PRAGUE-16 Registry Supports Direct Catheter-Based Thrombectomy for Ischemic Stroke
August 30, 2016—The European Society of Cardiology (ESC) announced the presentation of findings from the observational PRAGUE-16 registry that showed direct (without thrombolysis) catheter-based thrombectomy (d-CBT) is equally effective as bridging thrombolysis in the treatment of acute ischemic stroke. The PRAGUE-16 data were presented at the ESC 2016 Congress, held August 27–31 in Rome, Italy.
PRAGUE-16 Principal Investigator Prof. Petr Widimsky, MD, commented in the ESC announcement, “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.” Prof. Widimsky is head of the Third Faculty of Medicine, Charles University in Prague, Czech Republic.
As summarized by the ESC, PRAGUE-16 was a prospective, observational pilot registry study composed of 103 patients who presented within 6 hours from the onset of moderate to severe acute ischemic stroke. Patients had an occluded major cerebral artery but no large ischemia on a 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.
There were 73 patients who received d-CBT and 30 patients who 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.
Prof. Widimsky commented, “In our study, 41% of patients who received d-CBT had good functional recovery. This compares to 48% of patients given this intervention in seven randomized trials 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 d-CBT 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 multicenter studies or large international registries.”