Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study

Hamon, Martial; Niculescu, Rodica; Deleanu, Dan; Dorobanţu, Maria; Weissman, Neil J.; Waksman, Ron

doi:10.4244/eijv8i9a155

Cited by 81 publications

(37 citation statements)

References 12 publications

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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%

“…suggested as a trigger for a chronic inflammatory response, 10,11 and third-generation coronary DESs [12][13][14][15] with biodegradable polymers have been designed to overcome concerns over the delayed arterial healing, which might increase the risk of late stent thrombosis and restenosis. Third-generation biolimuseluting stent was designed with a biodegradable polymer.…”

Section: Sirolimus-eluting Vs Biolimus-eluting Biodegradable Polymer mentioning

confidence: 99%

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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

113

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

confidence: 99%

Section: Sirolimus-eluting Vs Biolimus-eluting Biodegradable Polymer mentioning

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

113

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“…11 Pharmacokinetic studies attested to adequate drug release and tissue retention in vivo, and experimental studies showed inflammatory scores comparable to bare metal stents during long-term follow-up throughout 6 months. 12 Following results of a firstin-man study comprising 30 patients, 13 the Biotronik-Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects With Single De Novo Coronary Artery Lesions-II (BIOFLOW-II) trial was designed to directly compare the angiographic efficacy of the novel biodegradable polymer-based sirolimus-eluting Orsiro stent (O-SES) with the durable polymer-based everolimus-eluting Xience Prime stent (X-EES) platform in a randomized, multicenter, assessor-blind, noninferiority trial. Our primary hypothesis was that O-SES is not inferior to X-EES in terms of the primary end point LLL at 9 months.…”

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confidence: 99%

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

Windecker

Haude

Neumann

et al. 2015

Circ: Cardiovascular Interventions

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186

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Background-Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. Methods and Results-A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.

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“…Finally, the BIOFLOW-I was a first-in-man study evaluating the efficacy and safety of the Orsiro BP-SES in 30 patients with single de novo native coronary lesions. 26 Angiographic in-stent LLL was 0.05±0.22 mm at 9-month follow-up; at 12 months, the cumulative incidence of device-oriented major adverse cardiovascular events was 10%; no ST was observed. The current study in non-diabetic patients with ACS demonstrated better OCT-detected neointimal strut coverage associated with the Orsiro BP-SES compared with DP-ZES at 3 months.…”

Section: Discussionmentioning

confidence: 99%

Early Neointimal Coverage and Vasodilator Response Following Biodegradable Polymer Sirolimus-Eluting vs. Durable Polymer Zotarolimus-Eluting Stents in Patients With Acute Coronary Syndrome

Karjalainen

Varho

Nammas

et al. 2015

Circ J

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360KARJALAINEN PP et al. Circulation JournalOfficial Journal of the Japanese Circulation Society http://www. j-circ.or.jp inflammatory and hypersensitivity reaction leading to incomplete endothelialization following DES implantation. Localized hypersensitivity reaction has been demonstrated in the vessel wall at autopsy, and in thrombus aspirates, from patients with very late ST following first-generation DES. 4,5 Newer generation DES have thinner stent platforms, biodegradable/biocompatible polymers and rapid drug elution compared to first-generation devices. The frequency of uncovered struts was reported lower with biodegradable polymer biolimecent reports suggest a paradigm shift in the occurrence of stent thrombosis (ST) as evidenced by lower event rates in patients treated with newer generation drugeluting stents (DES) compared to bare metal stents (BMS) or first-generation DES. 1 Incomplete neointimal coverage over stent struts has been suggested as a potential substrate for late ST in histopathological studies, 2 as well as in an observational case-control setting using optical coherence tomography (OCT) in vivo. Background: Patients at high bleeding risk would benefit from a shorter dual antiplatelet therapy after PCI. Compared to first-generation devices, the design of newer generation drug-eluting stents may facilitate more rapid anatomical and functional healing of stented vessel based on thinner stent platforms, biodegradable/biocompatible polymers and rapid drug elution.

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Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study

Abstract: The Orsiro drug-eluting stent demonstrated potency with low rates of in-stent neointimal hyperplasia and cardiovascular events but warrants further evaluation in a larger population cohort with longer follow-up time points.

Cited by 81 publications

References 12 publications

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

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

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

Early Neointimal Coverage and Vasodilator Response Following Biodegradable Polymer Sirolimus-Eluting vs. Durable Polymer Zotarolimus-Eluting Stents in Patients With Acute Coronary Syndrome

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