Lo mejor del ACC 2015 (San Diego) Miércoles, 18/3/15 De 14:00 a 15:30 Casa del Corazón. Sociedad Española de Cardiología. http://acc15.secardiologia.es/ SCA/Intervencionismo coronario II Dr. Gonzalo Barón y Esquivias Servicio de Cardiología. Hospital Virgen del Rocío, Sevilla

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18 Marzo a las 14:00h
Casa del Corazón, Madrid
La Sociedad Española de Cardiología
en colaboración con MSD,
presentan en directo

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AFTER EIGHT

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AFTER EIGHT

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AFTER EIGHT

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Conclusion
AFTER EIGHT

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Randomized Trial of Stents versus Bypass Surgery for Left
Main Coronary Artery Disease:
Five-Year Outcomes of the
PRECOMBAT Study
•DESIGN: a prospective, open-label, randomized trial
•OBJECTIVE: To compare PCI with sirolimus-eluting stents and CABG surgery for
optimal revascularization of patients with ULMCA stenosis.
• Sirolimus-eluting Cypher stent for all lesions
• Strong recommendation of IVUS-guidance
• Other adjunctive devices at the operator’s discretion
• Use of LIMA to LAD anastomosis
• Off- or on-pump surgery at the operator’s discretion
• Dual antiplatelet therapy at least for 6 months after PCI
• Standard medical treatment after PCI and CABG
• Clinical follow-up at 30 days and 6, 9, 12 months, and
annually thereafter, via clinic visit or telephone
interview.
• Routine angiographic follow-up at 8-10 months after
PCI.
• Ischemia-guided angiographic follow-up after CABG.
• Retrospective SYNTAX score measurement in the Core
Lab, CVRF, Seoul, Korea
PRECEDURES FOLLOW-UP
PRECOMBAT

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23 lost to FU18 lost to FU
2 lost to FU3 lost to FU
275 remained at 5 years279 remained at 5 years
298 remained at 2 years297 remained at 2 years
248 treated with CABG
51 treated with PCI
1 medically treated
24 treated with CABG
276 treated with PCI
0 medically treated
300 patients assigned to CABG300 patients assigned to PCI
600 patients were randomized
PRECOMBAT

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0 1 2 3 4 5
0
10
20
30
40
50
PCI
CABG
Patient at risk
PCI
CABG
300
300
272
279
261
274
252
267
246
256
231
235
p=0.26
17.5%
14.3%
Years Since Randomization
CumulativeIncidence,%
Primary End Point of MACCE
0 1 2 3 4 5
0
10
20
30
40
50
PCI
CABG
Patient at risk
PCI
CABG
300
300
288
287
284
284
277
277
270
268
256
247
p=0.66
8.4%
9.6%
Years Since Randomization
CumulativeIncidence,%
Death, MI or Stroke
0 1 2 3 4 5
0
10
20
30
40
50
PCI
CABG
Patient at risk
PCI
CABG
300
300
274
283
263
278
254
271
248
261
232
240
p=0.012
11.4%
5.5%
Years Since Randomization
CumulativeIncidence,%
Ischemia-Driven TVR
0 1 2 3 4 5
0
10
20
30
40
50
PCI
CABG
Patient at risk
PCI
CABG
300
300
279
284
269
279
260
272
253
262
237
240
p=0.057
9.3%
5.2%
Years Since Randomization
CumulativeIncidence,%
Clinical-driven TVR
PRECOMBAT

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Conclusion
At 5 years, no difference in MACCE was
found between patients assigned to PCI
with sirolimus-eluting stents and those
who underwent CABG, supporting
current guidelines stating that left main
stenting is a feasible revascularization
strategy for patients with suitable
coronary anatomy.
PRECOMBAT

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DESIGN: a prospective, open-label, randomized trial
OBJECTIVE: To compare PCI with everolimus-eluting stents and CABG for
optimal revascularization of patients with multivessel coronary artery
stenosis
• Everolimus-Eeluting Xience Stent for all lesions
• Strong recommendation of IVUS-guidance
• Other adjunctive devices at the physician’s discretion
• Use of LIMA to LAD anastomosis
• Off- or on-pump surgery at the surgeon’s discretion
• DAPT at least for 1 year after PCI
• Standard medical treatment after PCI and CABG
PRECEDURES FOLLOW-UP
•Clinical follow-up at 30 days and 6, 9, and 12 months
, and annually thereafter, via clinic visit or telephone
interview.
•Secondary preventive medication was strongly
recommended according to clinical guideline
•Routine angiographic follow-up was strongly
discouraged for all patients to reduce the occurrence
of repeat revascularization driven by angiography
alone without signs or symptoms of ischemia.
BEST

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Primary End Point
A composite of major adverse cardiac events (MACE) for the 2 years after
randomization including
-Death from any cause
-Myocardial infarction
-Target vessel revascularization
Premature Termination of Trial
•The enrollment rate was slower than expected, which was thought to be a
consequence of the rapid spread of measurement of fractional flow reserve
in clinical practice.
•The data and safety monitoring board recommended stopping enrollment
in October 2013 when 880 patients had been enrolled.
•We extended the follow-up period with a median of 4.6 years.
BEST

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BEST

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BEST

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BEST

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Primary End Point of MACCE Death, MI or Stroke
Any repeat revascularization New lesion revascularization
BEST

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Medication at Follow-Up
BEST

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•The BEST trial failed to show that PCI with everolimus-
eluting stents was noninferior to CABG with respective to
the primary end point of death, myocardial infarction, or
target vessel revascularization at 2 years.
•Among patients with multivessel coronary artery disease,
the rate of major adverse cardiovascular events was
higher among those who had undergone PCI with the use
of everolimus-eluting stents than among those who had
undergone CABG
•At longer-term follow-up (median 4.6 years), PCI was
associated with a significant increase
in the incidence of the primary end
point compared with CABG.
Conclusion
BEST

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TOTAL

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TOTAL

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TOTAL

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Conclusion
TOTAL

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MATRIX
* 8,404 patients with ACS undergoing coronary angiography ± PCI from 11th Oct 2011 to 7th Nov 2014
* Operator Eligibility Criteria: Interventional cardiologist expertise in TRI and TFI including at least 75
transradial coronary interventions and at least 50% of interventions performed via radial route in the year
preceding site initiation

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MATRIX

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MACE Results
NACE Results
NACE= MACE + Serius Bleeding (BARC 3-5)
MATRIX

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OBJETIVO 1ª a 30 días
Mortalidad total IAM
ICTUS Sangrado grave BARC 3-5
MATRIX

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Conclusion
In patients with acute coronary syndrome,
with or without ST-segment elevation,
undergoing invasive management, the use
of radial access compared with femoral
access decreases net adverse clinical
events
MATRIX

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Ulnar artery intervention non inferior to radial approach:
Reality or myth? AJmer ULnar ARtery working group study.
A randomized parallel group Non-Inferiority trial
– Frequent vasospasm, - More anatomical variation,
– Small caliber and - Unsuitability of radial artery to be
used as graft for CABG after cannulation.
Worldwide radial artery cannulation has been accepted as a default technique for coronary
access because of obvious safety advantages over femoral access.
AJULAR
“..Default radialist with a minimum experience of 50 transulnar cannulations ..”
“…Cannulation attempted only if ulnar artery easily palpable and anatomy is favorable….”

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AJULAR
Primary end Point
Composite of MACEs ,major vascular
events (large hematoma and
occlusion) during hospital stay and
crossover rate.
Secondary end Points
•Individual Components of Primary end
Points
•Spasm.
•Failed attempts( > 3 attempts)
•Total procedural and fluoroscopy time,
•Amount of contrast used
Does Ulnar artery cannulation still remain inferior,
even if performed by an Experienced operator ?

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RESULTS(%):
AJULAR

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1. Trans Ulnar cannulation is also an easy, safe
and comfortable procedure.
2. If used as a default strategy it is non-inferior
to transradial approach, when performed by
an experienced operator – “It’s Reality, not a
myth”.
CONCLUSIONS:
AJULAR

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