Results were presented 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.”
