Randomized comparison of a sirolimus-eluting stent with a biolimus-eluting stent in patients treated with PCI: the SORT OUT VII trial

Transcription

1 euro P C R Randomized comparison of a sirolimuseluting stent with a biolimuseluting stent in patients treated with PCI: the SORT OUT VII trial Lisette Okkels Jensen, Per Thayssen, Michael Maeng, Jan Ravkilde, Lars Krusell, HansHenrik 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

2 P C R euro 2015 Potential conflicts of interest 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

3 Background Drugeluting stents have reduced the risk of instent restenosis. Compared to first generation drugeluting stents the second generation with thinner stent struts have improved safety and efficacy Persistence of polymer material on first and second generation drugeluting stent after completion of drug release has been suggested to be a trigger of a chronic inflammatory response Third generation coronary drugeluting stents with biodegradable polymers have been designed to improve safety and efficacy New ultrathin strut third generation stents have been developed and may further improve safety and efficacy SORT OUT VII 1Y

4 Primary Endpoint Objective: To compare the efficacy and safety of the thin strut, cobaltchromium biodegradable polymer sirolimuseluting Orsiro stent and the stainless steel biodegradable polymer biolimuseluting Nobori stent in an allcomer 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 patients in each treatment arm, a onesided significance level and a 90% power to detect noninferiority. Noninferiority margin of 3.0% Clinically driven event detection based on Danish registries SORT OUT VII 1Y

5 Criteria of inclusion Patient Population Inclusion period: November 2012 to February 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 12month 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

6 Patient Characteristics SIROLIMUSELUTING ORSIRO STENT BIOLIMUSELUTING NOBORI STENT No. of patients Age (years) 66.1 ± ± 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 ± ± 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 % p

7 Lesion Characteristics SIROLIMUSELUTING ORSIRO STENT BIOLIMUSELUTING NOBORI STENT No. of lesions 1,590 1,588 No. of lesions per patient Lesion type B2/C Reference vessel size (mm) 3.2 ± ± 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 % No. of stents Per patient 1.5 ± ± Per lesion 1.2 ± ± Total stent length (mm) Per patient 25.2 ± ± Per lesion 20.6 ± ± Direct stenting 14.5 % 13.7% 0.56 Stent delivery failure 1.6 % 2.1 % 0.36 p

8 1º Endpoint: Target Lesion Failure (Cardiac death, myocardial infarction index lesion related, target lesion revascularization) Sirolimuseluting stent 5.2% 4.9% Everolimuseluting stent

9 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 noninferiority < Sirolimuseluting stent NOBORI Everolimuseluting stent ORSIRO 5.2% 4.9% 4.6% 3.8%

10 Secondary Endpoints Rate Ratio % CI ; p=ns Rate Ratio % CI ; p=ns 1.4% 1.3% Sirolimuseluting stent 5.2% 4.9% 2.9% 2.0% Everolimuseluting stent Rate Ratio % CI ; p=ns Rate Ratio % CI ; p=ns 5.2% 4.1% 2.4% 1.6%

11 Stent Thrombosis Rate Ratio % CI ; p=0.03 Rate Ratio % CI ; p=0.11 NOBORI 1.2% Sirolimuseluting stent 5.2% NOBORI 1.6% 4.9% ORSIRO 0.4% Everolimuseluting stent 0.9% ORSIRO

12 Target Lesion Failure In subgroups Acute coronary syndrom NO Acute coronary syndrom YES Age 65 years Age > 65 years Diabetes mellitus NO Diabetes mellitus YES LAD NO LAD YES Lesion type C NO Lesion type C YES Male NO Male YES Multivessel disease NO Multivessel disease YES One stent per patient NO One stent per patient YES Previous MI NO Previous MI YES Previous PCI NO Previous PCI YES STEMI NO STEMI YES All Events (%) Hazard Ratio SES BES 95% CI P 21 (3.5) 27 (4.1) 15 (2.7) 33 (4.7) 37 (3.6) 11 (4.7) 22 (3.5) 26 (4.2) 26 (5.2) 22 (2.9) 13 (4.1) 35 (3.7) 39 (3.6) 9 (5.1) 25 (3.0) 23 (5.5) 36 (3.5) 12 (5.6) 38 (3.8) 10 (4.2) 31 (3.1) 17 (6.4) 48 (3.8) 29 (4.9) 29 (4.3) 28 (4.3) 30 (4.8) 42 (4.1) 16 (6.8) 32 (4.8) 26 (4.3) 33 (6.7) 25 (3.2) 15 (4.8) 43 (4.5) 52 (4.7) 6 (3.9) 39 (4.6) 19 (4.6) 43 (4.2) 13 (5.9) 42 (4.2) 15 (5.9) 46 (4.6) 12 (4.6) 58 (4.6) 0.70 ( ) 0.96 ( ) 0.60 ( ) 0.99 ( ) 0.88 ( ) 0.68 ( ) 0.71 ( ) 0.97 ( ) 0.77 ( ) 0.89 ( ) 0.86 ( ) 0.82 ( ) 0.77 ( ) 1.32 ( ) 0.65 ( ) 1.19 ( ) 0.84 ( ) 0.97 ( ) 0.90 ( ) 0.71 ( ) 0.68 ( ) 1.38 ( ) 0.83 ( ) Favours SES Favours BES

13 Conclusion The thin strut biodegradable polymer sirolimuseluting Orsiro stent was noninferior to the biodegradable polymer biolimuseluting Nobori stent in unselected patients for the combined safety and efficacy endpoint target lesion failure at 1 year The sirolimuseluting Orsiro stent was associated with a reduced risk of definite stent thrombosis SORT OUT VII 1Y

14 SORT OUT VII 1Y