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 Sirolimus-Eluting Stents in Bifurcation Lesions Trial

www. Clinical trial results.org 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.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. Presented at ACC 2006 Side Branch Stenting Using SES in Bifurcation Lesions Trial: Background

www. Clinical trial results.org Side Branch Stenting Using SES in Bifurcation Lesions Trial: Study Design  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. Stenting of the main vessel and side branch (MV+SB) and side branch (MV+SB)n=206 If TIMI Flow Grade was <3 following main vessel stenting, the side branch was dilated 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 If after dilation the TIMI Flow Grade was 0, the side branch was then stented Stenting of the main vessel and side branch (MV+SB) and side branch (MV+SB)n=206 If TIMI Flow Grade was <3 following main vessel stenting, the side branch was dilated 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 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 n= patients presenting with angina pectoris and a bifurcation lesion Randomized. 22% female, mean age 64 years, mean follow-up 6 months 413 patients presenting with angina pectoris and a bifurcation lesion Randomized. 22% female, mean age 64 years, mean follow-up 6 months Presented at ACC 2006

www. Clinical trial results.org Stenting of the side branch was performed in 95.1% of the MV+SB group and 4.3% of the MV groupStenting 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 patientsGP IIb/IIIa inhibitors were used in 51% of the patients Presented at ACC 2006 Side Branch Stenting Using SES in Bifurcation Lesions Trial: Background Data

www. Clinical trial results.org Biomarker elevation was more common in the MV+SB groupBiomarker elevation was more common in the MV+SB group Presented at ACC 2006 Side Branch Stenting Using SES in Bifurcation Lesions Trial: Procedural Outcomes p=0.008 p=0.011 Biomarker Elevation at 6 months (%)

www. Clinical trial results.org The duration of the procedure and fluoroscopy time were increased in the MV+SB group, as well as the use of contrast.The duration of the procedure and fluoroscopy time were increased in the MV+SB group, as well as the use of contrast. Presented at ACC 2006 Side Branch Stenting Using SES in Bifurcation Lesions Trial: Procedural Outcomes Time (minutes) Volume (mL) Procedure and Fluoroscopy Duration (min) p<0.001 Vol. of Contrast Administered (mL) p<0.001

www. Clinical trial results.org Side Branch Stenting Using SES in Bifurcation Lesions Trial: Primary Endpoint Primary Endpoint of MACE at 6 months (%) p=NS Presented at ACC 2006 There was no difference in major adverse cardiac events at 6 months (4.4% vs 3.4%; p=NS).There was no difference in major adverse cardiac events at 6 months (4.4% vs 3.4%; p=NS).

www. Clinical trial results.org There was no difference in six month cardiac death (1.0% each).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%).There was no significant difference in clinical MI (1.0% vs 1.4%) or target lesion revascularization (2.0% vs 1.4%). Components of the Primary Endpoint (%) p=NS Presented at ACC 2006 Side Branch Stenting Using SES in Bifurcation Lesions Trial: Primary Endpoint Components

www. Clinical trial results.org Procedure related MI was defined as a five- fold elevation of biochemical markers.Procedure related MI was defined as a five- fold 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).Procedure related MI occurred more than three times as often in the MV+SB group (13% vs 4%; p=0.008). Procedure Related Myocardial Infarction (%) p=0.008 Presented at ACC 2006 Side Branch Stenting Using SES in Bifurcation Lesions Trial: Procedure Related MI

www. Clinical trial results.org There was no significant difference in stent thrombosis between the two groups (0% vs 1.0%; p=NS).There was no significant difference in stent thrombosis between the two groups (0% vs 1.0%; p=NS). Stent Thrombosis (%) p=NS Presented at ACC 2006 Side Branch Stenting Using SES in Bifurcation Lesions Trial: Stent Thrombosis

www. Clinical trial results.org Treatment success was similar in both groups (95% vs 97%; p=NS).Treatment success was similar in both groups (95% vs 97%; p=NS). Treatment Success (%) p=NS Presented at ACC 2006 Side Branch Stenting Using SES in Bifurcation Lesions Trial: Treatment Success

www. Clinical trial results.org 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.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. Presented at ACC 2006

www. Clinical trial results.org 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.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 peri- procedural MI, side-branch stenting of bifurcation lesions does not appear to be a valid treatment strategy.Given the lack of clinical benefit and the increase in peri- procedural MI, side-branch stenting of bifurcation lesions does not appear to be a valid treatment strategy. 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.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 peri- procedural MI, side-branch stenting of bifurcation lesions does not appear to be a valid treatment strategy.Given the lack of clinical benefit and the increase in peri- procedural MI, side-branch stenting of bifurcation lesions does not appear to be a valid treatment strategy. Presented at ACC 2006