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 mm(2) (DS) and 8.07+/-2.37 mm(2) (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.