Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy

Abstract

Aims: Lesion length remains a predictor of target lesion revascularisation and results of long lesion stenting remain poor. Sirolimus-eluting stents have been shown to perform better than paclitaxel eluting stents in long lesions. In this substudy of the LEADERS trial, we compared the performance of biolimus biodegradable polymer (BES) and sirolimus permanent polymer stents (SES) in long lesions. Methods and results: A total of 1,707 'all-comer' patients were randomly allocated to treatment with BES and SES. A stratified analysis of angiographic and clinical outcomes at nine months and one year, respectively was performed for vessels with lesion length <20 mm versus >20 mm (as measured by quantitative angiography). Of 1,707 patients, 592 BES patients with 831 lesions and 619 SES patients with 876 lesions had only short lesions treated. One hundred and fifty-three BES patients with 166 lesions and 151 SES patients with 162 lesions had long lesions. There were no significant differences in baseline clinical characteristics, except for higher number of patients with long lesions presenting with acute myocardial infarction in both stent groups. Long lesions tended to have lower MLD and greater percent diameter stenosis at baseline than short lesions. Late loss was greater for long lesions than short lesions. There was no statistically significant difference in late loss between BES and SES stents (0.32±0.69 vs 0.24±0.57, p=0.59). Binary in-segment restenosis was present in 23.2% versus 13.1% of long lesions treated with BES and SES, respectively (p=0.042). In patients with long lesions, the overall MACE rate was similar for BES and SES (17% vs 14.6%; p=0.62). There was a trend towards higher overall TLR rate with BES (12.4 % vs 6.0%; HR=2.06; p=0.07) and clinically driven TLR (10.5% vs 5.3%: HR 1.94; p=0.13). Rates of definite stent thrombosis were 3.3% in the long lesion group and 1.3-1.7 % in the short lesion group. Conclusions: BES and SES appear similar with respect to MACE in long lesions in this "all-comer" patient population. However, long lesions tended to have a higher rate of binary in-segment restenosis and TLR following BES than SES treatment. KEYWORDS

Two‐year safety and effectiveness of the platinum chromium everolimus‐eluting stent for the treatment of small vessels and longer lesions

“…The 1‐year TLR rate of 3.1% observed with the PtCr‐EES in long lesions in this study is consistent with published rates for contemporary DES in long lesions, including a 1‐year rate of 12.4% with the BioMatrix Flex BES in the LEADERS Study long lesion analysis and 9‐month rates of 2.4% for the sirolimus‐eluting stent (SES) and 7.2% for the PES in the LONG DES II Study . One‐year clinical safety outcomes for the PtCr‐EES in long lesions compare favorably with these two analyses of contemporary DES in long lesions.…”

“…There were no MIs or ARC‐defined definite or probable stent thromboses reported at 1 or 2 years for the PtCR‐EES. One‐year clinical safety outcomes with the BioMatrix Flex BES included 3.3% cardiac death, 9.2% MI, and 3.3% stent thrombosis (definite) Nine‐month clinical safety outcomes with SES and PES included cardiac death 0.4% and 0%, MI 8.8% and 10.8%, and stent thrombosis 0.8% and 0%, respectively . Similar to the PtCr‐EES outcomes in small vessels, the absence of stent thrombosis through 2 years with PtCr‐EES in long lesions was observed despite a decline in use of dual antiplatelet therapy between 1 and 2 years.…”

Percutaneous Coronary Intervention in Diabetic Patients

“…Finally, the biolimus-eluting stent (BES) has been compared to SES in the LEADERS all-comer trial. BES appeared to be non-inferior to SES with regard to the primary endpoint in the subgroup of diabetics [76].…”

The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer

“…This was largely driven by reduction in sub-acute ST and TVR within the first 30 days 18 . Other available analyses indicates similar performance between both stents in the management of patients with bifurcation lesions 19 , lesions in vessels less than 2.75 mm in diameter 20 , and lesions longer than 20 mm 21 . The higher rate of MI noted with BES was largely driven by periprocedural events, as opposed to spontaneous MIs.…”