1. Incidence and management of restenosis after treatment of unprotected left main disease with drug-eluting stents: 70 restenotic cases from a cohort of 718 patients – Failure In Left Main Study (FAILS)
Giuseppe BIONDI-ZOCCAI, M.D. on behalf of the FAILS Investigators Division of Cardiology, University of Turin, Italy Meta-analysis and Evidence-based medicine Training in Cardiology, Ospedaletti, Italy

2. BACKGROUND & AIM
The promising role of drug-eluting stents (DES) for percutaneous revascularization of unprotected left main (ULM) has been reported in several settings, including the meta-analyses1 and the recent SYNTAX trial.2
However no detailed data are available on subsequent restenosis.
We thus aimed to appraise the incidence and management of restenosis following DES implantation for ULM disease.
1. Biondi-Zoccai et al, Am Heart J 2008;155:
2. Serruys et al, New Engl J Med 2009;360:

3. METHODS
From the total sample of patients with ULM treated with DES at several high-volume centers, we identified those presenting with angiographic ULM restenosis.
The primary end-point was the long-term rate of major adverse cardiac events (MACE), ie death, myocardial infarction (MI) or target lesion revascularization (TLR).
We also adjudicated stent thrombosis according to the Academic Research Consortium.

4. PARTICIPATING CENTERS
Milan
Sheffield
Los Angeles
Turin
Firenze
Arezzo

5. STUDY FLOWCHART
*5.1% (2.5%
dying suddenly) *

6. BASELINE FEATURES Medical Rx (N=4) Re-PCI (N=59) CABG (N=7) P value
Age, years
67.6±21.2
64.8±12.7
69.7±8.9
0.60
Men, %
3 (75.0)
49 (83.1)
7 (100)
0.44
Diabetes mellitus, %
18 (31.0)
0.10
Non-insulin-dependent
12 (20.7)
0.25
Insulin-dependent
6 (10.3)
0.54
Hypertension, %
43 (74.1)
4 (57.1)
0.63
Hypercholesterolemia, %
41 (69.5)
5 (71.4)
0.97
Current smoking, %
3 (5.3)
2 (28.6)
0.07
LVEF%
43.0±23.4
53.9±9.5
45.0±7.1
0.02
Prior myocardial infarction, %
2 (50.0))
18 (45.0)
0.22
Prior CABG, %
6 (15.0)
Clinical presentation, %
Elective control
1 (25.0)
13 (22.8)
1 (14.3)
0.87
Silent myocardial ischemia
11 (19.3)
Stable angina
16 (28.1)
3 (42.9)
0.71
Unstable angina
2 (50.0)
15 (26.3)
0.59
Acute myocardial infarction
2 (3.5)
0.82
Cardiogenic shock
1 (1.8)
0.91
EuroSCORE
7.0±6.1
7.1±13
5.0±1.9

7. 1ST PROCEDURE ON ULM Medical Rx (N=4) Re- PCI (N=59) CABG (N=7)
P value
Lesion location, %
Ostium only
1 (25.0)
9 (15.3)
2 (28.6)
0.62
Ostium and/or shaft
8 (13.6)
1 (14.3)
0.73
Distal and/or bifurcational
3 (75.0)
42 (71.2)
4 (57.1)
PCI in the ULM
No. of implanted stents
2.0±0.8
1.7±0.9
1.4±0.8
0.54
Only SES, %
33 (57.9)
0.25
Only PES, %
20 (35.1)
0.46
Only ZES, %
1 (1.8)
0.17
DES and BMS, %
2 (3.5)
0.82
Total stent length per patient, mm
36.0±21.4
26.5±13.3
23.0±11.3
0.31
Maximum balloon diameter, mm
2.94±0.13
3.40±0.55
2.96±0.59
0.05
Maximum dilation pressure, ATM
15.0±4.2
16.1±3.9
14.4±2.2
0.48
Bifurcation stenting, %
45 (76.3)
0.55
Main branch only
13 (28.9)
Simultaneous kissing stenting
3 (100)
6 (13.3)
0.001
Final kissing balloon inflation, %
2 (75.0)
41 (91.1)
4 (100)
0.30

8. 1ST PROCEDURE ON ULM Medical Rx (N=4) Re-PCI (N=59) CABG (N=7) P value
Lesion characteristics
Ostium only, %
1 (25.0)
10 (16.9)
1 (14.3)
0.90
Ostium and/or shaft, %
12 (20.3)
2 (28.6)
0.52
Distal and/or bifurcational, %
3 (75.0)
37 (62.7)
4 (57.1)
0.84
Restenosis involving ostial LAD
19 (51.4)
3 (50.0)
0.23
Restenosis involving ostial LCx
3 (100)
30 (81.1)
2 (33.3)
0.02
Restenosis involving Ramus
4 (10.8)
0.25
Diffuse restenosis, %
0.48
PCI for ULM restenosis
Balloon-only PCI, % -
16 (27.1)
Cutting balloon, %
6 (10.2)
Directional atherectomy, %
2 (3.4)
PCI with BMS, %
1 (1.7) …

9. 2ND PROCEDURE ON ULM Medical Rx (N=4) Re-PCI (N=59) CABG (N=7) P value
PCI with DES, % -
34 (57.6)
Number of implanted stents
1.3±0.5
Only SES, %
13 (39.4)
Only PES, %
20 (60.6)
Maximum balloon diameter, mm
3.3±0.4
Total stent length per patient, mm
17.7±10.4
Maximum dilation pressure, ATM
17.7±5.0
Bifurcation stenting, %
27 (45.8)
Main branch only
15 (62.5) T
2 (8.3) V
3 (12.5)
Crushing
Culottes
1 (4.2)
Simultaneous kissing stenting
Final kissing balloon inflation, %
21 (87.5)
Glycoprotein IIb/IIIa inhibitors, %
9 (13.8)
Intra-aortic balloon pump, %
5 (7.2)

10. Cumulative events after >35 months
CLINICAL OUTCOMES
All p>0.05 %
In-hospital
Cumulative events after >35 months

11. CLINICAL OUTCOMES Medical Rx (N=4) Re-PCI (N=59) CABG (N=7)
Overall P value
P value PCI vs CABG
In-hospital events
Death, %
1 (1.7)
0.91
1.00
MI or CABG, % -
Long-term events
Follow-up, %
4 (100)
59 (100)
7 (100)
Follow-up from restenosis, m
27.1±18.5
23.9±16.8
32.4±9.2
0.42
0.20
Follow-up from 1st PCI, m
45.1±17.4
35.5±15.7
44.3±10.8
0.21
0.16
MACE, %
2 (50.0)
15 (25.4)
1 (14.3)
1 (25.0)
3 (5.1)
Cardiac death, %
0.022
MI, %
2 (3.4)
0.83
CABG, %
0.54
0.37
ULM TLR, %
13 (22.0)
0.88
Non-ULM* PCI, %
14 (23.7)
0.35
0.33
Stent thrombosis, %
Definite
Probable or possible

12. CONCLUSIONS
Significant ULM DES restenosis is characterized by a stable clinical condition in most patients, even if a subset of them can present with an acute coronary syndrome.
After more than 24 months of clinical follow-up from the diagnosis of restenosis, MACE rates appear quite favorable in both the interventional and surgical therapy groups.