New Trials Set to Examine Drug-eluting Stents
Doctors urged to weigh benefits, risks of drug-eluting stents on per-patient basis.
Three new trials were announced to help better examine the long-term effects of drug-eluting stents following recent reports of risks associated with the devices.
Gregg Stone, MD, Chairman of the Cardiovascular Research Foundation and a Professor of Medicine at Columbia University Medical Center in New York, discussed the controversies regarding drug-eluting stents at a morning plenary session yesterday. He said new studies with larger cohorts are needed to better understand the long-term risks and benefits of drug-eluting stent treatment.
New studies
The new studies are as follows:
l STENT Thrombosis — This study will examine 10,000 consecutive patients receiving drug-eluting stents at 12 centers and compare them with 30,000 control patients. Patients will be followed for two to five years.
l INSIGHT — This trial will examine standard vs. long-duration clopidogrel in patients treated with drug-eluting stents. The study will utilize a global registry of 30,000 patients.
l PROTECT — This study will examine the Endeavor (Medtronic) vs. the Cypher (Cordis/Johnson & Johnson) stent. This study will be a randomized, international trial of 8,000 patients; its primary endpoint is in-stent thrombosis.
Safety questioned
Several studies presented at the World Congress of Cardiology meeting, held last month in Barcelona, indicated that drug-eluting stents may be associated with an increased risk of mortality and adverse events.
“Like any medical advance, drug-eluting stents have side effects, the most concerning of which is an increased incidence of late-stent thrombosis in about two to four patients per 1,000 patients per year,” Stone said.
The data presented at the WCC meeting have several limitations. “These data were limited in terms of follow-up,” Stone said. “This increased the likelihood that patients presenting with adverse events were entered into the trial.”
Some other trial results seem to contradict the findings presented at the WCC meeting. “Current studies suggest that drug-eluting stents do not increase overall death and myocardial infarction rates,” he said.
The use of drug-eluting stents should not be discontinued based on early reports, Stone said. “As with all drugs and devices, the risks and benefits of drug-eluting stents should be carefully weighed on a per-patient basis, especially when considering off-label use,” he said.
Stone added that despite the recent controversy, the benefits of drug-eluting stents are extensive. “By preventing restenosis, drug-eluting stents have reduced the need for repeat percutaneous coronary intervention and coronary artery bypass graft and improved the quality of life for millions of patients.”
MSCT
CRF founder Martin Leon, MD, Professor of Medicine at Columbia University Medical Center, also spoke at yesterday’s morning plenary session. Leon said he expects to see several important changes in the field of cardiology in the next few years.
In particular, Leon expects that improvements in multisection computed tomography (MSCT) may represent an important advance in interventional cardiovascular medicine.
“The high specificity of MSCT will influence diagnostic paradigms in both outpatient and inpatient settings,” Leon said.