Prof. Chaim Lotan, head of Hadassah’s Heart Institute, and his colleague, Dr. David Planer, have just published the long-term results from the Israeli e-Cypher Registry’s assessment of stent safety and efficacy in the April 1, 2008 issue of The American Journal of Cardiology.
Closely monitored randomized trials have shown Cypher® Sirolimus-eluting Stents “to be highly effective in lowering rates of coronary artery re-stenosis and target-lesion revascularization when compared with bare metal stents for up to at least three years,” Prof. Lotan, one of the principal investigators of this registry reports. In addition, short-term results and one-year follow-up reports from the registry “have shown the stent to be safe and they closely correlate with results of the randomized trials.” The e-Cypher Registry is a multicenter, international internet-based registry, initiated in April 2002 to assess safety and efficacy in real-world use of the Cypher® Sirolimus (drug)-eluting Stent in treating coronary lesions. Drug-eluding stents aim to prevent re-stenosis caused by the proliferation of smooth muscles cells, which in turn result in an overgrowth of scar tissue. The drug inhibits proliferation in muscle cells and causes cell-cycle arrest. The problem, however, was that the drug also had a drawback—increasing the incidence of thrombus formation, or clotting, which could prove fatal. Since this discovery, patients have been given anti-platelet medication to prevent thrombosis, allowing the advantages of the drug-eluding stents to take hold without the dangers.
The length of patient follow-up was a median of 3.4 years. During this time, there were only 76 cases (16.3%) of major adverse cardiac events, a relatively low rate as compared with studies of bare metal stent use.