Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial

Windecker, Stephan; Serruys, Patrick W.; Wandel, Simon; Buszman, Paweł; Trznadel, Stanisław; Linke, Axel; Lenk, Karsten; Ischinger, Thomas; Klauß, Volker; Eberli, Franz R.; Corti, Roberto; Wijns, William; Morice, Marie‐Claude; Mario, Carlo Di; Davies, Simon; Geuns, Robert Jan van; Eerdmans, Pedro; Es, Gerrit Anne van; Meier, B; Jüni, Peter

doi:10.1016/s0140-6736(08)61244-1

Cited by 606 publications

(373 citation statements)

References 27 publications

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“…Rates of definite or probable stent thrombosis in this study were high, although they are similar to those reported in some "all-comer" trials of drug-eluting stents [19][20][21] as well as in trials of triple therapy 9 or in trials involving patients who were considered to be uncertain candidates for drug-eluting stents. 22 The rate of stent thrombosis did not differ significantly between the two groups, and more than half the stent thromboses in both groups occurred during the first 30 days, when patients were prescribed dual antiplatelet therapy.…”

Section: Discussionsupporting

confidence: 86%

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

et al. 2015

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BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS: We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the baremetal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001). CONCLUSIONS: Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).

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Section: Discussionsupporting

confidence: 86%

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

et al. 2015

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“…The Yukon PC Choice stent comprised a pre-mounted, sandblasted microporous 316L stainless steel stent coated with sirolimus and a polylactate polymer which fully degraded within nine weeks; the BioMatrix Flex stent is a stainless steel stent with an abluminal coating of biolimus and a polylactate polymer degrading fully within six months. Detailed descriptions of the design of the three trials are reported in the primary publications [9][10][11] . A summary of the principal trial characteristics was reported previously 12 .…”

Section: Patient Population and Device Descriptionmentioning

confidence: 99%

Long-term outcomes of biodegradable versus durable polymer drug-eluting stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of individual patient data from three randomised trials

Waha¹,

King²,

Byrne³

et al. 2015

EuroIntervention

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Aims: Arterial plaque rupture and thrombus characterise ST-elevation myocardial infarction (STEMI) and may aggravate delayed arterial healing following durable polymer drug-eluting stent (DP-DES) implantation. Biodegradable polymer (BP) may improve biocompatibility. We compared long-term outcomes in STEMI patients receiving BP-DES vs. durable polymer sirolimus-eluting stents (DP-SES).Methods and results: We pooled individual patient-level data from three randomised clinical trials (ISAR-TEST-3, ISAR-TEST-4 and LEADERS) comparing outcomes from BP-DES with DP-SES at four years. The primary endpoint (MACE) comprised cardiac death, MI, or target lesion revascularisation (TLR). Secondary endpoints were TLR, cardiac death or MI, and definite or probable stent thrombosis. Of 497 patients with STEMI, 291 received BP-DES and 206 DP-SES. At four years, MACE was significantly reduced following treatment with BP-DES (hazard ratio [HR] 0.59, 95% CI: 0.39-0.90; p=0.01) driven by reduced TLR (HR 0.54, 95% CI: 0.30-0.98; p=0.04). Trends towards reduction were seen for cardiac death or MI (HR 0.63, 95% CI: 0.37-1.05; p=0.07) and definite or probable stent thrombosis (3.6% vs. 7.1%; HR 0.49, 95% CI: 0.22-1.11; p=0.09). Conclusions:In STEMI, BP-DES demonstrated superior clinical outcomes to DP-SES at four years. Trends towards reduced cardiac death or myocardial infarction and reduced stent thrombosis require corroboration in specifically powered trials.

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“…In the LEADERS multicentre randomised study of biolimus-eluting biodegradable polymer stent (BES) versus sirolimus-eluting permanent polymer stent (SES), we noted that late loss in the overall patient population was similar for BES than SES (0.13 versus 0.19 mm; p=0.34 at 9 months). 9 In the present stratified analysis of lesion length, we investigated the outcome of patients with short and long lesions following treatment with BES and SES. We hypothesised that since late loss and TLR rates were non-inferior for the BES in the overall population in LEADERS, that this stent will also perform equivalently to SES in the long lesion subset.…”

Section: Introductionmentioning

confidence: 99%

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

Wykrzykowska

Räber²,

Vries³

et al. 2009

EuroIntervention

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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

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Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial

Cited by 606 publications

References 27 publications

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

Long-term outcomes of biodegradable versus durable polymer drug-eluting stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of individual patient data from three randomised trials

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

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