ABSTRACT

The ABSORB II trial is a prospective, randomized, active-controlled, single-blind, parallel two-arm, multicenter clinical trial. At that time, clinical evidence of the everolimus-eluting Absorb scaffold had been attained without the use of a comparator. There was a need to conduct a trial with the metallic comparator that was at that time the best-in-class drug-eluting stent. Angiography was documented prior to and after intracoronary administration of nitrate to assess vasomotion. Multiple matched angiographic views were used for the assessment of vasomotion and long-term luminal dimensions. For quantitative coronary angiography, preprocedural measurements did not differ between the two groups, whereas for quantitative intravascular ultrasound, both preprocedural vessel area and plaque area were larger in the metallic stent group than in the bioresorbable scaffold group. Rates of clinical device success and clinical procedural success were similar in the two treatment groups. The chapter tabulates the characteristics of patients and lesions at baseline.