Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent - TAXUS IV: Results Through 5 Years

Dec 21, 2009
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Trial Sponsor:
Boston Scientific
Date Presented:
01/01/2003
Date Published:
01/01/2004
Date Updated:
12/21/2009
Original Posted Date:
12/21/2009
References

Description:

The goal of the TAXUS IV trial was to evaluate the efficacy of the slow-rate release polymer-based paclitaxel-eluting stent (PES) compared with a bare-metal stent (BMS) in patients with single de novo coronary lesions.

Hypothesis:

Treatment with the slow-rate release polymer-based PES would be associated with a reduction in target vessel revascularization (TVR) compared with a BMS.

Study Design

Study Design:

Patients Enrolled: 1,326
Mean Follow Up: 1-5 years; angiographic 9 months
Mean Patient Age: 62 years
Female: 28%

Patient Populations:

  • Single de novo lesion, 10-28 mm in length and 2.5-3.75 mm in diameter

Exclusions:

  • Prior or planned percutaneous coronary intervention in target vessel within 9 months

Primary Endpoints:

  • Ischemic-driven TVR, adjudicated by the Clinical Event Committee

Secondary Endpoints:

  • MACE at 30 days and 1 year, defined as cardiac death, MI, or TVR
  • Angiographic restenosis at 9 months
  • IVUS at 9 months

Drug/Procedures Used:

Patients with a single de novo lesion were randomized in a double-blind manner to either a PES (n = 662) or a BMS (n = 652). A subset of patients (n = 532) were followed for 9-month angiographic and intravascular ultrasound (IVUS) follow-up (n = 268).

Principal Findings:

Glycoprotein (GP) IIb/IIIa inhibitors were used in 56.7% of patients in the BMS arm and 57.7% of patients in the PES arm (p = 0.74). Stent length did not differ between the treatment arms (21.7 mm in BMS vs. 21.9 mm in PES arm, p = 0.68), nor did the mean number of stents used (1.09 vs. 1.08). There was no difference in 30-day death (0.5% vs. 0.3%) or major adverse cardiac events (MACE) (2.5% vs. 2.9%, p = 0.73). The primary endpoint of TVR was lower in the PES arm (12.0% vs. 4.7%, p < 0.0001), as was target lesion revascularization (TLR) (11.3% vs. 3.0%, p < 0.0001).

The reduction in TVR was similar in many subgroups, including diabetic status; reference vessel diameter <3.0 mm and ≥3.0 mm; stent diameter 2.5 mm, 3.0 mm, and 3.5 mm; artery location; stent length; lesion length; and use of GP IIb/IIIa.

There was no difference in 1-year cardiac death (1.3% vs. 1.4%, p = 0.83) or myocardial infarction (MI) (4.7% vs. 3.5%, p = 0.31), but MACE was higher in the BMS arm (20.0% vs. 10.8%, p < 0.0001), due to more TVR (17.1% vs 7.1%, p < 0.0001). Stent thrombosis occurred infrequently in both arms (0.8% with BMS vs. 0.6% with PES, p = 0.72).

At 2-years, freedom from TLR was 94.4% in the TAXUS group and 82.6% in the control group (p < 0.0001). Subgroup analysis including diabetes, infarct location, vessel diameter, and lesion length all favored the TAXUS stent. No significant difference in late stent thrombosis was noted. MACE rates between 1 and 2 years were not significantly different (7.3% control vs. 5.1% TAXUS; p = 0.009), but the TLR rate was significantly reduced between 1 and 2 years in patients receiving the TAXUS stent (1.6% vs. 3.6%; p = 0.03). Overall MACE rate at 2 years remained in favor of the TAXUS stent (24.9% control vs. 14.7% TAXUS; p < 0.0001). The overall 2-year TLR rates were 17.4% in the control group and 5.6% in the TAXUS group; p < 0.0001).

At 5 years, TVR was 27.4% versus 16.9% (p < 0.0001) and stent thrombosis was 2.1% versus 2.2% (p = 0.87), respectively, for BMS versus PES.

Interpretation:

Among patients with single de novo coronary lesions, treatment with the slow-rate release polymer-based PES was associated with a reduction in the primary endpoint of TLR at 1 year compared with BMS. The incremental benefits of the TAXUS stent were durable at 2- and 5-years of clinical follow-up showing that the TAXUS stent markedly reduced clinical restenosis and the need for repeat coronary artery bypass grafting or percutaneuous coronary intervention.

Results of the present trial were in line with results from the SIRIUS trial, which compared sirolimus-eluting stents with BMS and also showed a significant reduction in TVR with the drug-eluting stent. Neither trial has shown a reduction in the clinical endpoints of death or MI.

References:

Ellis SG, Stone GW, Cox DA, et al. Long-term safety and efficacy with paclitaxel-eluting stents. 5-year final results of the TAXUS IV clinical trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent). JACC Cardiovasc Interv 2009;2:1248-59.

Stone GW, et al. A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease. N Engl J Med 2004;350:221-31.

Stone GW, et al. One-Year Clinical Results With the Slow-Release, Polymer-Based, Paclitaxel-Eluting TAXUS Stent. Circulation 2004;109:1942-7.

Presented at the 2003 Transcatheter Cardiovascular Therapeutics conference, by Gregg W. Stone, MD

2-Year Results Presented at the 2004 Transcatheter Cardiovascular Therapeutics conference, by Gregg W. Stone, MD

Keywords: Mitosis, Myocardial Infarction, Follow-Up Studies, S Phase, Drug-Eluting Stents, Coronary Disease, Sirolimus, Hyperplasia, Angioplasty, Balloon, Coronary, Platelet Membrane Glycoprotein IIb, Paclitaxel, Microtubules, Metals, Polymers, Myocytes, Smooth Muscle, Thrombosis, Biological Products, Coronary Artery Bypass, Diabetes Mellitus, Cyclin-Dependent Kinase Inhibitor p27


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