Comparison of angiographically guided direct stenting technique with direct stenting and optimal balloon angioplasty guided with intravascular ultrasound. The multicenter, randomized trial results

Aim The primary objective of the trial was to test the hypothesis that intravascular ultrasound (IVUS) guidance for coronary angioplasty is superior to the quantitative coronary angiography approach both during stenting and plain balloon angioplasty. Methods Two hundred fifty-nine patients (70 females, 189 males; mean age, 54 ± 9) were enrolled into our study. They were randomized into 3 groups: group 1—direct stenting guided with quantitative coronary angiography; group 2—direct stenting guided with IVUS; group 3—optimal balloon angioplasty guided with IVUS. At 6-month follow-up, we recorded evidence of major adverse cardiac events (death, myocardial infarction, repeat coronary revascularization). Results Procedural success was achieved in 95% of cases. At 6-month follow-up, the evidence of composite end point (major adverse cardiac events) was 16.2%, 7.3%, and 21.8% in groups 1, 2, and 3, respectively (P < .05). Use of IVUS led to 55% reduction of the primary end point between group 1 and group 2. The same when compared to the balloon angioplasty group assumed 66% reduction. Conclusion Ultrasound guidance for direct stenting is the most effective for long-term outcome in comparison with other strategies. It is very likely that bigger lumen gain due to appropriate device sizing is responsible for better outcome. Direct stenting guided with IVUS might be an alternative option for patients requiring coronary revascularization and have contraindications to prolonged antiplatet therapy as is mandatory for drug-eluting stent implantation.