Final 5-Year Results in Unselected Patients Implanted With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study)

• Published in: The American journal of cardiology Vol. 123; no. 11; pp. 1765 - 1771
• Main Authors: Kandzari, David E., Amjadi, Nima, Caputo, Christopher, Rowe, Steven K., Chen, Henry, Williams, Jerome, Tamboli, Hoshedar P., Underwood, Paul L., Allocco, Dominic J., Meredith, Ian T.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2019; Elsevier Limited
• Subjects: Blood vessels; Chromium; Chromium plating; Clinical outcomes; Combined Modality Therapy; Coronary Artery Disease - therapy; Diabetes; Diabetes mellitus; Drug-Eluting Stents; Enrollments; Everolimus - administration & dosage; Female; Heart attacks; Humans; Implants; Inhibitor drugs; Lesions; Male; Myocardial infarction; Patients; Platinum; Prospective Studies; Prosthesis Design; Risk groups; Safety; Stents; Subgroups; Surgical implants; Thromboembolism; Thrombosis; Time Factors; Transplants & implants; Treatment Outcome; United States; United States; United States > US
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2019.02.041

PROMUS Element (PE) Plus post-approval study was a large prospective, observational, all-comers study designed to evaluate the safety and performance of a thin-strut platinum chromium everolimus-eluting PE Plus stent in everyday clinical practice. A total of 2,683 “real-world” patients with limited clinical or anatomic exclusion criteria were enrolled at 52 clinical sites in the United States. The study met its primary end point of 12-month cardiac death or myocardial infarction (CD/MI) compared with a prespecified performance goal (p <0.0001). Five-year clinical outcomes were evaluated in overall PE Plus post-approval study patients and high-risk subgroups. During the 5-year follow-up period, CD/MI and stent thrombosis related to the PE Plus stent occurred in 9% and 2.2% overall patients, respectively. The reported all-cause mortality rate was 15%, with 7% classified as cardiac-related. A total of 18% patients underwent target vessel revascularization, and 11% were reported as target lesion revascularization. The rates of PE Plus stent-related CD/MI remained low in patients with medically treated diabetes (13%), small vessels (9%), and long stents (10%). PE Plus stent-related thrombosis through 5 years in patients with diabetes, small vessels and long stents was 4.2%, 2.2%, and 2.6%, respectively. The occurrence of target lesion revascularization was numerically higher in patients with diabetes (16%) and long lesions (18%) than the small vessels subgroup (11%). In conclusion, the final 5-year results establish the long-term safety and efficacy of the PE Plus stent in a broad, unselected patient population representative of “real-world” clinical practice.