By Charles A. Pilcher MD FACEP
June, 2018
The standard of care for stroke is changing – rapidly.
Up until 2 years ago, the “clot-buster drug” alteplase (or its thrombolytic congeners) had become the standard of care for stroke, despite significant debate over its merits – and dubious marketing by its maker, Genentec. The debate ranges/ranged from questions of timing to questions of whether or not the drug did/does more harm than good. That debate escalated in 2015-2016 when the AHA promulgated guidelines increasing the time window for the use of alteplase in an article by Demaerschalk et al. in Stroke titled “Scientific rationale for the inclusion and exclusion criteria for intravenous alteplase in acute ischemic stroke”
Examples of the controversy at the time can be found in articles such as these:
- The Case Against Thrombolytic Therapy in Stroke by Mandrola in Medscape [Free login required]. Dr. Mandrola found that “the resistance to thrombolysis promoted through social media channels and in emergency medicine literature is rational. Further, the fact that the marginal benefit of tPA is so low (benefit to possibly 1 in 10 patients and a risk of harm to about 1 in 20 in the best of studies) makes a lawsuit an even a riskier game of ‘chicken’ for all parties involved.”
- Dr. Mandrola’s review was apparently triggered by an article by Dr. Ryan Radecki in an article titled Factors Driving Expanded Use of Tissue Plasminogen Activator for Acute Ischemic Stroke in ACEPNow. Dr. Radecki says “these recommendations selectively overstate the quality of supporting evidence or simply use the absence of evidence to the contrary as justification… It is frankly impossible to estimate any of the magnitudes of benefit or harms from the practices endorsed by this new guideline… This is not the sort of work that improves the lives of our patients. We do not need to expand the use of tPA.” A reader in a followup comment says simply “Thanks… tPA kills, and this is simply an attempt to expand Genentech’s war zone.”
- Alper et al wrote in JAMA Network “Until more data are gathered and systematically evaluated, it is not warranted to promote thrombolytics more than 3 hours after stroke onset as a standard of care.”
Within the past 5 years the treatment of stroke has risen to a new level. Just as thrombolytics were first promulgated for the treatment of heart attack and later advocated for the treatment of stroke, mechanical clot retrieval (thrombectomy) and stenting are now moving from the coronary arteries to the carotid artery and its major branches. The impact of this approach is that it expands the time window, even to beyond the point of “last seen normal” to perhaps as much as 24 hours. Thrombectomy is being advocated as beneficial for stroke onset as long as 24 hours prior. It is rapidly becoming the new standard of care for stroke – but with major caveats, the biggest of these being that it is likely to be appropriate for only a small minority of new onset stroke patients, perhaps only 10%.
There are at least a dozen major studies investigating this new approach and explaining the selection process for eligible candidates. To understand this new paradigm shift, a good place to start might be this editorial by Wagner and Shen recently published in ACEPNow, explaining Stanford’s “New Stroke Protocol” outlining their selection process.
Litigating stroke cases, whether for missed diagnosis or for failing to provide the “appropriate” treatment, has always been fraught with difficulty. Thrombolysis is not a “magic bullet.” Only about 1 in 8-10 patients benefit and the risks of treatment are high. The question now is “Can the new thrombectomy guidelines withstand the same scrutiny that led to the debate on thrombolysis?”
The evidence thus far is more robust for the latter than for the former. but the caveats currently being applied are many. Some of these are:
- Major artery strokes are the only candidates for such treatment.
- Thrombectomy requires a trained team usually found in a tertiary or quaternary medical center, eliminating a major segment of the stroke population who could benefit.
- The process requires a considerable investment in staff and technology. That comes with a price.
- Patients do not present with a unique set of symptoms. Diagnostic accuracy for selection of candidates for treatment are notoriously inaccurate, both for type and location of stroke but also for conditions that may not even be a stroke. See article on “clinical mimics” by Long and Koyfman in
- This inaccuracy results in the vast majority of patients being triaged to these other facilities, only to find out their stroke is not one amenable to the new approach. See article by Flint et al. on pre-hospital diagnosis and triage in Stroke.
In summary, while this new option for the treatment of stroke is promising for patients, nothing about it makes life easier for malpractice attorneys. In fact the challenges may be even greater. With stroke being such a devastating disease and even our current treatments being less effective than the miracle that patients hope for, attorneys representing plaintiffs in stroke cases, as well as their defense counterparts, will continue to be engaged in a “battle of the experts.”
Additional References:
- Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging by Albers et al in NEJM.
- Selecting Stroke Patients for Late Thrombectomy in Real World, a summary of the practical considerations involved, by Sue Hughes in Medscape (free login required)
- Endovascular treatment for acute ischaemic stroke in routine clinical practice: prospective, observational cohort study (MR CLEAN Registry) by Jansen et al. This is one of the studies on which the Hughes article for laypersons (above) is based.
- 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association by Powers et al in Stroke. This could be considered the current “bible” for the management of stroke.