HOUSTON (FRONTLINE MEDICAL NEWS) – Thrombolytic therapy for U.S. patients experiencing an acute ischemic stroke is no longer the poster child for proven, but neglected, therapies.

Long bemoaned since its introduction in the mid-1990s as an effective but woefully underused treatment, thrombolytic therapy with tissue plasminogen activator (tPA) has seen robust growth in U.S. practice recently, largely due to the promotion and quality-improvement efforts of a voluntary, non-profit program, Get With the Guidelines (GWTG)-Stroke .

During April-June 2016, 68% of acute ischemic stroke patients who were brought to hospitals quickly enough to be eligible for the time-sensitive treatment of thrombolysis not only received tPA but got it within 60 minutes or less of their arrival at the nearly 2,000 U.S. hospitals that actively participated in the GWTG-Stroke program last year. These hospitals treated well over half of the nation’s acute ischemic stroke patients. In sharp contrast, as recently as the end of 2009, successful, fast treatment rates were about 30%, Eric E. Smith, MD , said at the International Stroke Conference sponsored by the American Heart Association.

“We’ve seen a dramatic increase in tPA treatment in eligible patients,” said Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).

“This represents remarkable and clinically meaningful improvements in stroke care, overcoming substantial barriers using a systems of care approach,” Gregg C. Fonarow, MD , professor of medicine and cochief of clinical cardiology at the University of California, Los Angeles and one of the long-time leaders of GWTG-Stroke, said in an interview. “This represents one of the most transformative improvements and success stories ever observed in stroke care.”

“These data show dramatic changes in the GWTG-Stroke hospitals,” agreed Lee H. Schwamm, MD , professor of neurology at Harvard Medical School and chief of stroke services at Massachusetts General Hospital in Boston and another leader of the GWTG-Stroke program. However, “we still have work to do,” cautioned Dr. Schwamm, who notes that 68% remains significantly short of the ideal 100%. The positive is that several GWTG-Stroke participating hospitals have surged to a better than 90% rate of administering tPA to eligible patients within a 60-minute door-to-needle window.

“What is really remarkable is that shining a spotlight on a process like this can improve the percentage of patients getting this treatment more rapidly,” Dr. Schwamm said in an interview. “It’s a recapitulation of what we saw happen with coronary artery disease. It’s fair to say that the changes we have seen have been largely due to GWTG-Stroke.”

What is GWTG-Stroke?

GWTG was launched in 2000 by the American Heart Association as a hospital-based–quality improvement initiative focused on U.S. management of acute MI. In 2003, acute stroke became another focus of the program and inspired added participation of the American Stroke Association.

“Improvements in tPA use in eligible patients were seen soon after the introduction of GWTG-Stroke in 2003, but there was minimal improvement in the percentage of patients with door-to-needle times within 60 minutes despite national guidelines,” recalled Dr. Fonarow. This slow rate of advance led him, Dr. Schwamm, and others to create a more activist program within GWTG-Stroke, Target Stroke , that not only provided resources and collected data from participating hospitals but also set acute-treatment goals that challenged participating hospitals to up their game. Target Stroke phase I asked them to try to achieve a tPA door-to-needle time within 60 minutes in at least 50% of eligible patients. By mid-2013, the program reached this goal with 53% of patients treated in the allotted time frame ( JAMA. 2014 Apr 23;311[16]:1632-40 ).

GWTG-Stroke launched Target Stroke phase II in April 2014 with a new pair of goals: have tPA door-to-needle times within 60 minutes in 75% of patients and within 45 minutes or less in at least 50%. The most recent data that Dr. Smith reported at the Conference showed that, in addition to a door-to-needle time within 60 minutes in 68% of patients, the hospitals achieved delivery of tPA within 45 minutes in about 40%. During his report, Dr. Smith voiced optimism that the recent pace of improvement suggested the Phase II goals could be reached by 2018.

These time-based goals lead directly to meaningful improvements in patient outcomes. “We know that, for every 15 minute reduction in tPA door-to-needle time, there is a 5% reduction of in-hospital mortality and a substantial increase in the percentage of patients who are discharged home instead of to a rehabilitation hospital or nursing home,” Dr. Schwamm said.

Dr. Smith highlighted the 11 best practices steps that Target Stroke promotes to GWTG-Stroke hospitals as their road map to achieving the performance goals. These include things such as notification of a hospital by emergency medical services that a patient showing signs of an acute ischemic stroke is on the way, transfer of the patient after hospital arrival directly to a CT or MRI scanner to get the imaging that can confirm tPA eligibility, rapid reading of the scan, premixing of the tPA, a team-based approach to acute stroke management, and quick feedback to the team regarding their performance on each stroke patient they treat.

Dr. Schwamm noted that he, Dr. Fonarow, and other program leaders are already planning a phase III for Target Stroke that will branch out to even more facets of acute stroke care, such as incorporation of goals for using endovascular thrombectomy in appropriate patients and for using telemedicine to quicken and broaden the availability of expert neurologic consults for identifying tPA- and thrombectomy-eligible patients.

Growing the program

The success of GWTG-Stroke in transforming U.S. acute stroke care has not only relied on setting aggressive performance goals but also on advancing by boosting the number of U.S. hospitals participating of more U.S. hospitals. During the Target Stroke years since the start of 2010, the number of hospitals active in GWTG-Stroke jumped from 1427 to 1,950 by mid-2016, including a 12% year-over-year jump in 2016, compared with 2015. During October 2015-October 2016, participating hospitals treated more than 570,000 acute stroke patients, or roughly 71% of the estimated 800,000 U.S. patients who have an acute stroke each year.

These numbers seem on track to continue expanding. “With the recent evidence showing that participating in GWTG-Stroke improves care and outcomes there has been even greater interest by hospitals, recently, in joining,” said Dr. Fonarow. “While many hospitals currently participate, ideally all would join and be active.”

“Hospitals now feel that they can’t afford not to focus on stroke as a quality improvement program, so they join,” said Dr. Schwamm. He believes that essentially all of the roughly 200 certified U.S. Comprehensive Stroke Centers and of the roughly 1,000 certified U.S. Primary Stroke Centers are already members of GWTG-Stroke. “We’re now in all the high-value hospitals, based on their higher numbers of patients. It’s the Acute Stroke Ready hospitals where we now have the greatest potential to penetrate, hospitals that generally treat about 20-50 stroke patients a year,” he said.

Joining GWTG-Stroke holds major attraction for hospitals because the program gives them a tool for measuring their performance, data that hospitals often now need to prove the value of the care they deliver to insurers and to avoid penalization for readmissions. However, the barrier to hospitals, especially smaller hospitals, is that data collection can be expensive. It’s something that larger hospitals now routinely do, but smaller hospitals have often balked because of the expense. To address this, the GWTG-Stroke program is trying to develop a “lighter” version of their data collection tool that involves a smaller financial burden.

“I think we can sell a trimmed down version of GWTG-Stroke to smaller hospitals that is affordable and use it to recruit another 1,000 hospitals. That’s a realistic goal,” Dr. Schwamm said.

What is also notable about GWTG-Stroke is that hospitals sign up despite the somewhat ambiguous payback they receive.

“It’s remarkable to me how many hospitals are in this program that is totally voluntary,” Dr. Schwamm observed. “I think a big part is that they are competitive. Hospitals want to get an A+ on their care, and we leverage that natural competitive and perfectionist instinct.” The GWTG-Stroke program issues awards to member hospitals annually based on their performance achievements, handing out recognition “medals” with names like, “elite,” “elite-plus,” and “gold-plus.” An Internet search shows that recognized hospitals then trumpet these awards to their communities in press releases, although, as Dr. Schwamm noted, “stroke patients don’t usually choose which hospital they go to.” He added that it could be possible to create an app that EMS crews could use to identify the closest and best-performing hospital to take a given patient from the field, something to which he has given serious thought. However, such an app is still at least a few years off.

“In the past, stroke was the third-leading U.S. cause of death, but now it’s fifth ,” noted Steven R. Messe, MD , a stroke neurologist at the University of Pennsylvania in Philadelphia and a member of the GWTG-Stroke steering committee. “That’s an amazing accomplishment – to drop stroke from third place to fifth – and it’s due to advances in thrombolytic use and to improved systems of care and quality improvement measures.”

Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association and uses funding provided by several drug companies. Dr. Smith, Dr. Fonarow, Dr. Schwamm and Dr. Messe had no relevant commercial disclosures.

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