No one ever wants to suffer a stroke. But when Paula suffered a major, life-threatening stroke in September 2013 while working at a local deli, one might say that her timing was perfect.
First and foremost, Paula got to the University of Cincinnati Medical Center quickly and in time for effective treatment. Paula’s manager realized that Paula couldn’t speak and that her mouth was drooping – classic signs of a stroke caused by a blockage. The manager called 9-1-1, ensuring that Paula could be evaluated, diagnosed and treated within the 4 ½-hour window for acute stroke care.
Then, in a turn of fate, Paula’s arrival at the emergency room also coincided with a pivotal moment in stroke care: the arrival of the successful clot-retrieving device.
For years stroke researchers around the world had been trying to prove that in a case like Paula’s, where oxygen to the brain is cut off by a large clot in a major blood vessel, it would be most effective to remove the clot rather than to simply try to dissolve it. But the doctors who wanted so desperately to retrieve those clots were unable to prove that this method was any better or safer than administering the clot-dissolving drug tPA, which for years was the only FDA-approved therapy for acute ischemic stroke.
By the time Paula received her diagnosis of an intracranial left carotid occlusion – a major stroke on the left side of her brain – some of those same stroke specialists at the University of Cincinnati Comprehensive Stroke Center were poised with new clot-retrieval technologies. At that very moment, they were prepared to begin testing one of those technologies in Cincinnati as part of an international study called THERAPY.
The THERAPY study, a Phase 3 clinical trial, was comparing standard delivery of rtPA (recombinant tPA) through an IV with the delivery of rtPA plus “mechanical thrombectomy,” an endovascular (in-the-artery) procedure in which a catheter is threaded up from the groin to the brain to allow doctors to retrieve the clot. The THERAPY study’s name stands for “Assess the Penumbra System in the Treatment of Acute Stroke.”
Because Paula was unable to speak or understand, Dawn Kleindorfer, MD, a neurologist and Co-Director of the Comprehensive Stroke Center, discussed the study with Paula’s husband, a UC graduate who recognized the value of clinical trials and agreed to have Paula participate in the research study. By enrolling in the study, Paula had a 50-50 chance of being treated in the conventional way – with rtPA alone – and a 50-50 chance of being treated with both rtPA and the promising new clot retrieval device.
With a flip of a coin, Paula was assigned to receive the newer treatment from members of the UC Comprehensive Stroke Center. Paula received rtPA through an IV from Dr. Kleindorfer, then received endovascular treatment from Andrew Ringer, MD, an endovascular neurosurgeon and member of the UC Stroke Team, who used the Penumbra System to evacuate her clot.
Paula’s outcome was dramatic. Despite the severity of her stroke, she went home a few days later and recovered without major deficits.
“The stroke has caused lingering effects,” Paula acknowledges. “I don’t have the strength in my right leg or right arm, and I walk with a limp. But I’m walking. My voice is raspy, and I can’t talk any louder than I am right now. But I’m talking.”
Paula is continuing physical therapy to strengthen her right side, and she participates in Zumba exercise classes.
Paula doesn’t remember any details about the stroke, which she suffered at age 66. She remembers walking over to the deli’s salad case, but nothing more. She is grateful to her manager for calling 9-1-1. And of her doctors and nurses at UC Medical Center: “I can’t say enough about them. They were super nice to me. I had all kinds of doctors coming to see me. The first question they always asked was, ‘Who is the President of the United States?’”
The THERAPY clinical trial followed on the heels of other studies, beginning with MR CLEAN in the Netherlands, which showed that treatment with rtPA plus the new generation of clot-retrieval devices was indeed more helpful to patients than treatment with rtPA alone. As a result, in a kind of domino effect, the THERAPY trial and other similar trials were halted early. Pooja Khatri, MD, MSc, a member of the UC Stroke Team and the international coordinator of the THERAPY study, presented the results of THERAPY in May 2015 at the European Stroke Organization Conference.
The UC Comprehensive Stroke Center is now in the process of deciding whether to establish rtPA followed by interventional treatment as the standard of care for all patients who suffer large-vessel strokes. “The results of these trials were just published in the beginning of the year, with more on the way,” Dr. Kleindorfer says. “It is a rapidly changing field, but yes, large-vessel occlusions with the appropriate imaging within the appropriate timeframe should be treated with endovascular intervention.”
At this time the dual treatment will not be used to treat less threatening strokes, Dr. Kleindorfer says. But researchers at multiple sites, including the UC Comprehensive Stroke Center, have begun a new study (PRISMS) to see whether mild strokes should be treated with tPA.
— Cindy Starr
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Hope Story Disclaimer – This story describes an individual patient’s experience. Because every person is unique, individual patients may respond to treatment in different ways. Outcomes are influenced by many factors and may vary from patient to patient.