1. Μηνύματα από τις σπουδαιότερες μελέτες στην Επεμβατική Καρδιολογία την τελευταία διετία
Χριστόδουλος Παπαδόπουλος MD, PhD, FESC
Επίκουρος Καθηγητής Καρδιολογίας Ιατρικής Σχολής ΑΠΘ
Γ' Πανεπιστημιακή Καρδιολογική Κλινική
Γ.Ν. Ιπποκράτειο, Θεσσαλονίκη 1

2. Nothing to declare

3. TAVI

4. Patients at Intermediate Surgical Risk
SAPIEN XT and SAPIEN 3
CoreValve 4

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8. Intermediate Risk NOTION | The CoreValve Platform
Though the study was likely under-powered, NOTION showed all-cause mortality with TAVR with CoreValve to be non-inferior to SAVR in patients at lower surgical risk
1Sondergaard, presented at EuroPCR 2015 8

15. Low Surgical Risk Active Trials Randomizing TAVR to SAVR
Currently there is significant clinical investment in applying TAVR to younger patients at low surgical risk, both in North America and in Europe
Medtronic Low Risk1
UK TAVI3
N = ~1200
Up to 80 centers
Evolut R, all routes
Industry-sponsored
10-year follow-up
N = 1228
Up to 64 centers
SAPIEN 3, transfemoral
PARTNER 32
N = 808
All UK TAVI centers
All valves, all routes
Publically funded
5-year follow-up
NOTION-24
N = 992
All Nordic countries
All valves, transfemoral
Physician and industry-sponsored
1Popma, et al., presented at TCT 2016; 2Mack, et al., presented at TCT 2016; 3Moat, et al., presented at TCT 2016; 4Sondergaard, et al., presented at TCT 2016 15

16. ΑΓΓΕΙΟΠΛΑΣΤΙΚΗ 16

17. PCI vs CABG for unprotected LM disease NOBLE / EXCEL trials17

18. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis Nordic–Baltic–British left main revascularisation study (NOBLE) A prospective, randomised, open-label, non-inferiority trial
NOBLE
Evald Høj Christiansen
Timo Mäkikallio, Niels R Holm, Mitchell Lindsay, Mark S Spence, Andrejs Erglis, Ian B A Menown, Thor Trovik, Markku Eskola, Hannu Romppanen, Thomas Kellerth, Jan Ravkilde, Lisette O Jensen, Gintaras Kalinauskas, Rikard B A Linder, Markku Pentikainen, Anders Hervold, Adrian Banning, Azfar Zaman, Jamen Cotton, Erlend Eriksen, Sulev Margus, Henrik T Sørensen, Per H Nielsen, Matti Niemelä, Kari Kervinen, Jens F Lassen, Michael Maeng, Keith Oldroyd, Geoff Berg, Simon J Walsh, Colm G Hanratty, Indulis Kumsars, Peteris Stradins, Terje K Steigen, Ole Fröbert, Alastair NJ Graham, Petter C Endresen, Matthias Corbascio, Olli A Kajander, Uday Trivedi, Juha Hartikainen, Vesa Anttila, David Hildick–Smith, Leif Thuesen, and Evald H Christiansen
On behalf of the NOBLE investigators 18 18

19. Did not receive PCI (n=13) Died before PCI (n=1)
Randomized (n= 1201)
Allocated to PCI (n=598)
Received PCI (n=585)
Did not receive PCI (n=13)
Died before PCI (n=1)
Patient declined PCI (n=4)
PCI operator declined (n=4)
LMCA lesion not significant (n=4)
Allocated to CABG (n=603)
Received CABG (n=570 )
Did not receive CABG (n=33)
Died before CABG (n=1)
Patient declined CABG (n=15)
Not eligible for CABG (n=15)
Cross over by mistake (n=2)
Lost to follow-up (n=6)
Emigration (n=1)
Contact lost (n=2)
Withdrawal (n=3)
Lost to follow-up (n=11)
Emigration (n=0)
Contact lost (n=0)
Withdrawal (n=11)
Patients allocated to PCI in analysis (n=592)
580 received PCI
7 received CABG
Patients allocated to CABG in analysis (n=592)
567 received CABG
23 received PCI 19 19

20. Primary endpoint
A composite of major adverse cardiac and cerebrovascular events (MACCE)
Death from any cause
Non-procedural myocardial infarction
Repeat revascularization
Stroke 20

21. Lesion characteristics
PCI
CABG
P–value
SYNTAX score
22·5±7·5
22·4±8·0
0·74
Distal LMCA lesion
477 (81%)
482 (81%)
0·77 21 21

22. Treatment PCI LMCA stenting involving ostium and not the bifurcation
59 (10%)
Shaft LMCA stenting only
11 (2%)
LMCA bifurcation lesion stenting
508 (88%)
IVUS pre–evaluation
270 (47%)
IVUS post–evaluation
430 (74%)
Complete revascularization
543 (94%) 22 22

23. Results Primary endpoint: MACCE
28·9%
HR 1·48 (1·11–1·96); p=0·0066
19·1%
PCI did not show non-inferiority
and CABG was superior to PCI 23 23

24. Conclusions
PCI did not meet non-inferiority for the primary endpoint of 5- year MACCE compared to CABG
CABG was superior to PCI
PCI resulted in higher rates of non-procedural myocardial infarctions
Repeat revascularization was higher after PCI, primarily due to de novo lesions and non LMCA target lesion revascularization
All-cause mortality was similar for PCI and CABG 24 24

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29. ΒΙΟΑΠΟΡΡΟΦΗΣΙΜΑ STENTS BVS29

37. ΑΝΤΙΑΙΜΟΠΕΤΑΛΙΑΚΑ ΦΑΡΜΑΚΑ ΣΤΗΝ ΕΠΕΜΒΑΤΙΚΗ ΚΑΡΔΙΟΛΟΓΙΑ37

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45. PRAGUE-18

46. PRAGUE-18 Ticagrelor vs Prasugrel in STEMI

47. PRAGUE-18 Ticagrelor vs Prasugrel in STEMI

48. PRAGUE-18 - Conclusions No difference in the early phase of STEMI pPCI
Follow up in 1 year
Study underpowered
Premature discontinuation
1/3 pts modified DAPT in 30 days
Larger trials are needed – feasible?
Registries?

49. ΑΝΤΙΘΡΟΜΒΩΤΙΚΗ ΑΓΩΓΗ ΣΕ ΑΣΘΕΝΕΙΣ ΜΕ AF ΚΑΙ ΑΓΓΕΙΟΠΛΑΣΤΙΚΗ49

50. PIONEER AF -2016 50

52. 52

53. REDUAL PCI 53

60. ΑΝΤΙΔΡΑΣΤΙΚΟΤΗΤΑ ΑΙΜΟΠΕΤΑΛΙΩΝ60

61. ANTARCTIC - Platelet reactivity guided DAPT in PCI61

63. ANTARCTIC - Platelet reactivity guided DAPT in PCI

64. ANTARCTIC - Platelet reactivity guided DAPT in PCI

65. PFO CLOSURE 65

66. RESPECT Trial
Randomized, event-driven, open-label trial with blinded endpoint adjudication
Patients randomized 1:1 to AMPLATZER PFO Occluder (device) vs. guideline-directed medical management (MM)
980 subjects enrolled from 2003 to 2011
69 sites in U.S. and Canada

67. Primary Endpoint Composite of: Stroke definition:
Recurrent nonfatal ischemic stroke
Fatal ischemic stroke
Early post-randomization death (within 45 days)
Stroke definition:
Acute focal neurological deficit due to cerebral ischemia with:
Neuroanatomically relevant infarct on imaging or
Symptoms >24 hours

68. Enrollment Criteria RESPECT Trial Key Inclusion Criteria
Key Exclusion Criteria
Cryptogenic stroke within last 9 months
TEE-confirmed PFO
18-60 years
Patients > 60 at higher risk of recurrent stroke from non-PFO mechanisms
Stroke due to identified cause such as:
Large vessel atherosclerosis (e.g., carotid stenosis)
Atrial fibrillation
Intrinsic small vessel disease (lacunar infarcts)
11 other specific etiologies
Inability to discontinue anticoagulation

69. RESPECT Final Results 69

70. FDA Approval 10/28/16
The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.
Earlier trials with shorter-term follow-up had reported no benefit with PFO closure: the CLOSURE I trial (with the STARFlex device) and the PC trial (with the Amplatzer device). 70

72. RESPECT Longer-term follow-up (5 years)
No difference was noted in all-cause strokes between PFO and medical management
There was a significant benefit in favor of PFO closure among patients
with a recurrent cryptogenic stroke (HR 0.46, p = 0.042), in patients aged <60 years (HR 0.48, p = 0.035), and in those with an atrial septal aneurysm (HR 0.25, p = 0.007).
No mortality benefit
On further long-term follow-up (mean 5.9 years)
there was a significant reduction in recurrent ischemic strokes in favor of PFO closure (HR 0.55, 95% CI , p = 0.046). No device embolizations or erosions were reported.
Atrial fibrillation rates between PFO closure and medical management were 0.25/100 PY vs. 0.15/100 PY, p = 0.37. 72

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77. REDUCE
664 patients 2:1 to PFO closure with the Gore Helex Septal Occluder or the Gore Cardioform Septal Occluder (both WL Gore & Associates) plus antiplatelet therapy or antiplatelet therapy alone
cryptogenic ischemic stroke within the past 180 days.
Antiplatelet therapy
Recurrent clinical ischemic stroke through at least 2 years (average follow-up was 3.4 years) occurred in six patients (1.4%) in the closure group and 12 (5.4%) in the control group, a relative risk reduction of 77% (HR 0.23; 95% CI ). The number needed to treat was 28.
The other primary endpoint, a composite of new clinical ischemic stroke or silent brain infarct on MRI through 2 years, occurred in 5.7% of patients who underwent PFO closure and 11.3% of the controls, a relative reduction of 49% (RR 0.51; 95% CI ).
Low risk of device- or procedure-related complications, although there was a higher risk of A-fib in the closure group, which has been seen in prior trials. 77

85. TAVI PCI DRUGS PFO CLOSURE STENTS
ΜΗΝΥΜΑΤΑ ΓΙΑ ΤΟ ΣΠΙΤΙ
TAVI
PCI
DRUGS
PFO CLOSURE
STENTS

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