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on January 20, 2003

Circulation. 2003
Published online before print January 20, 2003, doi: 10.1161/01.CIR.0000047212.94399.7E
A more recent version of this article appeared on February 4, 2003
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Submitted on July 11, 2002
Revised on October 18, 2002
Accepted on October 20, 2002

Intravascular Ultrasound-Guided Balloon Angioplasty Compared With Stent. Immediate and 6-Month Results of the Multicenter, Randomized Balloon Equivalent to Stent Study (BEST)

François Schiele MD, PhD*, Nicolas Meneveau MD, PhD, Martine Gilard MD, Jacques Boschat MD, Philippe Commeau MD, Liu Pin Ming MD, Pradip Sewoke MD, Marie-France Seronde MD, Mariette Mercier MD, Sanjiv Gupta MD, and Jean-Pierre Bassand MD

From the University Hospital Jean-Minjoz, Besançon, France (F.S., N.M., L.P.M., P.S., M.-F.S., M.M., S.G., J.-P.B.); the Hôpital de la Cavale Blanche, CHU Brest, France (M.G., J.B.); and CHP St Martin, Caen, France (P.C.).

* To whom correspondence should be addressed. E-mail: francois.schiele{at}ufc-chu.univ-fcomte.fr.

Background--Balloon angioplasty guided by intravascular ultrasound (IVUS) makes it possible to choose the balloon size according to the true vessel diameter and to detect suboptimal results requiring subsequent stent implantation. The Balloon Equivalent to STent (BEST) study aimed to assess whether this strategy would give the same results as systematic stenting.

Methods and Results--A total of 132 of 254 patients were randomized to IVUS-guided percutaneous transluminal coronary angioplasty (aggressive PTCA), and 122 were randomized to stenting (stent group). We hypothesized that a difference of <8% in the 6-month angiographic restenosis rate (primary end point) could be considered noninferior. The aggressive PTCA procedure was longer and had a greater use of contrast medium than stenting. In the aggressive PTCA group, crossover to stent was needed in 58 patients (44%). At 6 months, 20 of 119 patients (16.8±6.7%) in the aggressive PTCA group and 21 of 116 patients (18.1±7.0%) in the stent group had restenosis. The difference was -1.3%, with an upper limit of 95% confidence interval of 7.1% (ie, less than the noninferiority boundary). The in-stent restenosis rate was higher in the stent group (15.5% versus 5%; P=0.02). The differences in minimum lumen diameter, lumen cross-section area, and 1-year event rate were not significant.

Conclusions--A strategy of IVUS-guided angioplasty with provisional stenting is feasible and safe. At the cost of a more complex procedure, it reduces the stent rate by half, with similar 6-month angiographic IVUS and clinical outcome compared with stent implantation.


Key words: angioplasty • ultrasonics • stent • restenosis




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