December 23, 2003Open Access
View Full PaperChronic Arterial Responses to Polymer-Controlled Paclitaxel-Eluting Stents
Structured PICO
Do polymer-controlled paclitaxel-eluting stents reduce neointimal hyperplasia compared to bare metal stents in patients undergoing percutaneous coronary intervention?
P
Population
314 patients from the TAXUS II trial treated with one study stent who underwent serial intravascular ultrasound (IVUS) examination after the procedure and at 6-month follow-up
I
Intervention
Polymer-controlled paclitaxel-eluting stents (slow-release [n=81] or moderate-release [n=81])
C
Comparator
Bare metal stents (n=152)
O
Outcome
Local arterial responses including mean vessel area, stent area, lumen area, intrastent neointimal hyperplasia area, and peristent area measured by serial quantitative IVUS at 6-month follow-upsurrogate
Both slow-release and moderate-release paclitaxel-eluting stents significantly reduce neointimal hyperplasia compared to bare metal stents, though they exhibit release-dependent differences in peristent remodeling.
Abstract
BACKGROUND: Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial. METHODS AND RESULTS: TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7+/-0.9 mm2, P<0.001) and MR (0.6+/-0.8 mm2, P<0.001) compared with BMS (1.9+/-1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5+/-1.7, 1.0+/-1.8, and 1.4+/-2.0 mm2, respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA. CONCLUSIONS: Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.