- A randomized trial compared percutaneous coronary intervention (PCI) using everolimus-eluting stents to coronary artery bypass grafting (CABG) in over 1900 patients with left main coronary artery disease. - At 3 years, PCI was found to be noninferior to CABG for the primary endpoint of death, stroke, or myocardial infarction. However, the rate of revascularization was 5% higher in the PCI group. - Early adverse events such as myocardial infarction, bleeding, and renal failure within 30 days were lower with PCI, but adverse events increased between 30 days and 3 years for PCI compared to CABG. Long-term follow up is still needed to compare outcomes.

1. Original Article
Everolimus-Eluting Stents or Bypass Surgery for
Left Main Coronary Artery Disease
Gregg W. Stone, M.D., Joseph F. Sabik, M.D., Patrick W. Serruys, M.D., Ph.D.,
Charles A. Simonton, M.D., Philippe Généreux, M.D., John Puskas, M.D., David E.
Kandzari, M.D., Marie-Claude Morice, M.D., Nicholas Lembo, M.D., W. Morris
Brown, III, M.D., David P. Taggart, M.D., Adrian Banning, M.D., Béla Merkely, M.D.,
Ferenc Horkay, M.D., Piet W. Boonstra, M.D., Ad J. van Boven, M.D., Imre
Ungi, M.D., Gabor Bogáts, M.D., Samer Mansour, M.D., Nicolas Noiseux, M.D.,
Manel Sabaté, M.D., José Pomar, M.D., Mark Hickey, M.D., Anthony Gershlick, M.D.,
Pawel Buszman, M.D., Andrzej Bochenek, M.D., Erick Schampaert, M.D., Pierre
Pagé, M.D., Ovidiu Dressler, M.D., Ioanna Kosmidou, M.D., Roxana Mehran, M.D.,
Stuart J. Pocock, Ph.D., A. Pieter Kappetein, M.D., Ph.D., for the EXCEL Trial
Investigators
N Engl J Med
Volume 375(23):2223-2235
December 8, 2016

2. EXCEL trial
From September 2010 to march 2014
At 126 cities in 17 countries
Left main coronary artery disease is associated with
high morbidity and mortality
Previous RCTs have suggested that PCI with drug
eluting stents might be an alternative to CABG in
selected patients

3. In SYNTAX TRIAL the rate of death, stroke, MI and
unplanned revascularization at 5 year was similar in
patients treated with Paclitaxel eluting stents and
CABG
However the outcome of PCI was accepted only in
patients with low or intermediate anatomical complexity
of Coronary artery
Evaluation of XIENCE vs CABG for effectiveness of left
main Revascularization (EXCEL) was sponsored by
Abbott Vascular

4. Patients were assessed by interventional
cardiologist and cardiac surgeon.
Main inclusion criteria
1 . stenosis of main coronary artery > 70%
estimated visually
2 . stenosis of main coronary artery 50-70%
determined by non invasive testing
3. SYNTAX score 32 or less. .higher score
indicating more complex anatomy of artery
Methods

5. Randomization was done by interactive voice based
or Web based system with stratification according
to diabetes (present/absent), SYNTAX score (<22
or> 23) and study centre
ECG was performed at baseline, 24 hrs post
procedure, at discharge and after 1 yr
CKMB at baseline, 12 hrs and 24 hrs after
procedure
No routine angiography

6. The goal of PCI was complete revascularization
with XIENCE. .use of heparin is allowed. .but
glycoprotein 2b/3a inhibitors was discouraged
DUAL anti platelet therapy was initiated before
procedure and continued up to 1 year
In CABG arterial grafts were strongly
recommended. .revascularization of all vessels
more than 1.5 mm diameter was achieved.
.Aspirin was administered in perioperative
period

7. Primary objective...composite end point of death, stroke
or myocardial infarction at 3 years
Secondary objectives. ...composite of death from any
cause, stroke or myocardial infarction at 30 days.
..ischaemia driven revascularization at 3 years. ..stent
thrombosis, graft occlusion, bleeding etc
They estimated 1900 patients would provide 80% power
to show non inferiority of PCI to CABG

8. Results
Among 1905 patients underwent randomization 948 were
assigned to PCI group and 957 to CABG group
Distal main bifurcation or trifurcation disease in 80.5%
and two vessel or three vessel disease in 51.3%
A mean of 2.4 stents and mean length of 49.1 mm were
implanted and 99.2% were everolimus eluting
For CABG mean of 2.6 grafts were placed

9. In 98.8% of patients internal thoracic artery graft was
used
Median duration of follow up was 3 years
Primary end point...15.4% vs 14.7% in PCI and
CABG group. ..P value 0.02 for non inferiority and
other 0.98 for superiority
Secondary end points at 30 days...4.9% vs 7.9%...P
value <0.001 for non inferiority
Secondary end points at 3 year..23.1% vs 19.1%...p
value 0.01 for non inferiority

10. Other adverse effects %
Ischemia driven revascularization ..12.6 vs 7.5
Stent thrombosis in PCI vs graft occlusion in
CABG. ..0.7 vs 5.4
Major periprocedural adverse effects. ..8.1 vs 23
18 more deaths in PCI than CABG. .mostly due to
non cardiovascular causes

12. Primary and Hierarchical Secondary Clinical End Points.
Stone GW et al. N Engl J Med 2016;375:2223-2235

13. Analysis
PCI with everolimus eluting stent is non inferior to
CABG in this trial..an acceptable alternative
The 3 year rate of revascularization was 5 percentage
higher in PCI group. ..but early MI, bleeding, major
arrhythmia and renal failure were 15 percentage
lower in PCI group
Rate of stent thrombosis was significantly low ..0.7%
during 3 years ...than previous trials with Paclitaxel
eluting stents

14. Intravascular ultrasound is used in 80% patients in
this trial
Limitations. ..blinding of patients and investigators to
the treatment was not possible
24% of patients underwent randomization had high
SYNTAX score according to angigraphic core
laboratory analysis
Long term medication use in PCI and CABG varied
Long term follow up is required for determining
additional difference

15. Left main coronary artery disease can be equally managed
by 2 strategies. .but shorter hospital stay, rapid recovery
and return to normal activities favor PCI
However PCI group showed increase in adverse events
between 30 days and 3 years. ..so more long term follow up
is needed

16. Study Overview
• In a randomized trial, over 1900 patients with left main coronary artery
disease were assigned to percutaneous coronary intervention or
coronary-artery bypass grafting.
• At 3 years, PCI was noninferior to CABG with respect to the rate of
death, stroke, or myocardial infarction.

17. Conclusions
• In patients with left main coronary artery disease and low or intermediate
SYNTAX scores by site assessment, PCI with everolimus-eluting stents
was noninferior to CABG with respect to the rate of the composite end
point of death, stroke, or myocardial infarction at 3 years.

18. Thank you