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European Heart Journal Advance Access published online on May 11, 2005
European Heart Journal, doi:10.1093/eurheartj/ehi286
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved
Received August 22, 2004
Revised February 13, 2005
Accepted March 24, 2005

Clinical research

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

William Wijns 1*, Stefan Verheye 2, Ganesh Manoharan 1, Gerald S. Werner 3, Eberhard Grube 4, Bernard De Bruyne 1, Jacques Koolen 5, Christian W. Hamm 6, Alfonso Medina 7, Jan Willem Bech 8, Pim J. De Feyter 9, and for the CONVERTIBLE investigators

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

* To whom correspondence should be addressed.
William Wijns, E-mail: william.wijns{at}olvz-aalst.be


  Abstract

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.

Keywords: Direct stenting; Restenosis; Angioplasty; IVUS; FFR.
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