Acute stroke trials: the elephant in the room

Abstract

AbbreviationsNIHSS National Institutes of Health Stroke ScaleMCA Middle cerebral arteryACA Anterior cerebral arteryM1 Horizontal segment of the middle cerebral ar-tery up to its first divisionFDA Food and Drug AdministrationCOPD Chronic obstructive pulmonary diseaseCAD Coronary artery diseaseASPECTS Alberta Stroke Program Early CT ScoreINR Interventional neuroradiologist510K Section 510(k) of the Food Drug and CosmeticAct requires device manufacturers, who mustregister, to notify the Food and Drug Admin-istration (FDA) of their intent to market amedical device at least 90 days in advance.This is known as Premarket Notification—alsocalled PMN or 510(k). This allows FDA todetermine whether the device is equivalent to adevice already placed into one of the threeclassification categories (more details at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm).The following are based on true stories (either from personalexperience or conversations with colleagues at meetings).Scenario 1A 65-year-old otherwise healthy female patient presentswith large left middle cerebral artery (MCA) stroke 80 minfrom onset and a National Institutes of Health Stroke Scale(NIHSS) of21.Imagingshowsasmall coreandocclusioninthe M1 segment of the left middle cerebral artery.Stroke neurologist (to patient's son who is well edu-cated, works as an accountant): Your mother is having asevere stroke due to blockage in one of the large ves-sels in her brain. This requires urgent intervention togive her the best chance of recovery. We are going tobe starting her on a clot busting drug called tPA. How-ever, we are also part of a randomized trial, to test anew therapy.Patient's son: What is the new therapy?Stroke neurologist: Your mother would be taken to thecath lab where a small tube would be advanced to thevessels of the brain under X-ray guidance similar towhat is done for a heart attack. Once it is in position,we would try and suck the clot out to reestablish flowto the brain. This procedure, however, is not a well-established procedure and does carry a risk. If youchoose to participate in the trial, there is a66 % chancethat your mother will go to the cath lab. Of course,there is a one-third chance that she won't in whichcase, she would receive the intravenous clot bustingdrug and be shifted to the stroke unit.Patient's son: How is she doing now?Stroke neurologist: There has been no change in herstatus so far.Patient's son: What would you do if I refuse to partic-ipate in the trial?Stroke neurologist (hesitantly…): We would take herto the cath lab.Patient's son: In that case, we don't want to participatein the trial.Questions1. Why do patients and their relatives find the idea of the“cath lab” attractive even though it is unproven andcarries risk?