Presentación de la ponencia "Oclusión Crónica Total (CTO): Intervención Coronaria Percutánea (ICP) vs Tratamiento Médico Óptimo (TMO)" realizada por Tomás Benito González para foroepic.org en los Diálogos EPIC_Cierre Percutáneo de la Orejuela Izquierda el 15 de Marzo de 2018 en Madrid (España)

1. OCLUSIÓN CRÓNICA TOTAL (CTO)
Intervención Coronaria Percutánea (ICP)
vs
Tratamiento Médico Óptimo (TMO)
Tomás Benito-González
CAULE

2. INTRODUCCIÓN:Beneficios de ICP en CTO
• Evidencia limitada a estudiosobservacionalesenlosque se comparaba ICP exitosa
vs fallidaenCTO(sin grupo control de tratamiento médico).
• Recientemente se hancomunicado los resultados de 4 ECaleatorizados.
• Disminución de episodios de angina deesfuerzo
• Mejoría dela capacidadfuncional
• Mejoría decalidadde vida
Síntomas
• Mejoría dela función ventricular(FEVI)
• Remodelado ventricularreverso
Función
ventricular
• Reducción de isquemia miocárdica (>10%)
• Revascularización completa
• Tolerancia eventos isquémicos futuros
Mortalidad

3. Percutaneous Intervention for
Concurrent Chronic Total Occlusions
in Patients With STEMI
The EXPLORE Trial
José P.S. Henriques, MD, PHD,a
Loes P. Hoebers, MD,a
Truls Råmunddal, MD, PHD,b
Peep Laanmets, MD,c
Erlend Eriksen, MD,d
Matthijs Bax, MD,e
Dan Ioanes, MD,b
Maarten J. Suttorp, MD, PHD,f
Bradley H. Strauss, MD, PHD,g
Emanuele Barbato, MD, PHD,h
Robin Nijveldt, MD, PHD,i
Albert C. van Rossum, MD, PHD,i
Koen M. Marques, MD, PHD,i
Joëlle Elias, MD,a
Ivo M. van Dongen, MD,a
Bimmer E.P.M. Claessen, MD, PHD,a
Jan G. Tijssen, PHD,a
René J. van der Schaaf, MD, PHD,j
for the EXPLORE Trial Investigators
ABSTRACT
BACKGROUND In 10% to 15% of patients with ST-segment elevation myocardial infarction (STEMI), concurrent cor-
onary chronic total occlusion (CTO) in a non–infarct-related artery is present and is associated with increased morbidity
and mortality.
OBJECTIVES The EXPLORE (Evaluating Xience and Left Ventricular Function in Percutaneous Coronary Intervention on
Occlusions After ST-Elevation Myocardial Infarction) trial evaluated whether patients with STEMI and concurrent CTO in a
non–infarct-related artery benefit from additional percutaneous coronary intervention (PCI) of CTO shortly after primary PCI.
METHODS From November 2007 through April 2015, we enrolled 304 patients with acute STEMI who underwent
primary PCI and had concurrent CTO in 14 centers in Europe and Canada. A total of 150 patients were randomly assigned
to early PCI of the CTO (CTO PCI), and 154 patients were assigned to conservative treatment without PCI of the CTO
(no CTO PCI). Primary outcomes were left ventricular ejection fraction (LVEF) and left ventricular end diastolic volume
(LVEDV) on cardiac magnetic resonance imaging after 4 months.
RESULTS The investigator-reported procedural success rate in the CTO PCI arm of the trial was 77%, and the
adjudicated success rate was 73%. At 4 months, mean LVEF did not differ between the 2 groups (44.1 � 12.2% vs.
44.8 � 11.9%, respectively; p ¼ 0.60). Mean LVEDV at 4 months was 215.6 � 62.5 ml in the CTO PCI arm versus
212.8 � 60.3 ml in the no–CTO PCI arm (p ¼ 0.70). Subgroup analysis revealed that patients with CTO located in the left
anterior descending coronary artery who were randomized to the CTO PCI strategy had significantly higher LVEF
compared with patients randomized to the no–CTO PCI strategy (47.2 � 12.3% vs. 40.4 � 11.9%; p ¼ 0.02). There
were no differences in terms of 4-month major adverse coronary events (5.4% vs. 2.6%; p ¼ 0.25).
CONCLUSIONS Additional CTO PCI within 1 week after primary PCI for STEMI was feasible and safe. In patients with
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ª 2 0 1 6 B Y T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y F O U N D A T I O N
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J Am Coll Cardiol 2016;68:1622–32
vessel with a reference diameter of at least 2.5 mm.
Among the exclusion criteria were hemodynamic
PCI OF CTO. The technique of the CTO PCI procedure
was left to the operator without any restrictions,
FIGURE 1 Trial Profile
304 patients randomly assigned
150 randomized to CTO-PCI 154 randomized to No CTO-PCI
2 withdrew consent 0 withdrew consent
148 CTO-PCI
(1 refusal of CTO-PCI)
154 No CTO-PCI
148 with clinical follow-up 154 with clinical follow-up
12 primary imaging endpoints not available
6 poor imaging quality
6 imaging not available
10 primary imaging endpoints not available
5 poor imaging quality
5 imaging not available
136 analyzed for primary imaging endpoints 144 analyzed for primary imaging endpoints
CTO ¼ chronic total occlusion; PCI ¼ percutaneous coronary intervention.
Henriques et al. J A C C V O L . 6 8 , N O . 1 5 , 2 0 1 6
PCI in Chronic Occlusion in Myocardial Infarction O C T O B E R 1 1 , 2 0 1 6 : 1 6 2 2 – 3 2
1624
Criterios de inclusión
-IAMCEST
re- CTO D f ≥ 2.5mm
-Éxito ICPp (TIMI ≥ 2)
Objetivo primario
RMN cardiacaa los 4 meses
-Función ventricular (FEVI)
-Remodeladoventricular (VTDVI)
Objetivo secundario
MACE a 1 año
- Muerte por cualquier causa
- IAM
- CABG

4. EXPLORE
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TABLE 2 Procedural Characteristics in Patients Undergoing CTO PCI
CTO Treatment CTO PCI (n ¼ 147*)
Number of days from primary PCI to CTO PCI 5 � 2
Number of days from randomization to CTO PCI 2 � 2
Multiple CTO arteries treated 6 (4)
Technique CTO procedure
Antegrade only 124 (84)
Retrograde 23 (16)
CrossBoss or Stingray 5 (3)
PCI successful (investigator reported) 113 (77)
PCI successful (core laboratory adjudicated) 106 (73)
Stent usage (in patients with successful CTO PCI, n ¼ 106)
Everolimus-eluting stent 97 (90)
Other drug-eluting stent 11 (10)
Number of stents used 2 (1–3)
Periprocedural Adverse Events CTO Vessel Donor Artery
Dissection 12 1
Occlusion side branch 2 0
Thrombus 1 0
Tamponade 1 0
Major arrhythmia† 2 —
Resuscitation 4 —
Periprocedural myocardial infarction —
Third universal definition of myocardial infarction 4 —
Study protocol‡ 13 —
Emergency CABG operation 0 —
Stroke 0 —
Periprocedural death 0 —
Values are mean � SD, n (%), median (interquartile range), or n. *1 patient refusal of PCI CTO.
†Ventricular fibrillation or sustained ventricular tachycardia. ‡Data available in n ¼ 71.
CABG ¼ coronary artery bypass graft; other abbreviations as in Table 1.
Henriques et al.
PCI in Chronic Occlusion in Myocardial Infarction
1626
Data were gathered electronically and were stored
onadedicated,secureserverbyMed-Base,Zwolle,the
Netherlands. Trial data were independently moni-
tored by Cordinamo, Wezep, the Netherlands. All
baseline coronary angiograms, (non)CTO PCI proce-
dural characteristics, complications, and success rates
were adjudicated by a dedicated blinded core labora-
tory, and calculation ofSYNTAX scores was performed
by Cardialysis, Rotterdam, the Netherlands.
OUTCOMES. The 2 co-primary endpoints were LVEF
and LVEDV, assessed by CMR at 4 months. The short
axis cine images were used to measure LVEDV and
were indexed for body surface area. LVEF was
calculated from the LVEDV and left ventricular end-
systolic volume. Patients who died before the
4-month endpoint were attributed the lowest LVEF
and the largest LVEDV. If CMR was not available,
primary endpoint parameters were obtained from
alternative imaging modalities, preferably from
nuclear-based imaging or echocardiography. Assess-
ment of primary endpoints using alternative imaging
modalities was performed by an independent core
laboratory blinded to other trial data and randomi-
zation outcome.
Secondary CMR endpoints were infarct size and
regional myocardial function. Infarct size was deter-
mined on the late gadolinium-enhanced images as
previously described using a standardized definition
of hyperenhancement (13). Regional myocardial
function was assessed by dividing each short-axis
slice into 12 equiangular segments to calculate wall
thickening (in millimeters) of each segment by
subtracting end-diastolic from end-systolic wall
thickness. Myocardial segments were considered
dysfunctional if segmental wall thickening was
Left anterior descending artery 72 (49) 64 (42)
TIMI flow pre-PCI 0/1 101 (68) 97 (63)
TIMI flow post-PCI 2/3 148 (100) 154 (100)
Stent placement 146 (99) 154 (100)
Drug-eluting stent 88 (59) 103 (67)
Triple-vessel disease (>70% stenosis) 62 (42) 67 (44)
MI SYNTAX score I (pre-PCI) 29 � 8 29 � 10
MI SYNTAX score II (wiring/balloon/aspiration) 27 � 8 27 � 10
Infarct size
Peak CK-MB 130 (39–272) 111 (43–256)
Peak troponin T 3.1 (1.1–7.8) 3.3 (0.9–6.0)
LVEF before randomization* 41 � 11 42 � 12
CTO characteristics during primary PCI (adjudicated)
Patients with multiple CTOs† 13 (9) 22 (14)
CTO-related artery
Right coronary artery 64 (43) 78 (51)
Left circumflex artery 48 (32) 37 (24)
Left anterior descending artery 36 (24) 39 (25)
TIMI flow
0 132 (89) 139 (90)
1 15 (10) 14 (9)
2 1 (1) 1 (1)
Total J-CTO score 2 � 1 2 � 1
Previously failed lesion 2 (1) 4 (3)
Blunt stump 33 (22) 45 (29)
Bending 98 (66) 108 (70)
Calcification 115 (78) 132 (86)
Occlusion length $20 mm 60 (41) 68 (44)
Discharge medication
Aspirin 148 (100) 152 (99)
Clopidogrel, prasugrel, or ticagrelor 148 (100) 154 (100)
Beta-blocker 138 (93) 139 (90)
ACE inhibitor or ARB 133 (90) 121 (79)
Lipid-lowering drugs 144 (97) 147 (96)
Values are mean � SD, n (%), or median (interquartile range). *Imaging modality is MRI only; data available in
n ¼ 201 patients. †For patients with multiple CTOs, the CTO supplying the largest amount of myocardium
was defined as the main CTO.
ACE ¼ angiotensin-converting enzyme; ARB ¼ angiotensin II receptor blocker; CK-MB ¼ creatine kinase-MB
isoenzyme; CTO ¼ chronic total occlusion; J-CTO ¼ Multicenter CTO registry of Japan; LVEF ¼ left ventricular
ejection fraction; MI ¼ myocardial infarction; MRI ¼ magnetic resonance imaging; PCI ¼ percutaneous coronary
electrocardiogram-gated steady-state free-precession
cine images were obtained during repeated breath
holds in short-axis orientation covering the left
ventricle from base to apex. At least 10 min after
administration of a gadolinium-based contrast agent,
the late gadolinium-enhanced images were acquired
using an inversion recovery gradient-echo pulse
sequence with slice locations identical to the cine
images to identify the size and extent of myocardial
infarction. All CMR images were sent to an indepen-
dent core laboratory (ClinFact Corelab, Leiden, the
Netherlands) for quality control and blinded central
analysis using dedicated software (QMass MR
analyticalsoftwareversion7.6,MedisBV,Leiden,the
Netherlands).
Data were gathered electronically and were stored
onadedicated,secureserverbyMed-Base,Zwolle,the
Netherlands. Trial data were independently moni-
tored by Cordinamo, Wezep, the Netherlands. All
baseline coronary angiograms, (non)CTO PCI proce-
TABLE 1 Baseline Characteristics and Discharge Medication
CTO PCI (n ¼148) No CTO PCI (n ¼154)
Age, yrs 60� 10 60� 10
Men 131 (89) 126 (82)
Diabetes 22(15) 25(16)
Hypertension 59(40) 69(45)
Familyhistoryof coronary arterydisease 66(45) 64(42)
Hypercholesterolemiaor receiving statintherapy 51(35) 52(34)
Currentsmoker 77(52) 76 (49)
Previousmyocardialinfarction 19(13) 24 (16)
PreviousPCI 9(6) 16(10)
Previousstroke 5 (3) 6(4)
Primary PCI
Infarct-relatedartery
Right coronaryartery 46(31) 47(31)
Left circumflex artery 30 (20) 43(28)
Left anteriordescending artery 72 (49) 64(42)
TIMIflowpre-PCI 0/1 101 (68) 97 (63)
TIMIflowpost-PCI 2/3 148(100) 154 (100)
Stent placement 146 (99) 154 (100)
Drug-elutingstent 88(59) 103(67)
JACC VOL. 68, NO. 15, 2016 Henriqueset al.
OCTOBER 11, 2016:1622–32 PCI inChronicOcclusion in Myocardial Infarction
1625
e free-precession
repeated breath
vering the left
ast 10 min after
d contrast agent,
es were acquired
ient-echo pulse
ical to the cine
nt of myocardial
t to an indepen-
lab, Leiden, the
blinded central
re (QMass MR
s BV, Leiden, the
and were stored
Base, Zwolle, the
pendently moni-
Netherlands. All
)CTO PCI proce-
and success rates
ded core labora-
s was performed
rlands.
oints were LVEF
onths. The short
sure LVEDV and
rea. LVEF was
ventricular end-
ied before the
he lowest LVEF
TABLE 1 Baseline Characteristics and Discharge Medication
CTO PCI (n ¼ 148) No CTO PCI (n ¼ 154)
Age, yrs 60 � 10 60 � 10
Men 131 (89) 126 (82)
Diabetes 22 (15) 25 (16)
Hypertension 59 (40) 69 (45)
Family history of coronary artery disease 66 (45) 64 (42)
Hypercholesterolemia or receiving statin therapy 51 (35) 52 (34)
Current smoker 77 (52) 76 (49)
Previous myocardial infarction 19 (13) 24 (16)
Previous PCI 9 (6) 16 (10)
Previous stroke 5 (3) 6 (4)
Primary PCI
Infarct-related artery
Right coronary artery 46 (31) 47 (31)
Left circumflex artery 30 (20) 43 (28)
Left anterior descending artery 72 (49) 64 (42)
TIMI flow pre-PCI 0/1 101 (68) 97 (63)
TIMI flow post-PCI 2/3 148 (100) 154 (100)
Stent placement 146 (99) 154 (100)
Drug-eluting stent 88 (59) 103 (67)
Triple-vessel disease (>70% stenosis) 62 (42) 67 (44)
MI SYNTAX score I (pre-PCI) 29 � 8 29 � 10
MI SYNTAX score II (wiring/balloon/aspiration) 27 � 8 27 � 10
Infarct size
Peak CK-MB 130 (39–272) 111 (43–256)
Peak troponin T 3.1 (1.1–7.8) 3.3 (0.9–6.0)
LVEF before randomization* 41 � 11 42 � 12
CTO characteristics during primary PCI (adjudicated)
Patients with multiple CTOs† 13 (9) 22 (14)
CTO-related artery
Right coronary artery 64 (43) 78 (51)
Left circumflex artery 48 (32) 37 (24)
Left anterior descending artery 36 (24) 39 (25)
Henriques et al.
PCI in Chronic Occlusion in Myocardial Infarction
1625
e free-precession
repeated breath
vering the left
ast 10 min after
d contrast agent,
es were acquired
ient-echo pulse
ical to the cine
nt of myocardial
t to an indepen-
lab, Leiden, the
blinded central
re (QMass MR
sBV,Leiden,the
and were stored
Base,Zwolle,the
pendently moni-
Netherlands. All
)CTO PCI proce-
TABLE 1 Baseline Characteristics and Discharge Medication
CTO PCI (n ¼148) No CTO PCI (n ¼154)
Age, yrs 60� 10 60� 10
Men 131 (89) 126 (82)
Diabetes 22(15) 25(16)
Hypertension 59(40) 69(45)
Familyhistoryof coronary arterydisease 66(45) 64(42)
Hypercholesterolemiaor receiving statintherapy 51(35) 52(34)
Currentsmoker 77(52) 76 (49)
Previousmyocardialinfarction 19(13) 24 (16)
PreviousPCI 9(6) 16(10)
Previousstroke 5 (3) 6(4)
Primary PCI
Infarct-relatedartery
Right coronaryartery 46(31) 47(31)
Left circumflex artery 30 (20) 43(28)
Left anteriordescending artery 72 (49) 64(42)
TIMIflowpre-PCI 0/1 101 (68) 97 (63)
TIMIflowpost-PCI 2/3 148(100) 154 (100)
Stent placement 146 (99) 154 (100)
Drug-elutingstent 88(59) 103(67)
Henriqueset al.
PCI inChronicOcclusion in Myocardial Infarction
1625
gated steady-state free-precession
obtained during repeated breath
is orientation covering the left
e to apex. At least 10 min after
gadolinium-based contrast agent,
m-enhanced images were acquired
n recovery gradient-echo pulse
ce locations identical to the cine
the size and extent of myocardial
images were sent to an indepen-
ry (ClinFact Corelab, Leiden, the
uality control and blinded central
edicated software (QMass MR
version 7.6, Medis BV, Leiden, the
red electronically and were stored
ure server by Med-Base, Zwolle, the
data were independently moni-
mo, Wezep, the Netherlands. All
angiograms, (non)CTO PCI proce-
s, complications, and success rates
y a dedicated blinded core labora-
n of SYNTAX scores was performed
erdam, the Netherlands.
co-primary endpoints were LVEF
ed by CMR at 4 months. The short
TABLE 1 Baseline Characteristics and Discharge Medication
CTO PCI (n ¼ 148) No CTO PCI (n ¼ 154)
Age, yrs 60 � 10 60 � 10
Men 131 (89) 126 (82)
Diabetes 22 (15) 25 (16)
Hypertension 59 (40) 69 (45)
Family history of coronary artery disease 66 (45) 64 (42)
Hypercholesterolemia or receiving statin therapy 51 (35) 52 (34)
Current smoker 77 (52) 76 (49)
Previous myocardial infarction 19 (13) 24 (16)
Previous PCI 9 (6) 16 (10)
Previous stroke 5 (3) 6 (4)
Primary PCI
Infarct-related artery
Right coronary artery 46 (31) 47 (31)
Left circumflex artery 30 (20) 43 (28)
Left anterior descending artery 72 (49) 64 (42)
TIMI flow pre-PCI 0/1 101 (68) 97 (63)
TIMI flow post-PCI 2/3 148 (100) 154 (100)
Stent placement 146 (99) 154 (100)
Drug-eluting stent 88 (59) 103 (67)
Triple-vessel disease (>70% stenosis) 62 (42) 67 (44)
MI SYNTAX score I (pre-PCI) 29 � 8 29 � 10
MI SYNTAX score II (wiring/balloon/aspiration) 27 � 8 27 � 10
Infarct size
Peak CK-MB 130 (39–272) 111 (43–256)
Peak troponin T 3.1 (1.1–7.8) 3.3 (0.9–6.0)
LVEF before randomization* 41 � 11 42 � 12
2 0 1 6 Henriques et al.
– 3 2 PCI in Chronic Occlusion in Myocardial Infarction
1625

5. infarction, MACE, repeat PCI, stent thrombosis, and
all other periprocedural complications.
†Ventricular fibrillation or sustained ventricular tachycardia. ‡Data available in n ¼ 71.
CABG ¼ coronary artery bypass graft; other abbreviations as in Table 1.
TABLE 3 Imaging Outcomes
CTO PCI No CTO PCI Difference (95% CI) p Value
Primary endpoint 136 144
Left ventricular ejection fraction, % 44.1 (12.2) 44.8 (11.9) �0.8 (�3.6 to 2.1) 0.60
Left ventricular end-diastolic volume, ml 215.6 (62.5) 212.8 (60.3) 2.8 (�11.6 to 17.2) 0.70
MRI or other imaging 132 143
Left ventricular ejection fraction, % 45.1 (10.9) 45.1 (11.6) 0.1 (�2.7 to 2.7) 1.00
Left ventricular end-diastolic volume, ml 209.9 (53.8) 211.5 (58.3) �1.6 (�14.9 to 11.8) 0.82
Left ventricular end-diastolic volume index, ml/m2
102.9 (23.9) 104.3 (25.4) �1.4 (�7.3 to 4.4) 0.63
Left ventricular end-systolic volume index, ml/m2
57.9 (22.6) 58.9 (24.8) �1.1 (�6.7 to 4.6) 0.71
MRI only 124 135
Left ventricular ejection fraction, % 45.0 (10.6) 45.2 (11.5) �0.2 (-2.9 to 2.5) 0.88
Left ventricular end-diastolic volume, ml 213.8 (51.8) 214.8 (56.4) �1.0 (�14.2 to 12.3) 0.89
Left ventricular end-diastolic volume index, ml/m2
104.9 (22.6) 105.9 (24.2) �1.0 (�6.7 to 4.7) 0.73
Left ventricular end-systolic volume index, ml/m2
59.0 (22.4) 59.7 (24.5) �0.7 (�6.5 to 5.0) 0.81
Left ventricular end-diastolic mass index, g/m2
* 51.6 (9.2) 52.4 (12.0) �0.8 (�3.5 to 2.0) 0.58
Dysfunctional segments, %* 58.0 (26.6) 61.5 (27.0) �3.6 (�10.4 to 3.2) 0.30
Total infarct size, g† 7.6 (6.0) 7.2 (5.6) 0.4 (�1.1 to 2.0) 0.59
Values are n or n (%), unless otherwise indicated. *Data available in n ¼ 113/n ¼ 130. †Data available in n ¼ 95/n ¼ 114.
CI ¼ confidence interval; MRI ¼ magnetic resonance imaging; other abbreviations as in Table 1.
EXPLORE
STATISTICAL ANALYSIS. The trial was powered to
detect differences between the 2 groups in CMR-
assessed LVEF and LVEDV at 4 months after STEMI
(Online Appendix C). With 2 � 150 randomized
patients, there was 80% power to detect absolute
differences of 4% in LVEF and 15 ml in LVEDV in favor
of PCI of the CTO with a 2-sided alpha of 5%. We
assumed that CTO PCI would be successful in 80% of
cases. The mean global LVEF in patients randomized
endpoint was made on the basis of the assumption of
a net mean LVEDV of 185 ml for patients randomized
to CTO PCI and 200 ml for patients randomized to
no CTO PCI. The standard deviation for LVEDV was
assumed to be 45 ml. The primary endpoint was
analyzed on an intention-to-treat basis.
Because this study had 2 primary endpoints, the
Hochberg extension of the Bonferroni method for
multiple comparisons was used to test for statistical
C E N T R A L I L L U ST R A T I O N Left Ventricular Function at 4-Month Follow-Up in STEMI Patients
Undergoing CTO PCI Versus no CTO PCI
Henriques, J.P.S. et al. J Am Coll Cardiol. 2016;68(15):1622–32.
Left ventricular ejection fraction (LVEF) (left) and left ventricular end-diastolic volume (LVEDV) (right) at 4-month follow-up. All analyses were performed
on an intention-to-treat basis: core-laboratory–reported success rates of chronic total occlusion percutaneous coronary intervention were 73%; and
operator-reported success rates were 77%. Whiskers indicate standard deviation. CTO ¼ chronic total occlusion; PCI ¼ percutaneous coronary intervention;
STEMI ¼ ST-segment elevation myocardial infarction.
J A C C V O L . 6 8 , N O . 1 5 , 2 0 1 6 Henriques et al.
O C T O B E R 1 1 , 2 0 1 6 : 1 6 2 2 – 3 2 PCI in Chronic Occlusion in Myocardial Infarction
1627
Kaplan-Meier curves displaying the pattern of events
over the 4-month follow-up period were constructed;
the log-rank statistic was used to calculate statistical
significance.
RESULTS
From November 2007 through April 2015, 304 pa-
tients were enrolled at 14 sites (Online Appendix D).
A total of 150 patients were randomly assigned to
the CTO PCI arm of the trial, and 154 patients were
randomized to the no–CTO PCI arm. Two patients
randomized to the CTO PCI arm withdrew informed
consent before CTO PCI, thus reducing the CTO PCI
group to 148 patients.
BASELINE AND PROCEDURAL CHARACTERISTICS. The
study populations in both trial arms were well
balanced, without any significant differences in
baseline characteristics (Table 1). The most common
infarct-related coronary artery was the left anterior
descending coronary artery (LAD) (n ¼136; 45%), fol-
lowed by the right coronary artery (RCA) (n ¼ 93; 31%)
and the circumflex artery (n ¼ 73; 24%). Triple-vessel
disease was present in 43% of the study population
(n ¼ 129). Most concurrent CTOs were located in the
RCA (n ¼ 142; 47%), followed by the circumflex artery
(n ¼ 85; 28%) and the LAD (n ¼ 75; 25%). Trans-
murality of scar tissue in the myocardial territory
supplied by the CTOs was assessed in 149 patients
(49.0%), and >75% transmurality in the CTO territory
was present in none of the patients.
Patients randomized to a CTO PCI strategy under-
went the procedure on average on day 5.0 � 1.9. One
patient randomized to the CTO PCI arm refused the
procedure. The investigator-reported procedural suc-
cess rate in the CTO PCI arm was 77%, and the adjudi-
cated success rate was 73%. Procedural characteristics
including procedural complications are presented in
Table 2. No periprocedural death or emergency CABG
procedures occurred during CTO PCI.
PRIMARY AND SECONDARY CMR ENDPOINTS. A
total of 136 patients were analyzed for the primary
endpoints in the CTO PCI arm and 144 in the no–CTO
PCI arm, as elucidated in the flow chart (Figure 1).
At 4 months, mean LVEF was 44.1 � 12.2% in the CTO
PCI arm and 44.8 � 11.9% in the no–CTO PCI arm
(p ¼ 0.597). Mean LVEDV was 215.6 � 62.5 ml in the CTO
compared with the no–CTO PCI arm (47.2 � 12.3% vs.
40.4 � 11.9%; p ¼ 0.02). For the co-primary endpoint of
LVEDV, there was also a significant interaction
between CTO location and randomized treatment
assignment (p ¼ 0.039) (Figure 2). Additional subgroup
TABLE 4 Adjudicated Clinical Outcomes From Randomization to 4-Month Follow-Up
CTO PCI
(n ¼ 148)
No CTO PCI
(n ¼ 154) p Value
Major adverse cardiac events
Cardiac death 4 (2.7) 0 (0.0) 0.056
Myocardial infarction 5 (3.4) 3 (1.9) 0.49
Periprocedural* 4 (2.7) 1 (0.6) —
Spontaneous or recurrent 2 (1.4) 2 (1.3) —
CABG operation — 1 (0.6) —
MACE 8 (5.4) 4 (2.6) 0.25
Other events
PCI 39 (26.4) 20 (13.0) 0.004
CTO PCI — 5 (3.2) —
Repeat CTO PCI 2 (1.4) 0 (0.0) —
Non-CTO PCI in CTO vessel 10 (6.8) 0 (0.0) 0.001
Before initial CTO procedure 1 (0.7) — —
During initial CTO procedure 9 (6.1) — —
Post-initial CTO procedure — — —
PCI in non-CTO vessel 31 (20.9) 17 (11.0) 0.027
Before initial CTO procedure 0 (0.0) — —
During initial CTO procedure 26 (17.6) — —
Post-initial CTO procedure 5 (3.4) — —
Total stent thrombosis 5 (3.4) 3 (1.9) 0.49
Stent thrombosis CTO lesion 2 (1.4) 0 (0.0) —
Definite 1 (0.7) 0 (0.0) —
Probable 1 (0.7) 0 (0.0) —
Timing of stent thrombosis CTO lesion
Acute 0 (0.0) 0 (0.0) —
Subacute 2 (1.4) 0 (0.0) —
Stent thrombosis non-CTO lesion 4 (2.7) 3 (1.9) 0.72
Definite 3 (2.0) 3 (1.9) —
Probable 1 (0.7) 0 (0.0) —
Timing of stent thrombosis non-CTO lesion
Acute 0 (0.0) 1 (0.6) —
Subacute 3 (2.0) 2 (1.3) —
Stroke† 0 (0.0) 2 (1.3) —
Bleeding according to GUSTO-criteria 5 (3.4) 2 (1.3) 0.28
Mild 1 (0.7) 1 (0.6) —
Moderate 3 (2.0) 1 (0.6) —
Severe or life-threatening 1 (0.7) 0 (0.0) —
Values are number of events (%). The first event per patient is listed. *Periprocedural myocardial infarction was
defined according to the third universal definition of myocardial infarction criteria. †1 patient had a fatal stroke;
there were no other noncardiac deaths.
GUSTO ¼ Global Use of Strategies to Open Occluded Coronary Arteries; MACE ¼ a composite of cardiac death,
myocardial infarction, and coronary artery bypass graft; other abbreviations as in Tables 1 and 2.
J A C C V O L . 6 8 , N O . 1 5 , 2 0 1 6 Henriques et al.
O C T O B E R 1 1 , 2 0 1 6 : 1 6 2 2 – 3 2 PCI in Chronic Occlusion in Myocardial Infarction
1629
Objetivo primario
Larevascularizaciónrutinaria de unaCTO en pacientes con IAMCEST NO se relacionó con
unamejor FEVI o menor dilatación ventricular (salvo en el caso de CTO de la DA -análisis
de subgrupos-).
Objetivo secundario
Sin diferencias en MACEa 4 meses

6. Criterios de inclusión
- Isquemiasilente,anginaestable,SCA-
- CTO Dref ≥ 2.5mm
-CTO segmentoproximal/medio
-FEVI > 30%
Objetivo primario
MACE a 3 años
-Muerte por cualquier causa
-IAM
-Revascularización
-Ictus
Study Flow
834 patients randomized
from 2010.3.22 to 2016.10.10
417 allocated to PCI398 allocated to OMT
310 treated with OMT
72 treated with PCI
5 treated with OMT after failed PCI
11 had incomplete data
346 treated with PCI
(success rate: 90.6%)
29 treated with OMT
36 treated with OMT after failed PCI
6 had incomplete data
1-year FU
348/357 (97.5%)
1-year FU
344/354 (97.2%)
3-year FU
215/231 (93.1%)
3-year FU
218/238 (91.6%)
5-year FU
87/99 (87.9%)
5-year FU
85/102 (83.3%)
19 withdrew consents

7. CTO PCI Characteristics
Attempted PCI N=459
CTO PCI success 418 (91.1%)
Retrograde approach 113 (24.6%)
Lesion passaged wire
Low penetration force wire 117/418 (28.0%)
Intermediate to high penetration force wire 301/418 (72.0%)
CTO technique
Single wire technique only 309/418 (73.9%)
Parallel wire technique 72/418 (17.2%)
IVUS-guided wiring 25/418 (6.0%)
CART technique 55/418 (13.2%)
Additional back-up support
Corsair 91/418 (21.8%)
Microcatheter other than Corsair 230/418 (55.0%)
Over-the-wire balloon 6/418 (1.4%)
Aspirin Thienopyridine
StatinBeta blocker
Medication at Follow-Up
PCI
OMT
96
88
85 83
99
90
87
83
0
20
40
60
80
100
DC 1Yr 2Yr 3Yr
76
60
43
30
95
76
57
38
0
20
40
60
80
100
DC 1Yr 2Yr 3Yr
63
60 62 6365
68 67 67
0
20
40
60
80
100
DC 1Yr 2Yr 3Yr
94 93 92 9294 92 91
88
0
20
40
60
80
100
DC 1Yr 2Yr 3Yr
%
%%
%
All P<0.05
ITT Population
DECISIONBaseline Characteristics
OMT (N=398) PCI (N=417) P value
Age (years) 62.9±9.9 62.2±10.2 0.35
Male sex 315 (81.4%) 342 (83.2%) 0.50
BMI, kg/m2 25.4±3.3 25.6±3.6 0.66
Hypertension 235 (60.7%) 261 (63.5%) 0.50
Diabetes mellitus 133 (34.4%) 132 (32.1%)
Hypercholesterolemia 215 (55.6%) 248 (60.3%) 0.17
Current smoker 102 (26.4%) 125 (30.4%) 0.20
Previous PCI 74 (19.1%) 62 (15.1%) 0.13
Previous MI 34 (8.8%) 45 (10.9%) 0.31
Previous CABG 5 (1.3%) 4 (1.0%) 0.75
Chronic renal failure 5 (1.3%) 6 (1.5%) 0.84
LVEF, % 57.2±9.4% 57.2±9.8% 0.95
ITT Population
Baseline Characteristics
OMT (N=398) PCI (N=417) P value
Clinical presentation 0.58
Stable angina 290 (74.9%) 297 (72.3%)
Unstable angina 75 (19.4%) 84 (20.4%)
AMI 22 (5.7%) 30 (7.3%)
Location of CTO 0.71
LAD 161 (41.6%) 183 (44.5%)
LCX 42 (10.9%) 40 (10.2%)
RCA 184 (47.5%) 186 (45.3%)
Multivessel disease 286 (73.9%) 301 (73.3%) 0.76
SYNTAX score 21.0±9.5 21.2±9.1 0.79
J-CTO score 2.3±1.2 2.2±1.2 0.23
Number of total stents 2.0±1.4 2.4±1.3 <0.001
Total stent length, mm 53.6±39.4 71.2±40.5 <0.001
ITT Population

8. DECISIONPrimary End Point
(Death, MI, Stroke, Any Repeat Revascularization)
ITT Population
No. at Risk
OMT 398 305 246 178 129 72
PCI 417 293 241 175 117 65
Y e a rs S in c e R a n d o m iz a tio n
Probability(%)
0 1 2 3 4 5
0
1 0
2 0
3 0
4 0
5 0
6 0
Crude HR 0.95 (95% CI, 0.74-1.22), P=0.67
Adjusted HR 0.91 (95% CI, 0.68-1.23), P=0.54
20.6%
19.6%
25.1%
26.3%
PCI
OMT
Objetivo primario
Sin diferencias en MACEa 1 año
MACE
0 1 2 3 4 5
0
1 0
2 0
3 0
4 0
5 0
6 0
Y e a r s s i n c e R a n d o m i z a t i o n
Probability(%)
Death from any cause
ITT Population
No. at Risk
OMT 398 344 285 207 140 81
PCI 417 337 285 202 142 74
PCI
OMT
3.6
1.61.9
1.2
0
2
4
6
8
10
Cardiac Death Non-CD
P=0.22 P=0.31
Muerte
0 1 2 3 4 5
0
1 0
2 0
3 0
4 0
5 0
6 0
Y e a r s s i n c e R a n d o m i z a t i o n
Probability(%)
Myocardial Infarction
ITT Population
No. at Risk
OMT 398 317 260 189 129 73
PCI 417 300 255 181 125 64
10.7%
8.4% 9.4%
11.9%
PCI
OMT
7.8
1.8
9.7
1.8
0
5
10
15
20
Periprocedural Spontaneous
P=0.35 P=0.93
IAM
0 1 2 3 4 5
0
1 0
2 0
3 0
4 0
5 0
6 0
Y e a r s s i n c e R a n d o m i z a t i o n
Probability(%)
Stroke
ITT Population
No. at Risk
OMT 398 339 280 203 137 77
PCI 417 337 284 201 142 74
Crude HR 2.56 (95% CI, 0.80-8.17), P=0.11
1.3%
1.0% 1.0%
5.0%
PCI
OMT
Ictus
0 1 2 3 4 5
0
1 0
2 0
3 0
4 0
5 0
6 0
Y e a r s s i n c e R a n d o m i z a t i o n
Probability(%)
Repeat Revascularization
ITT Population
No. at Risk
OMT 398 330 270 292 129 74
PCI 417 321 259 181 129 65
10.4%
8.6%
11.8%
14.0%
PCI
OMT
6.2
4.7
7.3
6.1
0
5
10
15
20
CTO lesion Non-CTO lesion
P=0.93 P=0.33
ICP
Quality of Life Measures Over Time
0.0 1.0 6.0 12.0
30
40
50
60
70
80
90
100
6 Mon
303 309
P=0.29P=0.94 P=0.74
Baseline 12 Mon
244 242 231 222
1 Mon
P=0.58
264 277
(A) EQ-5D Visual Analogue Scale
MeanScore
0.0 1.0 6.0 12.0
30
40
50
60
70
80
90
100
305 312
P=0.80P=0.52 P=0.75
243 242 231 221
P=0.05
265 276
(B) SAQ, Physical Limitation
MeanScore
6 MonBaseline 12 Mon1 Mon
6.0 12.0
30
40
50
60
70
80
90
100
304 312
P=0.15P=0.24 P=0.35
244 244 231 222
P=0.17
265 276
(C) SAQ, Angina Stability
MeanScore
6 MonBaseline 12 Mon1 Mon
30
40
50
60
70
80
90
100
304 313
P=0.62P=0.26 P=0.86
244 244 231 222
P=0.001
265 278
(D) SAQ, Angina Frequency
MeanScore
6 MonBaseline 12 Mon1 Mon
30
40
50
60
70
80
90
100
304 313
P=0.96P=0.06 P=0.89
244 244 231 222
P=0.25
265 278
(E) SAQ, Treatment Satisfaction
MeanScore
6 MonBaseline 12 Mon1 Mon
30
40
50
60
70
80
90
100
304 313
P=0.06P=0.28 P=0.90
244 244 231 222
P=0.81
265 278
(F) SAQ, Quality of Life
MeanScore
6 MonBaseline 12 Mon1 Mon
ITT Population
Objetivo secundario
Sin diferencias en calidad de vida o
síntomas a 1 año

9. A Randomized Multicentre Trial to
Evaluate the Utilization of
Revascularization or Optimal Medical
Therapy for the Treatment of Chronic
Total Coronary Occlusions
Gerald S. Werner, MD PhD
on behalf of the
EURO CTO trial investigators
A Randomized Multicentre Trial to
Evaluate the Utilization of
Revascularization or Optimal Medical
Therapy for the Treatment of Chronic
Total Coronary Occlusions
Gerald S. Werner, MD PhD
on behalf of the
EURO CTO trial investigators
Criteriosdeinclusión
- Anginaestable.
- Isquemia-viabilidad.
- CTO Dref≥ 2.5 mm
- SegmentosAHA1-3,6-7,11
Endpoint Eficacia Seguridad
Objetivo
Estado de salud
(SAQ)
MACE
(Muerte, IAM, Revasc, Ictus)
Tiempo
seguimiento
12 meses 36 meses
Tamaño
muestral
600 1200
Características basales ambos grupos
TMO TMO + ICP
N 137 259
Edad (años) 64.7±9.9 65.2±9.7
Varón (%) 86.1 83.0
DM (%) 29.2 32.5
IAM previo (%) 18.3 22.8
ICP previa (%) 7.3 13.1
CABG previa (%) 51.8 56.0
ICP otras lesiones (%) 27 30.5
Multivaso (%) 54.7 49.8
FEVI (%) 55.7±10.8 54.5±10.8

10. 0
10
20
30
40
50
60
70
80
90
100
OMT PCI
Physical
limitation
Anginal
frequency
Anginal
stability
Treatment
satisfaction
Quality of
life
Primary endpoint: SAQ health status (ITT)
For multiple testing the significance level is 0.01
BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU BL FU
P=0.022
P=0.009
P=0.049
P=0.89
P=0.47
Calidad de vida (Cuestionario de Angina Seattle)
EURO CTO
MACCE during follow-up
OMT
(N=137)
PCI
(N=259)
P-value
Patients with any adverse event 9 (6.7) 13 (5.2) 0.52
All cause Death 0 2 (0.8) 0.55
Cardiac death 0 2 (0.8)
Myocardial infarction 0 5 (1.9) 0.17
Non-Q-wave 0 4 (1.6)
Q-wave 0 1 (0.4)
Ischemia-driven revascularization 9 (6.7) 7 (2.9) 0.10
Cerebrovascular event 1 (0.7) 2 (0.8) 0.99
Stent thrombosis 0 1 (0.4) 0.99
Number of patients (%)
MACE seguimiento
ICP sobre oclusión crónica
Vaso (%)
CD
DA
CX
63.7
25.5
10.8
Longitud oclusión (mm) 31.4±20.5
Lesiones calcificadas (%) 37.3
J-CTO score 1.82±1.07
Acceso radial (%) 34.3
Acceso bilateral (%) 81.2
Abordaje retrógrado (%) 35.8
Longitud total stents (mm) 65.9±28.9
Éxito ICP (%) 86.3
Complicaciones procedimiento
Muerte 0
IAM Q 0
Revascularización urgente 0
Taponamiento cardiaco 4 (1.5 %)
Reparación vascular 2 (0.8 %)
Transfusión sangre 2 (0.8 %)
Objetivo secundario
Sin diferencias en MACEa 1 año
Changes in CCS class during follow-up
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Baseline Follow-up Baseline Follow-up
CCS 1 CCS 2 CCS 3 CCS 4
OMT PCI
P<0.001
Clase funcional para angina (CCS)
Significant change in SAQ subscale scores *)
0
10
20
30
40
50
60
70
80
90
100
Physical
limitation ≥8
Anginal
frequency ≥20
Freedom of
angina (100%)
Quality of life
≥16
OMT PCI
P=0.003 P=0.013 P=0.008 P=0.005
*) Spertus et al. JACC 1995;25:333-41
Score
Higher score, better health status
Cambios significativos en los scores SAQ
Objetivo primario
La ICP-CTO se asoció con una mejora del estado
de salud, la calidad de vida y la clase funcional
CCS

11. REVASC
ClinicalTrials.gov, Identifier: NCT01924962
Recovery of Left Ventricular Function in
Coronary Chronic Total Occlusion
K. Mashayekhi, T. Nührenberg, A.Toma, M.Gick, M. Ferenc, W. Hochholzer, T. Comberg, J.
Rothe, C.Valina, N. Löffelhardt, M. Ayoub, M.Zhao, J.Bremicker, N. Jander, J.Minners, P. Ruile,
M. Behnes, I. Akin, T. Schäufele, F. -J. Neumann, H.-J. Büttner.
University Heart Center Freiburg · Bad Krozingen
Bad Krozingen / Germany
REVASC
ClinicalTrials.gov, Identifier: NCT0192496
Recovery of Left Ventricular
Coronary Chronic Total O
K. Mashayekhi, T. Nührenberg, A.Toma, M.Gick, M. Ferenc, W.
Rothe, C.Valina, N. Löffelhardt, M. Ayoub, M.Zhao, J.Bremicker,
M. Behnes, I. Akin, T. Schäufele, F. -J. Neumann
University Heart Center Freiburg · B
Bad Krozingen / Germa
Study flow of REVASC
Baseline demographic and angiographic
characteristics
no-CTO-PCI
(n = 104)
CTO-PCI
(n = 101)
p Value
Age (years) 68 [61 - 74] 65 [57 - 72] 0.02
Male gender 90 (86.5) 91 (90.1) 0.43
Diabetes 31 (29.8) 32 (31.6) 0.77
LVEF (%) 59.6 [45.8 - 64.3] 54.7 [42.9 - 65.1] 0.48
Previous PCI 33 (31.7) 28 (27.7) 0.53
Previous myocardial
infarction
38 (36.5) 39 (38.6) 0.76
Previous bypass operation 14 (13.5) 12 (11.9) 0.73
Criterios de inclusión
-Angina oPDI positiva
- CTO Dref ≥ 2.5mm
-FEVI > 25%
Endpoint Primario Secundario
Objetivo
Engrosamiento
segmentario
(RMN)
VTDVI
VTSVI
FEVI
(RMN)
MACE
-Muerte
-IAM
-Revasc
Tiempo
seguimiento
6 meses 6 meses 12 meses

12. Angiographic characteristics
no-CTO-PCI
(n = 104)
CTO-PCI
(n = 101)
p Value
Coronary artery disease
1-vessel disease
2,3-vessel disease
10 (9.6)
94 (90.4)
14 (13.9)
87 (86.1)
0.55
SYNTAX-Score 16 [11 - 21] 14 [9 - 22] 0.33
Residual SYNTAX-Score 11 [8 - 16] 2 [0 - 7] <0.01
J-CTO Score 2 [1 - 2] 2 [1 – 3] 0.43
PROGRESS Score 0 [0 – 1] 1 [0 – 1] <0.01
REVASC
ProceduralCTOdata
CTO-PCI (n=101)
CTOrecanalizationtechnique
antegradeonly
retrograde
61(60.4)
40(39.6)
Technicalsuccessonfirstattempt 87(86.1)
Technicalsuccessincluding 2nd attempts 100(99.0)
Proceduretime(minutes) 96[65–149]
Fluoroscopytime(minutes) 37[20–76]
Radiationdose(µGy*cm²) 10322[5725–17539]
ContrastVolume(ml) 280[200–400]
Primary
-40
-20
0
20
40
ChangeinSegmentalWallThickening(%)
p = 0.57
All CTO segments
OMT + CTO PCI
OMT  no-CTO PCI
Objetivo primario
Sin diferencias en el engrosamiento segmentario a 6m
LVEDV index
baseline 6M FU baseline 6M FU
OMT +
CTO PCI
OMT 
non-CTO PCI
LVEF
p = 0.79
0
20
40
60
80
100
LVEF(%)
Secondary endpoint:
0
100
200
300
LVEDVindex(ml/m²)
p = 0.54
baseline 6M FU baseline 6M FU
OMT 
non-CTO PCI
OMT +
CTO PCI
Objetivo secundario
Sin diferencias en la FEVI a 6 m
Major adverse cardiac events at 12 months
(death, infarction, any revascularization)
Objetivo secundario
La ICP-CTO se relacionó con una menor
tasa de MACE a 1año

13. EXPLORE DECISION CTO EURO CTO REVASC
Centros
Pacientes incluidos
N predeterminado
Periodo reclutamiento
14 (Europa, Canadá)
304
300
89 meses
19 (Corea, Asia)
834
1284
78 meses
26 (Europa)
407
600 (EP1º) / 1200 (EP2º)
36 meses
2 (Alemania)
205
200
CI crónica estable
SCA 100 %
74 %
26 %
100 %
Isquemia-viabilidad No No Si SI
ICP-OCT DA 49 % 44.5 % 25.5 %
Enfermedad multivaso 100 % 72 % 52 % 88.3 %
FEVI (TMO / TMO + ICP) 42 % / 41 % 57 % / 57 % 56 % / 55 % 60 % / 55 %
ICP lesiones no-CTO No recomendado
Recomendado
(si Dref ≥ 2.5 mm)
Recomendado Recomendado
Éxito ICP 73 % 91.1 % 86.6 % 99 % (2º intento)
DES Segunda generación Primera generación Segunda generación Primera generación
Cross-over 23 % 18.1 % 7.3 %
Endpoint primario
Remodelado a 4m
(FEVI, VTDVI, VTSVI)
MACE a los 3 años
(muerte, IAM, ACV, ICP)
Calidad de vida a 1 año
(Seattle Angina Q)
Engrosamiento segmentario a 6 meses
Resultado EPprimario Negativo Negativo a 1 año Positivo Negativo
Endpoint secundario
Seguridad a los 3 años
(muerte, IAM)
Remodelado a 6m
(FEVI, VTDVI, VTSVI)
MACE a los 1 año
(muerte, IAM, ICP)
Negativo remodelado

14. ASPECTOSA CONSIDERAR…
u Reclutamiento muylento, incluso sin alcanzarNpredeterminada (sesgo de selección).
u Pacientes con enfermedad coronaria estable (baja incidencia de eventos duros).
u Pacientes incluidos menos sintomáticos queregistros actuales.
u No valoración isquemia-viabilidad previa ala randomizaciónen todos los estudios. u
Localización no-DA de la mayoría de CTO tratadas.
u FEVI > 40 %en todos los estudios (REVASC estudio remodelado con FE basalnormal).
u Control heterogéneo detratamiento médico óptimo.
u Tratamiento heterogéneo delesiones no-CTO coexistentes (ICP multivaso vs no ICP).u
Tasas de éxito de ICP-OCT bajasen algunos estudios (EXPLORE).
u Tasa de revascularización completa (éxito CTO+ ICPotras lesiones) no definida.
u ICP-OCT con DES de primera generación en algunosestudios (DECISION, REVASC). u
Cross-over elevado de TMO a ICP-CTO en algunosestudios (DECISION).
u La ICP-CTO “precoz” en el SCA podría aumentarel riesgo del procedimiento (EXPLORE).u
No se realizó control angiográficode la permeabilidaddelvaso en el seguimiento.