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

Size: px

Start display at page:

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

Jonah Lawrence
5 years ago
Views:

1 ΣΥΜΠΛΟΚΕΣ ΔΙΑΔΕΡΜΙΚΕΣ ΕΠΕΜΒΑΣΕΙΣ (στέλεχος, διχασµός, µακρές πολλαπλές βλάβες) ΠΕΤΡΟΣ Σ. ΔΑΡΔΑΣ, MD, FESC 16o Βορειοελλαδικό Καρδιολογικό Συνέδριο ΘΕΣΣΑΛΟΝΙΚΗ 2017

2 Left Main Disease 5-year Outcomes (N=705) CABG (n=348) TAXUS (n=357) P=0.53 P=0.10 P=0.03 P<0.001 P= Patients (%) All Death MI CVA Revasc. MACCE SYNTAX 3VD 5-year Outcomes TCT 2012 Mohr 23 October 2012 Slide 7

33 Cumulative Event Rate (%) Death, CVA or MI 19.8% 14.8% 0.16 0 0 12 24 36 48 Months Since Allocation 60 Revasc.

3 MACCE to 5 Years by SYNTAX Score Tercile LM Subset Low to Intermediate Scores (0-32) CABG (N=196) TAXUS (N=221) CABG PCI P value 50 P=0.74 LM Disease Death 15.1% 7.9% 0.02 CVA 3.9% 1.4% % % MI 3.8% 6.1% 0.33 Cumulative Event Rate (%) Death, CVA or MI 19.8% 14.8% Months Since Allocation 60 Revasc. 18.6% 22.6% 0.36 Serruys PW et al. Lancet 2013;381: SYNTAX 3VD 5-year Outcomes TCT 2012 Serruys 23 October 2012 Slide 9

4 MACCE to 5 Years by SYNTAX Score Tercile LM Subset High Scores CABG (N=149) TAXUS (N=135) P=0.003 LM Disease 46.5% CABG PCI P value Death 14.1% 20.9% 0.11 CVA 4.9% 1.6% MACCE (%) 29.7% MI Death, CVA or MI 6.1% 22.1% 11.7% 26.1% Months Revasc. 11.6% 34.1% <0.001 Serruys PW et al. Lancet 2013;381: SYNTAX 3VD 5-year Outcomes TCT 2012 Serruys 23 October 2012 Slide 8

Recommendations for LM Revascularization United States Europe PCI CABG PCI CABG Low SxScore 0-22 IIa B IB Low SxScore 0-22 IB IB Intermediate SxScore 23-32 IIb B IB

5 Recommendations for LM Revascularization United States Europe PCI CABG PCI CABG Low SxScore 0-22 IIa B IB Low SxScore 0-22 IB IB Intermediate SxScore IIb B IB Intermediate SxScore IIa B IB High SxScore >32 III B IB High SxScore >32 III B IB Levine G, et al. J Am Coll Cardiol. 2011;58: Windecker S, et al. Eur Heart J. 2014;35:

NOBLE: Study Design 1200 pts with unprotected left main disease @ 26

mm, CTO, 2-stent bifurcation, calcified or tortuous vessels) R PCI

7 NOBLE: Study Design 1200 pts with unprotected left main 26 EU sites With 3 additional non-complex lesions (excludes length >25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessels) R PCI (Biomatrix BES) (N=600) CABG (N=600) Clinical follow-up: Through 5 years

8 NOBLE: PCI vs CABG in Unprotected LM Stenosis Evald 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

9 NOBLE Results Primary endpoint: MACCE HR 1 48 ( ); p= % 19 1% PCI did not show non-inferiority and CABG was superior to PCI

10 NOBLE Results All-cause mortality HR 1 07 ( ); p= % 11 6% 9 5% 9.5%

11 NOBLE Results Non-procedural MI HR 2 88 ( ); p= % 1 9%

12 NOBLE Results Total repeat revascularization HR 1 50 ( ); p= % 10 4%

13 NOBLE Results Stroke HR 2 25 ( ); p= % 1 7%

14 Results SYNTAX score subgroups K-M estimates 4.9% 1.9% HR 1 88 ( ); p= HR 1 16 ( ); p=0 48 HR 1 41 ( ); p=0 41 SYNTAX score assessed by independent corelab (CERC)

15 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!!

EXCEL A 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.

16 EXCEL A 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 NCT

17 What is Novel About EXCEL? The primary endpoint: Death, MI or stroke at 3 years Revascularization not primary endpoint

18 What is Novel About EXCEL? Restriction of enrollment to Syntax Score 32

19 What is Novel About EXCEL? Use of 2nd Generation DES

equipoise by heart team No (N=1000) Enrollment registry PCI (Xience EES) (N=948) CABG (N=957) Follow-up: 1

20 EXCEL Study Design 2905 pts with unprotected left main disease Stratified by diabetes, SYNTAX score and center Yes (N=1905) R at 126 sites in 17 countries SYNTAX score 32 Consensus agreement of eligibility and equipoise by heart team No (N=1000) Enrollment registry PCI (Xience EES) (N=948) CABG (N=957) 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

21 Primary Endpoint Death, Stroke or MI at 3 Years 25% 20% CABG (n=957) PCI (n=948) 15% 15.4% 14.7% 10% Death, stroke or MI (%) 5% HR [95%CI] = 1.00 [95% CI: 0.79, 1.26] P = % No. at Risk: PCI CABG Months

22 Conclusions PCI with CoCR EES similar Death MI CVA at 3 years Less 30 day adverse events with PCI

23 «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 201

Updated Meta-analysis of LM DES Trials 5 RCTs, 4,594 pts, longest FU data used (EXCEL, NOBLE, SYNTAX, PRECOMBAT, Boudriot et al) Death Trial OR (95% CI) Events, Events, % DES CABG Weight Boudriot et

24 Updated Meta-analysis of LM DES Trials 5 RCTs, 4,594 pts, longest FU data used (EXCEL, NOBLE, SYNTAX, PRECOMBAT, Boudriot et al) Death Trial OR (95% CI) Events, Events, % DES CABG Weight Boudriot et al 0.39 (0.07, 2.07) 2/100 5/ PRECOMBAT 0.72 (0.38, 1.38) 17/300 23/ SYNTAX 0.90 (0.58, 1.39) 45/357 48/ NOBLE 1.10 (0.67, 1.78) 36/592 33/ EXCEL 1.38 (0.96, 1.99) 71/948 53/ Overall (I-squared = 23.7%, p=0.26) 1.03 (0.78, 1.35) P= / % 162/ % 1 Favors DES Favors CABG 5 Nerlekar N et al. Circ Int 2017:on-line

25 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 Trial OR (95% CI) Events, Events, % DES CABG Weight Boudriot et al 1.01 (0.20, 5.13) 3/100 3/ PRECOMBAT 1.20 (0.36, 3.99) 6/300 5/ SYNTAX 1.77 (0.94, 3.33) 28/357 16/ NOBLE 3.00 (1.45, 6.21) 29/592 10/ EXCEL 0.94 (0.67, 1.31) 72/948 77/ Overall (I-squared = 58.1%, p=0.049) 1.46 (0.88, 2.45) P= / % 111/ % Favors DES 1 Favors CABG 5 Nerlekar N et al. Circ Int 2017:on-line

26 Updated Meta-analysis of LM DES Trials 5 RCTs, 4,594 pts, longest FU data used (EXCEL, NOBLE, SYNTAX, PRECOMBAT, Boudriot et al) Stroke Trial OR (95% CI) Events, DES Events, CABG % Weight PRECOMBAT 1.00 (0.14, 7.15) 2/300 2/ SYNTAX 0.34 (0.12, 0.95) 5/357 14/ NOBLE 2.32 (0.95, 5.68) 16/592 7/ EXCEL 0.77 (0.43, 1.39) 20/948 26/ Overall (I-squared = 62.5%, p=0.046) 0.88 (0.39, 1.97) P= / % 49/ % Favors DES 1 5 Favors CABG Nerlekar N et al. Circ Int 2017:on-line

37) 38/300 21/300 11.59 SYNTAX 2.06 (1.40, 3.02) 90/357 49/348 24.43 NOBLE 1.58 (1.07, 2.33) 71/592 47/592 24.11 EXCEL 1.82 (1.32, 2.

27 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 Trial OR (95% CI) Events, Events, % DES CABG Weight Boudriot et al 2.58 (0.95, 7.01) 14/100 6/ PRECOMBAT 1.93 (1.10, 3.37) 38/300 21/ SYNTAX 2.06 (1.40, 3.02) 90/357 49/ NOBLE 1.58 (1.07, 2.33) 71/592 47/ EXCEL 1.82 (1.32, 2.49) 114/948 67/ Overall (I-squared = 0.0%, p=0.85) 1.85 (1.53, 2.23) P< / % 67/ % Favors DES 1 5 Favors CABG Nerlekar N et al. Circ Int 2017:on-line

28 LM PCI: Key Points 2017 Heart Team approach Be skilled at bifurcation stenting Guideline Committee likely will wait for longer data with EXCEL

Randomized Bifurcation Trials Patients (N) Randomization Primary End Point Outcome (Provisional vs Systematic Unless Otherwise Specified) NORDIC 413 Provisional vs systematic (crush, culotte, T)

29 Randomized Bifurcation Trials Patients (N) Randomization Primary End Point Outcome (Provisional vs Systematic Unless Otherwise Specified) NORDIC 413 Provisional vs systematic (crush, culotte, T) Death, MI (nonprocedural), TVR, or stent thrombosis at 6 mo 2.9% vs 3.4% (P=NS) CACTUS 350 Provisional vs systematic (crush) Death, MI, TVR at 6 mo 15% vs 15.8% (P=NS) BBC ONE 500 Provisional vs systematic (crush, culotte) Death, MI, TVF at 9 mo 8.0% vs 15.2% (P<0.05) Ference et al. 202 Provisional vs systematic (T) Death, MI, TVF at 9 moangiographic restenosis (side branch) 9 mo 23.0% vs 27.7% (P=NS) Colombo et al. 85 Provisional vs systematic (crush, T, culotte) Angiographic restenosis (either branch) 6 mo 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 Systematic (crush vs culotte) Death, MI (nonprocedural), TVR, or stent thrombosis at 6 mo Crush 4.3% vs culotte 3.7% (P=NS)

30 Meta-Analysis Bifurcations with DES One (Provisional) vs Two Stents TLR Clinical outcome -> No difference Brar SS et al. Eurointervention 2009;5:475:84

31 Meta-Analysis Bifurcations with DES One (Provisional) vs Two Stents Side Branch Restenosis Angiographic outcome -> No difference Brar SS et al. Eurointervention 2009;5:475:84

Bifurcation Lesions I IIa IIb III 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

32 Bifurcation Lesions I IIa IIb III 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. I IIa IIb III 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.

33 DKCRUSH Studies: Outcomes DKCRUSH-1 Crush vs DK DKCRUSH-II PT vs DK DKCRUSH-III Culotte vs DK MACE,% 24.4 vs vs vs 6.2 TLR,% 18.9 vs vs vs 2.4 TVR,% 26.5 vs vs vs 4.3 CD,% 1.7 vs vs vs 1.0 QMI,% 3.5 vs vs vs 3.3 ST*, % 3.0 vs vs vs 0.5 c/o S. Chen, from EJCI, JACC, JACC

34 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 Ferenc et al. Eur Heart J Dec 1;37(45): imaging may help to elucidate the mechanism of ISR

35 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)

36 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

37 PRE CASE 1 Left Main DISTAL BIFURCATION MINI CRUSH

38 CASE 1 Left Main DISTAL BIFURCATION MINI CRUSH DIFFICULT ROTAWIRE ROTAWIRE THROUGH FINECROSS

39 CASE 1 Left Main DISTAL BIFURCATION MINI CRUSH ROTA 1.25 mm ROTA 1.5mm

40 CASE 1 Left Main DISTAL BIFURCATION MINI CRUSH

41 CASE 1 Left Main DISTAL BIFURCATION MINI CRUSH MINICRUSH MINICRUSH

42 CASE 1 Left Main DISTAL BIFURCATION MINI CRUSH KISSING BALLOON POT

43 CASE 1 Left Main DISTAL BIFURCATION MINI CRUSH FINAL FINAL

44 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

45 CASE 2 Left Main DISTAL LMS OSTIAL CX (dominant) CULOTTE PRE PRE

46 CASE 2 Left Main DISTAL LMS OSTIAL CX (dominant) CULOTTE STENT CX KISSING 1

47 CASE 2 Left Main DISTAL LMS OSTIAL CX (dominant) CULOTTE STENT LAD FINAL KISSING

48 CASE 2 Left Main DISTAL LMS OSTIAL CX (dominant) CULOTTE POT FINAL

49 LONG LESIONS May require special techniques Rotablation, CTO techniques

50 CASE 3 LONG LAD CTO X 2 67 MALE Hypertensive, hyperlidemic Stable increasing angina Long LAD CTO X 2 second attempt

51 CASE 3 LONG LAD CTO X 2 PRE PRE

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

53 CASE 3 LONG LAD CTO X 2 STING RAY BALLOON ALIGNED STING RAY BALLOON VERTICAL

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

55 CASE 3 LONG LAD CTO X 2 PILOT 200 IVUS

56 CASE 3 LONG LAD CTO X 2 FINAL FINAL

57 Decision Making Process for LM Disease Clinical factors Anatomical factors LM Revascularisation Local Factors Best solution for A particular patient

58 Factors for decision making in LM disease Clinical Factors Surgical Risk, Scores (EUROSCORE, STS) Age / Gender / Comorbidities Clinical Presentation (stable vs. ACS) Diabetes LV function Patient preference, cultural specifivity, social context Patient will drive the decision!

59 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 CABG vs PCI? Distal LM + 2-VD SYNTAX score 27 DM

60 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 CABG vspci? Distal LM + 2-VD SYNTAX score 27 DM

61 Factors for decision making in LM disease Anatomical Factors SYNTAX score? Lesion type (Ostium/mid vs. Distal) Associated MVD or not, CTO involved Prior CABG / PCI Anatomy is KEY for decision

62 Factors for decision making in LM disease Local Factors Cost, availability Skills of PCI operator Skills of surgeon (IMA vs. SVG) Availability of surgery* Volume quality center / operator * Higher rate of PCI in non-surgical center

63 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

64 Case Presentation Live Case from St Luke s Hospital Thessaloniki, Greece 24/04/2017

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

66 EF=15%

67 Mitral Valve: moderate to severe regurgitation

68 Metallic Aortic Valve: normal function

69 CORONARY ANGIOGRAPHY RCA: normal AVR: normal

70 CORONARY ANGIOGRAPHY severe heavily calcified distal LMS ostial LAD ostial CX (MEDINA 1,1,1)

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

72 Varying Mechanisms of Hemodynamic Support Left Ventricle Right Ventricle

73 Device Summary Cardiac Power and Myocardial Protection Hemodynamic Support (CPO) Myocardial Protection (PVA) Negative Positive Low Med High High Med Low Low Med High Inotropes IAB + Inotropes TandemHeart ECMO Impella 2.5/CP Impella 5.0

74 Considerations for Selection of Hemodynamic Support IABP VA-ECMO TandemHeart Impella! LV Pressure -- LV Volume " LV Pressure -- LV Volume -- LV Pressure! LV Volume! LV Pressure! LV Volume

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

76 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

78 PTCA: Rotablation LAD, CX, CULOTTE technique PILOT 50 LAD - FINECROSS IVUS CANNOT CROSS

79 PTCA: Rotablation LAD, CX, CULOTTE technique ROTAWIRE THROUGH FINECROSS ROTABURR 1.25mm rpm

80 PTCA: Rotablation LAD, CX, CULOTTE technique ROTABURR 1.5mm rpm POST ROTA LAD

81 PTCA: Rotablation LAD, CX, CULOTTE technique ROTABURR 1.5 mm CX rpm POST ROTA CX

82 PTCA: Rotablation LAD, CX, CULOTTE technique BALLOON LAD BALLOON CX

83 PTCA: Rotablation LAD, CX, CULOTTE technique STENT CX WIRE LAD

84 PTCA: Rotablation LAD, CX, CULOTTE technique FIRST KISSING STENT LAD

85 PTCA: Rotablation LAD, CX, CULOTTE technique STENT LAD DEPLOYED FINAL KISSING

86 PTCA: Rotablation LAD, CX, CULOTTE technique! FINAL POT 4.5 BALLOON 26 Atm

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

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

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

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

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

92 MR improved grade II

93 EF PRE POST

94 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

PCI for Left Main Coronary Artery Stenosis. Jean Fajadet Clinique Pasteur, Toulouse, France

PCI for Left Main Coronary Artery Stenosis Jean Fajadet Clinique Pasteur, Toulouse, France Athens, October 19, 2018 Left Main Coronary Artery Disease Significant unprotected left main coronary artery disease