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Two-Year Data Suggest Different Rates of Blood Clots and Heart Attacks Between Currently Available Stents
"Drug-eluting stents have made it possible for more patients to receive less invasive treatments for cardiovascular disease," said Antonio Colombo, M.D., from San Raffaele Hospital and Centro Cuore Columbus Hospital in Milan, Italy, one of the REALITY investigators and the presenter of the results. "As discussions over the safety of these devices take place, studies such as REALITY, can help physicians select the best treatment option for their patients."
Less than 1 percent (0.9 percent) of the patients in the Cypher Stent arm of the REALITY Trial experienced stent thrombosis. In contrast, 2.5 percent of the patients in the Taxus Stent arm suffered a blood clot (p=0.02).
In addition, patients treated with the Cypher Stent suffered a Q-wave myocardial infarction (a heart attack affecting the full thickness of the heart wall) much less frequently than those receiving the Taxus Stent (0.1 percent vs. 1.5 percent; p=0.006).
Major adverse cardiac events or MACE, which in this study were defined to include cardiac deaths, Q-wave myocardial infarctions, non-Q wave myocardial infarctions (heart attacks that do not involve the full thickness of the heart wall), target lesion revascularizations (re-interventions to reopen an artery) using bypass surgery or angioplasty, were also tracked. A composite of these did not show a statistical difference between the two drug-eluting stents.
"These results underscore once again that not all drug-eluting stents are created equal," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "The unsurpassed safety and efficacy of the Cypher Stent is consistently supported by a robust clinical trial program that examine its performance in a broad range of patients, including complex cases."
The Cypher Stent clinical trial program includes more than 60 studies, with many additional independent clinical trials, and hundreds of publications in the most respected peer reviewed journals.
The REALITY Trial involved 1,386 moderately complex patients from 90 centers in Europe, Latin America and Asia. These patients were randomly selected to receive either the Cypher Stent or the Taxus Stent. In the end, the Cypher Stent was used in 684 patients and 970 artery blockages, while the Taxus Stent was used in 669 patients and 941 artery blockages.
Cordis Corporation sponsored the REALITY trial.
About the Cypher Stent
The Cypher Stent has been chosen by cardiologists worldwide to treat more than two 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 60 studies, inclusive of independent clinical trials, that examine the performance of the Cypher Stent in a broad range of patients.
Source: Cordis Corporation