Randomized Comparison of the Efficacy of Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent in the Treatment of Long Native Coronary Lesions - LONG DES II - Presented at TCT 2006

Oct 23, 2006
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Date Presented:
01/01/2006
Date Published:
01/01/2006
Date Updated:
10/23/2006
Original Posted Date:
10/23/2006
References

Description:

The goal of the trial was to compare the sirolimus-eluting stent (SES) and the paclitaxel-eluting stent (PES) among patients with long native coronary artery lesions undergoing percutaneous coronary intervention (PCI).

Study Design

Study Design:

Patients Enrolled: 250
Mean Follow Up: 9 months
Mean Patient Age: Mean age 61 years
Female: 36

Patient Populations:

Patients with angina and documented ischemia; long de novo coronary lesion (>25 mm) with reference vessel diameter >2.5 mm and planned total stent length ≥32 mm

Exclusions:

Left main coronary artery stenosis; graft disease; left ventricular ejection fraction <30%; hematologic disease; hepatic dysfunction; renal dysfunction; life expectancy <1 year; inability to follow protocol; bifurcation lesion with planned treatment of sidebranch; primary angioplasty for acute MI within 24 hours; or contraindication to aspirin, clopidogrel, or cilostazol

Primary Endpoints:

In-segment binary restenosis (>50%) at 6 months

Secondary Endpoints:

  • In-segment late loss and restenosis rates
  • In-stent late loss restenosis
  • Death, MI, or target lesion revascularization at 30 days and 9 months
  • Stent thrombosis

Drug/Procedures Used:

Patients were randomized to SES (n = 250) or PES (n = 250) implantation. Patients were further randomized to triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol) or dual antiplatelet therapy (aspirin and clopidogrel). Angiographic follow-up was performed at 6 months and clinical follow-up at 9 months.

Concomitant Medications:

Aspirin (200 mg per day) and clopidogrel (300 mg load and 75 mg per day for at least 6 months)

Principal Findings:

Data regarding use of triple antiplatelet therapy were not yet presented.

No significant differences in the baseline clinical and angiographic differences were observed. Mean lesion length was 34 mm and stented length was 41 mm. Immediate post-procedure quantitative coronary angiography revealed no significant differences in procedural success in SES compared with PES.

Six-month angiographic follow-up was performed in 83% of patients. The primary endpoint of binary restenosis was lower with SES compared with PES (3.3% vs. 14.6%; p < 0.001). For both in-stent and in-segment analyses, diameter stenosis was lower in SES patients compared with PES (in-segment 20.1% vs. 31.4%; in-stent 13.0% vs. 26.2%, p < 0.001 for each). Likewise, late loss was lower in SES patients (in-segment 0.24 mm vs. 0.61 mm; in-stent 0.09 mm vs. 0.45, p < 0.001 for each).

Rates of major adverse cardiac events of death, myocardial infarction (MI), or target vessel revascularization (TVR) by 9 months trended lower with SES compared with PES (12.0% vs. 17.2%; p = 0.10). TVR was lower with SES compared with PES (3.2% vs. 7.6%; p = 0.030). One patient had a stent thrombosis within 30 days with SES and another SES patient had a fatal stent thrombosis at 3 months.

Interpretation:

Among patients undergoing PCI for long lesions, SES were associated with reductions in angiographic binary restenosis compared with PES at 6-month follow-up.

The rate of TVR was notably low in both groups. Even in trials with simple, shorter lesions comparing PES and SES such as REALITY and SIRTAX, rates of TVR were higher than in the present trial. It is unclear why the need for repeat revascularization would be less in long lesions than in shorter, simpler lesions.

References:

Kim YH, Park SW, Lee SW, et al. Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent for Patients With Long Coronary Artery Disease. Circulation 2006;114:epub before print.

Presented by Dr. Seung-Jung Park at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.

Hong MK. Presented at the i2 Summit Scientific Session of the American College of Cardiology in Atlanta, GA, March 12, 2006.

Keywords: Myocardial Infarction, Follow-Up Studies, Platelet Aggregation Inhibitors, Coronary Restenosis, Ticlopidine, Sirolimus, Fibrinolytic Agents, Constriction, Pathologic, Tetrazoles, Angioplasty, Balloon, Coronary, Vasodilator Agents, Purinergic P2Y Receptor Antagonists, Bronchodilator Agents, Stents, Paclitaxel, Coronary Angiography, Thrombosis, Neuroprotective Agents


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