LEADERS FREE ACS EN - Rev.01

Transcription

1 C.K. Naber, P. Urban, P.J. Ong, M. Valdes-Chavarri, A. Abizaid, S.J. Pocock, F. Fabbiocchi, C. Dubois, S. Copt, S. Greene and M.C. Morice for the LEADERS FREE Investigators Presented by CK Naber EuroPCR 17 th May 2016

2 Background For ACS patients undergoing PCI current guidelines recommend in general 12 months DAPT High bleeding risk patients presenting with ACS undergoing PCI have never been systematically studied. Current guidelines recommend for these patients: I. Implantation of a DES with 3-6 months DAPT II. Implantation of a BMS with 1-month DAPT Roffi et al. Eur Heart J. 2016;37: / Levine et al. JACC 2016 (epub ahead of print) 2

3 187: RESET: Kim BK et al, JACC 2012; 60: 1340 E-ZES 3 months DAPT 188: OPTIMIZE: Feres F et al, JAMA 2013; 310: 2510 E-ZES 3 months DAPT 189: EXCELLENT: Gwon HC et al, Circ 2012; 125: 505 DES 6 months DAPT 192: ISAR-SAFE: Schulz-Schupke S et al, EHJ 2015; 36: 1252 DES 6 months DAPT 3

4 Objectives The aim of this prespecified substudy was to evaluate the safety and efficacy of the BioFreedom BA9 DCS followed by 1 month DAPT in patients presenting with an ACS 4

5 2016. Biosensors International Group, Ltd. All rights reserved BioFreedom Drug Coated Stent (DCS) Potential Advantages: Avoid any possible polymer-related adverse effects Rapid drug transfer to vessel wall (98% within one month 2 ) DAPT can be shortened to 1 month in High Bleeding Risk patients Tada et al., Circ Cardiovasc Interv 2010;3; Urban P et al. Am Heart J 2013; 165:

6 Trial Design Prospective, double-blind randomized (1:1) trial 2466 High bleeding risk (HBR) PCI patients BioFreedom DCS vs. Gazelle BMS DAPT mandated for 1 month only, followed by long-term SAPT Primary efficacy endpoint: Clinically-driven TLR at 1 year (superiority) Primary safety endpoint: Composite of cardiac death, MI, definite / probable stent thrombosis at 1 year (non-inferiority then superiority) Urban P et al. Am Heart J 2013; 165:

7 Primary endpoint Efficacy (clinically driven TLR) Safety (cardiac death, MI, ST) DCS BMS DCS BMS Urban P et al. N Engl J Med 2015;373:

8 Study Flow 662 ACS patients underwent randomized 331 were assigned to DCS 331 were assigned to BMS 2 did not undergo PCI 1 did not undergo PCI 329 are include in the analysis 330 are include in the analysis 320 (97.2%) completed 12-month visit or died 323 (97.8%) completed 12-month visit or died 8

9 Study population Parameter DCS (N=330) BMS (N=329) Total (N=659) p-value Age (mean±sd) 76.9± ± ±9.5 n.s. Female N(%) 122 (37.0) 110 (33.4) 232 (35.3) n.s. NSTEMI N(%) 273 (82.8) 281 (85.5) 554 (84.1) n.s. STEMI N(%) 57 (17.2) 48 (14.5) 105 (15.9) n.s. Diabetes N(%) 111 (33.8) 108 (32.8) 219 (33.3) n.s. Renal Impairment N(%) 66 (20.1) 81 (24.8) 147 (22.4) n.s. Previous Stroke N(%) 46 (14.1) 26 (7.9) 72 (11.0) 0.01* Atrial Fibrillation N(%) 84 (25.5) 109 (33.1) 193 (29.3) 0.03* Previous MI N (%) 63 (19.1) 82 (24.9) 145 (22.0) n.s. Previous CABG N(%) 24 (7.3) 23 (7) 47 (7.1) n.s. Previous PCI N(%) 55 (16.7) 67 (20.4) 122 (18.5) n.s. In LEADERS FREE 659/2466 patients had an ACS (554 NSTEMI and 105 STEMI) *=Cox proportional hazard models displayed no influence on outcomes at FU 9

10 Criteria for High Risk of Bleeding* Age 75 Oral anticoagulation after PCI Creat. Clearance < 40 ml/min Hb < 11g/dl or TF < 4 weeks Major surgery in the next year Cancer in previous 3 years In hospital for bleeding < 1 year Nonadherence to > 30d DAPT Glucocorticoids or NSAID Thrombocytopenia* Stroke < 1 yr Severe chronic liver disease Prior intracerebral bleed n=1.8 per patient DCS (N=330)2 BMS (N=329) (%) * There were no significant differences (P<0.05) between the two groups 10

11 Procedural Data Parameter Lesion Length mm (mean±sd) DCS (N=330) BMS (N=329) Total (N=659) p-value 18.3± ± ±10.1 n.s. Lesion Length 30 mm N(%) 33 (6.7) 40 (7.2) 73 (7.0) n.s. RVD mm (mean±sd) RVD 2.75 mm (mean±sd) 3.0± ± ±0.5 n.s. 166 (33.9) 167 (30.0) 333 (31.8) n.s. ACC-Class B2&C* N (%) 244 (30.6) 266 (29.5) 500 (30.0) n.s. LAD N/(%) 192 (58.2) 174 (52.9) 366 (55.5) n.s. Stent Length per patient (mm) (mean±sd) 33.4± ± ±25.0 n.s. Overlapping Stent N(%) 49 (14.8) 62 (18.9) 111 (16.9) n.s. Procedural Success N(%)** 326 (95.0) 341 (94.7) 667 (94.9) n.s. * Lesion Level; LL=Lesion Length; RVD=Reference Vessel Diameter; LAD=Left Anterior Descending; SD = Standard Deviation; **: includes all procedures (index and staged) 11

12 Clinically-driven Target Lesion Revascularization - 12 Month FU 12

13 Cardiac Death, MI, or Def / Prob ST- 12 Month FU 13

14 12 Month Follow-Up 14

15 12 Month Follow-Up by Subgroup 15

16 Conclusions In ACS patients with high bleeding risk a polymer-free BA9-DCS combined with 1-month DAPT displays significantly better efficacy and safety than a BMS, the latter driven by significantly lower cardiac mortality and MI. Current guidelines should be reconsidered for high bleeding risk patients presenting with ACS: > BMS can no longer be recommended > Data on DES with shortened DAPT are scarce > BioFreedom BA9-DCS has strongest evidence in these patients. Presented by CK Naber EuroPCR 17 th May

17 Christoph K. Naber 1, Philip Urban 2, Paul J. Ong 3, Mariano Valdes-Chavarri 4, Alexandre A. Abizaid 5, Stuart J. Pocock 6, Franco Fabbiocchi 7, Christophe Dubois 8, Samuel Copt 9, Samantha Greene 9, and Marie-Claude Morice 10, for the LEADERS FREE Investigators 17

18 sub-study: Naber et al. European Heart Journal. First published online: 17th May 2016 DOI: LEADERS FREE: Urban P. et al. N Engl J Med. 2015;373(21): BioFreedom is not available for sale in France and the information related to this product is not intended for health care professionals who practice in France. Le produit BioFreedom n'est pas disponible à la vente en France et les informations le concernant ne sont pas destinées aux professionnels de la santé exerçant en France. BioFreedom, Biolimus A9 and BA9 are trademarks or registered trademarks of Biosensors International Group, Ltd. Not available for sale in the United States and certain other countries Biosensors International, Ltd. All rights reserved