What is the clinical evidence from this study?

Study design: RCT. Population: de novo coronary lesions (n=263). Intervention: Zotarolimus-eluting stent (ZES) vs. Paclitaxel-eluting stent (PES). Primary outcome: % neointimal obstruction.

What does this research mean for the field?

Zotarolimus-eluting stents result in significantly higher percentage of neointimal obstruction compared to paclitaxel-eluting stents at 9 months, although the rates of severe restenosis remain similar between the two. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

January 1, 2010Open Access

Comparison of Vascular Response to Zotarolimus-Eluting Stent vs Paclitaxel-Eluting Stent Implantation - Pooled IVUS Results From the ZoMaxx I and II Trials -

KWKatsuhisa WasedaAichi Medical University THTakao HasegawaTakaishi High School JAJunya AkoInterventional Cardiology

Key Result

Zotarolimus-eluting stents resulted in significantly higher % neointimal obstruction compared to paclitaxel-eluting stents (15.4% vs 11.3%) at 9 months, though severe restenosis rates were similar.

Study Design

Type

RCT (n=263)

Structured PICO

Does zotarolimus-eluting stent improve vessel response compared to paclitaxel-eluting stent in patients with de novo coronary lesions?

Population

263 patients with de novo coronary artery lesions from the ZoMaxx I and II trials with serial volumetric IVUS analysis available at baseline and 9-months follow up.

Intervention

Zotarolimus-eluting stent (ZES)

Comparator

Paclitaxel-eluting stent (PES)

Outcome

Vessel response assessed by intravascular ultrasound (IVUS), including neointima-free frame ratio, % neointimal obstruction, minimum lumen area, and incidence of IVUS-defined restenosis at 9 monthssurrogate

Zotarolimus-eluting stents demonstrated a moderate increase in neointimal hyperplasia but a similar incidence of severe narrowing and better neointimal coverage compared to paclitaxel-eluting stents at 9 months.

Main Result

Absolute Event Rate: 15.4% vs 11.3%

Abstract

BACKGROUND: The ZoMaxx I and II trials were randomized controlled studies of the zotarolimus-eluting, phosphorylcholine-coated, TriMaxx stent for the treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus- (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound (IVUS). METHODS AND RESULTS: Data were obtained from the ZoMaxx I and II trials, in which a standard IVUS parameter was available in 263 cases (baseline and 9-months follow up). Neointima-free frame ratio was calculated as the number of frames without IVUS-detectable neointima divided by the total number of frames within the stent. While an increase in vessel and plaque was observed in PES from baseline to follow up, there was no significant change in ZES. At follow up, % neointimal obstruction was significantly higher (15.4 ± 8.8% vs 11.3 ± 9.7%), and minimum lumen area at follow up was significantly smaller in ZES compared to PES. However, the incidence of IVUS-defined restenosis (maximum cross-sectional narrowing >60%) was similar in the 2 groups (3.2% vs 6.7%). Neointima-free frame ratio was significantly lower in ZES. There were 5 cases of late incomplete stent apposition in PES and none in ZES. CONCLUSIONS: These IVUS results demonstrate a similar incidence of severe narrowing between these 2 DES. There was a moderate increase in neointimal hyperplasia that was associated with a greater extent of neointimal coverage in ZES compared with PES.

Ask AI

Helpful

Bookmark

View Full Paper