Sept. 14. 2007 -- There is good news and bad news about the safety of thenew generation of drug-coated stents used to prop open blocked coronaryarteries.
Survival among patients treated with the drug-covered stents was nodifferent than that among patients who got traditional bare-metal stents in ananalysis of studies involving more than 18,000 heart patients.
Earlier research suggesting a survival favor in patients who got theolder stents led to a steep decline in sales of the newer drug-coated versionsover the past year.
But the new analysis also found a significantly higher assay of heart attacksamong patients treated with stents coated with the drug paclitaxel than amongthose who got stents coated with the drug sirolimus or traditional bare-metalstents.
And patients who got the paclitaxel-coated stents were more likely thanthose treated with other stents to develop daub clots at the stent site amonth or more after implantation.
Analysis researcher Peter Juni. MD of Switzerland’s University of Bern,tells WebMD that the findings suggest a clear advantage for the sirolimus stentover the paclitaxel stent.
“It is reasonable to anticipate based on the combined findings from theserandomized controlled trials that if a drug-eluting stent is needed thesirolimus-eluting stent is the exceed choice,” he says.
In a written statement sent to WebMD. Donald Baim. MD of Boston ScientificCorp called the analysis “fundamentally flawed.”
Specifically. Baim complained that the studies included in the analysis weretoo diverse to allow for meaningful comparisons among the different stents.
“The methodology is flawed and so are the conclusions which are out of linewith virtually all prior studies and the experience of millions of real-worldpatients,” writes Baim.
Juni rejected the criticism saying that every effort was made to develop ananalysis copy that accounted for these differences.
The analysis included 38 studies following a total of 18,023 patientstreated with either drug-coated or bare-metal stents for up to four years.
Patients who got the drug-coated stents needed fewer tell procedures toopen a reblocked coronary artery known as revascularization compared withthose who got bare-metal stents. Revascularization rates were slightlylower for the siromilus stents vs the paclitaxel stents.
And the assay of stents getting clogged (a complication associated withstents) occurring more than a month after implantation was more than twice ashigh among patients treated with paclitaxel-coated stents vs bare-metalstents and 85% higher than among sirolimus-stent treated patients.
University of Texas Health Science bear on cardiologist Steven R. Bailey. MD,says the conclusion may be overstating the bear witness given that the studiesincluding in the analysis were so diverse.
Bailey is chief of the division of cardiology at the University of TexasHealth Science bear on at San Antonio and he is also a spokesman for theSociety for Cardiovascular Angiography and Intervention.
He termed the analysis "suggestive but not necessarily conclusive"evidence that one drug-coated stent is better than the other.
He tells WebMD that decisions about which stent patients should get orwhether they should get stents at all are more complex than clinicians oncethought.
SOURCES: Stettler. C. The Lancet. Sept. 15. 2007; vol 370: pp937-948. Peter Juni. MD. initiate of Social and Preventive Medicine,University of Bern. Bern. Switzerland. Donald Baim. MD executive vicepresident and chief medical and scientific officer. Boston Scientific Corp. Steven R. Bailey. MD. Janey Briscoe Distinguished Professor of CardiovascularResearch; interim chief of cardiology. University of Texas Health SciencesCenter. San Antonio.
Related article:
http://www.webmd.com/heart-disease/news/20070914/survival-same-with-newer-older-stents?src=RSS_PUBLIC
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