1. Randomized Trial of Stents Versus Bypass
Surgery for Left Main Coronary Artery
Disease : 5-Year Outcomes of the
PRECOMBAT Study
Journal of the American College of
Cardiology
Volume 65, Issue 20, 26 May 2015

2. PRECOMBAT
Premier of Randomized Comparison of Bypass
Surgery versus Angioplasty Using Sirolimus-
Eluting Stent in Patients with Left Main
Coronary Artery Disease

3. Background
Percutaneous coronary intervention (PCI) was
not inferior to coronary artery bypass grafting
(CABG) for the treatment of unprotected left
main coronary artery stenosis at 1 year.

4. Study design and patients
• PRECOMBAT trial was a prospective, open-
label, randomized trial conducted at 13 sites in
South Korea
• Patients were randomly assigned to undergo
PCI with sirolimus-eluting stents or CABG in
a 1:1 ratio

5. Study design and patients
• Between April 2004 and August 2009, a total
of 1454 patients with unprotected left main
coronary artery stenosis were enrolled.

6. • 600 eligible patients were randomly assigned
to undergo PCI with sirolimus-eluting
stents (n = 300) or CABG (n = 300). Of those,
279 patients (93%) in the PCI group and 275
patients (91.7%) in the CABG group
completed 5 years of follow-up

7. Inclusion Criteria
• Atleast 18 years of age.
• The patient must have significant de novo
unprotected left main coronary artery (ULMCA)
stenosis (>50% by visual estimation) with or
without any additional target lesions (>70% by
visual estimation).
• Patients with stable angina or acute coronary
syndromes(UA & NSTEMI) or patients with
atypical chest pain or without symptoms but
having documented myocardial ischemia may be
enrolled.
• The patient or guardian must agree to the study
protocol and the schedule of clinical and
angiographic follow up, and must provide
informed, written consent.

8. Exclusion Criteria
1. Known hypersensitivity or contraindication to any of the
following medications:
• Heparin
• Aspirin
• Both clopidogrel and ticlopidine
• Sirolimus
• Stainless steel and/or
• Contrast media
2. Systemic (intravenous) sirolimus use within 12 months.
3. Any previous percutaneous coronary intervention (PCI)
within 1 year
4. Previous bypass surgery

9. Exclusion Criteria
5. Any previous PCI of a ULMCA or ostial left
circumflex artery or ostial left anterior descending
artery lesion within 1 year
6. Intention to treat more than one totally occluded
major epicardial vessel
7. Acute MI within 1 week
8. Ejection fraction <30%.
9. Cardiogenic shock
10. Any stroke with a persistent neurological deficit or
any cerebrovascular accident within 6 months
11. Creatinine level≥2.0mg/dL or dependence on
dialysis.

10. Exclusion Criteria
• Severe hepatic dysfunction (AST and ALT≥3 times
upper normal reference values).
• Gastrointestinal or genitourinary bleeding within the
prior 3 months, or major surgery within 2 months.
• Unable or unwilling to follow-up with visits required
by protocol
• History of bleeding diathesis or known coagulopathy
(including heparin-induced thrombocytopenia), or
will refuse blood transfusions.
• Current known current platelet count <100,000
cells/mm3 or Hgb <10 g/dL.

11. Procedures
• Sirolimus-eluting stents were the default drug-eluting
stents
• Use of IVUS, adjunctive devices, or glycoprotein
IIb/IIIa inhibitors was at the operator’s discretion
• All patients undergoing PCI took aspirin plus
clopidogrel (300-mg loading dose) or ticlopidine
(500-mg loading dose) before or during the procedure
• After PCI, all patients were prescribed 100 mg/day
aspirin indefinitely and 75 mg/day clopidogrel or 250
mg/day ticlopidine for at least 1 year
• During CABG, the internal thoracic artery was
preferred for bypass of the left anterior descending
artery

12. Follow-up and endpoints
• After PCI, all patients were asked to undergo
follow-up angiography 8 to 10 months after
the procedure or earlier if they were
experiencing symptoms of angina
• Routine follow-up angiography was not
performed for patients who underwent CABG
• Other follow-up assessments were performed
at 1, 6, 9, and 12 months and yearly

13. • Primary endpoint: major adverse cardiac or
cerebrovascular event (MACCE) (a composite
of death from any cause, MI, stroke, or
ischemia-driven target vessel revascularization
[TVR]) after randomization.
• Secondary endpoints included the individual
components of the primary endpoint

15. Results

19. AT 5 YEAR FOLLOW UP
• At 5 years, the cumulative incidence of
MACCE was 17.5% in the PCI group and
14.3% in the CABG group (HR: 1.27; 95% CI:
0.84 to 1.90; p = 0.26).

24. LIMITATIONS
• Selected patients with relatively low-risk
profiles
• limited sample size
• Systematic performance of follow-up
angiography in the PCI group may have
increased the rate of TVR

25. CONCLUSION
• During the 5-year follow-up, study did not
show a significant difference in the rate of
MACCE between patients who underwent PCI
with a sirolimus-eluting stent and those who
underwent CABG, supporting current
guidelines stating that left main stenting is a
feasible revascularization strategy for patients
with suitable coronary anatomy.