 16:30 to 18:00 in room Sarajevo - Village 2
2The modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
32015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015;46(10):3020-3035. doi: 10.1161/STR.0000000000000074.
4PRAGUE refers to a series of academic randomised trials coordinated by the Cardiocentre, Charles University, Prague. The acronym not only reflects the name of this city, but also the abbreviation of the first study from this series (published in 2000) - PRimary Angioplasty in patients with myocardial infarction transferred from General community hospitals to angioplasty Units of tertiary cardiology centres with or without Emergency thrombolysis.
5MR CLEAN, ESCAPE, EXTEND IA, SWIFT PRIME, REVASCAT, THERAPY, THRACE
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