Society-Led Quality Improvement Effort Speeds Treatment for Acute Ischemic Stroke

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A nationwide program to promote the timeliness of intravenous (IV) tissue plasminogen activator (tPA) therapy for patients with acute ischemic stroke has borne fruit, according to a paper published in the April 23/30, 2014, issue of the Journal of the American Medical Association. In the 3 years after its implementation, door-to-needle (DTN) times shortened and clinical outcomes improved.

Researchers led by Gregg C. Fonarow, MD, of the University of California, Los Angeles (Los Angeles, CA), analyzed data on 71,169 patients at 1,030 hospitals from the Get With The Guidelines (GWTG)–Stroke registry to assess the effectiveness of the Target: Stroke program, launched jointly in January 2010 by the American Heart Association (AHA) and American Stroke Association (ASA). Results were analyzed according to whether patients were treated before program initiation (n = 27,319; April 2003-December 2009) or after (n = 43,850; January 2010-September 2013).

“The Target: Stroke initiative disseminated 10 care strategies to achieve faster DTN times for tPA administration, provided clinical decision support tools, facilitated hospital participation, and encouraged sharing of best practices,” Dr. Fonarow and colleagues write. Participating hospitals aimed to administer tPA to at least 50% of patients with acute ischemic stroke within 60 minutes of hospital arrival.

Shorter Delays Accompanied by Better Outcomes

Median onset to arrival time was 51 minutes, and median National Institutes of Health Stroke Scale score at the time of presentation was 11. Most patient and hospital characteristics were similar between the 2 eras including the proportion of hospitals certified as primary stroke centers.

Timeliness of IV tPA use improved after initiation of Target: Stroke. Median DTN time decreased with a greater proportion of patients being treated within 60 minutes. In the latter part of the study, annual gains in the percentage of those treated within 60 minutes were greater (table 1).

Table 1. Measures of DTN

^aMedian (IQR).

Results were consistent across clinically relevant subgroups including men and women; patients older and younger than the median age of 72 years; white, black, and Hispanic patients; and those with NIHSS scores above or below the median of 11.

Clinical outcomes also were better after the program’s launch (table 2).

Table 2. Clinical Outcomes

Abbreviation: ICH, intracranial hemorrhage.

For comparison, the researchers also studied 1.2 million patients with acute ischemic stroke and more than 300,000 patients with hemorrhagic stroke hospitalized during the study’s time frame but not treated with IV tPA. Though all-cause mortality decreased across the board, the magnitude of benefit was greater in those who received tPA compared with patients who did not (P for interaction = 0.03) and patients with hemorrhagic stroke (P for interaction < 0.001).

Program ‘Scalable and Sustainable’

In an email to TCTMD, Dr. Fonarow said the “initiative is scalable and sustainable, and we hope to further improve stroke care and outcomes going forward.” Soon, Target: Stroke Phase II will be launched, with the goal of achieving DTN times within 60 minutes in 75% of patients and within 45 minutes in at least 50%, he reported.

“While there have been concerns that attempting to achieve shorter door-to-needle times may lead to rushed assessments, inappropriate patient selection, dosing errors, and greater likelihood of complications, our findings suggest that more rapid reperfusion therapy in acute ischemic stroke is feasible and, importantly, can be achieved not only without increasing rates of symptomatic intracranial hemorrhage, but with actual reductions in complications, improvements in clinical outcomes, and more eligible stroke patients treated with tPA,” he observed.

Target: Stroke “involved hospitals large and small, teaching and non-teaching, rural and urban, primary stroke centers and nonprimary stroke centers, and from every state in the country,” Dr. Fonarow noted, adding that its approach could be applied elsewhere in the United States and worldwide.

The JAMA paper documents “substantial changes in practice in the United States,” agreed Joseph P. Broderick, MD, of the University of Cincinnati (Cincinnati, OH), in a telephone interview with TCTMD. While praising Target: Stroke as one of the best initiatives of the AHA/ASA, he questioned how much of the improvement in clinical outcome could be directly attributed to the program.

Apart from Target: Stroke, other changes were afoot during the study period, he said, namely the publication of ECASS III in the New England Journal of Medicine in 2008, showing that alteplase therapy could be safely extended to a time window of 3 to 4.5 hours. Dr. Broderick also pointed out that, between the 2 eras examined by Fonarow et al, median NIHSS score decreased from 12 to 11, indicating that tPA was being offered to patients with less severe strokes.

Situation Differs Somewhat from STEMI

Philip M. Meyers, MD, of Columbia University Medical Center (New York, NY), told TCTMD in a telephone interview that stroke care, like MI, demands rapid triage.

“Stroke triage is challenging because stroke onset often involves the absence of symptoms. In fact, some patients are deprived of their ability to recognize their symptoms by the stroke itself. Heart attack is often accompanied by severe chest pain, maybe also shortness of breath. Most heart attack patients know something is wrong, so EMS is contacted right away. With stroke, there are often critical delays.” he commented.

Dr. Meyers continued, “The brain is exquisitely sensitive to ischemia, perhaps even more so than heart muscle, so anything that can be done to shorten the time to evaluation and treatment is very positive.”

Even greater gains are being made in some European countries, Dr. Meyers added, citing a German paper in the same issue of JAMA on ambulance-based thrombolysis (Ebinger M, et al. JAMA. 2014;311:1622-1631).

Dr. Fonarow agreed that the brain may be more vulnerable than the heart to quick damage from ischemia, as evidenced by recent findings that efforts to curb D2B times in STEMI did little to improve short-term mortality.

According to Dr. Broderick, there is still room for progress in stroke care. “It is probably as important to work on [speed] as [any interventions] we do, because if you save brain, you have a huge impact on patients’ lives and whether they’ll be in rehab,” he stressed.

Still, tPA may not help everyone, Dr. Broderick added, and this is where endovascular therapies may prove useful. “If we’re going to other therapies, like interventions, we need the same attention to speed,” he stressed. “We’ll probably eventually organize our systems differently so that we triage the patients who may not respond as well to tPA to a second treatment, as needed, to open up the clot.”

James C. Grotta, MD, of Memorial Hermann Hospital (Houston, TX), cautioned in an editorial accompanying the paper that any benefits associated with rapid tPA “need to be balanced against the costs to establish and maintain them, both to the payers who will pay for them and the hospital and EMS organizations that will implement and operate them.” Cost-effectiveness, he adds, is likely to vary by geographic region.

 

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Sources:
1. Fonarow GC, Zhao X, Smith EE, et al. Door-to-needle times for tissue plasminogen activator administration and clinical outcomes in acute ischemic stroke before and after a quality improvement initiative. JAMA. 2014;311:1632-1640.

2. Grotta JC. tPA for stroke: important progress in achieving faster treatment [editorial]. JAMA. 2014;311:1615-1617.

 

 

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