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The Take Home: ISC
The International Stroke Conference, which featured a number of presentations on endovascular thrombectomy and other topics of interest to interventional cardiologists and neurologists, was held Jan. 23-26, 2018, in Los Angeles. Cardiology Today’s Intervention asked Larry B. Goldstein, MD, from the University of Kentucky, and Philip B. Gorelick, MD, MPH, from Michigan State University College of Human Medicine, for their insights on some of the cutting-edge research presented.
DEFUSE 3
Gorelick: Congratulations to the DEFUSE study trialists. After some 20 years of work of tracking acute brain infarct growth and showing that the trajectory of growth of acute cerebral ischemia may be quite variable and potentially amendable to endovascular intervention plus medical therapy in a relatively late time window, the DEFUSE 3 trial strongly supports the hypothesis of salvageable brain tissue.
Proper selection of patients with advanced neuroimaging technology is key. An example of an appropriate population is patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion, an initial infarct size less than 70 mL and a ratio of the volume of ischemic tissue on perfusion imaging to infarct volume of 1.8 or more.
The researchers assigned 92 patients who met these criteria to endovascular therapy plus standard medical therapy and 90 to medical therapy alone. They used RAPID software, an automated image postprocessing system, that allowed them to see how much brain tissue was irreversibly injured when the patient arrived.
There was a more favorable distribution of disability scores on the modified Rankin scale at 90 days among patients randomly assigned to endovascular thrombectomy plus medical therapy vs. medical therapy alone (unadjusted common OR = 2.77; 95% CI, 1.63-4.7), a finding that held true after adjustment for stratification factors (adjusted OR = 3.36; 95% CI, 1.96-5.77).
Based on the DEFUSE 3 findings and a complementary study, DAWN, the window of opportunity for treatment of acute ischemic stroke has been increased to up to 24 hours with proper patient selection. Thus, the acute ischemic stroke treatment bar has been set higher, and stroke centers will need to be armed with software to measure ischemic core and possible penumbral tissue to now make endovascular treatment decisions.
ARISE II
Goldstein: The ARISE II study was designed to secure 510(k) clearance of the EmboTrap Revascularization Device (Neuravi/Cerenovus). The researchers analyzed data from 227 patients (mean age, 68 years; 46% men) with anterior and posterior circulation proximal large vessel occlusion who presented with acute ischemic stroke.
The primary efficacy endpoint of interest was a modified Treatment in Cerebral Ischemia score between 2b and 3 within three passes of the device without rescue. The primary safety endpoint of interest was a composite of symptomatic intracerebral hemorrhage within 24 hours after the procedure and other serious adverse device events. Patients were followed up at 24 hours, 7 days and 90 days.
Eighty percent of those treated had successful recanalization within three passes of the device, comparing favorably with previous studies of other devices. In addition, 65% of patients achieved a modified Treatment in Cerebral Ischemia score between 2c and 3. Symptomatic intracerebral hemorrhage within 24 hours occurred in 5.3% of patients, and all-cause mortality at 90 days occurred in 9% of the group. There were no concurrent controls, so it is difficult to conclude more.
NEW STROKE GUIDELINES
Goldstein: The new American Heart Association and American Stroke Association stroke guidelines, unveiled at ISC, are nearly 340 pages long and are based on 421 references. They include more than 220 recommendations, 117 of which are new, revised or reworded from previous versions. Many will affect current practice.
They re-endorse first-line treatment of selected patients with acute ischemic stroke with IV alteplase (Activase, Genentech), but expand the opportunity for endovascular clot removal to up to 24 hours in selected patients based on neuroimaging criteria. Specifically, patients should receive mechanical thrombectomy with a stent retriever if they are aged at least 18 years, have a pre-stroke modified Rankin scale between 0 and 1, have a NIH Stroke Scale score of 6 or greater, have causative occlusion of the internal carotid artery or middle cerebral artery segment 1 and have an ASPECTS score of at least 6. The guidelines now include those who are ineligible for IV alteplase, as they may benefit from this treatment.
Diagnostically, echocardiography is now suggested in selected patients and MRI should be used selectively as well. For selected patients, a combination of aspirin and clopidogrel for 90 days is now endorsed. The benefit of patent foramen ovale closure for secondary prevention in patients with cryptogenic stroke is questioned in the text, but a specific recommendation was not provided.
THE CHALLENGE OF CANCER
Gorelick: To assess whether patients with cancer receive acute recanalization therapies as often as those without cancer among those with acute ischemic stroke, and to characterize temporal trends in stroke recanalization therapy in patients with and without cancer, the researchers conducted a retrospective cohort study of 8.5 million patients hospitalized for acute ischemic stroke (5.2% with cancer) between 1998 and 2013.
Between 1998 and 2013, patients with cancer were less likely to receive IV tissue plasminogen activator (tPA) than those without it (demographic-adjusted OR = 0.64; 95% CI, 0.61-0.68). However, between 2006 and 2013, the likelihood of receiving endovascular therapy was similar in both groups (demographic adjusted OR = 0.97; 95% CI, 0.86-1.09).
It may not be surprising that persons with cancer are less likely to receive IV tPA for acute ischemic stroke than persons without cancer, as the former group, depending on the type and stage of cancer, may be considered a higher-risk group to receive tPA and may be considered less likely to survive for a sustained duration of time, and thus, not good candidates for such therapy. On the other hand, one may not expect to see a difference when neurothrombectomy is considered for the two groups, as the eligibility for neurothrombectomy may be viewed with substantial scrutiny for both patient groups during the time period of interest (2006 to 2013), and thus, candidates may be sought who are less ill from a systemic standpoint and more likely to survive. It would be interesting to know what types and stages of cancer were treated with neurothrombectomy.
Disclosures: Goldstein and Gorelick report no relevant financial disclosures.