Sexual HealthIn Patients With Heart Attacks, CYPHER(R) Sirolimus-Eluting Coronary Stent Results Sustained Out To Four Years Compared To Bare Metal Stents
Four-year results of a large, multi-center clinical trial 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 Late Breaking Clinical Trials at EuroPCR 09, the leading medical conference in Europe for physicians specializing in interventional procedures.
The study found that, four years after implantation, patients receiving the CYPHER® Stent remained 53 percent less likely to experience target lesion revascularization (TLR) than those receiving a BMS. Specifically, patients in the CYPHER® Stent arm of the study had a TLR rate of 7.2 percent compared to 15.2 percent in the BMS arm of the study (p=0.005). The reduction of target vessel revascularization (TVR) by the CYPHER® Stent was also 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, especially the highly significant reduction in TVR, are impressive because of the sustained benefits seen in these patients receiving the CYPHER® Stent," said Christian Spaulding, M.D., F.A.C.C., Professor of Cardiology, Assistance Publique-Paris Decartes University Hospitals, Paris, France. "These results will be helpful to physicians as they assess treatment options for patients having an acute heart attack."
There continued to be no differences in the key safety parameters of cardiac death, heart attack 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 data available to evaluate the safety of a drug-eluting stent during the acute phase of a heart attack. There were numerous clinical trial data assessing the safety of bare metal stents in these patients. At four years, there were no differences in rates of ARC (Academic Research 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 complex patient population were similar to what we have seen in the BMS arm," said Dr. Spaulding.
"This study provides important evidence about the long-term performance of the CYPHER® Stent in patients experiencing a heart attack, which represents a significant percentage of patients who undergo emergency angioplasty," said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research & Development, Cordis Corporation. "With the TYPHOON data, the long-term clinical body of knowledge in complex patient populations for the CYPHER® Stent continues to grow."
In August 2008, CYPHER SELECT® Plus, which is available outside 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.
About TYPHOON
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 trial to study the safety and efficacy of the CYPHER® Stent in patients who have suffered a heart attack.
TYPHOON was closed in 2006 after 1-year of follow-up by study design. However, because 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 data were presented originally at the American College of Cardiology annual scientific session in March 2006 and were published later that year in the New England Journal of Medicine.
In addition to his role as the lead investigator, Dr. Spaulding is compensated for his time 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 approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad 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, see the Instructions for Use available at http://www.cypherstent.com.
Cordis Corporation