2. INTRODUCTION
• Recent registry and sub-study results have shown
that percutaneous coronary intervention (PCI) is safe
and effective in patients with unprotected left main
coronary artery (ULMCA) stenosis.
• However, due to the lack of randomized clinical trials,
the comparability of PCI with coronary artery bypass
graft (CABG) remains uncertain.
3. PRECOMBAT Trial Premier of Randomized Comparison of Bypass
Surgery versus Angioplasty Using Sirolimus-Eluting Stent in
Patients with Left Main Coronary Artery Disease
• DESIGN: a prospective, randomized clinical trial
• OBJECTIVE: To compare PCI with sirolimus-eluting
stents and CABG surgery for optimal revascularization of
patients with ULMCA stenosis.
• PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD, Asan Medical Center,
Seoul, Korea
5. MAJOR INCLUSION CRITERIA
• 18 years of age.
• Significant de novo ULMCA stenosis (>50%)
• Left main lesion and lesions outside ULMCA (if
present) potentially comparably treatable with PCI
and CABG.
• Objective evidence of ischemia or ischemic symptom
with angina or NSTEMI
6. MAJOR EXCLUSION CRITERIA
• Any contraindication to dual antiplatelet therapy
• Any previous PCI within 1 year
• Previous CABG
• Chronic total occlusion > 1
• AMI within 1 week
• Shock or LV EF < 30%
• Planned surgery
• Disabling stroke
• Other comorbidity, such as CRF, liver disease, etc
7. STUDY PROCEDURES
• 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
8. FOLLOW-UP
• Clinical follow-up at 30 days and 6, 9, and 12 months
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
9. PRIMARY END POINT
• A composite of major adverse cardiac or
cerebrovascular events (MACCE) for the 12-month
period after randomization including
– Death from any cause
– Myocardial infarction (MI)
– Stroke
– Ischemia-driven target vessel revascularization (TVR)
10. POWER CALCULATION
• A non-inferiority margin : 7%
• A one-sided type I error rate : 0.05
• Power : 80%
• Assumption : a total of 572 patients (286 per group)
• A final sample size : 600 patients (300 per group)
assuming 5% of loss
12. The baseline clinical characteristics of the PCI and
CABG groups were similar.
Mean age of participants- 62 years
76.5% were men.
The baseline angiographic characteristics of the
two groups were also similar.
13. PROCEDURAL CHARACTERISTICS OF THE STUDY
GROUPS
.
Complete revascularization
68.3% in the PCI group
70.3% in the CABG group (P = 0.60).
Duration of the hospital stay after the procedure
8.4±14.5 days in the CABG group
3.1±5.8 days in the PCI group (P<0.001).
At the time of discharge, patients in the PCI group
more consistently received medications.
Follow-up angiography at 8 to 10 months
performed more frequently in the PCI group
16. TRIAL END POINT
median follow-up period was 24.0 months in both the
PCI and CABG groups.
The primary end point of major adverse cardiac or
cerebrovascular events at 12 months
occurred in 26 patients assigned to PCI
20 patients assigned to CABG
21. INFERENCE
No significant between-group differences in the cumulative incidence rates of
the individual components of the primary end point .
2-year rate of ischemia-driven target-vessel revascularization was significantly
lower in the CABG group than in the PCI group.
There was no significant differences between the PCI and CABG groups in the
registry cohort with respect to the rates of most of the major trial end points
at 1 or 2 years.
The exception was the end point of ischemia-driven target-vessel
revascularization, which occurred significantly more frequently in
PCI group.
22. DISCUSSION: COMPARISON WITH SYNTAX TRIAL
PRECOMBAT SYNTAX
Lower CV or cerebrovascular Higher event rate
event rate. Event rate similar in
Lower in stent thrombosis PCI/CABG
Pt. had less complex coronary Mean SYNTAX score=30
lesions & clinical settings. Mean EUROSCORE=3.8
Mean SYNTAX score=25 US & European population
Mean EUROSCORE=2.7
Better device & technique
Asian population
23. LIMITATIONS OF THE STUDY
Underpowered study due to low event rate
Wide inferiority margin of 7% point, so findings can
not be considered clinically directive.
Relatively high rate of cross over between PCI & CABG
group.
2 yr follow up period may not be enough for
comparison.
Restricted sample size. Difficult to extrapolate.
24. CONCLUSION
At 1 yr, rate of CV or cerebrovascular events are similar
in PCI & CABG groups .
Meets the pre-specified criteria on non-inferiority of
PCI to CABG.
However due to low power and wide inferiority margin
of trial, findings can not be considered as clinically
directive.
