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
• 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
Stenting of the main vessel and optional stenting of the side branch (MV) n=207
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.
Presented at ACC 2006
www. Clinical trial results.org
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% 15% 10% 5% 0%
Biomarker elevation >3x ULN Biomarker elevation >5x ULN
Biomarker Elevation at 6 months (%)
18%
p=0.011
13%
p=0.008
8%
4%
MV+SB group
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
Procedure and Fluoroscopy Duration (min)
75 74 59
Time (minutes) Volume (mL)
Vol. of Contrast Administered (mL)
p<0.001
p<0.001
300
283 233
50
200
25
21 15
100
0
Duration of procedure Fluoroscopy
0 Contrast
MV+SB group
MV group
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% 3% 2% 1% 0%
4.4% 3.4%
• There was no difference in major adverse cardiac events at 6 months (4.4% vs 3.4%; p=NS).
MV+SB group
MV group
www. Clinical trial results.org
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation Lesions Trial: Primary Endpoint Components
Components of the Primary Endpoint (%)
p=NS
3% 2.0% 2% 1.4% 1.0% 1% 1.0% 1.0% 1.4%
• There was no difference in six month cardiac death (1.0% each). • There was no significant difference in clinical MI (1.0% vs 1.4%) or target lesion revascularization (2.0% vs 1.4%).
0% 6 month cardiac death Clinical MI TLR
MV+SB group
www. Clinical trial results.org
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%
13%
10%
• Procedure related MI was defined as a fivefold elevation of biochemical markers. • Procedure related MI occurred more than three times as often in the MV+SB group (13% vs 4%; p=0.008).
5%
4%
0% MV+SB group MV group
www. Clinical trial results.org
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
MV group
www. Clinical trial results.org
Presented at ACC 2006
Side Branch Stenting Using SES in Bifurcation Lesions Trial: Treatment Success
Treatment Success (%)
p=NS
100% 75% 50% 25% 0%
95%
97%
• Treatment success was similar in both groups (95% vs 97%; p=NS).
MV+SB group
MV group
www. Clinical trial results.org
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