One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study

Aims: The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective,
open-label, multicentre observational study designed to assess outcomes following PROMUS Element
everolimus-eluting stent implantation in an unselected patient population.
Methods and results: A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9%
with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8%
with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target
lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel
failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac
death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%,
and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related
to the PROMUS Element stent.
Conclusions: In a large and relatively complex group of “real-world” patients, coronary artery revascularisation
with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates
consistent with those reported for other contemporary drug-eluting stents.