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(Circulation. 2003;107:545.)
© 2003 American Heart Association, Inc.

Clinical Investigation and Reports

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; 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.).

Correspondence to François Schiele, MD, PhD, Department of Cardiology, University Hospital Jean-Minjoz, Boulevard Fleming, 25030 Besançon Cedex, France. 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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