P C R Randomized comparison of a sirolimus-eluting stent with a - - PowerPoint PPT Presentation

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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

Potential conflicts of interest

SORT OUT VII 1Y

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

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2015

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 ORSIRO STENT BIOLIMUS-ELUTING NOBORI STENT

p

• 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/m2) 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 ORSIRO STENT BIOLIMUS-ELUTING NOBORI STENT

p

• 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 %

• No. of stents

Per patient

1.5 ± 0.8 1.5 ± 0.8 0.49

Per lesion

1.2 ± 0.5 1.2 ± 0.5 0.45 Total stent length (mm)

Per patient

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 infarctionindex lesion related, target lesion revascularization)

Sirolimus-eluting stent Everolimus-eluting stent

5.2% 4.9%

Sirolimus-eluting stent Everolimus-eluting stent

5.2% 4.9%

1º Endpoint: Target Lesion Failure

(Cardiac death, myocardial infarctionindex lesion related, target lesion revascularization)

12 months: ORSIRO 3.8% vs. NOBORI 4.6% Pnon-inferiority < 0.0001

ORSIRO NOBORI 3.8% 4.6%

Sirolimus-eluting stent Everolimus-eluting stent

5.2% 4.9%

Secondary Endpoints

Rate Ratio 0.89 95% CI 0.46-1.75; p=ns Rate Ratio 0.65 95% CI 0.37-1.13; p=ns Rate Ratio 0.68 95% CI 0.41-1.12; p=ns Rate Ratio 0.79 95% CI 0.55-1.13; p=ns

1.3% 1.4% 1.6% 2.4% 2.0% 2.9% 4.1% 5.2%

Sirolimus-eluting stent Everolimus-eluting stent

5.2% 4.9%

Stent Thrombosis

ORSIRO NOBORI 0.9% 1.6% ORSIRO NOBORI 0.4% 1.2%

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

Target Lesion Failure

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 Multi-vessel disease NO Multi-vessel 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 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 (0.40 – 1.23) 0.96 (0.57 – 1.61) 0.60 (0.32 – 1.13) 0.99 (0.60 – 1.62) 0.88 (0.57 – 1.37) 0.68 (0.32 – 1.46) 0.71 (0.41 – 1.22) 0.97 (0.56 – 1.66) 0.77 (0.46 – 1.29) 0.89 (0.50 – 1.58) 0.86 (0.41 – 1.80) 0.82 (0.52 – 1.28) 0.77 (0.51 – 1.16) 1.32 (0.47 – 3.71) 0.65 (0.39 – 1.07) 1.19 (0.65 – 2.18) 0.84 (0.54 – 1.31) 0.97 (0.44 – 2.12) 0.90 (0.58 – 1.39) 0.71 (0.32 – 1.58) 0.68 (0.43 – 1.07) 1.38 (0.66 – 2.90) 0.83 (0.56 – 1.21) 0.43

• 0.23
• 0.56
• 0.43
• 0.71
• 0.92
• 0.34
• 0.13
• 0.77
• 0.61
• 0.10
• Events (%)

Hazard Ratio SES BES 95% CI P

Favours SES Favours BES

In sub-groups

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
• f definite stent thrombosis

SORT OUT VII 1Y

SORT OUT VII 1Y