European Sonotherapy Trial to Prevent Arterial Hyperplasia - EURO-SPAH

Nov 17, 2002
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Date Presented:
01/01/2002
Date Published:
01/01/2004
Date Updated:
11/17/2002
Original Posted Date:
11/17/2002
References

Description:

Evaluation of intravascular sonotherapy v. placebo in de novo coronary arteries undergoing stent implantation

Hypothesis:

Intravascular sonotherapy will limit arterial hyperplasia after coronary stent implantation and reduce rates of restenosis.

Study Design

Patients Enrolled: 403
Mean Follow Up: 12 months
Mean Patient Age: Mean 62 years
Female: 21%

Patient Populations:

1) De novo coronary lesion or nonstented coronary lesions >1 year old 2) Only one lesion in a major epicardial vessel >2.5 mm in diameter and <38 mm in length. 3) Successful stent deployment in the lesion with residual stenosis <20% by online quantitative coronary angiography and TIMI 3 flow

Secondary Endpoints:

1) Late loss in sonotherapy treated segment 2) Late loss in vessel segment 3) Combined endpoint of death, myocardial infarction or repeat revascularization

Drug/Procedures Used:

Intravascular sonotherapy applied to the lesion using a 5 French sonotherapy catheter OR sham catheter placement. Angiographic and IVUS follow-up obtained at 6 months.

Principal Findings:

Type B2 lesions accounted for approximately 60% of lesions and type B1 lesions accounted for 25% of lesions. The average lesion length was 12 mm in both groups. Within stent, the restenosis rate was 23% in the sonotherapy group an 25% in the sham treatment arm (p=0.73). Late loss was similar (0.86 mm sonotherapy v. 0.94 sham treatment; p=0.09). Similar results were seen if the entire segmented treated with sonotherapy or vessel segment were analyzed with no difference in restenosis rates (p=NS). The only significant angiographic difference was in the mean lumen diameter (1.63 mm sonotherapy v. 1.53 sham therapy; p=0.05). A difference was noted in a combined endpoint of death, myocardial infarction or revascularization was noted due to a decreased rate of revascularization (18.8% sonotherapy v. 25.9% sham treatment; p=0.045 [RR 0.73, 95% CI 0.5-1.1]). A significant reduction in the rate of revascularization was noted in the sonotherapy arm (14.4% sonotherapy v. 23.4% sham therapy; p=0.02; [RR 0.63, 95% CI 0.4-0.9]).

Interpretation:

A reduction in the rates of revascularization was noted in patients treated with sonotherapy, but this was not supported by significant differences in angiographic findings. It is not clear whether in the absence of angiographically significant differences whether revascularization rates are clinically relevant and would translate into a reduction in hard cardiac endpoints. Larger trials with longer follow-up will be required to determine whether the minor reductions in restenosis rates would justify the added expense and procedure time.

References:

Presented by P.W. Serruys at the Annual Meeting of the European Society of Cardiology, September 2, 2002.

Serruys PW, Hoye A, Grollier G, Colombo A, Symons J, Mudra H. A European multi-center trial investigating the anti-restenotic effect of intravascular sonotherapy after stenting of de novo lesions (EUROSPAH: EUROpean Sonotherapy Prevention of Arterial Hyperplasia). Int J Cardiovasc Intervent. 2004;6(2):53-60.

Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Coronary Angiography, Constriction, Pathologic, Hyperplasia, Stents


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