Side Branch Stenting Using Sirolimus-Eluting
Stents in Bifurcation Lesions Trial
Side Branch Stenting Using Sirolimus-Eluting Stents
in Bifurcation Lesions Trial
Presented at
The American College of Cardiology
Scientific Session 2006
Presented by Dr. Terje K. Steigen
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Background
• This study sought to determine whether side branch
stenting using sirolimus-eluting stents could offer any
advantage in the stenting of bifurcation lesions in patients
with angina pectoris.
www. Clinical trial results.org
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Study Design
413 patients presenting with angina pectoris and a bifurcation lesion
Randomized.
22% female, mean age 64 years, mean follow-up 6 months
Stenting of the main vessel
and side branch (MV+SB)
n=206
Stenting of the main vessel and optional
stenting of the side branch (MV)
n=207
• If TIMI Flow Grade was <3 following main
vessel stenting, the side branch was dilated
• If after dilation the TIMI Flow Grade was 0, the
side branch was then stented

Primary Endpoint: Major adverse cardiac event (MACE) at 6 months, defined as
cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) or
stent thrombosis of index lesion.
www. Clinical trial results.org
Presented at ACC 2006
Side Branch Stenting Using SES
in Bifurcation Lesions Trial: Background Data
• Stenting of the side branch was performed in 95.1% of the
MV+SB group and 4.3% of the MV group
• GP IIb/IIIa inhibitors were used in 51% of the patients
www. Clinical trial results.org
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Procedural Outcomes
25%
20%
Biomarker Elevation at 6 months (%)
18%
p=0.011
15%
10%
8%
13%
p=0.008
4%
5%
0%
Biomarker elevation >3x ULN
MV+SB group
Biomarker elevation >5x ULN
MV group
• Biomarker elevation was more common in the MV+SB group
www. Clinical trial results.org
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Procedural Outcomes
75
Procedure and Fluoroscopy Duration (min)
Vol. of Contrast Administered (mL)
p<0.001
p<0.001
74
300
283
233
50
21
25
15
0
Volume (mL)
Time (minutes)
59
200
100
0
Duration of procedure
Fluoroscopy
MV+SB group
MV group
Contrast
MV+SB group
MV group
• The duration of the procedure and fluoroscopy time were increased in the MV+SB
group, as well as the use of contrast.
www. Clinical trial results.org
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Primary Endpoint
Primary Endpoint of MACE at 6 months (%)
p=NS
5%
4.4%
4%
3.4%
3%
• There was no difference
in major adverse cardiac
events at 6 months (4.4%
vs 3.4%; p=NS).
2%
1%
0%
MV+SB group
www. Clinical trial results.org
MV group
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Primary Endpoint Components
Components of the Primary Endpoint (%)
p=NS
• There was no
difference in six month
cardiac death (1.0%
each).
3%
2.0%
2%
1.4%
1.0%
1.0%
1.4%
1.0%
1%
0%
6 month
cardiac death
Clinical MI
MV+SB group
www. Clinical trial results.org
• There was no
significant difference in
clinical MI (1.0% vs
1.4%) or target lesion
revascularization (2.0%
vs 1.4%).
TLR
MV group
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Procedure Related MI
Procedure Related Myocardial Infarction (%)
p=0.008
15%
• Procedure related MI
was defined as a fivefold elevation of
biochemical markers.
13%
10%
4%
5%
• Procedure related MI
occurred more than
three times as often in
the MV+SB group (13%
vs 4%; p=0.008).
0%
MV+SB group
www. Clinical trial results.org
MV group
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Stent Thrombosis
Stent Thrombosis (%)
p=NS
1.5%
1.0%
1.0%
• There was no
significant difference in
stent thrombosis
between the two
groups (0% vs 1.0%;
p=NS).
0.5%
0.0%
0.0%
MV+SB group
www. Clinical trial results.org
MV group
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Treatment Success
Treatment Success (%)
p=NS
100%
95%
97%
• Treatment success was
similar in both groups
(95% vs 97%; p=NS).
75%
50%
25%
0%
MV+SB group
www. Clinical trial results.org
MV group
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Limitations
• A future study might include/exclude patients based on
lesion location to allow for a more controlled patient
population. The present trial stented bifurcation lesions
in the Left Main, LAD, LCx, and RCA.
www. Clinical trial results.org
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation
Lesions Trial: Summary
• Among patients with angina pectoris and a bifurcation lesion,
stenting of the main vessel and side branch was associated
with no difference in MACE at six months but an increase in
peri-procedural MI compared with a strategy of stenting of the
main vessel and optional stenting of side branch.
• Given the lack of clinical benefit and the increase in periprocedural MI, side-branch stenting of bifurcation lesions
does not appear to be a valid treatment strategy.
www. Clinical trial results.org
Presented at ACC 2006