ISAR SMART-2 - ISAR SMART-2

Oct 14, 2003
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Date Presented:
01/01/2003
Date Published:
01/01/2004
Date Updated:
10/14/2003
Original Posted Date:
10/14/2003
References

Description:

The goal of the ISAR SMART-2 trial was to evaluate whether: 1) placement of phosphorylcholine (PC)-coated stents is associated with a reduction in restenosis in small coronary arteries compared with percutaneous transluminal coronary angioplasty (PTCA); and 2) whether the administration of abciximab compared with placebo is associated with a reduction in restenosis after interventions in patients with small coronary arteries undergoing percutaneous coronary intervention (PCI).

Hypothesis:

In patients with small coronary arteries, treatment with PC-coated stents and abciximab will be associated with a reduction in restenosis.

Study Design

Patients Enrolled: 502
Mean Follow Up: 6 month angiographic; 1 year clinical
Mean Patient Age: mean 66 years
Female: 24%
Mean Ejection Fraction: Mean 57%

Patient Populations:

Symptomatic coronary artery disease without acute MI; native coronary vessels (≤2.5 mm); and no allergy to aspirin or abciximab

Primary Endpoints:

Angiographic restenosis, defined as diameter stenosis ≥50%

Secondary Endpoints:

Death, myocardial infarction (MI), TVR, and freedom from MACE

Drug/Procedures Used:

Patients (n=502) were randomized in a factorial design to: 1) stent (n=253) or PTCA (n=249); and 2) abciximab (n=251) or placebo (n=251).

Concomitant Medications:

Aspirin (100 mg); clopidogrel (600 mg loading dose; 75 mg at time of PCI; 75 mg/day)

Principal Findings:

Crossover occurred in 3.6% of patients in the PTCA arm and 40.2% of patients in the stent arm (p<0.001). Angiographic restenosis did not differ between stent and PTCA treatment (39.0% vs. 34.2%, p=0.30), nor did minimum lumen diameter (1.18 mm vs. 1.21 mm, p=0.5). There was also no difference in target vessel revascularization (TVR) (20.9% vs. 21.3%, p=0.93), death (1.2% vs. 0%), or freedom from major adverse cardiac events (MACE) (92.4% vs. 92.1%, p=0.91).

Angiographic restenosis was similar between the abciximab and placebo arms (39.3% vs. 34.3%, p=0.29), as was minimum lumen diameter (1.20 mm vs. 1.18 mm, p=0.81). There was also no difference in TVR (19.9% vs. 22.3%, p=0.51), death (0.8% vs 0.4%), or freedom from MACE (91.2% vs. 93.1%, p=0.40).

Interpretation:

Among patients with small coronary vessels undergoing PCI, neither treatment with PC-coated stents compared with PTCA or treatment with abciximab compared with placebo was associated with a reduction in the primary endpoint of angiographic restenosis at six-month follow-up. Prior studies have shown no significant benefit of bare stents over PTCA in small coronary arteries.

The present trial was based on the hypothesis that PC-coated stents would reduce restenosis by reducing protein absorption and platelet activation. Given the lack of efficacy with the therapies studied in the present trial, it is likely that future research will focus on drug-eluting stents, which have been shown in multiple trials to reduce angiographic restenosis and TVR.

References:

Hausleiter J, Kastrati A, Mehilli J, et al. A randomized trial comparing phosphorylcholine-coated stenting with balloon angioplasty as well as abciximab with placebo for restenosis reduction in small coronary arteries. J Intern Med. 2004 Nov;256(5):388-97.

Presented at the 2003 Transcatheter Cardiovascular Therapeutics conference, by Adnan Kastrati, MD

 

Keywords: Follow-Up Studies, Platelet Aggregation Inhibitors, Coronary Restenosis, Drug-Eluting Stents, Hypersensitivity, Ticlopidine, Immunoglobulin Fab Fragments, Platelet Activation, Angioplasty, Balloon, Coronary, Phosphorylcholine


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