The September 14, 2006, New England Journal of Medicine, published 2 studies that found drug eluding stents offer modest benefits, if any, over bare-metal stents.
In one trial, researchers compared the Taxus to bare-metal stents, looking at their effectiveness in warding off cardiac death, recurrent heart attack or vessel re-closure. A total of 619 patients, who received a stent after a heart attack, were included in the study.
The researchers found no statistically significant difference in the rate of "serious adverse cardiac events" between the two groups during a one-year follow-up.
After one year, 8.8% of Taxus patients experienced an adverse event, compared with 12.8% of the bare-metal patients. Slightly fewer Taxus patients died from cardiac causes, had a reclogging, or needed another intervention, but blood clot rates were similar in both groups.
The second study compared the 8-month outcomes of 712 heart attack patients who were implanted with either the Cypher or a bare-metal stent.
In this study, time reductions in risk did reach statistical significance, with 7.3% of Cypher patients having a target-vessel failure, defined as a related death, complete reclogging, or need to reclear the vessel, compared with 14.3% of those given a bare metal stent.
However, the significant difference, the study said, was caused by a need for another surgery, as deaths and complete recloggings and blood clots were even in both groups, but patients with the Cypher needed their treated blood vessels unblocked after a year.
Another factor that must be considered in any risk benefit debate, is that according to the September 18, 2006 Boston Globe, "stents cannot be removed once they are implanted, making them a permanent fixture in coronary arteries."
As researchers tracked patients over time, they found clots forming more than a month, and sometimes a year or more after the implant. "With bare-metal stents, such late clotting is almost unknown," according to the Globe.
This past summer, Boston Scientific conducted its own an analysis of the company's drug eluding stent trials and acknowledged publicly that Cypher patients were marginally more likely to get a clot than patients with bare-metal stents.
J&J claims to monitor the long-term effects of its stents, and says that in 1,800 patients, five developed late clots, whereas none of the bare-metal stent patients had clots.
However, experts point out that the device maker's only track patients with fairly routine problems in their arteries but that in real-world practice, surgeons use drug-coated stents in many more complex cases.
In extreme situations, the Boston Globe says, doctors have implanted a dozen or more stents, or have completely lined a coronary artery with stents, a tactic called the "full metal jacket."
Experts say the more metal put in, the greater the risk.
Moreover, the number of cases of clotting problems may not be as small as experts predict. According to the September 18, 2006 Boston Globe, American doctors are starting to track their own patients and the Washington Hospital Center in Washington DC, looked at 3,000 patients and found 8 cases of late clotting.
In California, the Globe says, the Kaiser Permanente healthcare system is now launching a review of all its stent patients, though cardiologist Calvin Weisberger, who initiated the project but says a lack of funding will make the process slow.
In one trial, researchers compared the Taxus to bare-metal stents, looking at their effectiveness in warding off cardiac death, recurrent heart attack or vessel re-closure. A total of 619 patients, who received a stent after a heart attack, were included in the study.
The researchers found no statistically significant difference in the rate of "serious adverse cardiac events" between the two groups during a one-year follow-up.
After one year, 8.8% of Taxus patients experienced an adverse event, compared with 12.8% of the bare-metal patients. Slightly fewer Taxus patients died from cardiac causes, had a reclogging, or needed another intervention, but blood clot rates were similar in both groups.
In this study, time reductions in risk did reach statistical significance, with 7.3% of Cypher patients having a target-vessel failure, defined as a related death, complete reclogging, or need to reclear the vessel, compared with 14.3% of those given a bare metal stent.
However, the significant difference, the study said, was caused by a need for another surgery, as deaths and complete recloggings and blood clots were even in both groups, but patients with the Cypher needed their treated blood vessels unblocked after a year.
Another factor that must be considered in any risk benefit debate, is that according to the September 18, 2006 Boston Globe, "stents cannot be removed once they are implanted, making them a permanent fixture in coronary arteries."
As researchers tracked patients over time, they found clots forming more than a month, and sometimes a year or more after the implant. "With bare-metal stents, such late clotting is almost unknown," according to the Globe.
This past summer, Boston Scientific conducted its own an analysis of the company's drug eluding stent trials and acknowledged publicly that Cypher patients were marginally more likely to get a clot than patients with bare-metal stents.
J&J claims to monitor the long-term effects of its stents, and says that in 1,800 patients, five developed late clots, whereas none of the bare-metal stent patients had clots.
However, experts point out that the device maker's only track patients with fairly routine problems in their arteries but that in real-world practice, surgeons use drug-coated stents in many more complex cases.
In extreme situations, the Boston Globe says, doctors have implanted a dozen or more stents, or have completely lined a coronary artery with stents, a tactic called the "full metal jacket."
Experts say the more metal put in, the greater the risk.
Moreover, the number of cases of clotting problems may not be as small as experts predict. According to the September 18, 2006 Boston Globe, American doctors are starting to track their own patients and the Washington Hospital Center in Washington DC, looked at 3,000 patients and found 8 cases of late clotting.
In California, the Globe says, the Kaiser Permanente healthcare system is now launching a review of all its stent patients, though cardiologist Calvin Weisberger, who initiated the project but says a lack of funding will make the process slow.
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