It may benefit them but survivors want 100% recovery and you're not measuring that! No measurements, you'll never improve! I'd have you all fired for incompetence!
“What's measured, improves.” So said management legend and author Peter F. Drucker
The latest crapola here:
Triage of Emergent Large Vessel Occlusion (ELVO) patients directly to Comprehensive Stroke Centers (CSCs) is good practice and benefits patients in Urban and Suburban population Centers – New insights from the TRIAGE-STROKE and RACECAT studies
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In 2013, three randomized controlled trials (RCTs) comparing the interventional management of stroke with intravenous (IV) thrombolytic therapy were simultaneously published in the New England Journal of Medicine.1–3 These trials showed neither benefit nor harm associated with endovascular stroke therapies and the widespread interpretation of their collective results can be summarized with the blanket statement that “thrombectomy is not effective for the treatment of stroke”. However, the SWIFT and TREVO studies (published in 2012) had clearly demonstrated that the interventional approaches used in the three RCTs were vastly inferior to contemporary thrombectomy techniques.4 5 Although this new generation of highly effective reperfusion therapies had become widely available by the time the negative trials were published, guidelines derived from the three negative trials did not endorse thrombectomy for stroke, which led to a drastic reduction (and in some regions a complete interruption) of the practice of thrombectomy. Fortunately, multiple RCTs were being conducted concurrently with these more effective second-generation devices and techniques. These newer studies conclusively demonstrated, in 2015, that thrombectomy is not only effective, but is one of the most effective interventions in medicine,6–10 firmly establishing thrombectomy as the standard of care for emergent large vessel occlusion (ELVO) patients. While this rapid course correction was fortunate, one can imagine how many ELVO patients were denied a procedure which could have markedly reduced their chances of living with significant disability in the interim. With this background in mind, it is important that we proceed thoughtfully and carefully when interpreting and acting on data from the recent RACECAT and TRIAGE-STROKE studies as they pertain to the critically important issue of the directed transport of ELVO patients directly to thrombectomy capable centers.
Combined analyses of the existing trials have unequivocally demonstrated that the benefits of the thrombectomy are heavily time dependent.11 To shorten the times to interventional therapy, stroke triage systems in some regions were reorganized to transport patients identified in the field with possible ELVO directly to comprehensive stroke centers (CSCs) or thrombectomy capable stroke centers (TCCs) rather than primary stroke centers (PSCs). Where implemented, these direct to CSC/TCC triage programs have consistently led to marked reductions in times to intervention without sacrificing access to IV thrombolytic therapy.12–16 Mohamad et al, reported improved outcomes, with higher rates of functional independence(Survivors want 100% recovery, not just functional independence! Talk to survivors sometime instead of pushing your tyranny of low expectations on them!) (62% vs 43%, odds ratio (OR) 3.08, confidence interval (CI) 1.08 to 8.78), for patients undergoing thrombectomy when they were transported directly to a CSC under a field triage system.12 Jayaraman et al, demonstrated that stroke patients with a Los Angeles Motor Score (LAMS) of 4 or higher, achieved functional independence in 68% of cases if transported directly to a CSC vs only 42% if first taken to a PSC.13 14 Similarly, Keselman et al, demonstrated that a direct to TCC triage policy for patients with suspected ELVO resulted in a significant reduction in morbidity, with 34.6% of patients undergoing thrombectomy reaching a modified Rankin Score (mRS) of 0–1 at 90 days after institution of the program vs 23.7% (OR 2.3, 95% CI, 1.4 to 3.6) during the previous years.15 16 Thus, an analysis of the existing “real-world” experience has been uniformly in favor of direct triage of patients with suspected ELVO to TCCs. In line with these data, the most recent American Heart Association guidelines endorse direct triage to CSCs for patients with suspected ELVO who are within 30 minutes of a CSC in urban areas, 45 minutes in suburban areas and 60 minutes in rural areas.17
Recently, two well designed, prospective RCTs – RACECAT and TRIAGE-STROKE – reported that they did not find a benefit for a direct to TCC triage program for ELVO patients. These concurrent and seemingly negative trials predictably led to immediate messaging proclaiming, without qualification, that direct triage programs are ineffective – “Latest TRIAGE-STROKE and RACECAT data put the brakes on alternative stroke transfer protocols” (NeuroNews, October 30, 2023). Even more troubling, these data are currently being aggressively and inappropriately applied to interrupt or prevent direct to CSC triage programs from being implemented in some areas. We will review each of these trials and their implications for direct to CSC triage programs in the United States and other similarly distributed population centers.
TRIAGE-STROKE
TRIAGE-STROKE is a prospective RCT comparing outcomes in tissue plasminogen activator (tPA) eligible patients with suspected ELVO triaged to the nearest PSC to those triaged directly to a CSC.18 Although the authors sought to enroll 600 patients, due to challenges with recruitment and issues related to funding, the study was terminated after only 171 patients (28.5% of the targeted population). They reported a robust trend (OR 1.42) in favor of direct triage to a CSC, but in this small study population, the observation failed to reach statistical significance (95% CI, 0.72 to 2.82). While the trial results have been largely presented as “negative”, it seems clear that TRIAGE-STROKE was simply a very encouraging pilot trial which, on balance, consistently supports a direct to CSC triage policy.
Secondary analysis of the data demonstrated a 19% absolute risk reduction (OR 2.63, 95% CI, 1.06 to 7.13, p=0.034) for becoming non-ambulatory (mRS 0–3 at 90 days) for patients triaged directly to a CSC vs those triaged to a PSC. The authors reported trends toward benefit for direct to CSC triage for all but two (females and hypertensive patients) of 18 different analyzed patient subgroups. Importantly, there were also higher rates of IV lytic administration to patients triaged directly to CSCs (78%) vs PSCs (67%) – confirming previous studies which have consistently demonstrated that the excess transportation time required to get to a CSC does not diminish access to lytic therapy.12–16 Finally, there was absolutely no indication in the data that direct to CSC triage could be harmful for patients with suspected ELVO. On the contrary, the risk of dependence or death trended higher for patients triaged to a PSC for patients both with (1.72; 95% CI, 0.46 to 7.27) and without (3.85; 95% CI, 0.32 to 210) a demonstrated ELVO.
In summary, all analyses of the available data from TRIAGE-STROKE support a direct to CSC triage for tPA eligible patients with suspected ELVO. It is difficult to understand how the results of this underpowered study would provide any justification to “put the brakes on alternative transfer programs”. When an underpowered study fails to prove a definitive benefit for a therapy, it should not be interpreted as evidence that the therapy has no benefit.
RACECAT
RACECAT is a prospective multicenter RCT of 1400 patients comparing outcomes in patients with suspected ELVO triaged to the closest local stroke center vs those triaged directly to a TCC.19 The study was stopped early for futility as the median mRS score was 3 for each group (OR 1.03, 95% CI, 0.82 to 1.29), indicating that there was no outcome benefit for a direct to TCC triage program. While RACECAT is a truly negative study, it is important to be cautious when applying these results to other geographies. First, RACECAT was conducted in Catalonia, Spain. In that very large, diffusely populated, non-urban geography, all of the TCCs are clustered in Barcelona. In RACECAT, no PSC was located within 30 minutes of a TCC and the majority (56%) of patients triaged directly to a TCC required greater than 60 minutes of transport time. For this reason, the data have little or no relevance to most of the population of the United States which is distributed within 60 minutes of a TCC. The authors were very careful in their assessment of the data, specifically stating that the “reported results apply only to patients…located more than 30 min away from a TCC.”
Moreover, the emergency medical services in Catalonia responsible for transporting the patients were not capable of “administering treatment”, performing intubation or even placing peripheral venous access, further exacerbating the detrimental effects of prolonged transport times. Not surprisingly, the impact of prolonged transfer times in the absence of airway protection was most evident in RACECAT patients with cerebral hemorrhage who experienced reduced rates of functional outcomes and greater rates of medical complications (particularly pneumonia) when transported long distances directly to TCCs.20 Again, while the results of this secondary analysis of intracerebral hemorrhage (ICH) patients is certainly a significant concern in a truly rural environment, most (54%) of the ICH patients in RACECAT were transported 60 minutes or more to get to a TCC, again limiting its relevance to the vast majority of the US population. Moreover, no trend toward poorer outcomes was observed in the 51 TRIAGE-STROKE patients with ICH (OR 0.94; 95% CI 0.34 to 2.63).
Another important factor in RACECAT was the remarkably efficient door-to-needle times (DTN, 33 minutes) and door-in-door-out times (DIDO, 77 minutes) achieved by participating PSCs. This efficiency likely functioned, in part, to offset the benefits of earlier reperfusion achieved for ELVO patients with direct to TCC triage. Unfortunately, these times have not been replicated in the United States despite extensive education and outreach. Current data from Get with the Guidelines show a national median DIDO of 174 minutes.21 This phenomenon further limits the generalizability of the RACECAT results to US centers.
Finally, and possibly of most relevance to patients in the US, when the RACECAT data are partitioned by transfer time, a trend toward benefit is observed for patients triaged directly to a TCC when transport times are less than 1 hour. Moreover, the trend for direct to CSC triage becomes even stronger as the transfer times became shorter. Thus, for the portion of the population in RACECAT which most closely resembles that of the US, a direct to TCC triage program showed a trend toward benefit.
In summary, RACECAT demonstrated no benefit for direct to TCC triage in regions where transport times to a TCC were greater than 1 hour on average, where no PSC is located within 30 minutes of a TCC, where all the transports were performed by emergency medical service (EMS) providers who were not certified to perform intubation or IV access and where PSCs consistently achieved exceptional door-to-needle and door-in-door-out times. While pertinent in very rural geographies, the data have no relevance to the urban and suburban geographies that comprise the majority of the US. A detailed analysis of census data show that average additional transport times to a TCC in the United States was only 10 minutes in urban and 23 minutes in suburban regions which account for more than 80% of the US population.22 The application of the RACECAT data for decision making for predominantly non-rural geographies (where most patients are less than 60 minutes from a CSC) is both inappropriate and misleading.
Conclusion
On cursory review, it might be easy to view the TRIAGE-STROKE and RACECAT results as a reason to reconsider direct to CSC/TCC triage systems for suspected ELVO patients. However, a careful evaluation of the entire body of existing evidence (including TRIAGE-STROKE and RACECAT) clearly indicates that most of the population of the US, and international urban and suburban population centers, would benefit from a direct to CSC/TCC triage policy for suspected ELVO patients.
It is important that these new RCTs are not misinterpreted in a way that would harm patients by interrupting appropriate field triage. This poses a potentially grave risk to our patients, particularly in the US where PSCs themselves, and/or hospital systems which incorporate a number of PSCs, may be financially incentivized to interrupt direct to CSC triage policies which could adversely affect the volume of stroke patients delivered to their institutions. The misrepresentation and misapplication of these data, whether intentional or unintentional, to interrupt or prevent direct to CSC triage strategies in suburban and urban geographies would be directly harmful to ELVO patients who are at highest risk of disability with delayed intervention and carry the greatest opportunity for recovery from timely thrombectomy.
We should not repeat our previous mistakes.
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