June 29, 2009
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Stents may not be solely to blame for late events in patients with drug-eluting stents

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Late events occurring in patients receiving paclitaxel-eluting stents may be related more to underlying disease activity than to the stent-related segments, study results suggested.

Researchers conducted a pooled analysis on patients with de novo lesions from the TAXUS I (n=61), II (n=266), IV (n=1,314) and V (n=1,156) trials on whom follow-up data were available. The researchers compared 1,400 patients treated with a paclitaxel-eluting stent (Taxus Express, Boston Scientific) with 1,397 patients who were treated with bare metal stents. Annualized hazard rates were calculated for major adverse events, including target vessel revascularization and target lesion revascularization.

According to the researchers, an early difference between groups in TVR during year one (HR=0.55; 95% CI, 0.45-0.67) was driven by TLR (HR=0.42; 95% CI, 0.33-0.53). After year two years, TLR decreased. Treatment with a paclitaxel-eluting stent reduced the hazard rates of TVR vs. the bare metal stent (11.2% vs. 20.4%, P<.0001) in year one, and the hazard rates for TLR then remained both low and similar in the paclitaxel group vs. the bare metal stent group from years two to five (3.3% vs. 3.8%, P=.21). The annualized Q-wave MI (HR=1.80; 95% CI, 0.60-5.38) and non-Q-wave MI (HR=0.81; 95% CI, 0.55-1.19) remained similar between groups during the first year and from years two through five (Q-wave MI, HR=1.34; 95% CI, 0.57-3.19; non-Q-wave MI, HR=1.59; 95% CI, 0.92-2,74). The rate of TVR outside of the stented segment also did not differ in the paclitaxel group vs. the bare metal group between years two and five (2.1% vs. 1.8%, P=.41).

“These data suggest that paclitaxel-eluting stents significantly reduce TLR during the first year after procedure, but that they do not reduce the late ongoing 2% to 4% annual rate of repeat revascularization of target vessel due to disease progression outside the stented zone,” the researchers concluded. “Late, ongoing non-target lesion TVR, death, MI and to some extent Academic Research Consortium-defined very late stent thrombosis occur at roughly equal rates in both drug-eluting stent and bare metal stents, but are increased in patients with markers of more diffuse or aggressive atherosclerosis.”

In an accompanying editorial, Robert A. Vogel, MD, a professor of medicine at the University of Maryland Medical Center in Baltimore, noted that while recent research has suggested that drug-eluting stents are safe, the focus should be switching back to the treatment of progressive coronary atherosclerosis.

“Interventions do not cure atherosclerosis, and interventionalists need to be familiar with all the medical details of each patients,” the author wrote. “As an example, I have encountered several drug-eluting stent-treated patients who were known to require noncardiac surgery within months of their intervention, unnecessarily complicating antiplatelet therapy. A good stent is necessary, but having a good physician is even more important.”

You can read more Cardiology Today articles about drug-eluting stent research here.

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