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
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 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 EmanueleCatania, 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 EmanueleCatania, Italy
Davide Capodanno Optics in Cardiology 2018 – April 20, 2018 – Slide 4
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.
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 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 EmanueleCatania, 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 EmanueleCatania, 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
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
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 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 NAP=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 EmanueleCatania, 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
IVUS27 studies7,825 patients
Angiography29 studies8,434 patients
OCT/OFDI7 studies1,623 patients
5
Studies Year Patients Study design Type of stent FU
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
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 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. AngioP=0.38
IVUS vs. OCT P=1.00
IVUS vs. AngioP=0.50
IVUS vs. OCT P=1.00
IVUS vs. AngioP=1.00
IVUS vs. OCT P=1.00
IVUS vs. AngioP=1.00
IVUS vs. OCT P=NA
IVUS vs. AngioP=NA
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 11
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)
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 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
IVUS27 studies7,825 patients
Angiography29 studies8,434 patients
OCT/OFDI7 studies1,623 patients
5
Studies Year Patients Study design Type of stent FU
OPINION 2016 405/412 Randomized DES 12ILUMIEN III 2016 146/146/158 Randomized DES 1Kim et al. 2016 114/114 Observational, PSM DES 12
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 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 EmanueleCatania, 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)
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
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 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
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
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 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)
directindirect 0.65network
directindirect 0.63network
directindirect 0.63network
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)
directindirect 0.65network
directindirect 0.63network
directindirect 0.63network
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 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/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) -
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 18
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