Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention

Jensen, Lisette Okkels; Thayssen, Per; Hansen, Henrik Steen; Christiansen, Evald Høj; Tilsted, Hans Henrik; Krusell, Lars Romer; Villadsen, Anton Boel; Junker, Anders; Hansen, Knud Nørregaard; Kaltoft, Anne; Mæng, Michael; Pedersen, Knud Erik; Kristensen, Steen Dalby; Bøtker, Hans Erik; Ravkilde, Jan; Sanchez, R.; Aarøe, Jens; Madsen, Morten; Sørensen, Henrik Toft; Thuesen, Leif; Lassen, Jens Flensted

doi:10.1161/circulationaha.111.063644

Cited by 146 publications

(27 citation statements)

References 30 publications

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“…This difference can be explained partly by the procedure-related myocardial infarction, which was not part of the primary end point in the SORT OUT VII trial, and by the slightly higher clinically indicated target lesion revascularization rate in the BIOSCIENCE trial. The SORT OUT VII trial, such as the previous SORT OUT trials, 7,17,25,27 relied on registry-based event detection without study-related angiographic or clinical follow-up. Patient care complied with standard clinical practice (hospital outpatient visit after 1-3 months).…”

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

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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%

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

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113

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“…According to statistical data published by the World Health Organization (WHO) in 2012, the number of the people dying from CVDs is expected to increase from 17 million in 2008 to 25 million in 20301. With the wide application and rapid development of micro-traumatic intervention treatment, the implantation of vascular stents is acknowledged to be one of the most effective approaches for CVDs234.…”

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confidence: 99%

Novel Ti-Ta-Hf-Zr alloys with promising mechanical properties for prospective stent applications

Lin

Ozan

et al. 2016

Sci Rep

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Titanium alloys are receiving increasing research interest for the development of metallic stent materials due to their excellent biocompatibility, corrosion resistance, non-magnetism and radiopacity. In this study, a new series of Ti-Ta-Hf-Zr (TTHZ) alloys including Ti-37Ta-26Hf-13Zr, Ti-40Ta-22Hf-11.7Zr and Ti-45Ta-18.4Hf-10Zr (wt.%) were designed using the d-electron theory combined with electron to atom ratio (e/a) and molybdenum equivalence (Moeq) approaches. The microstructure of the TTHZ alloys were investigated using optical microscopy, XRD, SEM and TEM and the mechanical properties were tested using a Vickers micro-indenter, compression and tensile testing machines. The cytocompatibility of the alloys was assessed using osteoblast-like cells in vitro. The as-cast TTHZ alloys consisted of primarily β and ω nanoparticles and their tensile strength, yield strength, Young’s modulus and elastic admissible strain were measured as being between 1000.7–1172.8 MPa, 1000.7–1132.2 MPa, 71.7–79.1 GPa and 1.32–1.58%, respectively. The compressive yield strength of the as-cast alloys ranged from 1137.0 to 1158.0 MPa. The TTHZ alloys exhibited excellent cytocompatibility as indicated by their high cell viability ratios, which were close to that of CP-Ti. The TTHZ alloys can be anticipated to be promising metallic stent materials by virtue of the unique combination of extraordinarily high elastic admissible strain, high mechanical strength and excellent biocompatibility.

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“…In the BASKET-PROVE (BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination) study, SES and EES showed similar composite endpoints and stent thrombosis rates at 24 months 66. The SORT OUT IV trial showed noninferiority of the EES platform with regards to a composite clinical endpoint of safety (cardiac death, MI, and stent thrombosis) and efficacy, ie, target vessel revascularization (hazard ratio 0.94; 95% CI [0.67–1.31], P =0.71) 67. At 18 months, the EES continued to show noninferiority, with significantly lower rates of stent thrombosis (0.2% versus 0.9%, P =0.02) 67.…”

Section: Stent Evolution In Clinical Trialsmentioning

confidence: 92%

“…The SORT OUT IV trial showed noninferiority of the EES platform with regards to a composite clinical endpoint of safety (cardiac death, MI, and stent thrombosis) and efficacy, ie, target vessel revascularization (hazard ratio 0.94; 95% CI [0.67–1.31], P =0.71) 67. At 18 months, the EES continued to show noninferiority, with significantly lower rates of stent thrombosis (0.2% versus 0.9%, P =0.02) 67. These data suggest that the EES platform has improved safety and efficacy over the first-generation SES.…”

Section: Stent Evolution In Clinical Trialsmentioning

confidence: 99%

Advances in stent technologies and their effect on clinical efficacy and safety

Nikam¹,

Steinberg²,

Steinberg³

2014

MDER

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The introduction of intracoronary stents represented a major advance in interventional cardiology. While bare metal stents set the benchmark for improved safety over angioplasty, intimal hyperplasia and subsequent restenosis were important limitations. First-generation drug-eluting stents demonstrated significant improvements in efficacy, but not necessarily safety, and further technologic developments have focused on optimizing both. Current advances and understanding in stent design continue to improve on these concepts. This review summarizes past and present technology with particular emphasis on the principles underlying the efficacy and safety of drug-eluting stents, and offers a glimpse into the next generations of stents aimed at treating symptomatic coronary artery disease.

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Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention

Cited by 146 publications

References 30 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

Novel Ti-Ta-Hf-Zr alloys with promising mechanical properties for prospective stent applications

Advances in stent technologies and their effect on clinical efficacy and safety

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