PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses

Aims: Assess clinical, angiographic, and intravascular ultrasound results in lesions treated with the PROMUS Element platinum chromium everolimus-eluting stent (EES). Methods and results: Patients (N=100) with one de novo target lesion <34 mm long and reference vessel diameter (RVD) ≥2.25―≤4.25 mm were enrolled at 14 sites. The primary endpoint was the 30-day composite of cardiac death, myocardial infarction, target lesion revascularisation (TLR), or definite/probable stent thrombosis (ST). The efficacy endpoint of 9-month in-stent late loss in workhorse lesions (defined as RVD ≥2.5―≤4.25 mm, lesion <24 mm) was compared to a performance goal based on historical results with TAXUS Express paclitaxel-eluting stents. Post-procedure incomplete stent apposition (ISA) was compared to a performance goal based on results with the PROMUS/XIENCE V EES in SPIRIT III. Mean age was 61.8±9.9 years; 77.0% were male; 19% had medically treated diabetes. Baseline RVD was 2.72±0.53 mm; lesion length was 15.4±7.0 mm. The primary endpoint occurred in one patient (periprocedural ST with TLR) with no additional major clinical events through one year. Nine-month in-stent late loss in workhorse lesions (0.17±0.25 mm, N=73) and post-procedure ISA (5.7%, 5/88) were below performance goals (p<0.001). Conclusions: Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA.