Balloon Equivalent to Stent Trial - BEST (Balloon Equivalent to Stent Trial)


The goal of the BEST trial was to compare the restenosis rate with IVUS-guided balloon angioplasty vs systematic stent implantation.


IVUS-guided balloon angioplasty would not be inferior with regard to rates of restenosis compared to systematic stent implantation.

Study Design

Patients Enrolled: 254
Mean Follow Up: 12 months
Mean Patient Age: Mean 62 years
Female: 16%
Mean Ejection Fraction: Mean EF 61%

Patient Populations:

Age 18-80 years, stable or unstable angina or demonstrated ischemia, significant stenosis <=20 mm="" suitable="" for="" stent="" implantation="" and="" without="" excessive="" calcification="" or="" angulation,="" lesion="" not="" located="" on="" the="" left="" main="" artery,="" ostium,="" or="" bifurcation="" mm="" suitable="" for="" stent="" implantation="" and="" without="" excessive="" calcification="" or="" angulation,="" lesion="" not="" located="" on="" the="" left="" main="" artery,="" ostium,="" or="">/html>


Recent (<3 days)="" or="" evolving="" acute="" coronary="" syndrome,="" left="" ventricular="" ejection="" fraction=""><0.30, or="" contraindication="" to="" aspirin,="" ticlopidine,="" clopidogrel="" treatment="">

Primary Endpoints:

6 month angiographic restenosis rate on QCA, defined as >50% diameter stenosis at the target site

Secondary Endpoints:

Angiographic MLD, minimum lumen cross-sectional area (L-CSA) at lesion site, and 1-year event rate (survival without MI, unstable angina, major bleeding, or target vessel revascularization)

Drug/Procedures Used:

Stent implantation under angiographic guidance (n=122) v. balloon sizing according to IVUS pre-PTCA measurements with balloon inflation according to compliance curve (n=132). Crossover to stenting allowed if 1) >30% residual stenosis by online QCA or 2) >30% residual stenosis by IVUS and minimal cross sectional area <6 mm2.="">

Concomitant Medications:

GP IIb/IIIa receptor antagonists (7-11%)

Principal Findings:

The IVUS catheter would not cross the lesion before balloon dilation in 4% of patients and after PTCA in 3% of patients. Dissection leading to impaired flow was treated with stenting in 5% at the lesion site and in 2% of patients distal to the lesion site. Crossover to stenting occurred in 44% of patients randomized to IVUS guided PTCA. The nominal size of the balloon was greater in the PTCA group (3.60 mm v. 3.37 mm, p=0.001). Procedure times (51 min v. 39 min, p=0.001) and fluoroscopy times (10.6 min v. 8.6 min, p=0.01) were significantly longer in patients treated with IVUS guided PTCA. Contrast usage was also higher in this group (192 mL v. 158 mL, p=0.001). The mean lumen diameter after intervention was larger in the stent group (2.55 mm v. 2.75 mm, p=0.013) as was the cross sectional area (7.28 mm v. 6.6 mm, p=0.02). The residual stenosis was larger in the PTCA group (16% vs. 13%, p=0.001). At 6-month angiographic follow-up, restenosis rates were not significantly different (18.1% stent v. 16.8% PTCA, p=0.70) and which was within the non-inferiority primary endpoint hypothesis. There were no significant differences in mean lumen diameter (2.03 +/- 0.62 vs 1.97 +/- 0.72 mm, p=0.38), percent diameter stenosis (28 +/- 17 vs 31 +/- 20 mm, p=0.14) or cross sectional area on IVUS (5.24 +/- 2.51 vs 5.12 +/- 2.80 mm, p=0.57). The in-stent restenosis rate was higher in the stent group (15.5% v 5%, p=0.02) and the late loss trended higher (0.71 +/- 0.54 vs 0.55 +/- 0.60 mm, p=0.06). There was no difference in the 1 year composite clinical endpoint of death, MI, unstable angina, or TVR (20% vs 16%, p=0.52).


Among patients with stable or unstable angina or demonstrated ischemia, treatment with IVUS guided PTCA with provisional stenting was not inferior to systematic stent implantation with regard to the 6 month restenosis rate. While fewer stents would be placed using this strategy, increased technical demands as well as cost associated with IVUS catheter use, procedure time, and contrast use may make this strategy less attractive. This trial was underpowered and was not designed to detect differences in long-term clinical outcomes. The clinical and angiographic outcomes of this strategy in more complex lesions remains to be determined. Finally, this approach has obviously not been compared to that of drug eluting stents.


Circulation. 2003;107:545-551.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Nuclear Imaging

Keywords: Fluoroscopy, Follow-Up Studies, Drug-Eluting Stents, Constriction, Pathologic, Angioplasty, Balloon, Coronary

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