PROMUS Element Plus US Post-Approval Study

The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo
lesions. The PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
is indicated for improving luminal diameter in patients with symptomatic heart disease or
documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to
≤4.00 mm in diameter in lesions ≤34 mm in length. The proposed study will compile real-world
clinical outcomes data for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium
Coronary Stent System in routine clinical practice.

Patients enrolled in this study are expected to follow antiplatelet therapy recommendations
per American College of Cardiology (ACC)/American Heart Association (AHA)/Society for
Cardiovascular Angiography and Interventions (SCAI) guidelines for percutaneous coronary
intervention (PCI). Recommended medications include aspirin, which should be taken for 3 days
prior to the procedure or as a peri-procedural loading dose and then continued indefinitely.
Additionally, one of the following P2Y12 antagonists may be given in a peri-procedural
loading dose and in a maintenance dose per physician discretion: clopidogrel, prasugrel,
ticagrelor, or ticlopidine.

Inclusion Criteria:

- The population will include consecutive, consented patients.

Exclusion Criteria:

- There are no exclusion criteria in this all-comers study.