In Patients With Affection Attacks, CYPHER R Sirolimus-Eluting Coronary Stent Results Sustained Out To Four Years Compared To Naked Metal Stents
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Four-year results of a large, multi-center clinical evaluation show that earlier results favoring the CYPHER® Sirolimus-eluting Coronary Stent over bare metal stents (BMS) in patients with acute myocardial infarction (heart attack) were maintained in long-term follow-up. In addition, there were no differences in key safety measures between the CYPHER® Stent and BMS.
Results were presented today during Unpunctual Breaking Clinical Trials at EuroPCR 09, the salient medical conference in Europe for physicians specializing in interventional procedures.
The peruse create that, four years after implantation, patients receiving the CYPHER® Stent remained 53 percent less likely to experience protest lesion revascularization (TLR) than those receiving a BMS. Specifically, patients in the CYPHER® Stent arm of the announce had a TLR rate of 7.2 percent compared to 15.2 percent in the BMS arm of the study (p=0.005). The lessening of target vessel revascularization (TVR) by the CYPHER® Stent was too maintained with 44 percent reduction at four years (9.6 percent in the CYPHER® Stent arm versus 17.2 percent in the BMS arm; p=0.013).
"The four-year results of this trial, exceptionally the highly cogent diminution in TVR, are impressive for of the sustained benefits seen in these patients receiving the CYPHER® Stent," said Christian Spaulding, M.D., F.A.C.C., Professor of Cardiology, Overhaul Publique-Paris Decartes University Hospitals, Paris, France. "These results testament be helpful to physicians as they assess treatment options for patients having an acute passion attack."
There continued to be no differences in the primary safety parameters of cardiac death, emotions initiative or stent thrombosis in the four-year follow-up (death=4.0 percent for the CYPHER® Stent vs. 6.4 for BMS).
Prior to TYPHOON, there were insufficient randomized clinical facts available to evaluate the safety of a drug-eluting stent during the acute phase of a heart attack. There were numerous clinical proof information assessing the safety of bare metal stents in these patients. At four years, there were no differences in rates of ARC (Academic Proof Consortium)-defined definite/probably stent thromboses between the two treatment arms (4.8 percent for the CYPHER® Stent vs. 4.4 percent for bare metal stents; p=0.83).
"The safety outcomes for the CYPHER® Stent in this compounded patient population were similar to what we have seen in the BMS arm," said Dr. Spaulding.
"This study provides far-reaching evidence approximately the long-term performance of the CYPHER® Stent in patients experiencing a love attack, which represents a significant percentage of patients who undergo emergency angioplasty," said Campbell Rogers, M.D., Manager Scientific Officer and Global Head, Evaluation & Development, Cordis Corporation. "With the TYPHOON data, the long-term clinical target of knowledge in elaborate patient populations for the CYPHER® Stent continues to grow."
In August 2008, CYPHER SELECT® Plus, which is available away the United States and Japan, received CE marking for treatment of acute myocardial infarction. The CYPHER® Stent is not approved for the treatment of AMI in the U.S.
TYPHOON (Trial to Assess the use of the CYPHER® Stent in Acute Myocardial Infarction Treated with BallOON Angioplasty) is the first large, randomized, multi-center clinical analysis to scan the safety and efficacy of the CYPHER® Stent in patients who bear suffered a feelings attack.
TYPHOON was closed in 2006 after 1-year of follow-up by study design. However, through of concerns of stent thrombosis at that time, the trial was re-opened in 2007 to ascertain four-year follow-up data. TYPHOON was conducted 48 sites across Europe, Israel and Australia.
The one-year material were presented originally at the American College of Cardiology annual scientific session in Trudge 2006 and were published later that year in the New England Log of Medicine.
In addition to his role as the lead investigator, Dr. Spaulding is compensated for his generation as a member of Cordis' scientific advisory board.
Cordis Corporation sponsored the TYPHOON trial.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat on all sides of three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical test program that includes exceeding than 70 studies that study the performance of the CYPHER® Stent in a wide range of patients.
Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has the longest-term clinical follow-up of any drug-eluting stent. For more complete information on indications, contraindications, warnings and precautions, beam the Directions for Use available at http://www.cypherstent.com.
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