Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent

Windecker, Stephan; Haude, Michael; Neumann, Franz Josef; Stangl, Karl; Witzenbichler, Bernhard; Slagboom, Ton; Sabaté, Manel; Goicolea, Javier; Barragan, Paul; Cook, Stéphane; Piot, Christophe; Richardt, Gert; Merkely, Béla; Schneider, Henrik; Bilger, Johannes; Erné, Paul; Waksman, Ron; Zaugg, Serge; Jüni, Peter; Lefèvre, Thierry

doi:10.1161/circinterventions.114.001441

Cited by 181 publications

(113 citation statements)

References 35 publications

(39 reference statements)

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“…The observed rate of TVR (5%) in our study was similar to those observed in other large BP-SES studies like the INSPIRE trial (3.9% of TVR) [20] and COMPARE II trial (3.7% of TVR) [16] at 12-month follow-up. Furthermore, the randomised BIOFLOW II trial confirmed promising results of these initial observational studies and presented non-inferiority of BP-SES as compared to everolimus eluting stents [21]. The rate of primary study endpoint (composite of cardiac death, myocardial infarction, and clinically driven TVR) in our study was in line with the COMPARE II trial, in which it occurred in 4.9% of patients at 12-month follow-up [16].…”

Section: (89%)supporting

confidence: 83%

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

et al. 2016

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A b s t r a c tBackground: Data from clinical trials suggested that biodegradable-polymer-based drug-eluting stents (DES) might improve long-term clinical outcomes. PROLIM (Balton, Warsaw, Poland) DES is based on a stainless steel platform with a closed cell design releasing sirolimus from biodegradable copolymer (lactic and glycolic acid) in eight weeks. Aim:In the present study the safety and the efficacy of a PROLIM stent was assessed in patients with de novo coronary lesions in 12-month clinical follow-up. Methods:It was a single-centre, observational, prospective registry to assess the safety and efficacy of a PROLIM stent implantation in all consecutive patients with de novo coronary artery lesions treated with percutaneous coronary intervention (PCI). The primary study endpoint was a composite safety (cardiac death, non-fatal myocardial infarction), and the second study endpoint was the efficacy of PROLIM implantation-clinically driven target vessel revascularisation (TVR) assessed at 12-month follow-up. Results:One hundred patients were enrolled into the study and 118 PROLIM stents were implanted. Thirty-two (32%) patients had diabetes, 46 (46%) patients were prior PCI, and 17 (17%) patients had coronary artery bypass grafting. 67% of stented lesions were complex ones (B2/C) and 17% were bifurcations. During the 12-month follow-up primary study endpoints occurred in five (5%) patients. Two (2%) cardiac deaths were reported and three (3%) TVRs were performed, of which one was related to in-PROLIM stent restenosis.Conclusions: PCI with biodegradable-polymer PROLIM DES seems to be safe and effective in 12-month follow-up. A larger trial is warranted to assess clinical outcomes post PROLIM stent implantation.

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Section: (89%)supporting

confidence: 83%

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

et al. 2016

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“…The individual components of the primary end point were numerically higher in diabetic patients treated with BP-SES; however, the difference with the DP-EES group did not reach statistical significance: rates of cardiac death were 3.6% in the BP-SES group and 3.1% in the DP-EES group (HR, 1.18; 95% CI, 0.44-3.16; P=0.74); rates of target-vessel myocardial infarction were 4.9% and 2.7% (HR, 1.83; 95% CI, 0.69-4.88; P=0. 23), and rates of clinically indicated TLR were 6.6% in the BP-SES groups versus 4.5% in the DP-EES group (HR, 1.49; 95% CI, 0.68-3.28; P=0.32), respectively. Although the absolute number of definite ST was higher in diabetic patients treated with BP-SES, no significant differences were recorded between the study arms at different time points.…”

Section: Clinical Outcomes According To Stent Typementioning

confidence: 92%

Clinical Outcomes According to Diabetic Status in Patients Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents

Franzone

Pilgrim

Heg

et al. 2015

Circ: Cardiovascular Interventions

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Diabetic patients are at higher risk for adverse events after percutaneous coronary intervention (PCI) compared with patients without diabetes mellitus.1 New-generation drugeluting stents (DES) are recommended for treatment of patients with diabetes mellitus undergoing PCI because of a lower risk of repeat revascularization compared with bare-metal stents and early generation DES.2 Among available DES, the thin strut durable polymer everolimus-eluting stent (DP-EES) has been shown to provide the best safety and efficacy profile in this high-risk group.3 However, diabetes mellitus attenuates the antirestenotic effects of DES and the risk of adverse events after PCI is higher for diabetic patients compared with patients

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“…Slower polymer degradation or thinner stent struts may reduce the inflammatory response and the risk of early 29,30 and progressively thinner strut profiles. 13,31,32 Thin stent struts have been associated with less wall shear and thrombogenicity, 33 which may be an explanation for the lower stent thrombosis rate in the SORT OUT VII despite that thinner stent struts may be more prone to longitudinal compression 34 and to an increased risk of tissue prolapse intensifying thrombogenicity. 35 In head-to-head randomized trials, the biodegradable polymer stents have shown noninferiority to the durable flouropolymer everolimus-eluting stent 13,14 and the first-generation sirolimus-eluting stent 15 within the first year after stent implantation, whereas the biolimus-eluting Nobori stent failed to show noninferiority within 1 year in the SORT OUT V trial.…”

Section: Downloaded From Sirolimus-eluting Vs Biolimus-eluting Biodegmentioning

confidence: 99%

Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention

Jensen

Thayssen

Mæng

et al. 2016

Circ: Cardiovascular Interventions

111

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I n percutaneous coronary interventions, drug-eluting stents (DESs) have reduced the risk of restenosis and repeat revascularization compared with bare-metal stents.1-3 The secondgeneration DESs with thinner stent struts 4,5 have improved safety and efficacy compared with the first-generation DESs [6][7][8] and has been associated with a reduced risk of late stent thrombosis. 6,8,9 The persistence of polymer material on first-and second-generation DESs after completion of drug release has been Background-Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. Methods and Results-The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT)VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, −0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05). Conclusions-The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358.(Circ Cardiovasc Interv. 2016;9:e003610.

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Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent

Cited by 181 publications

References 35 publications

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

Clinical Outcomes According to Diabetic Status in Patients Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents

Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention

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