CLOTS 3 Study Delivers Lifesaving Results Using Covidien’s Blood Clot Prevention Technology
Study Shows Sequential Compression Sleeves Reduce DVT Events in Immobile Stroke Patients
MANSFIELD, Mass.--(BUSINESS WIRE)-- Covidien (NYSE: COV ) , a leading global provider of healthcare products, today announced that an independent study conducted by the University of Edinburgh has successfully demonstrated the effectiveness of Covidien’s Kendall SCD™ system with Vascular Refill Detection Technology on immobile stroke patients.
An independent study conducted by the University of Edinburgh has successfully demonstrated the effectiveness of Covidien's Kendall SCD(TM) system with Vascular Refill Detection Technology on immobile stroke patients. (Photo: Business Wire)
The results of the CLOTS 3 trial were presented at the European Stroke Conference by Professor Martin S. Dennis of the University of Edinburgh’s Division of Clinical Neurosciences and also published in The Lancet. The new study showed a 29.9% decrease in the development of proximal deep vein thrombosis (DVT) in immobile stroke patients who received intermittent pneumatic compression (IPC) using the Kendall SCD system with Vascular Refill Detection Technology, which delivers sequential, circumferential, gradient compression through thigh-length sleeves. Compared to the routine care group only, the IPC group also showed a 14% mortality risk reduction (p = 0.042) during the first six months after hospital admission for stroke.
“At last we have a simple, safe and affordable treatment that reduces the risk of DVT and even appears to reduce the risk of dying after a stroke,” said Prof. Dennis. “We estimate that this treatment could potentially help about 400,000 stroke patients each year in the U.S. If this number were treated, we would prevent about 20,000 patients from developing a DVT and perhaps save 10,000 lives.
“We believe that the national guidelines need to be revised in the light of our findings,” added Prof. Dennis. “The current guidelines have suggested that IPC should be considered only where blood thinning injections are unsuccessful or inappropriate, but this research suggests that IPC should be used in all patients at high risk of DVT.”
“The results from the CLOTS 3 study are truly groundbreaking, “ said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “The large, statistically significant mortality reduction in stroke patients treated with sequential compression versus routine care, as well as the near 30% reduction in proximal DVT, should revolutionize post-stroke treatment leading to improved patient outcomes.”
About the CLOTS 3 Trial
The largest trial of its kind, CLOTS 3 was a multicenter, randomized, controlled study that evaluated the effectiveness of IPC in reducing the risk of DVT and death in stroke patients. The study enrolled 2,876 patients between 2008 and 2012, and involved 105 hospitals in the United Kingdom. The trial was funded by the National Institute of Health, the Health Technology Assessment program and the Chief Scientist Office Scotland. Covidien donated the Kendall SCD compression systems to participating hospitals.
About Deep Vein Thrombosis and Intermittent Pneumatic Compression
DVTs are blood clots that can form in the leg, travel to the lungs and cause death. Current methods to prevent DVT include medicines that thin the blood. However, these medications often carry an increased risk of bleeding, which can be a serious drawback for stroke patients. Blood thinning agents have not been conclusively shown to reduce the risk of dying after stroke1.
IPC is a medical device that squeezes the leg gently to increase blood flow and is proven to decrease the risk of DVT2. This is especially important in patients who are immobile, such as patients who suffer from acute stroke.
- Lederle FA, Zylla D, MacDonald R, Wilt TJ. Venous thromboembolism prophylaxis in hospitalized medical patients and those with stroke: a background review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2011 Nov 1;155(9):602-15.
- Collen JF, Jackson JL, Shorr AF, Moores LK. Prevention of venous thromboembolism in neurosurgery: a metaanalysis. Chest. 2008 Aug;134(2):237-49
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