Invasive Imaging Improves Prognosis and Saves Lives The ...ecc-conference.com/1/slides/OiC-2018-04-20-4.4... · 4/20/2018 · Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio

Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio EmanueleCatania, Italy

Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 1

Davide Capodanno, MD, PhDUniversity of Catania, Italy

Invasive Imaging Improves Prognosis

and Saves Lives The Evidence

Davide Capodanno, MD, PhDDivision of Cardiology, C.A.S.T.

University Hospital of Catania, ItalyOptics in Cardiology 2018 � ZurichFriday, April 20, 2018



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



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



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

Literature Perspectives1. 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.



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



24 Studies (14 RCT) of IVUS- vs. Angio-Guided PCI


3

24

IVUS27 studies7,825 patients

Angiography29 studies8,434 patients

OCT/OFDI7 studies1,623 patients

5

Studies Year Patients Study design Type of stent FU

RESIST 1998 76/79 Randomized BMS 6CRUISE 2000 229/270 Randomized BMS 9OPTICUS 2001 275/273 Randomized BMS 12Gaster et al. 2003 54/54 Randomized BMS 30TULIP 2003 76/74 Randomized BMS 6 to 12DIPOL 2007 80/83 Randomized BMS 6AVID 2009 406/394 Randomized BMS 12HOME DES IVUS 2010 105/105 Randomized DES 18Kim et al. 2013 274/269 Randomized DES 12AVIO 2013 142/142 Randomized DES 24CTO-IVUS 2015 201/201 Randomized DES 12AIR-CTO 2015 115/115 Randomized DES 24IVUS-XPL 2015 700/700 Randomized DES 12Tan et al. 2015 62/61 Randomized DES 24Roy et al. 2008 884/884 Observational, PSM DES 12MAIN-COMPARE 2009 201/201 Observational, PSM BMS/DES 36MATRIX 2011 548/548 Observational, PSM DES 24Kim et al. 2011 487/487 Observational, PSM DES 36Chen et al. 2012 123/123 Observational, PSM DES 12Wakabayashi et al. 2012 637/637 Observational, PSM BMS/DES 12EXCELLENT 2013 463/463 Observational, PSM DES 12De la Torre Hdez et al. 2014 505/505 Observational, PSM DES 36Gao et al. 2014 291/291 Observational, PSM DES 12Hong et al. 2014 201/201 Observational, PSM DES 24



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 NAP=0.32

HR 0.51 (0.28-0.91)

P=0.02

HR 1.00 (0.14-7.10)

P=1.00



5 Studies (2 RCT) of OCT/OFDI- vs. Angio-Guided PCI


3

24




5


DOCTORS 2016 120/120 Randomized BMS or DES 6ILUMIEN III 2016 146/146/158 Randomized DES 1CLI-OPCI 2012 335/335 Observational, Matched BMS/DES 12Sheth et al. 2016 428/214 Observational, PSM BMS/DES 12Iannaccone et al. 2016 270/270 Observational, PSM NA 23



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. AngioP=0.38

IVUS vs. OCT P=1.00


IVUS vs. OCT P=1.00


IVUS vs. OCT P=1.00


IVUS vs. OCT P=NA

IVUS vs. AngioP=NA



What Next for OCT vs Angio-guided PCI? ILUMIEN IV

OCT-guided PCI with ILUMIEN III stentoptimization protocol

Angiography-guided PCI IC guidance for bail-out only

Final blinded OCT

>2500 patients with high-risk clinical or lesion characteristics125 sites in North America (US and Canada), Western Europe, Australia and Japan

R1:1

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)



3 studies (2 RCT) of OCT/OFDI- vs. IVUS-Guided PCI


3

24




5


OPINION 2016 405/412 Randomized DES 12ILUMIEN III 2016 146/146/158 Randomized DES 1Kim et al. 2016 114/114 Observational, PSM DES 12



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



Summary Statistics: All-Cause Death



Forest plots Rankograms

0.75 (0.57, 0.98)0.59 (0.29, 1.20)

IVUSOCT/OFDI

AngiographyOCT/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)

AngiographyIVUS

Compared with OCT/OFDI

0.25 1.00 4.00

100

75

50

25

01st 2nd 3rd

Ranks

OCT

IVUS

IVUS

OCT

Angio

OR



Stratified Analyses for RCTs and Observational Studies



All-cause death CV Death

IVUS vs Angiography

Odd

sR

atio

3.0

2.5

2.0

1.5

1.0

0.5

0.0All-cause death CV Death

OCT/OFDI vs Angiography

Odd

sR

atio

3.0

2.5

2.0

1.5

1.0

0.5

0.0All-cause death CV Death

Odd

sR

atio

3.0

2.5

2.0

1.5

1.0

0.5

0.0

IVUS vs OCT

RCTs Observational studiesRCTs Observational studies RCTs Observational studies



Node Split of Direct and Indirect Evidence



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 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)

directindirect 0.65network



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 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)






Summary Statistics: Secondary Outcomes



Angiography IVUS OCT/OFDIMyocardial infarctionAngiography - 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 -

TLRAngiography - 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 thrombosisAngiography - 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) -



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

Closing Remarks1. 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

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Invasive Imaging Improves Prognosis and Saves Lives The ...ecc-conference.com/1/slides/OiC-2018-04-20-4.4... · 4/20/2018 · Cardiology, C.A.S.T. P.O. “Rodolico” A.O.U. Policlinico-Vittorio