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European Heart Journal Advance Access originally published online on May 11, 2005
European Heart Journal 2005 26(18):1852-1859; doi:10.1093/eurheartj/ehi286
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org

Angiographic, intravascular ultrasound, and fractional flow reserve evaluation of direct stenting vs. conventional stenting using BeStent2 in a multicentre randomized trial

William Wijns1,*, Stefan Verheye2, Ganesh Manoharan1, Gerald S. Werner3, Eberhard Grube4, Bernard De Bruyne1, Jacques Koolen5, Christian W. Hamm6, Alfonso Medina7, Jan Willem Bech8, Pim J. De Feyter9 for the CONVERTIBLE investigators

1Cardiovascular Centre, OLV Hospital, Moorselbaan 164, 9300 Aalst, Belgium
2AZ Middelheim, Antwerpen, Belgium
3Friedrich-Schiller-Universitat Jena, Jena, Germany
4Krankenhaus Siegburg GmbH, Siegburg, Germany
5Catharina Ziekenhuis, Eindhoven, The Netherlands
6Kerckhoff-Klinik GmbH Bad Nauheim, Nauheim, Germany
7Hospital de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria
8Reinier de Graaf Gasthuis, Delft, The Netherlands
9Erasmus Medical Centre, Rotterdam, The Netherlands

Received 22 August 2004; revised 13 February 2005; accepted 24 March 2005; online publish-ahead-of-print 11 May 2005.

* Corresponding author. Tel: +32 53724439; fax: +32 53724185. E-mail address: william.wijns{at}olvz-aalst.be

Aims Direct stenting (DS) may not be as safe and effective as conventional stenting. The objective was to demonstrate equivalence of post-procedural mean luminal diameter (MLD) by angiography after BeStent2 placement between DS and pre-dilatation (PD) strategy.

Methods and results Two hundred and two patients with a single de novo lesion (diameter ≥3.0 mm and length ≤13 mm) were randomized to DS (n=101) vs. PD. Stent deployment was guided by on-line quantitative coronary angiography (QCA). A second randomization assigned half of the patients to intravascular ultrasound (IVUS) and fractional flow reserve (FFR) assessment. QCA was repeated at 6 months. Baseline characteristics were similar. Crossover to PD was necessary in seven DS patients. Stent deployment was successful in 97% (DS) and 98% (PD). The post-procedural MLD was 2.79±0.45 mm (DS) and 2.76±0.40 mm (PD). The null-hypothesis of non-equivalence could be rejected (95% one-sided; P=0.0003). The minimum stent area (IVUS) was 7.89±1.75 mm2 (DS) and 8.07±2.37 mm2 (PD; P=0.69), with an FFR of 0.92±0.07 and 0.92±0.05, respectively (P=0.97). Major adverse cardiac event rates at 6 months were 9% (DS) and 11% (PD; P=0.93). Target lesion re-angioplasty was 6% (DS) and 5% (PD; P=0.77). The in-stent restenosis rate by QCA was 7.4% (DS) and 6.8% (PD; P=0.87).

Conclusion DS with BeStent2 is equivalent to PD. Both strategies resulted in a low angiographic restenosis rate.

Key Words: Direct stenting • Restenosis • Angioplasty • IVUS • FFR


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