Update. 1 Institute of Cardiology G. d Annunzio University Chieti; 2 Laboratory of Interventional Cardiology and Department of Cardiology, Clinica

Transcription

1 Update Marco Zimarino 1, MD, PhD, Carlo Briguori 2, MD; Robert J Gil 3, MD, Francesco Radico 1, MD, Ignacio J Amat-Santos 4, Emanuele Barbato 5,6, MD, PhD, Andrejs Erglis 7, MD, Habib Gamra 8, MD, Francesca Angeramo 1, MD, Mariano Pellicano 5,6, MD, PhD, Vojko Kanic 9, MD, Sasko A Kedev 10, MD, PhD, Maja Strozzi 11, MD, Tullio Tesorio 12, MD, Vladan Vukcevic 13, MD, PhD, Plinio Cirillo 6, MD, PhD, Ricardo A Costa 14, MD, PhD, Alaide Chieffo 15, MD, PhD, Sunao Nakamura 16, MD, PhD, Goran Stankovic 13, MD, PhD on behalf of the EuroBifurcation Club. 1 Institute of Cardiology G. d Annunzio University Chieti; 2 Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy; 3 Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland; 4 Hospital Clínico Universitario de Valladolid, Spain; 5 Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; 6 Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy; 7 Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia; 8 Cardiology Department, Fattouma Bourguiba Hospital, University of Monastir, Tunisia; 9 Department of Cardiology, University Medical Centre Maribor, Maribor, Slovenia; 10 University Clinic of Cardiology Skopje, Skopje, Macedonia; 11 Department of Cardiovascular Medicine, University Hospital Centre Zagreb, Zagreb, Croatia; 12 Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy; 13 Department of Cardiology, Clinical Center of Serbia, University of Belgrade, Serbia; 14 Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil; 15 Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; 16 Department of Cardiology, New Tokyo Hospital, Chiba, Japan.

2 Background - 1 Prasugrel and ticagrelor were both associated with a significant reduction in the risk of MACE in patients undergoing PCI for an ACS, mostly through a reduction of stent thrombosis. The 1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials 1-yr DES thrombosis (%) P<0.001 RRR 57% 2,31 2,5 0,84 P=NS RRR 10% 1. Wiviott SD et al. N Engl J Med. 2007;357: Cannon CP et al. Lancet. 2010;375: Steg PG et al. Circulation 2013;128: P=0.017 RRR 25% 2,87 2,3 2, * TRITON-TIMI 38 PLATO PLATO Clop Pras Tica * taking into account stents either previously implanted or inserted during the course of the trial

3 Background - 2 The incidence of DES thrombosis is largely variable according to different lesion settings. We aimed to focus at a direct comparison between newer P2Y12 inhibitors in a worst-case scenario Overlapping DES after CTO recanalization Double DES for true Bifurcations Stent thrombosis 7.5% (3.0 57%) Stent thrombosis 2% (1 11%) 4. Valenti R et al. J Am Coll Cardiol. 2013;61: Zimarino M et al. JACC Cardiovasc Interv. 2013;6:

4 Aim of the Study Descriptive analysis (registry) of the real-world attitude of P2Y12 inhibitors utilization in PCI of coronary bifurcation in the period To verify the translation of the postulated different reduction in the risk of biologically active (DES and BVS) stent thrombosis among various P2Y12 inhibitors (prasugrel and ticagrelor as compared with clopidogrel) in the treatment of a coronary bifurcation. Primary endpoint: 1 year-death/mi/stent thrombosis

5 Statistical Analysis Assuming a 10% rate of MACE at 1-year An overall sample size of 1,422 patients in each group would allow to detect a reduction of 30% in the occurrence of the combined primary end-point among patients receiving the newer P2Y12 inhibitors as compared to clopidogrel. By estimating a 10% drop-off rate for incomplete data, data on 1,575 patients will have to be grouped in each arm and therefore a total of 3,150-4,725 patients will have to be screened in the study.

6 Participating Centers data collected update 8/24/2016 Japan Brasil

7 Clinical and procedural variables Age (ys) 65,5 ± 7,1 N = 3,868 % Sex (M) 2,785 72% ACS - STEMI - NSTEMI - UA Stent - DES - BVS - BMS 1, ,209 4, % 1.35 stent / pt Medina «true» 1,707 53% Follow-up (n) 3,222 84% Median Follow-up (months) 16 (IQR 12-28) Zimarino M, on behalf of P2BiTO investigators; Eur Heart J 2016; 37 (supp): 676 Amat-Santos I, on behalf of P2BiTO investigators; Eur Heart J 2016; 37 (supp): 678

8 Primary outcomes N = 3,868 % MACE % - Death - MI - Stent thrombosis % 3.2 % 1.3 % Zimarino M, on behalf of P2BiTO investigators; Eur Heart J 2016; 37 (supp): 676 Amat-Santos I, on behalf of P2BiTO investigators; Eur Heart J 2016; 37 (supp): 678

9 Kaplan-Meier curves of MACE as stratified for clinical presentation and Medina classification. 10 MACE (%) ACS Medina «true» n= 1,083 (28%) ACS Medina «non-true» n= 731 (19%) SCAD Medina «true» n= 962 (25%) SCAD Medina «non true» n= 1,092 (29%) 9.1% 8.6% P=NS 6.9% 6.8% P=NS P< Log-rank comparisons Time (months) Zimarino M, on behalf of P2BiTO investigators; Eur Heart J 2016; 37 (supp): 676

10 Kaplan-Meier curves of MACE as stratified for stenting strategy MACE (%) 10 5 Single stenting Double stenting Bailout stenting 18.6% 8.5% 7.0% P= NS Log-rank comparisons P< Time (months) Amat-Santos I, on behalf of P2BiTO investigators; Eur Heart J 2016; 37 (supp): 678

11 MACE according to stent strategy Follow-up outcome n (%) MACE N (%) P Single stent - Final kissing Double stent - T-stent - TAP - Crush (+ mini) - Culotte - V-stent - SKS - trousers+legs; - Other - Not specified 2502 (77) 954 (38) 570 (18) 116 (20) 64 (12) 17 (3) 47 (8) 10 (2) 1 (0.1) 0 (0) 27 (5) 282 (50) 176 (7.0) NS vs Double <0.01 vs Bailout 49 (8.5) NS vs Single <0.01vs Bailout Bailout stent 150 (5) 28 (18.6) Amat-Santos I, on behalf of P2BiTO investigators; Eur Heart J 2016; 37 (supp): 678

12 Conclusions the P2BiTO Currently available largest descriptive analysis of the real-world attitude in the management of patients with PCI and active stents in coronary bifurcation. As expected, the rate of MACE was higher in patients suffering from ACS as compared with stable CAD, regardless of bifurcation complexity. Bailout stenting is associated with an unacceptable higher risk of both in-hospital and 1-year adverseoutcomes.

13

14 P2BiTO the prospective registry Open to enrollment from January 1 st,