TAXUS-II 2 year Angiographic Follow-up - TAXUS-II 2 year Angiographic Follow-up

Nov 08, 2004
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Date Presented:
01/01/2004
Date Updated:
11/08/2004
Original Posted Date:
11/08/2004
References

Description:

This trial reports 24 month clinical (n=524) and angiographic (n=207) follow up of the TAXUS-II trial which compared a paclitaxel-eluting coronary stent with a bare, uncoated stent in de novo lesions. The trial was conducted with two cohorts, a slow release paclitaxel-eluting stent (cohort 1) and a moderate release paclitaxel-eluting stent (cohort 2).

Hypothesis:

In-stent volume obstruction as assessed by intravascular ultrasound (IVUS) will be reduced with use of the paclitaxel-eluting coronary stent.

Study Design

Study Design:

Patients Enrolled: 536
Mean Follow Up: 24 months

Patient Populations:

Standard risk de novo lesions, length ≤12 mm, and reference vessel diameter ≥3.0 mm and ≤3.5 mm

Primary Endpoints:

In-stent volume obstruction as assessed by IVUS at six months

Secondary Endpoints:

Clinical procedural success; MACE (cardiac death, MI, and TVR) at 30 days, six months, and years 1-5; TLR and TVR at six months; angiographic restenosis rate at six months; quantitative coronary angiography parameters at six months; and IVUS parameters at six months

Drug/Procedures Used:

Cohort 1: Patients were randomized triple-blind to the slow release paclitaxel-eluting stent (n=131) or to an uncoated stent (n=136).

Cohort 2: Patients were randomized triple-blind to the moderate release paclitaxel-eluting stent (n=135) or to an uncoated stent (n=134).

With the slow release formulation, the drug is released over the course of approximately one month; with the moderate release formulation, the majority of the drug is released within the first two days.

Concomitant Medications:

Aspirin ≥75 mg (loading dose and maintained indefinitely) and clopidogrel (loading dose 300 mg and 75 mg/d for six months)

Principal Findings:

Between years 1 and 2, there was a single cardiac death in each of the control, slow-release and moderate-release formulations. TLR occurred in 8 control patients, 1 TAXUS slow release patient and no TAXUS moderate release patients. TVR occurred in 19 patients in the control group, 2 patients in the slow-release and 3 patients in the moderate release formulations. The total 2 year MACE rates were 24.6% in the combined control group, 14.2% in the slow-release TAXUS group, and 14.2% in the moderate release TAXUS group (p=0.0178). No increased rate of TLR was noted over time. Survival free of TLR was 96.3% for the moderate release formulation, 94.6 for the slow release formulation and 83.3% for the control arm (p=0.0002). 6-month TLR rate for the slow-release formulation was 4.6% at 6 months, 4.7% at 1 year and 5.5% at 2 years. With the moderate release formulation, the TLR rate was 3.1% at 6 months, 3.8% at 1 year and 3.9% at 2 years. For the control, bare-metal stent group, the TLR rate was 13.3% at 6 months, 14.4% at 1 year and 15.5% at 2 years. No significant difference in late stent thrombosis was detected. Angiographic and IVUS subdata revealed that late loss and minimum lumen diameter (MLD) remained stable over time. The primary endpoint of percent in-stent volume obstruction was 17.07% +/- 12.21 in the control group (n=77), 10.59% +/- 8.43 (n=43) in the slow release TAXUS stent and 11.93% +/- 9.67 (n=41) for the moderate release TAXUS stent (p=0.0018 for control v. TAXUS slow release and p=0.0139 for control v. TAXUS moderate release).

Interpretation:

These data demonstrate a durable safety profile for the slow-release and moderate release TAXUS drug-eluting stents with low rates of late stent thrombosis and cornary aneurysm formation. Efficacy was noted by clinical, QCA and IVUS measures that was durable over 2 years.

References:

1. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based Paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003 Aug 19;108(7):788-94. 2. Presented at Transcatheter Cardiovascular Therapeutics Conference, September 2002; and Late-Breaking Clinical Trials, ACC 2003 (12-month data).

3. Presented at the European Society of Cardiology, Vienna, Austria, September 2003. 4. Presented at Late-Breaking Clinical Trials during Transcatheter Cardiovascular Therapeutics Conference, September 2004(24-month data).

Keywords: Paclitaxel, Coronary Artery Disease, Follow-Up Studies, Metals, Thrombosis, Drug-Eluting Stents


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