In the BASKET trial, researchers compared outcomes among 264 patients randomized to Cypher, 281 to Taxus, and 281 patients to a bare-metal stent, who were treated from May 2003 through May 2004, at University Hospital of Basel, Switzerland and were followed for 18 months.
The average age of the patients was 64 and forty-two percent had stable angina, 36% had unstable coronary syndromes, and 21% had acute MI and the analysis was based on data from patients who survived the first six months after stenting.
At 18 months, the rate of death or myocardial infarction was 8.4% for patients with drug-eluting stents and 7.5% for bare metal stents, but the study found a significantly higher rate of non-infarct target vessel revascularization for patients who received bare-metal stents compared with drug-eluting stents, specifically 11.6% versus 7.5%.
As a result, there was no statically significant difference in the overall major adverse cardiac event rate at 18 months, 15.8% for drug-eluting stents and 18.9% for bare-metal stents.
Patients who had treatment on larger vessels had no significant benefit from drug-eluting stents and possibly even a small late harm, the study found.
The take home message is clear, said Christoph Kaiser, MD of University Hospital Basel in Switzerland in MedPage Today on September 4, 2006, "Drug-eluting stents should be reserved for use in small vessels or bypass grafts because it is here that they have demonstrated a benefit."
Currently, drug-coated stents are used in more than 90% of procedures in rich countries like the US and Switzerland. But some cardiologists now say they will be much more cautious about their use. "It raises the flag of caution over the indiscriminate use of first-generation, drug-eluting stents and reminds us that we should stick with tested indications and not over-extend this to any patient," Dr Gabriel Steg, of Hospital Bichat-Claude Bernard in Paris, co-author of a Swiss meta-analysis, told reporters in Barcelona.
At one press conference, Salim Yusuf, MD, a professor of medicine and director of cardiology at McMaster University in Hamilton, Ontario, said that he plans to ask interventional cardiologists at his hospital to re-evaluate their use of drug-eluting stents so that they are used "in a limited way" until more data are available to determine whether the stents are "a panacea -- as many of our patients and residents believe -- or an expensive placebo, or -- as I suspect -- a Trojan horse."
Dr Yusuf says the stents may be more of a Trojan horse, carrying hidden long-term danger in the guise of a useful therapy to avoid restenosis. As it is now, Dr Yusuf characterized the widespread use of drug eluting stents as "madness" and said that coronary interventions should not be used to treat stable angina, unless it has "failed to respond to full and exhaustive medical therapy, something that is never done."
He is calling for the creation of a panel of interventional and non-interventional cardiologists, health economists, and government agencies to "re-evaluate the real role of stenting" in coronary disease and says the panel should exclude industry representatives.
During his presentation at the Barcelona conference, Dr Robert Harrington, of Duke in Durham, NC, warned the audience about the need to go slowly and evaluate the long term outcomes of the drug coated stents already implanted all over the world. "In days of balloon angioplasty, we worried about thrombus formation for 12 to 24 hours, and when bare metal stents were introduced, we worried for seven to 14 days," he advised.
But now the worry with drug-eluting stents, he pointed out, may "be extended to years."
Co-author of one of the meta-analysis, Dr Philippe Steg, MD, of Hospitalier Bichat-Claude-Bernard in Paris, likened the long term drug-eluting stent studies to long term data on Vioxx, which was viewed as a superior pain relieve treatment until long term studies found that the drug drastically increased the risk of heart attack and stroke.
The increased risk with Vioxx was small, but the drug was used by tens of millions of consumers before the risk became known. The same applies to drug-eluding stents. According to MedPage Today on September 5, 2006, an estimated 6 million drug eluting stents have been implanted, which means even a small percentage of problems can add up to a large number of patients.
"This is a classic kind of thing," said Dr David Brown, chief of cardiovascular medicine at Stony Brook University Medical Center, in Newsday on September 13, 2006, "every time we have a technological breakthrough, we invent a new disease along with it."
"In this case," he said, "it's late-stage thrombosis."
The average age of the patients was 64 and forty-two percent had stable angina, 36% had unstable coronary syndromes, and 21% had acute MI and the analysis was based on data from patients who survived the first six months after stenting.
At 18 months, the rate of death or myocardial infarction was 8.4% for patients with drug-eluting stents and 7.5% for bare metal stents, but the study found a significantly higher rate of non-infarct target vessel revascularization for patients who received bare-metal stents compared with drug-eluting stents, specifically 11.6% versus 7.5%.
As a result, there was no statically significant difference in the overall major adverse cardiac event rate at 18 months, 15.8% for drug-eluting stents and 18.9% for bare-metal stents.
The take home message is clear, said Christoph Kaiser, MD of University Hospital Basel in Switzerland in MedPage Today on September 4, 2006, "Drug-eluting stents should be reserved for use in small vessels or bypass grafts because it is here that they have demonstrated a benefit."
Currently, drug-coated stents are used in more than 90% of procedures in rich countries like the US and Switzerland. But some cardiologists now say they will be much more cautious about their use. "It raises the flag of caution over the indiscriminate use of first-generation, drug-eluting stents and reminds us that we should stick with tested indications and not over-extend this to any patient," Dr Gabriel Steg, of Hospital Bichat-Claude Bernard in Paris, co-author of a Swiss meta-analysis, told reporters in Barcelona.
At one press conference, Salim Yusuf, MD, a professor of medicine and director of cardiology at McMaster University in Hamilton, Ontario, said that he plans to ask interventional cardiologists at his hospital to re-evaluate their use of drug-eluting stents so that they are used "in a limited way" until more data are available to determine whether the stents are "a panacea -- as many of our patients and residents believe -- or an expensive placebo, or -- as I suspect -- a Trojan horse."
Dr Yusuf says the stents may be more of a Trojan horse, carrying hidden long-term danger in the guise of a useful therapy to avoid restenosis. As it is now, Dr Yusuf characterized the widespread use of drug eluting stents as "madness" and said that coronary interventions should not be used to treat stable angina, unless it has "failed to respond to full and exhaustive medical therapy, something that is never done."
He is calling for the creation of a panel of interventional and non-interventional cardiologists, health economists, and government agencies to "re-evaluate the real role of stenting" in coronary disease and says the panel should exclude industry representatives.
During his presentation at the Barcelona conference, Dr Robert Harrington, of Duke in Durham, NC, warned the audience about the need to go slowly and evaluate the long term outcomes of the drug coated stents already implanted all over the world. "In days of balloon angioplasty, we worried about thrombus formation for 12 to 24 hours, and when bare metal stents were introduced, we worried for seven to 14 days," he advised.
But now the worry with drug-eluting stents, he pointed out, may "be extended to years."
Co-author of one of the meta-analysis, Dr Philippe Steg, MD, of Hospitalier Bichat-Claude-Bernard in Paris, likened the long term drug-eluting stent studies to long term data on Vioxx, which was viewed as a superior pain relieve treatment until long term studies found that the drug drastically increased the risk of heart attack and stroke.
The increased risk with Vioxx was small, but the drug was used by tens of millions of consumers before the risk became known. The same applies to drug-eluding stents. According to MedPage Today on September 5, 2006, an estimated 6 million drug eluting stents have been implanted, which means even a small percentage of problems can add up to a large number of patients.
"This is a classic kind of thing," said Dr David Brown, chief of cardiovascular medicine at Stony Brook University Medical Center, in Newsday on September 13, 2006, "every time we have a technological breakthrough, we invent a new disease along with it."
"In this case," he said, "it's late-stage thrombosis."
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