1. Dr.Ravi Prakash
Moderator –Dr Roopa Salwan

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

4. PATIENT FLOW
Enrolled Patients (N=1454)
Randomized Cohort CABG registry N=335
N=600 PCI registry N=475
Medication registry N=44
Assigned CABG Assigned PCI
N=300 N=300
1-year follow-up
Treated CABG Treated CABG
CABG registry N=310
N=248 N=24
PCI registry N=457
Treated PCI Treated PCI
Medication registry N=41
N=51 N=276
Treated medical Treated medical
N=1 N=0
2-year follow-up
1-year follow-up 1-year follow-up
N=296 N=298 CABG registry N=259
PCI registry N=289
2-year follow-up 2-year F/U Medication registry N=39
N=266 N=270

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

11. RESULTS

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

14. PROCEDURAL
CHARACTERISATION

15. PROCEDURAL CHARACTERISATION

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

17. DEATH FROM ANY CAUSE

18. MYOCARDIAL INFARCTION

19. STROKE

20. TARGET VESSEL REVASCULARISATION

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.

25. Thanks