Invasive Imaging Improves Prognosis and Saves Lives The Evidence - PowerPoint PPT Presentation

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 1 Invasive Imaging Improves Prognosis and Saves Lives The Evidence Davide Capodanno, MD, PhD Davide Capodanno, MD, PhD Division of Cardiology, C.A.S.T. University of Catania, Italy University Hospital of Catania, Italy Optics in Cardiology 2018 Ÿ Zurich Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Friday, April 20, 2018 Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 2 Disclosure Statement of Financial Interest Within the past 12 months, I, Davide Capodanno , have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial relationship Company AstraZeneca, Abbott Vascular, Bayer, Sanofi Speakers’ honoraria Aventis Consulting Abbott Vascular, Bayer Advisory Board Abbott Vascular, AstraZeneca, Bayer Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 3 Recommendations for Invasive Imaging 2014 ESC Guidelines for Myocardial Revascularization Recommendation Class LOE IIa B IVUS in selected patients to optimize stent implantation. IVUS to assess severity and optimize treatment of IIa B unprotected left main lesions. IIa C IVUS or OCT to assess mechanisms of stent failure. IIb C OCT in selected patients to optimize stent implantation. Windecker S, et al. Eur Heart J 2014;35:3541-619 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 4 Does Intravascular Imaging Improve The Clinical Outcomes of Percutaneous Coronary Intervention? Literature Perspectives 1. Most RCTs with DES showed a directionally favorable trend but no significant superiority of routine IVUS guidance vs. angiography, likely due to limited power. ▶ Success rate in RCTs with DES was high, and complication rate was low, pointing to a good safety profile of intravascular imaging . ▶ Small trials suggest the clinical benefit of IVUS guidance for selected anatomic subsets (e.g. long lesions, CTOs, left main). 2. No adequately powered clinical data on OCT- vs. angiography- and OCT- vs. IVUS-guided PCI. Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 5 Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 6 Network meta-analysis of 31 studies of intravascular imaging guidance for percutaneous coronary intervention encompassing 17,882 patients Methods ▶ Included : RCTs or observational studies using matching algorithms for statistical adjustment comparing 2 or more invasive imaging modalities for guiding PCI with stent implantation. ▶ Excluded : studies of intravascular imaging to guide bailout stenting or “spot stenting”. ▶ Primary endpoint : all-cause mortality. ▶ Sensitivity analyses : RCTs only, studies with >100 pts, all-comers, DES, G2-DES Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 7 24 Studies (14 RCT) of IVUS- vs. Angio-Guided PCI Studies Year Patients Study design Type of stent FU RESIST 1998 76/79 Randomized BMS 6 IVUS CRUISE 2000 229/270 Randomized BMS 9 OPTICUS 2001 275/273 Randomized BMS 12 27 studies Gaster et al. 2003 54/54 Randomized BMS 30 7,825 patients TULIP 2003 76/74 Randomized BMS 6 to 12 DIPOL 2007 80/83 Randomized BMS 6 AVID 2009 406/394 Randomized BMS 12 HOME DES IVUS 2010 105/105 Randomized DES 18 Kim et al. 2013 274/269 Randomized DES 12 24 AVIO 2013 142/142 Randomized DES 24 CTO-IVUS 2015 201/201 Randomized DES 12 AIR-CTO 2015 115/115 Randomized DES 24 3 IVUS-XPL 2015 700/700 Randomized DES 12 Tan et al. 2015 62/61 Randomized DES 24 Roy et al. 2008 884/884 Observational, PSM DES 12 Angiography 5 MAIN-COMPARE 2009 201/201 Observational, PSM BMS/DES 36 29 studies MATRIX 2011 548/548 Observational, PSM DES 24 8,434 patients Kim et al. 2011 487/487 Observational, PSM DES 36 Chen et al. 2012 123/123 Observational, PSM DES 12 Wakabayashi et al. 2012 637/637 Observational, PSM BMS/DES 12 OCT/OFDI EXCELLENT 2013 463/463 Observational, PSM DES 12 7 studies De la Torre Hdez et al. 2014 505/505 Observational, PSM DES 36 1,623 patients Gao et al. 2014 291/291 Observational, PSM DES 12 Hong et al. 2014 201/201 Observational, PSM DES 24 Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 8 IVUS- vs. Angiography-Guided PCI IVUS-XPL: 1,400 pts with long coronary lesions (implanted stent ≥28 mm) randomized to IVUS-guided (n=700) or angiography-guided (n=700) EES PCI 12-mo Clinical Outcomes HR 0.48 HR 0.51 (0.28-0.83) (0.28-0.91) P=0.007 P=0.02 5,8% 5,0% HR 0.60 HR NA HR 1.00 (0.14-2.52) P=0.32 (0.14-7.10) 2,9% P=0.48 2,5% P=1.00 0,7% 0,4% 0,3% 0,3% 0,1% 0,0% MACE Cardiac death TL-MI ID-TLR Definite or probable ST IVUS-Guided Angio-Guided Hong SJ, et al. JAMA 2015;314:2155-63 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 9 5 Studies (2 RCT) of OCT/OFDI- vs. Angio-Guided PCI Studies Year Patients Study design Type of stent FU DOCTORS 2016 120/120 Randomized BMS or DES 6 IVUS ILUMIEN III 2016 146/146/158 Randomized DES 1 CLI-OPCI 2012 335/335 Observational, Matched BMS/DES 12 27 studies Sheth et al. 2016 428/214 Observational, PSM BMS/DES 12 7,825 patients Iannaccone et al. 2016 270/270 Observational, PSM NA 23 24 3 Angiography 5 29 studies 8,434 patients OCT/OFDI 7 studies 1,623 patients Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 10 OCT/OFDI- vs. IVUS- vs. Angiography-Guided PCI ILUMIEN III: 450 patients undergoing PCI (no LM, ISR, CTO) were randomly assigned to OCT guidance, IVUS guidance, or angiography-guided stent implantation 30-Day Outcomes IVUS vs. OCT P=0.69 IVUS vs. Angio IVUS vs. OCT P=0.38 P=1.00 IVUS vs. OCT IVUS vs. OCT IVUS vs. OCT IVUS vs. Angio P=1.00 P=1.00 2,5% P=NA P=0.50 IVUS vs. Angio IVUS vs. Angio IVUS vs. Angio P=1.00 P=1.00 1,4% 1,3% P=NA 0,7% 0,7% 0,7% 0,6% 0,6% 0% 0% 0% 0% 0% 0% 0% MACE Death MI ID-TLR Def/prob ST OCT-Guided IVUS-Guided Angio-Guided Ali ZA, et al. Lancet. 2016;388:2618-2628 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 11 What Next for OCT vs Angio-guided PCI? ILUMIEN IV >2500 patients with high-risk clinical or lesion characteristics 125 sites in North America (US and Canada), Western Europe, Australia and Japan R 1:1 OCT-guided PCI Angiography-guided PCI with ILUMIEN III stent IC guidance for bail-out only optimization protocol Final blinded OCT Follow-up at 30 days, 1 year and 2 years Primary endpoint: 1-year rate of target vessel failure (cardiac death, target vessel MI, or ischemia-driven TVR) Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 12 3 studies (2 RCT) of OCT/OFDI- vs. IVUS-Guided PCI Studies Year Patients Study design Type of stent FU OPINION 2016 405/412 Randomized DES 12 IVUS ILUMIEN III 2016 146/146/158 Randomized DES 1 Kim et al. 2016 114/114 Observational, PSM DES 12 27 studies 7,825 patients 24 3 Angiography 5 29 studies 8,434 patients OCT/OFDI 7 studies 1,623 patients Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 13 OCT/OFDI- vs. IVUS-Guided PCI OPINION: non-inferiority study to compare head-to-head OFDI vs. IVUS in 829 patients undergoing PCI with a second generation drug-eluting stent 12-Mo Clinical Outcomes HR 0.84 HR 0.90 (0.35-1.98) (0.35–2.25) P=0.81 P=0.97 HR 0.65 HR 0.49 HR 0.98 (0.05–5.74 ) (0.01–9.46) 3,5% (0.00–18.68) 3,0% P=0.98 P=0.99 2,9% 2,7% P=0.99 0,7% 0,5% 0,5% 0,2% 0,2% 0,0% MACE Cardiac death TL-MI ID-TLR Stent thrombosis OCT/OFDI-Guided IVUS-Guided Kubo T, et al. Eur Heart J. 2017;38:3139-3147 Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio Emanuele Catania, Italy