ΣΥΜΠΛΟΚΕΣ ΔΙΑΔΕΡΜΙΚΕΣ ΕΠΕΜΒΑΣΕΙΣ (στέλεχος, διχασµός, µακρές πολλαπλές βλάβες)

ΠΕΤΡΟΣ Σ. ΔΑΡΔΑΣ, MD, FESC 16o Βορειοελλαδικό Καρδιολογικό Συνέδριο

ΘΕΣΣΑΛΟΝΙΚΗ 2017

Patients (%)

SYNTAX 3VD 5-year Outcomes • TCT 2012 • Mohr • 23 October 2012 • Slide 7

TAXUS (n=357)CABG (n=348)

All Death MI CVA Revasc.

P=0.53 P=0.10 P=0.03 P<0.001 P=0.12

36.9

31.0

MACCE

Left Main Disease 5-year Outcomes (N=705)

Cumulative Event Rate (%)

CABG PCI P value

Death 15.1% 7.9% 0.02

CVA 3.9% 1.4% 0.11

MI

Death, CVA or MI

3.8%

19.8%

6.1%

14.8%

0.33

0.16

Revasc. 18.6% 22.6% 0.36

CABG (N=196)

TAXUS (N=221)

31.3%32.1%

0

50

0

25

12 24 36 48 Months Since Allocation

60

P=0.74

MACCE to 5 Years by SYNTAX Score Tercile LM Subset Low to Intermediate Scores (0-32)

Serruys PW et al. Lancet 2013;381:629–38 SYNTAX 3VD 5-year Outcomes • TCT 2012 • Serruys• 23 October 2012 • Slide 9

LM Disease

MACCE (%)

CABG (N=149)

TAXUS (N=135)CABG PCI P value

Death 14.1% 20.9% 0.11

CVA 4.9% 1.6% 0.13

MI

Death, CVA or MI

6.1%

22.1%

11.7%

26.1%

0.13

0.40

Revasc. 11.6% 34.1% <0.0010 12

50

0

25

4824 36 Months

60

MACCE to 5 Years by SYNTAX Score Tercile LM Subset High Scores ≥33

LM Disease 46.5%

29.7%

P=0.003

Serruys PW et al. Lancet 2013;381:629–38 SYNTAX 3VD 5-year Outcomes • TCT 2012 • Serruys• 23 October 2012 • Slide 8

Recommendations for LM Revascularization

•Levine G, et al. J Am Coll Cardiol. 2011;58:44-122 •Windecker S, et al. Eur Heart J. 2014;35:2541-619

United States Europe

PCI CABGLow SxScore 0-22

Intermediate SxScore 23-32

High SxScore >32

IIa B

IIb B

III B

IB

IB

IB

PCI CABGLow SxScore 0-22

Intermediate SxScore 23-32

High SxScore >32

IB

IIa B

III B

IB

IB

IB

Clinical follow-up: Through 5 years

PCI (Biomatrix BES) (N=600)

CABG (N=600)

NOBLE: Study Design

1200 pts with unprotected left main disease @ 26 EU sites

With ≤3 additional non-complex lesions

(excludes length >25 mm, CTO,

2-stent bifurcation, calcified or tortuous vessels)

R

NOBLE: PCI vs CABG in Unprotected LM StenosisEvald Hoj Christiansen et al, Lancet 2016 in press.

• Primary endpoint: MACCE including death,stroke, non-procedural MI or repeat revascularization

• 15% diabetic, 81% distal LM lesions

NOBLE Results

Primary endpoint: MACCE

HR 1·48 (1·11–1·96); 28·9%

p=0·0066

19·1%

PCI did not show non-inferiority and CABG was superior to PCI

NOBLE Results

All-cause mortality

11.5%

9.5%

HR 1·07 (0·67–1·72); p=0·77

11·6%

9·5%

NOBLE ResultsNon-procedural MI

HR 2·88 (1·40–5·90); p=0·004

6·9%

1·9%

NOBLE Results

Total repeat revascularization

HR 1·50 (1·04–2·17); p=0·03 16·2%

10·4%

NOBLE ResultsStroke

HR 2·25 (0·92–5·48); p=0·07

4·9% 1·7%

Results

SYNTAX score subgroups K-M estimates

4.9%

1.9%

HR 1·88 (1·23–2·89); p=0·0031 HR 1·16 (0·76–1·78); p=0·48 HR 1·41 (0·62–3·20); p=0·41

SYNTAX score assessed by independent corelab (CERC)

NOBLE• CABG better with revasc endpt • Death same• More MI with PCI• More CVA in PCI (5% 5 yr!) • Lower Syntax Score---

worse outcomes for PCI !!!

EXCELA Prospective, Randomized Trial

Comparing Everolimus-Eluting Stents and Bypass Graft Surgery in Selected Patients with Left Main Coronary Artery Disease

Gregg W. Stone MD Joseph F. Sabik, Patrick W. Serruys, Charles A. Simonton, Philippe Généreux, John Puskas, David E. Kandzari, Marie-Claude Morice, Nicholas Lembo, W. Morris Brown, III, David P. Taggart, Adrian Banning, Béla Merkely, Ferenc Horkay, Piet W. Boonstra, Ad Johannes van Boven, Imre Ungi, Gabor Bogáts, Samer Mansour, Nicolas Noiseux, Manel Sabaté, Jose Pomar, Mark Hickey, Anthony Gershlick, Pawel Buszman, Andrzej Bochenek, Erick Schampaert, Pierre Pagé, Ovidiu Dressler, Ioanna Kosmidou, Roxana Mehran, Stuart J. Pocock, and Arie Pieter Kappetein, for the EXCEL Trial Investigators

NCT01205776

What is Novel About EXCEL?

The primary endpoint:Death, MI or stroke at 3 years

Revascularizationnot primary endpoint

What is Novel About EXCEL?

Restriction of enrollment toSyntax Score ≤32

What is Novel About EXCEL?

Use of 2nd Generation DES

R

Follow-up: 1 month, 6 months, 1 year, annually through 5 years Primary endpoint: Measured at a median 3-yr FU, minimum 2-yr FU

(N=1000)

Enrollment registry

CABG (N=957)

Yes

(N=1905)

Stratified by diabetes, SYNTAX score and center

PCI (Xience EES) (N=948)

EXCEL Study Design

2905 pts with unprotected left main disease at 126 sites in 17 countries

SYNTAX score ≤32 Consensus agreement of eligibility and equipoise by heart team

No

Death, stroke or MI (%)

No. at Risk: PCI CABG

5%

15%

10%

6 12 24 36

850 817

784 763

445 458

HR [95%CI] =1.00 [95% CI: 0.79, 1.26]

P = 0.98

0%

875 836

0 1

948 896 957 868

15.4% 14.7%

Primary Endpoint

Death, Stroke or MI at 3 Years 25% CABG (n=957) PCI (n=948) 20%

Months

Conclusions

• PCI with CoCR EES similar Death MI CVA at 3years

• Less 30 day adverse events with PCI

« PICOT Principle »

Population

Intervention

Comparison

Outcome

Timeframe

EXCEL STUDY

LM, Syntax < 32

LM PCI

CABG

Death, MI, stroke

3 Years FU

NOBLE STUDY

All LM

LM PCI

CABG

Death, MI, stroke, Revasc.

5 Years FU

Stone et al, NEJM 2016

Mäkikallio et al, Lancet 2016

Updated Meta-analysis of LM DES Trials 5 RCTs, 4,594 pts, longest FU data used (EXCEL, NOBLE, SYNTAX, PRECOMBAT, Boudriot et al)

Death

Events, Events, %

1.03 (0.78, 1.35) P=0.61

171/2297 7.4%

162/2298 100.00 7.0%

5

Trial

Boudriot et al

PRECOMBAT

SYNTAX

NOBLE

EXCEL

OR (95% CI)

0.39 (0.07, 2.07)

0.72 (0.38, 1.38)

0.90 (0.58, 1.39)

1.10 (0.67, 1.78)

1.38 (0.96, 1.99)

DES

2/100

17/300

45/357

36/592

71/948

CABG

5/101

23/300

48/348

33/592

53/957

Weight

2.60

14.59

26.67

22.85

33.29

Nerlekar N et al. Circ Int 2017:on-line

Overall (I-squared = 23.7%, p=0.26)

1 Favors DES Favors CABG

Updated Meta-analysis of LM DES Trials 5 RCTs, 4,594 pts, longest FU data used (EXCEL, NOBLE, SYNTAX, PRECOMBAT, Boudriot et al)

Myocardial infarction

Events, Events, %

1.46 (0.88, 2.45) P=0.08

138/2297 6.0%

111/2298 100.00 4.8%

5

Overall (I-squared = 58.1%, p=0.049)

1

Trial

Boudriot et al

PRECOMBAT

SYNTAX

NOBLE

EXCEL

OR (95% CI)

1.01 (0.20, 5.13)

1.20 (0.36, 3.99)

1.77 (0.94, 3.33)

3.00 (1.45, 6.21)

0.94 (0.67, 1.31)

DES

3/100

6/300

28/357

29/592

72/948

CABG

3/101

5/300

16/348

10/592

77/957

Weight

7.97

12.50

24.43

21.82

33.28

Nerlekar N et al. Circ Int 2017:on-line

Favors DES Favors CABG

Updated Meta-analysis of LM DES Trials 5 RCTs, 4,594 pts, longest FU data used (EXCEL, NOBLE, SYNTAX, PRECOMBAT, Boudriot et al)

Stroke

43/2197 2.0%

49/2197 100.00 2.2%

1

Events, Events,Trial

PRECOMBAT

SYNTAX

NOBLE

EXCEL

% OR (95% CI)

1.00 (0.14, 7.15)

0.34 (0.12, 0.95)

2.32 (0.95, 5.68)

0.77 (0.43, 1.39)

DES

2/300

5/357

16/592

20/948

CABG

2/300

14/348

7/592

26/957

Weight

12.06

25.14

27.99

34.81

Nerlekar N et al. Circ Int 2017:on-line

Overall (I-squared = 62.5%, p=0.046)

Favors DES

0.88 (0.39, 1.97) P=0.88

5 Favors CABG

Updated Meta-analysis of LM DES Trials 5 RCTs, 4,594 pts, longest FU data used (EXCEL, NOBLE, SYNTAX, PRECOMBAT, Boudriot et al)

Repeat revascularization

Events, Events, %

327/2297 14.2%

67/2298 100.00 8.3%

1

Trial

Boudriot et al

PRECOMBAT

SYNTAX

NOBLE

EXCEL

OR (95% CI)

2.58 (0.95, 7.01)

1.93 (1.10, 3.37)

2.06 (1.40, 3.02)

1.58 (1.07, 2.33)

1.82 (1.32, 2.49)

DES

14/100

38/300

90/357

71/592

114/948

CABG

6/101

21/300

49/348

47/592

67/957

Weight

3.62

11.59

24.43

24.11

36.24

Nerlekar N et al. Circ Int 2017:on-line

Overall (I-squared = 0.0%, p=0.85)

Favors DES

1.85 (1.53, 2.23) P<0.001

5 Favors CABG

LM PCI: Key Points 2017• Heart Team approach• Be skilled at bifurcation stenting• Guideline Committee likely will wait

for longer data with EXCEL

Patients (N) Randomization Primary End Point

Randomized Bifurcation Trials Outcome (Provisional vs

Systematic UnlessOtherwise Specified)

NORDIC413

Provisional vs systematic (crush, culotte, T)

Death, MI (nonprocedural), TVR, or stent thrombosis at 6 mo

2.9% vs 3.4% (P=NS)

350CACTUS

BBC ONE500

Provisional vs systematic (crush)

Provisional vssystematic (crush, culotte)

Death, MI, TVR at 6 mo

Death, MI, TVF at 9 mo

15% vs 15.8% (P=NS)

8.0% vs 15.2% (P<0.05)

Ference et al.

Colombo et al.

202

85

Provisional vs systematic (T)

Provisional vs systematic (crush, T,culotte)

Death, MI, TVF at 9 moAngiographic restenosis (side branch) 9 mo

Angiographic restenosis (either branch) 6 mo

23.0% vs 27.7% (P=NS)

18.7% vs 28.0% (P=NS)

Pan et al.91

Provisional vs systematic (T)

Angiographic restenosis (either branch) 6 mo

7% vs 25% (P=NS)

NORDIC 2424

Systematic (crush vs culotte)

Death, MI (nonprocedural), TVR, or stent thrombosis at6 mo

Crush 4.3% vs culotte 3.7% (P=NS)

TLRClinical outcome -> No difference

Meta-Analysis – Bifurcations with DES One (Provisional) vs Two Stents

Brar SS et al. Eurointervention 2009;5:475:84

Meta-Analysis – Bifurcations with DESOne (Provisional) vs Two Stents

Side Branch RestenosisAngiographic outcome -> No difference

Brar SS et al. Eurointervention 2009;5:475:84

Provisional side-branch stenting should be the initial approach in patients with bifurcation lesions when the side branch is not large and has only mild or moderate focal disease at the ostium.

It is reasonable to use elective double stenting in

patients with complex bifurcation morphology involving a large side branch where the risk of side-branch occlusion is high and the likelihood of successful side-branch reaccess is low.

Bifurcation LesionsI IIa IIb III

I IIa IIb III

DKCRUSH-1 Crush vs DK

DKCRUSH-II PT vs DK

DKCRUSH-III Culotte vs DK

MACE,%

TLR,%

TVR,%

CD,%

QMI,%

ST*, %

24.4 vs 11.4

18.9 vs 9.0

26.5 vs 10.3

1.7 vs 0.6

3.5 vs 1.2

3.0 vs 1.1

17.3 vs 10.3

13.0 vs 4.3

14.6 vs 6.5

1.1 vs 1.1

2.2 vs 3.2

0.6 vs 2.2

16.3 vs 6.2

6.7 vs 2.4

11.0 vs 4.3

1.0 vs 1.0

5.3 vs 3.3

1.0 vs 0.5

c/o S. Chen, from EJCI, JACC, JACC

DKCRUSH Studies: Outcomes

BBK II : Culotte vs. T or TAP in true

bifurcations

Population: n=300 >95% true bifurcation SB ≥ 2.25mm Intervention: Culotte vs. TAP if SB stent needed after MV stenting/lesion preparation Clinical outcome at 1 year: lower TLR rate in Culotte QCA at 8 Mo: lower restenosis rate in Culotte

Lesson 2 for our case: SB ostium interrogation with invasive imaging may help to elucidate the mechanism of ISR Ferenc et al. Eur Heart J. 2016 Dec 1;37(45):3399-3405

Randomized evidence in bifurcation PCI

1. Provisional strategy at least non-inferior to two-stent strategy (Colombo et al 2004, Pan et al 2004, CACTUS, NORDIC I, BBK I, BBC One, DK-Crush II, EBC II) 2. SB predilatation in provisional not mandatory, also not harmful (Pan et al) 2. Final KBI in single-stent strategy not mandatory, also not harmful (NORDIC III) 3. KBI in two-stent strategy mandatory (NORDIC-KISS) 4. Head-to-head comparison of two-stent techniques (NORDIC II, BBK II)

CASE 1 – Left Main DISTAL BIFURCATION – MINI CRUSH

• 84 MALE • OLD PCI LAD • NSTEMI • ECHO – INFERIOR HYPOKINESIS EF40%

• LHC – CTO RCA (chronic) – Severe heavily calcified distal LMS ostial LAD CX

severe proximal LAD disease – MEDINA 1,1,1

CASE 1 – Left Main DISTAL BIFURCATION – MINI CRUSH

PRE

CASE 1 – Left Main DISTAL BIFURCATION – MINI CRUSH

DIFFICULT ROTAWIRE ROTAWIRE THROUGH FINECROSS

CASE 1 – Left Main DISTAL BIFURCATION – MINI CRUSH

ROTA 1.25 mm ROTA 1.5mm

CASE 1 – Left Main DISTAL BIFURCATION – MINI CRUSH

CASE 1 – Left Main DISTAL BIFURCATION – MINI CRUSH

MINICRUSH MINICRUSH

CASE 1 – Left Main DISTAL BIFURCATION – MINI CRUSH

KISSING BALLOON POT

CASE 1 – Left Main DISTAL BIFURCATION – MINI CRUSH

FINAL FINAL

CASE 2 – Left Main DISTAL LMS – OSTIAL CX (dominant)

CULOTTE

• 83 male • Hypertensive • PPM • ACUTE CORONARY SYNDROME – Troponin positive – Echo: anterolateral posterior hypokinesis, EF 40%

• LHC: – DISTAL LMS – OSTIAL CX (dominant) – MEDINA 1,0,1

CASE 2 – Left Main DISTAL LMS – OSTIAL CX (dominant)

CULOTTE

PRE PRE

CASE 2 – Left Main DISTAL LMS – OSTIAL CX (dominant)

CULOTTE

STENT CX KISSING 1

CASE 2 – Left Main DISTAL LMS – OSTIAL CX (dominant)

CULOTTE

STENT LAD FINAL KISSING

CASE 2 – Left Main DISTAL LMS – OSTIAL CX (dominant)

CULOTTE

POT FINAL

LONG LESIONS

• May require special techniques – Rotablation, CTO techniques

CASE 3 – LONG LAD CTO X 2

• 67 MALE • Hypertensive, hyperlidemic • Stable increasing angina • Long LAD CTO X 2 – second attempt

CASE 3 – LONG LAD CTO X 2

PRE PRE

CASE 3 – LONG LAD CTO X 2CROSS BOSS KNUCKLE FIELDER XTA CROSS BOSS AFTER KNUCKLE

CASE 3 – LONG LAD CTO X 2

STING RAY BALLOON ALIGNED STING RAY BALLOON VERTICAL

CASE 3 – LONG LAD CTO X 2STING RAY WIRE MULTIPLE HOLES

STING RAY WIRE MULTIPLE HOLES

CASE 3 – LONG LAD CTO X 2

PILOT 200 IVUS

CASE 3 – LONG LAD CTO X 2

FINAL FINAL

LM RevascularisationAnatomical factors Local Factors

Decision Making Process for LM Disease

Clinical factors

Best solution for A particular patient

Factors for decision making in LM diseaseClinical Factors

Surgical Risk, Scores (EUROSCORE, STS) Age / Gender / ComorbiditiesClinical Presentation (stable vs. ACS) DiabetesLV functionPatient preference, cultural specifivity, social context

Patient will drive the decision !

Decision for patient with LM

Man 48 Y.O SCAD, CCS 2 RF: T2DM Married, 3 children Driver in Public Transport

Critical LM stenosis Significant mid LAD and OM Normal RCA

Distal LM + 2-VD SYNTAX score 27

DM

CABG vs PCI ?

Decision for patient with LM

Man 83 Y.O NSTEMI COPD, renal dysfunction RF: HTA, smoker Retired

Critical LM stenosis Significant mid LAD and OM Normal RCA

Distal LM + 2-VD SYNTAX score 27

DM

CABG vsPCI ?

Factors for decision making in LM diseaseAnatomical Factors

SYNTAX score ?Lesion type (Ostium/mid vs. Distal) Associated MVD or not, CTO involved Prior CABG / PCI

Anatomy is KEY for decision

Factors for decision making in LM diseaseLocal Factors

Cost, availabilitySkills of PCI operatorSkills of surgeon (IMA vs. SVG) Availability of surgery*Volume quality center / operator

* Higher rate of PCI in non-surgical centers

Conclusion: EXCEL and NOBLE (1)

Reassuring data for LM PCI: No difference for mortality

Higher rate of repeat revascularisation with PCI

Different results mainly related to study design

Case Presentation

Live Case from St Luke’s Hospital Thessaloniki, Greece

24/04/2017

PAST MEDICAL HISTORY! 1997 Aortic Valve replacement- metallic (for aortic stenosis of BAV) ! 1997 Valvular Heart Failure (EF=35%) ! 2009 PCI LAD ! 2011 ICD implantation for primary prevention (EF=25%)

CAUSE OF HOSPITALIZATION ! Male 61 years old, hypertensive, non diabetic with moderate kidney

disease. ! Heart Failure Decompensation: peripheral edema + dyspnea ! Electrical Storm: 3 ICD therapies for VF

EF=15%

Mitral Valve: moderate to severe regurgitation

Metallic Aortic Valve: normal function

CORONARY ANGIOGRAPHY RCA: normal AVR: normal

CORONARY ANGIOGRAPHY severe heavily calcified distal LMS ostial LAD

ostial CX (MEDINA 1,1,1)

OPTIONS

! CABG – declined by surgeons STS score >10 ! PCI – Rotablation without support ! PCI – Rotablation with MECHANICAL SUPPORT

Right Ventricle

Left Ventricle

Varying Mechanisms of Hemodynamic Support

Inotropes

IAB + Inotropes

TandemHeart

ECMO

Impella 2.5/CP

Impella 5.0

Hemodynamic Support

(CPO)

Myocardial Protection (PVA)

Low Med High High Med Low Low Med High

Negative Positive

Device Summary Cardiac Power and Myocardial Protection

IABP

VA-ECMO

TandemHeart

Impella

Considerations for Selection of Hemodynamic Support

! LV Pressure -- LV Volume

" LV Pressure -- LV Volume -- LV Pressure ! LV Volume ! LV Pressure ! LV Volume

DECISION

! PCI – Rotablation with MECHANICAL SUPPORT ! IABP: Inadequte support ! IMPELLA: Non applicable (AVR)

! ECMO

ECMO

! Percutaneous femoral cannulation of both the common femoral vein (24 Fr cannula) and artery (18 Fr cannula with added distal leg perfusion branch)

! the circuit was connected to a third generation (magnetically levitated) centrifugal pump (Centrimag, Levitronix) and to a long term (low pressure) membrane oxygenator (Medtronic)

! cardiopulmonary support with flows up to 5.5 l/min

PILOT 50 LAD - FINECROSS IVUS CANNOT CROSS

PTCA: Rotablation LAD, CX, CULOTTE technique

ROTAWIRE THROUGH FINECROSS ROTABURR 1.25mm 140000rpm

PTCA: Rotablation LAD, CX, CULOTTE technique

ROTABURR 1.5mm 140000rpm POST ROTA LAD

PTCA: Rotablation LAD, CX, CULOTTE technique

ROTABURR 1.5 mm CX 140000rpm POST ROTA CX

PTCA: Rotablation LAD, CX, CULOTTE technique

BALLOON LAD BALLOON CX

PTCA: Rotablation LAD, CX, CULOTTE technique

STENT CX WIRE LAD

PTCA: Rotablation LAD, CX, CULOTTE technique

FIRST KISSING STENT LAD

PTCA: Rotablation LAD, CX, CULOTTE technique

STENT LAD DEPLOYED FINAL KISSING

PTCA: Rotablation LAD, CX, CULOTTE technique

PTCA: Rotablation LAD, CX, CULOTTE technique

! FINAL POT 4.5 BALLOON 26 Atm

PTCA: Rotablation LAD, CX, CULOTTE technique FINAL RESULT

PTCA: Rotablation LAD, CX, CULOTTE technique FINAL IVUS RESULT

DAY 1: patient completely dependent on ECMO – pressure tracing direct line – iv inotropes

DAY 1: patient completely dependent on ECMO – pressure tracing direct line – iv inotropes

DAY 5: ECMO REMOVED DAY 8: PATIENT DISCHARGED – NYHA I – EF 35%

MR improved grade II

PRE POST

EF

Conclusions Identification of high risk patients who most likely will benefit from MCS is crucial

! Type of MCS depends on:

! LV-circulatory status

! type and duration of procedure ! rotablation in heavily calcified tandem lesions, where any other method of

percutaneous intervention would have failed with detrimental effect for these particular patients

! It is important to utilize the expertise of the surgeons in this field