Direct Stenting with TAXUS Stents Seems to be as Safe and Effective as with Predilatation
2004
Although direct coronary stenting does not improve
angiographic outcome, it makes sense by reducing procedure
times, radiation exposure and costs. Other potential advantages
of direct stenting may be a reduction of myocardial ischemia
time, which could be clinically relevant in high-risk patients.
With the introduction of drug-eluting stents, however, concern
arose that direct stenting would possibly damage the polymer
coating and change or diminish the efficacy of the programmed
drug release. Also, concerns about safety by preventing optimal
apposition of single stent struts developed. It is the purpose
of this paper to retrospectively analyze the data from the
TAXUS-II Trial (536 patients) regarding patients with and
without direct stenting. While predilatation was recommended per
protocol, direct stenting was not forbidden: thus, direct
stenting was performed in 49 patients (TAXUS n = 23, control n =
26). In the TAXUS groups, there was no significant difference
regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%),
angiographic restenosis in the analysis segment (4.8% vs. 4.3%),
late loss (0.28 ± 0.36 vs. 0.33 ± 0.30 mm) or intravas- cular
ultrasound-(IVUS-)measured volume obstruction (7.95 ± 9.84% vs.
5.61 ± 7.91%) at six months between the predilated and directly
stented patients. The same was true for the patients receiving
the control stent. Compared with the directly stented control
group, the statistically significant positive effects of TAXUS
direct stenting were maintained, regarding angiographic
restenosis in the analysis segment (4.3% vs. 30.8%), late loss
(0.33 ± 0.30 vs. 0.80 ± 0.62 mm) or IVUS-measured volume
obstruction (5.61 ± 7.91% vs. 22.50 ± 21.62%) at six months.
MACE was reduced from 19.2% to 4.3%; due to the small number of
patients this trend did not reach statistical significance.
After predilatation, all parameters were significantly improved
by the TAXUS stent. Comparison of patients receiving TAXUS stents with or
without predilatation revealed no differences in clinical,
angiographic or IVUS parameters at six months. This suggests
that direct stenting with the polymer-based paclitaxeleluting
TAXUS stent is feasible, safe and equally effective. Randomized
trials comparing stenting after predilatation versus direct
stenting with drug-eluting stents are warranted.
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