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

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 1

Davide Capodanno, MD, PhD

University of Catania, Italy

Invasive Imaging Improves Prognosis and Saves Lives The Evidence

Davide Capodanno, MD, PhD

Division of Cardiology, C.A.S.T. University Hospital of Catania, Italy

Optics in Cardiology 2018 Ÿ Zurich Friday, April 20, 2018

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 2

Within the past 12 months, I, Davide Capodanno, have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Disclosure Statement of Financial Interest

Affiliation/Financial relationship Company Speakers’ honoraria

AstraZeneca, Abbott Vascular, Bayer, Sanofi 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

Windecker S, et al. Eur Heart J 2014;35:3541-619

Recommendation Class LOE IVUS in selected patients to optimize stent implantation.

IIa B

IVUS to assess severity and optimize treatment of unprotected left main lesions.

IIa B

IVUS or OCT to assess mechanisms of stent failure.

IIa C

OCT in selected patients to optimize stent implantation.

IIb C

2014 ESC Guidelines for Myocardial Revascularization

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

Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498

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

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

Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498

3 24 IVUS

27 studies 7,825 patients

Angiography

29 studies 8,434 patients

OCT/OFDI

7 studies 1,623 patients

5

Studies Year Patients Study design Type of stent FU RESIST 1998 76/79 Randomized BMS 6 CRUISE 2000 229/270 Randomized BMS 9 OPTICUS 2001 275/273 Randomized BMS 12 Gaster et al. 2003 54/54 Randomized BMS 30 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 AVIO 2013 142/142 Randomized DES 24 CTO-IVUS 2015 201/201 Randomized DES 12 AIR-CTO 2015 115/115 Randomized DES 24 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 MAIN-COMPARE 2009 201/201 Observational, PSM BMS/DES 36 MATRIX 2011 548/548 Observational, PSM DES 24 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 EXCELLENT 2013 463/463 Observational, PSM DES 12 De la Torre Hdez et al. 2014 505/505 Observational, PSM DES 36 Gao et al. 2014 291/291 Observational, PSM DES 12 Hong et al. 2014 201/201 Observational, PSM DES 24

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

Hong SJ, et al. JAMA 2015;314:2155-63

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

2,9% 0,4% 0,0% 2,5% 0,3% 5,8% 0,7% 0,1% 5,0% 0,3% MACE Cardiac death TL-MI ID-TLR Definite or probable ST

12-mo Clinical Outcomes

IVUS-Guided Angio-Guided HR 0.48 (0.28-0.83) P=0.007 HR 0.60 (0.14-2.52) P=0.48 HR NA P=0.32 HR 0.51 (0.28-0.91) P=0.02 HR 1.00 (0.14-7.10) P=1.00

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

Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498

3 24 IVUS

27 studies 7,825 patients

Angiography

29 studies 8,434 patients

OCT/OFDI

7 studies 1,623 patients

5

Studies Year Patients Study design Type of stent FU DOCTORS 2016 120/120 Randomized BMS or DES 6 ILUMIEN III 2016 146/146/158 Randomized DES 1 CLI-OPCI 2012 335/335 Observational, Matched BMS/DES 12 Sheth et al. 2016 428/214 Observational, PSM BMS/DES 12 Iannaccone et al. 2016 270/270 Observational, PSM NA 23

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

Ali ZA, et al. Lancet. 2016;388:2618-2628

ILUMIEN III: 450 patients undergoing PCI (no LM, ISR, CTO) were randomly assigned to OCT guidance, IVUS guidance, or angiography-guided stent implantation

2,5% 0% 1,3% 0,6% 0,6% 1,4% 0% 0,7% 0% 0% 0,7% 0% 0% 0,7% 0% MACE Death MI ID-TLR Def/prob ST

30-Day Outcomes

OCT-Guided IVUS-Guided Angio-Guided

IVUS vs. OCT P=0.69 IVUS vs. Angio P=0.38 IVUS vs. OCT P=1.00 IVUS vs. Angio P=0.50 IVUS vs. OCT P=1.00 IVUS vs. Angio P=1.00 IVUS vs. OCT P=1.00 IVUS vs. Angio P=1.00 IVUS vs. OCT P=NA IVUS vs. Angio P=NA

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

OCT-guided PCI with ILUMIEN III stent

• ptimization protocol

Angiography-guided PCI IC guidance for bail-out only Final blinded OCT >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

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

Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498

3 24 IVUS

27 studies 7,825 patients

Angiography

29 studies 8,434 patients

OCT/OFDI

7 studies 1,623 patients

5

Studies Year Patients Study design Type of stent FU OPINION 2016 405/412 Randomized DES 12 ILUMIEN III 2016 146/146/158 Randomized DES 1 Kim et al. 2016 114/114 Observational, PSM DES 12

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

Kubo T, et al. Eur Heart J. 2017;38:3139-3147

OPINION: non-inferiority study to compare head-to-head OFDI vs. IVUS in 829 patients undergoing PCI with a second generation drug-eluting stent

2,9% 0,0% 0,5% 2,7% 0,2% 3,5% 0,2% 0,7% 3,0% 0,5% MACE Cardiac death TL-MI ID-TLR Stent thrombosis

12-Mo Clinical Outcomes

OCT/OFDI-Guided IVUS-Guided HR 0.84 (0.35-1.98) P=0.81 HR 0.98 (0.00–18.68) P=0.99 HR 0.65 (0.05–5.74) P=0.98 HR 0.90 (0.35–2.25) P=0.97 HR 0.49 (0.01–9.46) P=0.99

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 14

Summary Statistics: All-Cause Death

Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498

Network meta-analysis of 31 studies of intravascular imaging guidance for percutaneous coronary intervention encompassing 17,882 patients Forest plots Rankograms

0.75 (0.57, 0.98) 0.59 (0.29, 1.20) IVUS OCT/OFDI Angiography OCT/OFDI 1.30 (1.00, 1.70) 0.59 (0.38, 1.70)

0.25 0.25 1.00 1.00 4.00 4.00

Compared with Angiography Compared with IVUS

1.70 (0.82, 3.40) 1.30 (0.58, 2.70) Angiography IVUS

Compared with OCT/OFDI

0.25 1.00 4.00

100 75 50 25 1st 2nd 3rd Ranks OCT IVUS IVUS OCT Angio OR

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 15

Stratified Analyses for RCTs and Observational Studies

Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498

Network meta-analysis of 31 studies of intravascular imaging guidance for percutaneous coronary intervention encompassing 17,882 patients

All-cause death CV Death

IVUS vs Angiography

Odds Ratio

3.0 2.5 2.0 1.5 1.0 0.5 0.0

All-cause death CV Death

OCT/OFDI vs Angiography

Odds Ratio

3.0 2.5 2.0 1.5 1.0 0.5 0.0

All-cause death CV Death

Odds Ratio

3.0 2.5 2.0 1.5 1.0 0.5 0.0

IVUS vs OCT

RCTs Observational studies RCTs Observational studies RCTs Observational studies

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 16

Node Split of Direct and Indirect Evidence

Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498

Network meta-analysis of 31 studies of intravascular imaging guidance for percutaneous coronary intervention encompassing 17,882 patients Death Cardiovascular death

0.33 (0.13, 0.79) 0.20 (0.02, 1.3) 0.31 (0.13, 0.67)

Study

0.25 1.00 4.00 IVUS vs Angiography OCT/OFDI vs Angiography OCT/OFDI vs IVUS

P value Odds Ratio (95% CI)

0.44 (0.05, 2.6) 0.72 (0.27, 1.9) 0.66 (0.28, 1.5) 0.46 (0.31, 0.66) 0.76 (0.10, 7.7) 0.47 (0.32, 0.66) direct indirect 0.65 network direct indirect 0.63 network direct indirect 0.63 network 0.33 (0.13, 0.79) 0.20 (0.02, 1.3) 0.31 (0.13, 0.67)

Study

0.25 1.00 4.00 IVUS vs Angiography OCT/OFDI vs Angiography OCT/OFDI vs IVUS

P value Odds Ratio (95% CI)

0.44 (0.05, 2.6) 0.72 (0.27, 1.9) 0.66 (0.28, 1.5) 0.46 (0.31, 0.66) 0.76 (0.10, 7.7) 0.47 (0.32, 0.66) direct indirect 0.65 network direct indirect 0.63 network direct indirect 0.63 network

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 17

Summary Statistics: Secondary Outcomes

Buccheri S, et al. JACC Cardiovasc Interv. 2017;10:2488-2498

Network meta-analysis of 31 studies of intravascular imaging guidance for percutaneous coronary intervention encompassing 17,882 patients

Angiography IVUS OCT/OFDI Myocardial infarction Angiography

• 0.72 (0.52–0.93)

0.79 (0.44–1.40)

IVUS

1.40 (1.10–1.70)

• 1.10 (0.60–2.10)

OCT/OFDI

1.30 (0.72–2.30) 0.90 (0.47–1.70

• TLR

Angiography

• 0.74 (0.58–0.90)

0.66 (0.35–1.20)

IVUS

1.40 (1.10–1.70)

• 0.88 (0.47–1.60)

OCT/OFDI

1.50 (0.83–2.90) 1.10 (0.61–2.10)

• Stent thrombosis

Angiography

• 0.42 (0.20–0.72)

0.39 (0.10–1.20)

IVUS

2.40 (1.40–5.10)

• 0.93 (0.24–3.40)

OCT/OFDI

2.60 (0.80–10.0) 1.10 (0.29–4.20)

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 18

Does Intravascular Imaging Improve The Clinical Outcomes of Percutaneous Coronary Intervention?

Closing Remarks

• 1. Compared with coronary angiography, the use of intravascular

imaging techniques during PCI reduces the risk of cardiovascular death and major adverse cardiovascular events.

• 2. Further studies are needed to confirm the clinical equipoise between

IVUS and OCT when used as imaging modalities for PCI guidance.

• 3. Potential advantages following future or current iterations of

intravascular imaging technology (i.e., better spatial resolution for IVUS and OCT) and the combined use of imaging techniques alongside the functional identification of lesions associated with ischemia should be investigated

dcapodanno@gmail.com