TRIAL

1. FREEDOM Trial -
Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of
Multivessel Disease
• NEJM 2012
• CABG v PCI for MVD + DM
• Inclusion criteria
• DM, CAD in > 2 arteries, suitable for PCI or
CABG, Sx. or objective evidence of
ischemia
• Study population
• 60 y.o., 80% had 3VD, Syntax score 26,
33% insulin dependent, LVEF >60%
• Primary endpoint – mortality/MI/CVA at 5 years
• Superior for CABG (27 v 19%)
• Secondary
• 5 year Mortality – CABG sup (16 v 11%)
• MI – CABG sup (14 v 6%)
• CVA – PCI sup (2 v 5%)
• Extended 7 year mortality – CABG sup (24 v 18%)

2. NOBLE Trial -Nordic–Baltic–British Left Main
Revascularisation
• Inclusion criteria:
• LM of >50% or FFR <0.8, no more than 3
additional non-complex lesions
• Different from Excel, where LM>70% or 50-
70% w/ FFR <0.8/IVUS
• Reached enrollment target of 1200 patients
• Different from Excel that had to stop early
due to poor enrollment (target 2600,
actual 1900)
• 5 year primary outcome of
mortality/CVA/MI/repeat revasc
• CABG superior (28 v 19%)
• Secondary individual outcomes
• CABG superior in MI, repeat
revasc, angina
• No difference in mortality, CVA

3. PRECOMBAT Trial-
Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using
Sirolimus‐Eluting Stent in Patients With Left Main Coronary Artery Disease trial
• A randomized trial of patients with LMCA disease comparing PCI with sirolimus‐eluting stents
(n=300) or CABG (n=300).
• Jeong et al reported extended follow‐up (10 years) focusing on the outcome of patients with or
without diabetes mellitus.
• The 10‐year rates of major adverse cardiac or cerebrovascular events, death, MI, stroke, and its
composite outcomes were not significantly different after PCI or CABG in patients with and
without diabetes mellitus.
• But the risk of target vessel revascularization and repeat revascularization was consistently higher
after PCI, irrespective of diabetes mellitus.
May 5, 2011
N Engl J Med 2011; 364:1718-
1727
DOI: 10.1056/NEJMoa1100452

4. EXCEL Trial-
Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for
Effectiveness of Left Main Revascularization
• 3 year results in 2016, 5 year
results in 2019
• LM RCT where Syntax score
<32
• Note LM lesion can yield
Syntax score anywhere
from 12-25. Average in this
study 20.6
• Primary endpoint composite of death,
CVA, MI at 3 years (PCI non inferior)
• Secondary endpoints:
• Composite death/CVA/MI at 30
days (PCI superior)
• Understand why
• Composite death/CVA/MI/revasc
at 3 years (PCI non inferior)
November 7, 2019
N Engl J Med 2019; 381:1820-1830
DOI: 10.1056/NEJMoa1909406

5. CONCLUSION
• The 2018 European clinical practice guidelines for myocardial revascularization
supported PCI of the LMCA, with a
• Class I recommendation and level of evidence A if the SYNTAX score was <22
• Class IIa recommendation with level of evidence A if the SYNTAX score was 23 to 32.6
• In contrast, the American Heart Association/American College of Cardiology
guidelines vary in their recommendations for PCI depending on the location of
the disease in the LMCA.
• PCI for ostial or shaft LMCA disease has a Class IIa recommendation
• Whereas distal LMCA disease has a Class IIb recommendation.
• The outcomes of nondistal lesions treated with PCI are favorable.

7. THANK YOU