How did I find out about the final publication of the new AHA/ASA Guidelines regarding endovascular intervention in acute ischemic stroke? I received unsolicited e-mail spam from their representative at a public relations firm, gushing about the technology and offering to put me in touch with their generously available expert.
Before getting into the content, the standard housekeeping exercise regarding declared financial conflicts of interest:
- Dr. Powers: None
- Dr. Derdeyn: Microvention, Penumbra, SILK Road, Pulse Therapeutics
- Dr. Biller: None
- Dr. Coffey: None
- Dr. Hoh: None
- Dr. Jauch: Covidien, Genentech, Penumbra, Stryker
- Dr. K. Johnston: Roche/Genentech
- Dr. S. Johnston: None
- Dr. Khalessi: Covidien, Microvention, Penumbra, Sequent, Codman, Stryker
- Dr. Kidwell: None
- Dr. Meschia: None
- Dr. Ovbiagele: None
- Dr. Yavagal: Covidien/Medtronic, Penumbra
Yes, Virginia, despite the worldwide availability of methodologists and clinicians to review evidence for guidelines, the AHA/ASA were unable to compose such content absent individuals with professional and financial relationships to the manufacturers of the products involved. Another sad failure regarding the Institute of Medicine’s Guidelines We Can Trust.
So, what’s wrong with these guidelines? I’ve written and published multiple times regarding endovascular intervention, and it’s a therapy I’m excited about. For once, the theory and the practice seem to demonstrably align. The new stent retrievers seem to substantially benefit patients with viable tissue behind a clot – whether because of collateral circulation, retrograde flow, or semi-permeable occlusion – and have the clot safely removed in a timely fashion.
But, that isn’t everyone. The most successful trials – ESCAPE, EXTEND-IA, and SWIFT-PRIME – were all designed to intervene on a narrow population with salvageable tissue. The less successful, but still positive, trials – REVASCAT and MR-CLEAN – generally intervened based only on broadly eligible angiographic occlusions. Such a strategy will definitely catch the few patients with salvageable tissue, but also involves significant resource utilization and procedural risk conferred upon those without the possibility of benefit.
However, that’s what these guidelines suggest – to treat all-comers presenting within six hours, discarding the use of tissue-based criteria for intervention. The benefit to the corporations involved is obvious, as routine angiography – let alone rapid perfusion calculation – is not widespread. Without the broadest possible criteria, many centers might not refer patients for intervention. Given the choice between maximizing yield of this intervention and generating profits for their financial and professional affiliates, the authors of this guideline have chosen the latter.
Not only that, these authors give this recommendation the strongest possible Class I and Level A qualifiers. The body of the text states this is a result of the findings of the five aforementioned trials published at the time this was drafted. Unfortunately, from just a simple methodologic standpoint, the authors have developed complete amnesia regarding the entire prior body of negative evidence regarding endovascular intervention – nor acknowledged the open-label nature of these trials stopped early, nor other threats to bias.
So, yet again – from the folks who gave us flawed tPA guidelines and “quality measures” – a guideline we can’t trust. The Society for Academic Emergency Medicine was solicited to endorse this guideline several months ago, and I was involved in the review process at that time. Unfortunately, none of the concerns expressed at that time appear to have been addressed – and as such, SAEM is not included among the professional societies endorsing this guideline.
Endovascular therapy is coming. And, unfortunately, it is certainly going to be coming to many more than for whom appropriate.
“2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment”