LEADERS: 5-Year Follow-up
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1 LEADERS: -Year Follow-up from a Prospective, Randomized Trial of Biolimus A9-eluting Stents with a Biodegradable Polymer vs. Sirolimus-eluting Stents with a Durable Polymer : Final Report of the LEADERS study Presented by P. Serruys at TCT 212 On behalf of the LEADERS investigators EN
2 Biolimus-A9 Eluting Stent Biolimus is a semi-synthetic sirolimus analogue with 1x higher lipophilicity and similar potency as sirolimus. Biolimus is immersed at a concentration of 1.6 g/mm into a biodegradable polymer, polylactic acid, and applied solely to the abluminal stent surface by a fully automated process. Biolimus is co-released with polylactic acid and completely desolves into carbon dioxide and water after a 6-9 months period. The stainless steel stent platform has a strut thickness of 12 m with a quadrature link design.
3 LEADERS all-comers Trial Design Stable and ACS Patients Undergoing PCI Assessor-blind 1:1 Randomisation N=17 Patients 1 European centers BioMatrix Flex () N=8 Cypher Select () N=8 1:3 Randomisation Clinical F/U N=64 Angio F/U N=21 Clinical F/U N=64 Angio F/U N=21 1 o endpoint: MACE: Cardiac death, MI, clinically-indicated TVR (9 mo) 2 o endpoints: Death, CV death, MI, TLR, TVR Stent thrombosis according to ARC Angiographic study: In-stent % diameter stenosis (9 mo) Late loss, binary restenosis DAPT recommended for 12 months
4 Patient Demographics 87 Patients 8 Patients Age in years Male gender 7% 7% Arterial hypertension 74% 73% Diabetes mellitus 26% 23% - insulin-dependent 1% 9% Hypercholesterolemia 6% 68% Family history of CAD 4% 44% Smoking 24% 2% Previous MI 32% 33% Previous PCI 36% 37% - with drug-eluting stent 12% 14% Previous CABG 11% 13%
5 Patient Characteristics 87 Patients 8 Patients Chronic stable angina 4% 44% Acute coronary syndrome % 6% Unstable angina 22% 21% Non-ST-elevation MI 17% 18% ST-elevation MI 16% 17% Left ventricular ejection fraction 6 11% 12% Number of lesions per patient Lesions per patient 1 lesion 63% 69% 2 lesions 29% 22% 3 lesions 7% 8% > 4 lesions 1% 2% De novo lesions 92% 91% Long lesions (>2 mm) 31% 27% Small vessels (RVD 2.7 mm) 68% 67% Off label use 81% 78%
6 Patient Flow - Clinical (N=87) (N=839) (N=832) (N=819) (N=838) (N=833) Randomized (N=1,77) 1-year follow-up (N=1,669; 97.8%) 2-year follow-up (N=1,67; 97.1%) 3-year follow-up (N=1,636; 9.8%) 4-year follow-up (N=1,663; 97.4%) -year follow-up (N=1,647; 96.%) (N=8) (N=83) (N=82) (N=817) (N=82) (N=814) 13 Lost to FU 2 lost to FU and alive 11 lost to FU and vital status unknown 11 withdrew 24 Lost to FU 8 lost to FU and alive 16 lost to FU and vital status unknown 12 withdrew
7 MACE (Cardiac Death, MI and ci-tvr) year RR.88 ( ) P=.38* 12.1% Δ % 2-year RR.83 ( ) P=.1* 1.% Δ % 3-year RR.8 ( ) P=.6* 19.3% Δ % 4-year RR.82 ( ) P=.9* 23.1% Δ % -year RR.83 ( ) P=.71* 26.1 % Δ % P non-inferiority < Number at risk MACE = cardiac death, MI, or clinically-indicated TVR
8 Cardiac Death year RR.78 ( ) P=.42* 2-year RR.79 ( ) P=.36* 3-year RR.81 ( ) P=.34* 4-year RR.88 ( ) P=.2* -year RR.94 ( ) P=.72* % 2.7% 4.%.2% 6.9% Δ.8 Δ.4 Δ.8 Δ 1. Δ.6 8. % 2.1% 3.2% 4.2% 6.1% Number at risk
9 MI year RR 1.27 ( ) P=.26* 2-year RR 1.12 ( ) P=.7* 3-year RR 1.1 ( ) P=.97* 4-year RR.97 (.7-1.3) P=.87* -year RR.96 ( ) P=.79* % 7.3% 9.%.9% 6.4% Δ 1.3 Δ.7 Δ.1 Δ.4 Δ.6 4.6%.7% 7.2% 8.6% % Number at risk
10 QW-MI 6 1-year RR.6 ( ) P=.36* 2-year RR.49 ( ) P=.2* 3-year RR.39 ( ) P=.12* 4-year RR.3 ( ) P=.17* -year RR.49 ( ) P=.98* % 1.% 1.2% 1.6%.8% Δ.3 Δ. Δ.7 Δ 1. Δ.7.%.%.%.9% 1.% Number at risk
11 Non QW-MI year RR 1.38 ( ) P=.1* 2-year RR 1.2 ( ) P=.38* 3-year RR 1.4 ( ) P=.82* 4-year RR 1. ( ) P=.98* -year RR.99 ( ) P=.9* 1 1.4% Δ % 4.9%.9% 6.8% Δ 1. Δ.4 6.4% 9. % 7.8% Δ.1 Δ.1 7.7% 8.9 % Number at risk
12 Clinically-Indicated TVR year RR.82 ( ) P=.3* 7.2% Δ % 2-year RR.8 ( ) P=.34* 3-year RR.8 (.9-1.8) P=.1* 8.9% 11.% Δ 1.2 Δ % 4-year RR.81 ( ) P=.14* 13.6% Δ % 11.2% -year RR.81 (.63-1.) P=.12* 1.% Δ % Number at risk
13 Patient Oriented Composite Endpoint (All-cause Death, Any MI, All Revascularization) Number at risk 1-year RR.84 ( ) P=.11* 21.6% Δ % 2-year RR.83 (.68-1.) P=.* 26.4% Δ % 3-year RR.81 ( ) P=.18* 31.8% Δ % 4-year RR.83 (.7-.98) P=.24* 36.2% Δ.2 31.% POCE = all death, MI, any revascularization (includes adjudicated and non-adjudicated events) -year RR.84 ( ) P=.24* 4.4% Δ.3 3.1%
14 Definite Stent Thrombosis (ARC) year RR.99 ( ) P=.98* 2.% Δ. 2-year RR.9 ( ) P=.73* 2.% 2.2% 3-year RR.78 ( ) P=.43* 4-year RR.62 (.3-1.8) P=.9* 4.% 2.% 2.9% Δ.3 Δ.7 Δ % 2.4% -year RR.6 (.3-1.2) P=.6* 4. % Δ % Number at risk
15 Effect of DAPT Discontinuation. Overall Population P =.62* Patient who d/c DAPT P =.3* P =.2* N=22/87 N=36/8 Y definite ST in LEADERS..3 N=/16 N=6/16 definite ST after DAPT d/c < 12 M N=2/9 N=1/72 definite ST after DAPT d/c > 12 M (Fisher Exact Test)
16 Definite ST (ARC) Landmark 1 Year 6 to 1 year RR.99 (.1-1.9) P=.98* 1 to year RR.26 (.1-.68) P=.3* 4 % 3 2. % 2 2. % 2. % 1.66 % P for interaction=.22
17 Cumulative incidence events (%) Cumulative incidence events (%) Cumulative incid 1 1 able) or triangle (possible) d: d: MACE Days Days since since Procedure Durable/Biodegradable Polymer DES Clinical Events (Corrected KM Estimates) Linked to to ARC Definition ST Definite ST Probable ST Cardiac Death/MI/Ci TVR Cardiac Death/MI Leaders Y: Leaders Y: Event incidence Possible curves, showing events ST related to ST as circle Cardiac (definite), square (probable) Death or triangle (possible) Event incidence curves, showing events related to ST as circle (definite), square (probable) or triangle (possible) Censoring 4 events related 6 to definite, 7 probable 8 and 9 possible 1 ST Censoring 2 events related to definite, probable and possible ST Black: Cardiac Death, Green: Composite of Cardiac Death and MI, Red: MACE Black: Cardiac Death, Green: Composite of Cardiac Death and MI, Red: MACE Days since Procedure Durable Polymer () Days 14 since 1 Procedure Days since Procedure Days since Procedure 4 6 Days Days since since Procedure Days since Procedure Δ 8.2% 2 Biodegradable Polymer () Δ 6.4% Δ 8.7% 1 Δ 7.4% Δ 6.4% Δ 6.% Days since Procedure Days since Procedure
18 Stratified Analysis of Years Favors Favors RR (9%CI) P* Overall 186 (21.7) 216 (2.4).83 (.68 to 1.2).69 Diabetes mellitus ACS Yes 66 (29.6) 6 (29.3) 1.2 (.71 to 1.46).91 No 94 (14.8) 136 (2.6).7 (.4 to.91).7 P for interaction Yes 83 (17.7) 16 (22.4).77 (.8 to 1.3).73 No 77 (19.9) 86 (22.8).86 (.63 to 1.18).3 ST elevation MI.4 Yes 1 (11.1) 32 (22.9).4 (.24 to.83).9 No 14 (2.1) 16 (22.).89 (.71 to 1.11).29 Left anterior descending ns Yes 74 (18.2) 8 (2.4).88 (.64 to 1.2).41 No 86 (19.2) 17 (24.8).76 (.7 to 1.1).6 Multivessel disease ns Yes 44 (21.1) 48 (27.3).7 (.49 to 1.13).16 No 116 (17.9) 144 (21.4).83 (.6 to 1.6).13 De-novo lesions ns Yes 139 (17.6) 16 (21.3).81 (.6 to 1.2).76 No 21 (3.9) 27 (36.).82 (.46 to 1.4).49 Small-vessel disease ns Yes 12 (2.) 131 (23.1).88 (.69 to 1.13).33 No 4 (14.8) 61 (21.8).6 (.44 to.97).33 Long lesions ns Yes 4 (2.6) 63 (28.).72 (. to 1.3).71 No 16 (17.8) 129 (2.7).8 (.66 to 1.1).21 ns ns All p-values are for superiority * Mantel Cox p-value
19 Conclusions Biodegradable polymer maintained non-inferiority and improved long-term clinical outcomes compared to through years (P sup =.71) Biodegradable polymer demonstrated a 74% relative risk reduction in very late definite stent thrombosis (VLST) The benefit of biodegradable polymer emerged in the very late phase and was mainly driven by a lower risk of MACE associated with definite VLST
20 Biolimus A9, BA9, and BioMatrix Flex are trademarks or registered trademarks of Biosensors International group, Ltd. All cited trademarks are the property of their respective owners Not available for sale in the United States and certain other countries. 212 Biosensors International Group, Ltd. All rights reserved
21 All Death year RR.96 ( ) P=.87* 3.3% Δ.1 3.2% 2-year RR.88 (.8-1.3) P=.7* 3-year RR.8 ( ) P=.24*.3% 7.6% Δ 1.4 Δ.6 4.7% 6.2% 4-year RR.9 ( ) P=.48* 1.4% Δ % -year RR.88 ( ) P=.34* 13.7 % Δ % Number at risk
22 Years Separated by Median SYNTAX Score (12) The SYNTAX score has no significant effect on the primary endpoint between and Syntax Score 12 Syntax Score 12 Syntax Score <12 Syntax Score <12 Low Syntax (< 12) vs. -year RR.86 ( ) P=.43* High Syntax ( 12) vs. -year RR.71 (.3-.9) P=.21* 3.3% 22.7% 18.8% 16.4% 1 Interaction p-value:.4 Log rank (low vs. high) p-value: <
23 Definite Years Separated by Median SYNTAX Score (12) is associated with a significant reduction in definite ST in the higher SYNTAX scores Syntax Score 12 Syntax Score 12 Syntax Score <12 Syntax Score <12 Low Syntax (< 12) vs -year RR 1.37 ( ) P=.6* High Syntax ( 12) vs -year RR.38 ( ) P=.1* 6.6% 4 2 Interaction p-value:.6 Log rank (high vs. low) p-value: % 2.4% 1.9%
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