ΣΥΜΠΛΟΚΕΣ ΔΙΑΔΕΡΜΙΚΕΣ ΕΠΕΜΒΑΣΕΙΣ€¦ · EXCEL A Prospective,...
Transcript of ΣΥΜΠΛΟΚΕΣ ΔΙΑΔΕΡΜΙΚΕΣ ΕΠΕΜΒΑΣΕΙΣ€¦ · EXCEL A Prospective,...
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