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University Hospital Careggi
Florence, 29th March 2017
Myocardial
Revascularization
Revascularization vs medical therapy
CABG technique
Acute Coronary
Syndrome
PCI vs CABG in diabetes
PCI vs CABG for left main
Devices
CTO treatment
Bifurcation
Funtional and
Imaging Guidance
Adjuntive
Pharmacological
Therapy
STICHES trial (Surgical Treatment for Ischemic Heart
Failure Extension Study)
•
1212 patients with EF ≤35%
•
602 patients in the OMT group
•
610 in the CABG group
•
Follow-up 9.8 years
•
Progressive divergence in the curve
for mortality : 66% in OMT group vs
58.9% in CABG group (p 0.02)
•
High mortality rate in both groups
N Engl J Med 2016;374:1511-20
Progressive divergence in the curve for
cardiovascular mortality : 49.3% in OMT
group vs 40.5% in CABG group (p 0.006)
NNT 14 to prevent one death
N Engl J Med 2016;374:1511-20
Excel trial
1905 eligible patients with left main coronary artery disease and low or
intermediate SYNTAX score randomized to PCI or CABG
Primary endpoint: composite of death from any cause, stroke, or MI at 3 years
stroke disability of modified
Rankin Scale (mRS) ≥1
PCI:
Xience (second generation DES)
IVUS performed in 77.6%
CABG:
off-pump 29.4%
bilateral artery graft in 28.8%
N Engl J Med. 2016 Dec 8;375(23):2223-2235.
Peri-procedural (within 72 h CK>5-10x URL)
and spontaneous
Secondary endpoints at 3 years
PCI
(n=948)
CABG
(n=957)
P value
Definite stent thrombosis/
graft sintomatic occlusion
0.7%
5.4%
<0.001
All revascularization
12.9%
7.6%
<0.001
Secondary Outcomes
N Engl J Med. 2016 Dec 8;375(23):2223-2235.
NOBLE trial
1201 patients with left main coronary artery disease were enrolled in 36 centres in northern
Europe and randomised 1:1 to treatment with PCI or CABG
Primary endpoint: MACCE (death from any cause, non-procedural MI, stroke,
repeat revascularization) 5 years
ischaemic or haemorrhagic cerebrovascular
event verified by brain CT or MRI
PCI:
Biomatrix stent (after March 2011)
First generation stent 11%
Distal left main bifurcation 87%
IVUS performed in 75%
CABG:
off-pump 15.6%
Lancet. 2016 Dec 3;388(10061):2743-2752.
Very low stroke rate
(0% at 30 days)
Secondary Outcomes
Definite stent thrombosis/
graft symptomatic occlusion
PCI
(n=592)
CABG
(n=592)
P value
3%
4%
<0.001
Lancet. 2016 Dec 3;388(10061):2743-2752.
SCAAR (Swedish Coronary Angiography and Angioplasty Registry)
• 14,441 patients with CTO (16%)
and 75,431 patients without CTO
• January 2005-January 2012
• CTO group vs non CTO group
• Follow-up mean: 3.1 years
CTO was associated with increased mortality
(average mortality increase of 6.6% each year).
This association was most prominent in younger and ACS patients
Ramunddal, Hoebers et al J Am Coll Card Intv 2016;9: 1535-44
RECHARGE (REgistry of Crossboss and Hybrid procedures in
FrAnce, NetheRlands, BelGium and UnitEd Kingdom)
•
•
•
•
1777 patients with CTO
59% lesion lenght >20 mm, 58% calcific lesions, J-CTO score 2.2 ±1.3
Overall procedure success: 86%
Hybrid algorithm: anterograde wire escalation 77%, retrograde 17%, anterograde
dissection re-entry 7%
• MACE 2.6%, peri-procedural mortality 0.2%
Maeremans, Walsh et al J Am Coll Cardiol 2016; vol 68,n°18
Explore trial
304 patients with STEMI and concurrent CTO in a non–infarct-related artery
randomized to early PCI of the CTO ( < 15 days) or conservative treatment
Primary outcomes:left ventricular EF
(LVEDV) on cardiac MR after 4 months.
and left ventricular end diastolic volume
Henriques, Hoebers et al J Am Coll Cardiol 2016; 68:1622-32
DECISION-CTO:death from any cause
815 CTO randomized to CTO PCI (91.1% successful) v Optimal Medical Treatment
Presented at ACC 2017 by Park
AS TREATED
BBK II trial (Bifurcation Bad Krozingen)
300 patients with a coronary bifurcation lesion requiring a side-branch stent
were randomly assigned to culotte stenting or TAP stenting
Primary endpoint:
in-stent diameter stenosis at angiographic follow-up at 9 months 21±20% as
compared with 27±25% after TAP stenting (P<0.038)
Secondary Endpoints
Binary restenosis
Target Lesion Revascularization
Target Lesion Failure
Culotte stenting
(n=150)
TAP stenting
(n=150)
P value
6.5%
17%
0.006
6.0 %
12.0%
0.11
6.7%
12.0%
0.069
Ferench, Gick et al European Heart Journal (2016)0, 1–7
Myocardial
Revascularization
Thrombectomy for STEMI
Acute Coronary
Syndrome
STEMI, immediate vs deferred stent
implantation
Non-culprit lesion treatment in STEMI
Devices
Timing of PCI in NSTEMI
PCI in out-of hospital cardiac arrest
Funtional and
Imaging Guidance
Adjuntive
Pharmacological
Therapy
ACS in elderly patients
Routine follow-up angiography after PCI
Sub-studies of the TOTAL Trial: A Randomized Trial of Routine
Thrombectomy vs PCI Alone in STEMI
TOTAL substudy examines patients receiving PCI with (n = 5,033) or
without routine thrombectomy (n = 5,030).
1-YEAR FOLLOW-UP:
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NO differences in the primary outcome at 1 year (8%) in both groups (p=0.99)
•
NO differences in cardiovascular death (4%) in both groups (p=0.48)
•
Stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group
compared with 36 (0·7%) in the PCI alone group (p=0·015).
ANGIOGRAPHIC SUB-STUDY (1610 randomly selected angiograms):
•
Routine thrombectomy did not improve final MBG (28% in thrombectomy group
vs 30% in PCI alone group, p=0.38) or TIMI flow (90% vs 89.5% respectively ,
p=0.73)
•
Routine thrombectomy was associated with less minor distal embolization ( 7.1%
vs 10.7%, p<0.01).
Jolly SS, Cairns et al Lancet 2016:387;127-135
Sharma, Jolly et al European Heart Journal (2016)37, 1891–1898
DANAMI-3 DEFER trial
1215 STEMI patients randomized to receive standard PCI with immediately stent
implantation or deferred stent implantation (median 3 days)
Primary endpoint: composite of all-cause
mortality, hospital admission for heart failure,
recurrent MI, or unplanned revascularisation of
the infarct-related artery.
Distal embolization was observed in <10% of
patients in both groups
Crossover from deferred to immediate PCI was
frequent (22%)
Kelbaek, Hofsten et al Lancet 2016;387:2199-2206
DANAMI-3 PRIMULTI trial
627 STEMI patients with multivessel desease undergoing primary PCI.
Non culprit lesion revascularization : FFR guided (median 2 days) vs conservative strategy
Primary endpoint: composite of all-cause
mortality, reinfarction, or ischaemia-driven
(subjective or objective) revascularization
of lesions in non-culprit vessel.
Mortality and non fatal MI were similar in
two groups
Primary end-point was mainly influenced
by ischemia -driven revascularization ( 17%
in conservative group vs 5.0% in FFR
guided group)
Engstrom, Kelbaek et al Lancet 2015; 386: 665–71
Confidential
Confidential
RIDDLE-NSTEMI: Randomized Study of Immediate vs Delayed Invasive Intervention in NSTEMI
323 patients randomized to angiography within 2 hours or within 2-72 hours
after hospital admission.
Immediate
(<2h)
Delayed
(2-72 h)
(n = 162)
(n = 161)
30 day-death or MI
4.3%
13.0%
0.008
1 year-death or MI
6.8%
18.8%
0.002
Outcomes
P Value
The benefit of early invasive angiography was driven by a reduction in MI
occurring in the pre-catheterization period
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Conclusion: A strategy of early invasive angiography is important for
reducing clinical outcomes in NSTEMI patients with high-risk features.
Milosevic A, et al. J Am Coll Cardiol Intv. 2016, vol 9, n 6
PROCAT II trial: emergency PCI in Post-Cardiac Arrest Patients
Without ST-Segment Elevation Pattern
Parisian registry data on 695 resuscitated patients who had an emergent
coronary angiogram, 2004-2013.
• In 29% of patients at least one significative coronary lesion was
observed had PCI
• Successful PCI of a culprit lesion was associated with better neurologic
outcome (adjusted OR 1.80; 95% CI 1.09-2.97)
• Other predictors of favorable outcome were shorter resuscitation length
and initial shockable rhythm, whereas a higher epinephrine dose
predicted poorer outcome
Implications: Early angiography in cardiac arrest patients appears to
benefit even in those lacking ST-segment elevation.
Dumas F, et al. J Am Coll Cardiol Interv. 2016; VOL. 9, NO. 10, 2016
EIGHTY trial
457 octuagenerians patients with ACS randomized to invasive or medical treatment
The invasive strategy was superior to a conservative strategy in the reduction of
composite events ( MI, urgent revascularization, stroke and death for any cause). No
differences in bleeding complications were observed
Tegn, Abdelnoor et al Lancet 2016; 387: 1057–65
Myocardial
Revascularization
Acute Coronary
Syndrome
Bare Metal Stent vs Drug Eluting Stent
Late follow-up after DES
Devices
Comparison of modern second
generation DES
Bioresorbable scaffolds
Funtional and
Imaging Guidance
Adjuntive
Pharmacological
Therapy
Other devices
NORSTENT (NORwegian coronary STENT trial)
9013 patients with stable or unstable coronary artery disease undergoing PCI
with the implantation of DES or BMS
Follow-up: median 5 years
Primary endpoint:death from any cause
and nonfatal spontaneous MI. 16.6% in
DES group vs 17.1% in BMS group, p=0.66
NNT 30 to prevent one
repeat revascularization
Secondary endpoints
DES
(n = 4504)
BMS
(n = 4504)
P Value
Repeat revascularization
16.5%
19.8%
<0.001
Definite stent thrombosis
0.8%
1.2%
0.0498
Bonaa KH, Mannsverk et al N Engl J Med 2016;375:1242-52.
LEADERS FREE trial
Biofreedom stent (polimer free eluting umirolimus) with 1 month DAPT vs BMS
in 2466 patients with high risk of bleeding
1-YEAR FOLLOW-UP:
Target lesion revascularization: 5.1% in DES group vs 9.8% in BMS group, p<0.01
2-YEAR FOLLOW-UP:
Target lesion revascularization: 6.8% in DES group vs 12.0% in BMS group , p<0.001
POST-HOC ANALYSIS (1545 ELDERLY patients ,>75 years):
Target lesion revascularization:5.8% in DES group vs 10.8% in BMS group, p=<0.01
Composite safety endpoint (cardiac death, MI, stent thrombosis) was reached in 10.7%
in DES group vs 14.3% in BMS group, p=0.03
Urban P, Meredith IT et al N Engl J Med 2015;373:2038-47.
Garot, Morice et al J Am Coll Cardiol 2016 Epub oh ahead
Prespecified analysis of ZEUS trial
High-bleeding-risk patients randomized to BMS or Endeavor ZES with 1 month
DAPT.
BMS
Endeavor ZES
(n = 404)
(n = 424)
P Value
29%
22.6%
0.033
MI
10.4%
3.5%
< 0.001
TVR
11.4%
5.9%
0.005
Definite/Probable Stent
Thrombosis
6.2%
2.6%
0.016
One-Year Outcomes
MACE
Even among patients at high risk for bleeding, a rapidly eluting DES and 1 month of DAPT
results in better overall outcomes than BMS.
Ariotti S, et al. J Am Coll Cardiol Intv. 2016;9:426-436.
SYRTAX-very late trial
10 years results of randomized comparison between sirolimus eluting stent
(CYPHER) and paclitaxel eluting stent (TAXUS)
Outcomes
1 years
5 years
10 years
Ischemia driven TLR
8.1%
14.6%
17.7%
Stent thombosis
1.9%
4.5%
5.6%
•The annual risk of TLR between 5 and 10 years was >60% lower than in the period
of 1-5 years (0.7%/year vs 1.8%/year, p<0.001)
•The annual risk of very late thrombosis decreased during the extended follow-up
period (5-10 years:0.23%/year vs 1-5 years:0.67%/year, p<0.01)
Yamaji K, Raber L et al European Heart Journal (2016)0, 1–10
Bioreasorbable scaffold: 1-Year Outcomes With Absorb BVS:
Patient-Level, Pooled Meta-Analysis
ABSORB II, III, ABSORB-China, and ABSORB-JAPAN.
Absorb BVS
Xience
(n = 2,164)
(n = 1,225)
P Value
Death, MI, or
Revascularization
11.9%
10.6%
0.38
Target-Lesion Failure
6.6%
5.2%
0.17
Probable/Definite Stent
Thrombosis
1.3%
0.6%
0.08
1-Year Outcomes
Scaffold thrombosis with Absorb approximately two-fold higher but events
clustered in small vessels
Stone GW, et al. Lancet. 2016;387:1277-89.
ORBIT II trial
443 patients with severe calcific lesions were treated with orbital
atherectomy pre-stent implantation
Overall
2-year Outcomes
(n = 443)
MACE
19.4%
All cause death
7.5%
Cardiac death
4.3%
Target lesion failure
8.1%
Target lesion revascularization
6.2%
The stratification for stent type showed a worse result in BMS when compared with
first generation DES and second generation DES
Genereux, Bettinger et al Cathet and Cardiovascular Interv 88:369–377 (2016)
DISRUPT CAD
60 patients with moderate or severe calcific lesions treated with coronary
lithoplasty before stent implantation
•Coronary lesions:
stenosis >50%
reference vessel diameter 2.5-4.0 mm
lesion lenght < 32mm
• Subanalysis OCT (30 patients) showed fractures of
superficial calcification in 58% and excellent stent expantion
•MACE at 30-days: 5% for non-Q wave MI (no cardiac death, no Q-wave MI, no TVR,
no angiographic complications)
Presented at TCT 2016 by Meredith
Myocardial
Revascularization
Acute Coronary
Syndrome
Devices
Funtional and
Imaging Guidance
FFR for intermediate lesions
OCT for stent optimization
Adjuntive
Pharmacological
Therapy
OCT to prevent stent thrombosis
DEFER 15 years
FFR was performed in 325 pts with intermediate stenosis for planning strategy:
• DEFER group: FFR ≥ 0.75, no PCI
• PERFORM group: FFR ≥ 0.75, PCI
• REFERENCE group:FFR <0.75, PCI
15-Year
Follow-up
DEFER
group (n=91)
PERFORM
group (n=90)
REFERENCE
group
(n=144)
All cause
mortality
30 (33.0%)
28 (31.1%)
36 (36.1%)
MI
Revascularizati
on
P Defer vs
Perform
P Defers vs
Reference
0.789
0.441
2 (2.2%)
9 (10.0%)
18 (12.5%)
0.033
0.044
39 (42.9%)
31(34.4%)
64 (44.4%)
0.245
0.294
Deferral of PCI of a functionally non-significant stenosis is associated with
a favourable very long-term follow-up
Zimmermann FM, Piljls NHJ et al European Heart Journal (2015)36, 3182–3188
• 2492 pts with stenoses of intermediate severity (30-70% visual)
• iFR or FFR guided revascularisation
• 1 year death,MI, unplanned revascularisation
iFR = instantaneous wave-free ratio
120
Definition:
Wave-free period
Pressure (mm Hg)
Instantaneous pressure
ratio, across a stenosis
during the wave-free
period, when resistance
is naturally constant and
minimised in the cardiac
cycle
Pa
70
Pd
0
100
200
300
400 500
600
700
800
900
Time (ms)
Sen S, ..., Davies J: J Am Coll Cardiol 2012;59:1392-402
ILUMIEN III trial
450 pts undergoing PCI
IVUS guidance
OCT guidance
angiography guidance
Primary efficacy endpoint : final post PCI minimal stent area by OCT in each
randomized arm
OCT guidance was non-inferior to IVUS guidance ( p=0·001), but
not superior (p=0·42)
Primary safety endpoint: procedural complication requiring active intervention
procedural MACE in 3% of OCT pts, in 1% of the IVUS group and
1 % in the angiography group (OCT vs IVUS p=0·37; OCT Vs
angiography p=0·37)
Ali ZA, Store GW et al Lancet2016; 388: 2618–28
Mechanisms of Very Late DES Thrombosis Assessed by OCT
64 patients with very late stent thrombosis assessed using OCT at 4
European centers.
100
90
80
70
60
50
40
34.5%
27.6%
30
20
12.1%
6.9%
10
0
Uncovered
Strut
Neoatherosclerosis
struts
malaposition
Stent
underexpansion
•
OCT identified underlyng mechanism of stent thrombosis in 98% of cases
•
Maximal length of malapposed or uncovered struts was greater in thrombosed
compared with non-thrombosed regions (3.40 mm vs 1.29 mm; p < 0.001)
Taniwaki M, et al. Circulation 2016;133,650-660
Myocardial
Revascularization
Acute Coronary
Syndrome
Devices
Prasugrel vs Ticagrelor
Onset of action of P2Y12 inhibition
Funtional and
Imaging Guidance
Duration of antiplatelet therapy
Triple antithrombotic therapy
Adjuntive
Pharmacological
Therapy
Other drugs
Myocardial
Revascularization
NO REVOLUTIONARY CHANGES
•Revascularization in low LVEF
Acute Coronary
Syndrome
•PCI non inferior to CABG for left main
•Elusive relationship CTO recanalisation/mortality
•FFR guided non culprit PCI in STEMI beneficial
Devices
•ABSORB minimally higher event rate but ST rare
•IVUS/OCT lead to similar stent expansion
Funtional and
Imaging Guidance
•iFR lower PCI rate but same1-year MACE than FFR
•No gross differences prasugrel/ticagrelor
Adjuntive
Pharmacological
Therapy
•Role of NOACS in PCI (AF, further protection ACS)
under assessment
Prague-18 study
Randomized comparison of Ticagrelor versus Prasugrel in STEMI patients (n=1257)
Primary endpoint: all-cause death, re-MI
stroke, serious bleeding within 7 days
Secondary endpoint: composite of CV
death, nonfatal MI, or stroke at 30 days
2500 PTS INITIALLY PLANNED
 INITIALLY
PREMATURELY
INTERRUPTED FOR FUTILITY
2500 PTS
PLANNED
(selection bias, prematury
switchFOR
to clopidogrel)
PREMATURELY
INTERRUPTED
FUTILITY
Motovska Z, Widimsky P et al, Circulation 2016;134:1603-12
DAPT score
• 11 648 randomized DAPT Study patients from 11 countries
• a prediction rule was derived stratifying patients into groups to distinguish
ischemic and bleeding risk 12 to 30 months
Yeh RW, Secemsky EA et al JAMA. 2016;315(16):1735-1749
PIONEER-AF PCI
End of
treatment
12 months
•
•
•
2100 patients
with NVAF
Coronary
stenting
No prior
stroke/TIA, GI
bleeding,
Hb<10,
CrCl<30
≤72
hours
After
Sheath
removal
R
A
N
D
O
M
I
Z
E
Rivaroxaban 15 mg qd*
Clopidogrel 75 mg qd†
1,6, or 12 months
Pre randomization MD Choice
Rivaroxaban 2.5 mg bid
Clopidogrel 75 mg qd†
Aspirin 75-100 mg qd‡
Rivaroxaban 15mg QD
Aspirin 75-100 mg qd
1,6, or 12 months
Pre randomization MD Choice
VKA (target INR 2.0-3.0)
Clopidogrel 75 mg qd†
Aspirin 75-100 mg qd
∆
∆
VKA (target INR 2.0-3.0)
Aspirin 75-100 mg qd
• Primary endpoint: TIMI major + minor + bleeding requiring medical attention
• Secondary endpoint: CV death, MI, and stroke (Ischemic, Hemorrhagic, or Uncertain Origin)
Gibson CM, Mehran R et al N Engl J Med 2016;375:2423-2434
Safety endpoint
Efficacy endpoint
3000 Patients
49% STEMI, 51% NSTEMI/UAP; 87% PCI (68% DES)
Myocardial
Revascularization
Acute Coronary
Syndrome
Devices
Prasugrel vs Ticagrelor
Onset of action of P2Y12 inhibition
Funtional and
Imaging Guidance
Duration of antiplatelet therapy
Triple antithrombotic therapy
Adjuntive
Pharmacological
Therapy
Other drugs
Myocardial
Revascularization
NO REVOLUTIONARY CHANGES
Revascularization in low LVEF
Acute Coronary
Syndrome
PCI non inferior to CABG for left main
Elusive relationship CTO recanalisation/mortality
FFR guided non culprit PCI in STEMI beneficial
Devices
ABSORB minimally higher event rate but ST rare
IVUS/OCT lead to similar stent expansion
Funtional and
Imaging Guidance
iFR lower PCI rate but same1-year MACE than FFR
No gross differences prasugrel/ticagrelor
Adjuntive
Pharmacological
Therapy
Role of NOACS in PCI (AF, further protection ACS)
under assessment