Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial

Birgelen, Clemens von; Sen, Hanim; Lam, Ming Kai; Danse, Peter W.; Jessurun, Gillian A.J.; Hautvast, Raymond W.M.; Houwelingen, Gert K. van; Schramm, Alexander; Gin, R. Melvyn Tjon Joe; Louwerenburg, J. W.; Man, Frits H.A.F. de; Stoel, Martin G.; Löwik, Marije M.; Linssen, Gerard C.M.; Saïd, Salah A.M.; Nienhuis, Mark B.; Verhorst, Patrick M.J.; Basalus, Mounir W.Z.; Doggen, Catharina Jacoba Maria; Tandjung, Kenneth

doi:10.1016/s0140-6736(13)62037-1

Cited by 172 publications

(133 citation statements)

References 29 publications

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“…The ultrathin strut sirolimus-eluting stent has circumferential polymer coating compared with an abluminal location for the biolimus-eluting stent. 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.…”

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

109

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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

109

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“…7) Our data support findings that even second generation DES cannot eliminate revascularization after PCI in patients with a history of CABG. Although a previous investigation has shown that clinical event rates were similar among second generation DES, 16) differences among the types of second generation DES have been pathologically demonstrated. 17) Our investigation evaluated only patients who underwent EES implantation and confirmed poor outcomes in those with a history of CABG.…”

Section: Nomura Et Almentioning

confidence: 79%

“…Two types of EES were available for use in the study: Xience V TM (Abbott Vascular, Santa Clara, CA, USA; diameters of 2.50, 2.75, 3.00, and 3.50 mm and lengths of 8,12,15,23, and 28 mm) and Promus Element TM (Boston Scientific, Natick, MA, USA; diameters of 2.50, 2.75, 3.00 and 3.50 mm and lengths of 8,12,16,20,24, and 28 mm). When loading of dual antiplatelet drugs was necessary, patients received 300 mg…”

Section: Methodsmentioning

confidence: 99%

Three-Year Clinical and Angiographic Outcomes After Everolimus-Eluting Stent Implantation in Patients With a History of Coronary Artery Bypass Grafting

et al. 2016

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SummaryThe clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stent (EES) implantation in patients with a history of coronary artery bypass grafting (CABG) have yet to be fully investigated. The aim of the present study was to investigate 3-year clinical outcomes after EES implantation in patients with a history of CABG.We retrospectively enrolled 176 consecutive patients who had undergone EES implantation. Three-year clinical follow-up data were obtained from all patients. Follow-up angiograms and serial quantitative coronary angiography analysis (QCA) were performed for 139 (79.0%) patients. Patients from the prior CABG (+) group (n = 17; 9.7%) had higher incidences of target lesion revascularization (TLR; 41.2% versus 3.8%, P < 0.001) and major adverse cardiac events (47.1% versus 15.1%, P = 0.004). A landmark analysis conducted 1 year into our study showed a higher incidence of TLR in the prior CABG (+) group (20.0% versus 3.0%, P = 0.017).The reason for EES implantation in the prior CABG (+) group was saphenous vein graft (SVG) failure in 19 (79.2%) lesions, although the target vessel was the SVG in 8 (33.3%) lesions. There were no significant differences in clinical and follow-up QCA data between the native vessel and SVG PCI groups.This study revealed that a history of CABG was a risk factor for TLR after EES implantation. The major reason for PCI after CABG was SVG failure; both native vessel and SVG PCI showed poor outcomes. Further investigations may be warranted to determine which interventions are most effective in this high-risk subset. (Int Heart J 2016; 57: 158-166)

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“…So, let us look at the non-randomised data we have up to now. Table 1 summarises the data from the most recent trials with a patient population at least 100 patients and with follow-up at least one year [10][11][12][13][14][15][16][17][18][19][20][21][22].…”

Section: What Do the Data Currently Demonstrate About Bifurcationmentioning

confidence: 99%

“…From the second half of the first decade of the 21 st century second-and currently even third-generation DESs were introduced [10][11][12][13][14][15][16][17][18][19][20]. The novel DES systems demonstrated better safety (much lower rate of all types of ST, including very late thrombosis rates below 0.5%) and efficacy (single-digit restenosis rates are a must not, with most currently available DESs less than 5% in one-year follow-up).…”

Section: Introductionmentioning

confidence: 99%

Is it possible to further improve clinical results with coronary bifurcation stenting, or what is more important — the technique or the stent?

2017

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Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial

Cited by 172 publications

References 29 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

Three-Year Clinical and Angiographic Outcomes After Everolimus-Eluting Stent Implantation in Patients With a History of Coronary Artery Bypass Grafting

Is it possible to further improve clinical results with coronary bifurcation stenting, or what is more important — the technique or the stent?

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