euro P C R Randomized comparison of a sirolimus-eluting stent with a biolimus-eluting stent in patients treated with PCI: the SORT OUT VII trial Lisette Okkels Jensen, Per Thayssen, Michael Maeng, Jan Ravkilde, Lars Krusell, Hans-Henrik Tilsted, Anders Junker, Christian Juhl Terkelsen, Karsten Tange Veien, Anne Kaltoft, Anton Boel Villadsen, Jens Aaroe, Klára Berencsi, Svend Eggert Jensen, Knud Nørregaard Hansen, Steen Dalby Kristensen, Morten Madsen, Hans Erik Bøtker Henrik Steen Hansen, Bent Raungaard, Jens Flensted Lassen, Evald Høj Christiansen Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital - DENMARK
euro P C R Potential conflicts of interest 2015 Speaker's name: Lisette Okkels Jensen I have the following potential conflicts of interest to report: Honorarium: ABBOTT VASCULAR, ASTRAZENECA, BIOTRONIK, ST. JUDE MEDICAL Institutional grant/research support: BIOSENSORS INTERNATIONAL, BIOTRONIK, ST. JUDE MEDICAL, TERUMO SORT OUT VII 1Y
Background Drug-eluting stents have reduced the risk of in-stent restenosis. Compared to first generation drug-eluting stents the second generation with thinner stent struts have improved safety and efficacy Persistence of polymer material on first and second generation drug-eluting stent after completion of drug release has been suggested to be a trigger of a chronic inflammatory response Third generation coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy New ultra-thin strut third generation stents have been developed and may further improve safety and efficacy SORT OUT VII 1Y
Primary Endpoint Objective: To compare the efficacy and safety of the thin strut, cobalt-chromium biodegradable polymer sirolimus-eluting Orsiro stent and the stainless steel biodegradable polymer biolimus-eluting Nobori stent in an all-comer population Primary Endpoint: Target lesion failure : a composite of cardiac death, myocardial infarction (not related to other than index lesion) or target lesion revascularization within 1 year An event rate of 6.5% was assumed in each group. Sample size of 1.157 patients in each treatment arm, a one-sided 0.050 significance level and a 90% power to detect non-inferiority. Non-inferiority margin of 3.0% Clinically driven event detection based on Danish registries SORT OUT VII 1Y
Patient Population Inclusion period: November 2012 to February 2014 Criteria of inclusion 18 years of age or older Chronic stable coronary artery disease or acute coronary syndromes Criteria of exclusion Life expectancy less than one year Allergy to aspirin, clopidogrel, ticagrelor, sirolimus, or biolimus Participation in another randomized trial Unacceptable risk by 12-month dual antiplatelet treatment Unable to provide written informed consent No restrictions were placed on number of treated lesions, treated vessels or lesion length SORT OUT VII 1Y
Patient Characteristics SIROLIMUS-ELUTING BIOLIMUS-ELUTING p ORSIRO STENT NOBORI STENT No. of patients 1261 1264 Age (years) 66.1 ± 10.7 64.8 ± 10.8 <0.01 Male gender 74.9 % 75.2 % 0.84 Diabetes 18.7 % 18.6 % 0.94 Hypertension 58.1 % 56.4 % 0.39 Current smoker 29.1 % 32.5 % 0.07 Prior CABG 8.0 % 7.6 % 0.72 Prior PCI 19.0 % 20.4 % 0.39 Prior myocardial infarction 17.4 % 17.8 % 0.83 Body mass Index (kg/m 2 ) 27.5 ± 4.7 27.4 ± 4.4 0.63 Indication for PCI 0.47 Stable angina pectoris 44.3 % 43.9 % NSTEMI / Unstable angina pectoris 30.7 % 32.6 % STEMI 21.2 % 20.7 % Other 3.7 % 2.8 %
Lesion Characteristics SIROLIMUS-ELUTING BIOLIMUS-ELUTING p ORSIRO STENT NOBORI STENT No. of lesions 1,590 1,588 No. of lesions per patient 1.26 1.26 0.71 Lesion type B2/C 56.6 56.2 0.67 Reference vessel size (mm) 3.2 ± 0.6 3.1 ± 0.5 0.02 Left main artery 1.1 % 0.8 % 0.46 Left anterior descending artery 43.1 % 42.3 % Left circumflex artery 21.3 % 22.0 % Right coronary artery 33.1 % 33.7 % Saphenous vein graft 1.4 % 1.2 % Per patient No. of stents 1.5 ± 0.8 1.5 ± 0.8 0.49 Per lesion 1.2 ± 0.5 1.2 ± 0.5 0.45 Per patient Total stent length (mm) 25.2 ± 15.5 25.6 ± 16.6 0.50 Per lesion 20.6 ± 11.0 20.9 ± 11.5 0.47 Direct stenting 14.5 % 13.7% 0.56 Stent delivery failure 1.6 % 2.1 % 0.36
1º Endpoint: Target Lesion Failure (Cardiac death, myocardial infarction index lesion related , target lesion revascularization) Sirolimus-eluting stent 5.2% 4.9% Everolimus-eluting stent
1º Endpoint: Target Lesion Failure (Cardiac death, myocardial infarction index lesion related , target lesion revascularization) 12 months: ORSIRO 3.8% vs. NOBORI 4.6% P non-inferiority < 0.0001 Sirolimus-eluting stent 5.2% NOBORI 4.9% 4.6% 3.8% Everolimus-eluting stent ORSIRO
Secondary Endpoints Rate Ratio 0.89 95% CI 0.46-1.75; p=ns Rate Ratio 0.68 95% CI 0.41-1.12; p=ns 2.9% 1.4% 2.0% Sirolimus-eluting stent 5.2% 1.3% 4.9% Everolimus-eluting stent Rate Ratio 0.65 95% CI 0.37-1.13; p=ns Rate Ratio 0.79 95% CI 0.55-1.13; p=ns 5.2% 4.1% 2.4% 1.6%
Stent Thrombosis Rate Ratio 0.33 95% CI 0.12-0.92; p=0.03 Rate Ratio 0.55 95% CI 0.26-1.15; p=0.11 Sirolimus-eluting stent 5.2% NOBORI 1.6% 4.9% NOBORI 1.2% 0.9% ORSIRO Everolimus-eluting stent 0.4% ORSIRO
Target Lesion Failure In sub-groups Events (%) Hazard Ratio SES BES 95% CI P 0.70 (0.40 – 1.23) Acute coronary syndrom NO 21 (3.5) 29 (4.9) 0.43 0.96 (0.57 – 1.61) Acute coronary syndrom YES 27 (4.1) 29 (4.3) - Age ≤ 65 years 0.60 (0.32 – 1.13) 15 (2.7) 28 (4.3) 0.23 0.99 (0.60 – 1.62) Age > 65 years 33 (4.7) 30 (4.8) - 0.88 (0.57 – 1.37) Diabetes mellitus NO 37 (3.6) 42 (4.1) 0.56 0.68 (0.32 – 1.46) Diabetes mellitus YES 11 (4.7) 16 (6.8) - 0.71 (0.41 – 1.22) LAD NO 22 (3.5) 32 (4.8) 0.43 0.97 (0.56 – 1.66) LAD YES 26 (4.2) 26 (4.3) - 0.77 (0.46 – 1.29) Lesion type C NO 26 (5.2) 33 (6.7) 0.71 0.89 (0.50 – 1.58) Lesion type C YES 22 (2.9) 25 (3.2) - 0.86 (0.41 – 1.80) Male NO 13 (4.1) 15 (4.8) 0.92 0.82 (0.52 – 1.28) Male YES 35 (3.7) 43 (4.5) - 0.77 (0.51 – 1.16) Multi-vessel disease NO 39 (3.6) 52 (4.7) 0.34 1.32 (0.47 – 3.71) Multi-vessel disease YES 9 (5.1) 6 (3.9) - 0.65 (0.39 – 1.07) One stent per patient NO 25 (3.0) 39 (4.6) 0.13 1.19 (0.65 – 2.18) One stent per patient YES 23 (5.5) 19 (4.6) - 0.84 (0.54 – 1.31) Previous MI NO 36 (3.5) 43 (4.2) 0.77 0.97 (0.44 – 2.12) Previous MI YES 12 (5.6) 13 (5.9) - 0.90 (0.58 – 1.39) Previous PCI NO 38 (3.8) 42 (4.2) 0.61 0.71 (0.32 – 1.58) Previous PCI YES 10 (4.2) 15 (5.9) - 0.68 (0.43 – 1.07) STEMI NO 31 (3.1) 46 (4.6) 0.10 1.38 (0.66 – 2.90) STEMI YES 17 (6.4) 12 (4.6) - 0.83 (0.56 – 1.21) All 48 (3.8) 58 (4.6) - Favours SES Favours BES
Conclusion The thin strut biodegradable polymer sirolimus-eluting Orsiro stent was non-inferior to the biodegradable polymer biolimus-eluting Nobori stent in unselected patients for the combined safety and efficacy endpoint target lesion failure at 1 year The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis SORT OUT VII 1Y
SORT OUT VII 1Y
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