LONG-DES II Trial Randomized Comparison of the Efficacy of Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent in the Treatment of Long Native Coronary Lesions: Presented at Transcatheter Cardiovascular Therapeutics 2006 Presented by Dr. Seung-Jung Park

LONG-DES II: Background The goal of this trial was to compare the Cypher sirolimus eluting stent and the Taxus paclitaxel eluting stent among patients with long native coronary artery lesions undergoing PCI The LONG-DES I registry study suggested that the sirolimus eluting stents might be better than the paclitaxel eluting stents at reducing angiographic restenosis rates. Long coronary lesions have traditionally been associated with higher rates of restenosis and worse outcomes. Current indications for drug eluting stent use do not extend to lesions greater than 30 mm for the Cypher stent or 28 mm for the Taxus stent. Presented at TCT 2006

LONG-DES II: Study Design 500 patients with angina and documented ischemia; long de novo coronary lesions (>25 mm) with reference vessel diameter > 2.5 mm and planned total stent length ≥ 32 mm Randomized. Factorial. 36% female, mean age 61 years, mean follow-up 9 months Patients randomized to dual anti-platelet therapy of aspirin (200 mg/day) and clopidogrel (300 mg load and 75 mg/day for 6 months) or triple anti-platelet therapy (aspirin, clopidogrel, and cilostazol) Angiographic follow-up at 6 months; Clinical follow-up at 9 months. Sirolimus Eluting Stent n=250 Paclitaxel Eluting Stent n=250 Primary Endpoint: In-segment binary restenosis (>50%) at 6 months Secondary Endpoints: In-segment late loss and restenosis; in-stent late loss restenosis; Death, MI, or target lesion revascularization at 30 days and 9 months; stent thrombosis Presented at TCT 2006

LONG-DES II: Primary Endpoint Binary restenosis at 6 months Binary restenosis, measured in 84% of SES-treated patients and 82% of PES-treated patients, was significantly lower with SES compared with PES (3.3% vs. 14.6%, p<0.001) at 6 month follow-up P<0.001 Binary restenosis (%) Presented at TCT 2006

LONG-DES II: Secondary Endpoints In-stent and In-segment Diameter Stenosis Both in-stent and in-segment diameter stenoses were lower in SES patients compared with PES (in-segment 20.1% vs 31.4%; in-stent 13.0% vs. 26.2%, p<0.001 for each) P<0.001 p<0.001 Diameter stenosis (%) Presented at TCT 2006

LONG-DES II: Secondary Endpoints (cont.) In-segment and In-stent Late loss Late loss was significantly lower in the SES-treated patients in both in-segment (0.24 mm vs 0.61 mm, p<0.001) and in-stent (0.09 mm vs 0.45 mm, p<0.001) P<0.001 P<0.001 In-stent and In-segment late loss (mm) Presented at TCT 2006

LONG-DES II: Secondary Endpoints (cont.) Rates of major adverse cardiac events of death, MI, or TVR by 9 months trended lower with SES compared with PES (12.0% vs 17.2%, p=0.10) Target vessel revascularization was lower with SES compared with PES (3.2% vs 7.6%, p=0.030) One patient had a stent thrombosis within 30 days with SES One SES patient had a fatal stent thrombosis at 3 months

LONG-DES II: Limitations Although the angiographic results of this study favor the sirolimus eluting stent, the issue of long-term safety is not addressed. The issue of long-term safety may not be fully addressed by the LONG-DES II study since the current investigational plan is only to follow patients for two years. Presented at TCT 2006

LONG-DES II: Conclusions Among patients undergoing PCI for long lesions (>25 mm), sirolimus-eluting stents were associated with reductions in binary restenosis compared with the paclitaxel eluting stents at 6 month follow-up. Late loss was also significantly lower in the SES-treated patients both in-segment and in-stent. At nine months, rates of death and MI were not significantly different between the two groups. There was no in-stent thrombosis in the PES group and two occurred in the SES group. Target lesion revascularization and target vessel revascularization rates were significantly lower in the SES-treated patients. Although the results of the study favor the sirolimus eluting stent for long lesions in terms of binary angiographic restenosis, the study does not address the long-term safety issue of late stent thrombosis Presented at TCT 2006