Lisette Okkels Jensen, Per Thayssen, Henrik Steen Hansen, Evald Høj Christiansen, Hans Henrik Tilsted, Lars Romer Krusell, Anton Boel Villadsen, Anders Junker, Knud Nørregaard Hansen, Anne Kaltoft, Michael Maeng, Knud Erik Pedersen, Steen Dalby Kristensen, Hans Erik Bøtker, Jan Ravkilde, Richardo Sanchez, Jens Aarøe, Morten Madsen, Henrik Toft Sørensen, Leif Thuesen, Jens Flensted Lassen Odense University Hospital, Aarhus University Hospital Skejby and Aalborg, Varde Denmark A Prospective, Randomized Trial of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease The SORT OUT IV Trial

Lisette Okkels Jensen, MD DMSci, Ph.D. FESC: Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) listed below.  Cordis, Johnson & Johnson: CEC member  Abbott: Advisory board member Disclosure Statement of Financial Interest

Background  Compared with bare metal stents, first-generation drug-eluting stents, such as sirolimus- and paclitaxel-eluting stents, have shown improved results and reduced the need for repeat revascularization, as assessed in randomized trials  Second-generation drug-eluting stents were designed to improve efficacy, safety, and device performance  The sirolimus-eluting stent has demonstrated the least amount of late lumen loss among previously released first-generation drug- eluting stents, but its efficacy and safety have not been compared head-to-head with the second-generation everolimus-eluting stent

SORT OUT IV - Objective The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IV trial. To compare the efficacy and safety of the first-generation sirolimus- eluting Cypher Select+ stent and the second-generation everolimus- eluting Xience V/Promus stent in a population-based healthcare setting.

Endpoint  Primary Clinical Endpoint: Major Adverse Cardiac Events at 9 months (composite of cardiac death, myocardial infarction, definite stent thrombosis and clinically driven target vessel revascularization)  Non-inferiority margin of and one-sided type I error of 0.05  2,678 patients would yield >80% power to detect non-inferiority

Klik for at redigere undertiteltypografien i masteren Patient Characteristics EVEROLIMUS- ELUTING STENT SIROLIMUS- ELUTING STENT No. of patients Age (years)64.2 ± ± Men75.9 %75.2 %0.68 Diabetes14.0 %14.2 %0.88 Hypertension56.7 %53.8 %0.15 Lipid-lowering therapy71.1 % 1.00 Current smoker29.2 %30.4 %0.53 Prior CABG9.6 %8.0 %0.16 Prior percutaneous coronary intervention21.5 %20.6 %0.58 Prior myocardial infarction22.6 %21.3 %0.46 Body mass Index (kg/m2)27.5 ± ±

Klik for at redigere undertiteltypografien i masteren Patient Characteristics EVEROLIMUS- ELUTING STENT SIROLIMUS- ELUTING STENT No. of patients Indication for PCI0.46 Stable angina55.6 %54.5% NSTEMI / unstable angina32.9 %32.7 % STEMI8.8 %10.5 % Other2.7 %2.3 %

Klik for at redigere undertiteltypografien i masteren Lesion Characteristics EVEROLIMUS- ELUTING STENT SIROLIMUS- ELUTING STENT No. of lesions per patient1.3 ± No. of stents Per patient1.6 ± ± Per lesion1.3 ± ± Total stent length (mm) Per patient26.4 ± ± Per lesion20.3 ± ± Direct stenting22.4 %20.4 %0.14 Maximum pressure (atm)16.4 ± ± 4.2 Stent delivery failure2.9 %2.0 %0.08 Use of glycoprotein IIb/IIIa inhibitors15.3 %16.9 %0.26 <0.001

Sirolimus-eluting stent Everolimus-eluting stent 5.2% 4.9% 1º Endpoint: Major Adverse Cardiac Events (Cardiac death, myocardial infarction, definite stent thrombosis, target vessel revascularization)

Sirolimus-eluting stent Everolimus-eluting stent 5.2% 4.9% 1º Endpoint: Major Adverse Cardiac Events (Cardiac death, myocardial infarction, definite stent thrombosis, target vessel revascularization)

Sirolimus-eluting stent Everolimus-eluting stent 5.2% 4.9% EES 4.9% vs. SES 5.2% Pnon-inferiority = 0.01 Primary Non-Inferiority Endpoint Met 1º Endpoint: Major Adverse Cardiac Events (Cardiac death, myocardial infarction, definite stent thrombosis, target vessel revascularization)

Conclusion  Both the sirolimus-eluting and the everolimus-eluting stents were associated with low major adverse cardiac events  The everolimus-eluting stent was found to be non-inferior to the sirolimus-eluting stent for patients treated with percutaneous coronary intervention