Direct stenting with TAXUS stents seems to be as safe and effective as with predilatation. A post hoc analysis of TAXUS II.
METHODS
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).


RESULTS
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 intravascular 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.


CONCLUSIONS
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 paclitaxel-eluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.
Silber
Sigmund
S
Cardiology Practice and Hospital, Munich, Germany. silber@med.de
Hamburger
Jaap
J
Grube
Eberhard
E
Pfisterer
Matthias
M
Belardi
Jorge
J
Webb
John
J
Zmudka
Krzysztof
K
Nienaber
Christoph
C
Hauptman
Karl
K
Rutsch
Wolfgang
W
Dawkins
Keith
K
Drzewiecki
Janusz
J
Koglin
Jörg
J
Colombo
Antonio
A
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D003627:Data Interpretation, Statistical; D003692:Delayed-Action Preparations; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012189:Retrospective Studies; D015607:Stents; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D003692:Delayed-Action Preparations; D017239:Paclitaxel