“More community hospitals are giving a powerful clot-busting medication to stroke victims, improving their chances of survival and recovery, new research shows.”
This statement comes from the American Heart Association press release regarding this synopsis of the Get-With-the-Guideline Registry. Part of this statement is true – more community hospitals are using tPA for acute ischemic stroke. In this review of 44,667 patients treated with tPA over the past decade, 23.5% received tPA outside of a specialized stroke or academic center.
The second half of this press statement is false.
Patients treated by the “drip and ship” method, as community administration of tPA is described, did not have an improved chance of survival. Patients treated at community hospitals were younger, had less-severe strokes, and had fewer prior strokes – yet their in-hospital mortality was 10.9%, compared with 9.7%. Additionally, their rate of symptomatic intracranial hemorrhage was 5.7% compared with 5.2%, and they had 1.8% serious tPA-related complications, compared with 1.6%. These small absolute differences are magnified when adjustments are made for baseline comorbidities, and, in fact the OR for in-hospital mortality increases to 1.23 or 1.33, depending on the precise statistics pursued. So, of course, the logical leading sentence of the Discussion is:
“In this study of >40000 patients with acute ischemic stroke treated with IV thrombolysis throughout the United States, drip and ship thrombolysis was …. safe.”
A better leading sentence to their Discussion might rather suggest the “drip and ship” model is, in fact, less safe than typical thrombolysis. Further, they might better suggest the “drip and ship” model should be curtailed while further investigation into additive risks are performed, or to confirm the effects noted from this somewhat dodgy registry data. But, these authors focus more on explaining away this inconsistency with their narrative than calling for safer, narrower administration of tPA. After all, these authors are well-funded by industry – including one affiliated with MGH TeleHealth, providing telestroke-enabled thrombolysis:
Dr Sheth is a member of the Get with the Guidelines (GWTG)- Stroke Clinical Workgroup, and he is a Co-Principal Investigator and Executive Committee member for Glyburide Advantage in Malignant Edema and Stroke-Remedy Pharmaceuticals (GAMES-RP), a phase II–trial to prevent swelling in patients with large stroke, funded by Remedy Pharmaceuticals, Inc. Dr Smith is a member of the GWTG- Stroke Workgroup. Dr Kleindorfer discloses speaking engagements. Dr Fonarow is a member of the GWTG Steering Committee; receipt of research support (to the institution) from Patient-Centered Outcomes Research Institute, and he is an employee of the University of California that holds a patent on retriever devices for stroke. Dr Schwamm is the chair of the GWTG-Stroke Clinical Workgroup, a principal investi- gator of the National Institutes of Health–funded MR WITNESS (A Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients) trial of extended window thrombolysis for which Genentech provides supplemental site payments and alteplase free of charge, a member of the international steering committee of the Desmoteplase in Acute Ischemic Stroke (DIAS) 3 and 4 trials of extended window thrombolysis, and the director of Massachusetts General Hospital (MGH) TeleHealth. The MGH provides a broad array of telehealth services to hospitals in New England, including telestroke-enabled thrombolysis. Dr Grau-Sepulveda reports no conflicts.
Perhaps the new ACEP Clinical Policy statement can explicitly address such settings in their “systems in place” language.
“Drip and Ship Thrombolytic Therapy for Acute Ischemic Stroke”