Polymer-free biolimus-coated stents versus ultrathin-strut biodegradable polymer sirolimus-eluting stents: two-year outcomes of the randomised SORT OUT IX trial

Ellert-Gregersen, Julia; Jensen, Lisette Okkels; Jakobsen, Lars; Freeman, Phillip; Eftekhari, Ashkan; Mæng, Michael; Raungaard, Bent; Engstroem, Thomas; Kahlert, Johnny; Hansen, Henrik Steen; Christiansen, Evald Høj

doi:10.4244/eij-d-21-00874

Cited by 11 publications

(13 citation statements)

References 29 publications

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“…5 Although limited to 1-year follow-up in the present study, additional long-term follow-up among randomized trials has also demonstrated significantly lower TLR favoring BP SES. 3,[15][16][17] These results are similarly in accord with a broader collection of both observational studies and systematic overviews comparing ultra-thin strut DES and contemporary thin-strut DES. Among 74,131 patients treated with contemporary DES in the SCAAR registry with 2-year follow-up, repeat TLR was significantly lower among those treated with the Orsiro BP SES (N = 4561) compared with alternative DES designs (1.6% vs. 2.3%, p = 0.013).…”

Section: Discussionsupporting

confidence: 81%

“…Further, in the large, randomized BIOSTEMI trial among patients with acute MI, BP SES were superior to DP EES regarding 1‐year TLF, a difference primarily driven by lower TLR 5 . Although limited to 1‐year follow‐up in the present study, additional long‐term follow‐up among randomized trials has also demonstrated significantly lower TLR favoring BP SES 3,15–17 …”

Section: Discussionmentioning

confidence: 51%

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Ultrathin bioresorbable polymer sirolimus‐eluting stents in US patients undergoing coronary revascularization: 1‐Year outcomes from the BIOFLOW VII trial

Kandzari

García‐García

Stoler

et al. 2023

Cathet Cardio Intervent

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BackgroundUltrathin strut coronary drug‐eluting stents (DES) have demonstrated improved safety and efficacy in large contemporary trials. The evaluation of an ultrathin strut DES in a post‐market United States (US) patient population was undertaken.ObjectiveThe purpose of this post‐approval study is to confirm that the clinical performance of an ultrathin strut bioresorbable polymer sirolimus‐eluting stent (BP SES) in clinical practice is similar to that observed with BP SES in the BIOFLOW V pivotal trial.MethodsBIOFLOW VII is a prospective, multicenter, single‐arm US post‐market approval study to confirm the clinical performance of BP SES in a real‐world setting. The primary endpoint of 1‐year target lesion failure (TLF) was compared with a performance goal of 6.9% based on an adapted BIOFLOW V trial BP SES TLF rate and TLF rates from other US market‐released DES utilizing the Society for Cardiovascular Angiography and Interventions definition for peri‐procedural myocardial infarction (MI). Subjects undergoing percutaneous coronary intervention with BP SES were consented within 24 h post‐index procedure with planned follow‐up through 5 years.ResultsAmong 556 enrolled patients, clinical demographics included: 34.7% female, 35.6% with diabetes mellitus, and 56.8% with acute coronary syndromes. The average stent length (mean ± standard deviation) was 20.2 ± 11.8 mm, and the mean number of stents per patient was 1.3 ± 0.6. Procedure success was 99.1% (551/556), and device success was 99.9% (689/690). Among 531 subjects included in the primary endpoint analysis, the 1‐year rate of TLF rate was 1.7% (9/531), and the primary endpoint was met compared with the performance goal (p < 0.0001, 95% confidence interval: 0.69%, 3.43%). Rates of target vessel MI and clinically driven target lesion revascularization were 1.3% (7/531) and 0.9% (5/531), with no occurrence of cardiac death. Definite stent thrombosis was observed for two cases (0.4%; 2/556) with one acute (≤24 h) and one late (>30 days and ≤1 year) event.ConclusionIn a post‐approval study, 1‐year clinical outcomes with BP SES were consistent with prior trials supporting the safety and effectiveness of ultrathin BP SES.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 51%

Ultrathin bioresorbable polymer sirolimus‐eluting stents in US patients undergoing coronary revascularization: 1‐Year outcomes from the BIOFLOW VII trial

Kandzari

García‐García

Stoler

et al. 2023

Cathet Cardio Intervent

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“…TLR risk persisted for an additional two years in the BioFreedom stent group. The risk of TLR was similar between groups in the second year after implant placement, while the risk of medically driven TLR was larger during the first year [ 36 ]. Different DES technologies used by the BioFreedom stent and the other stents tested resulted in a higher TLR rate for the former.…”

Section: Reviewmentioning

confidence: 99%

“…The Orsiro stent is coated in a polymer made of silicon carbide, which breaks down over the course of 12 to 24 months to release the drug gradually over the course of three months. Second, the BioFreedom stent's struts are thicker (120 m) than the Orsiro's (60-80 m), and this is known to affect restenosis risk [ 35 , 36 ].…”

Section: Reviewmentioning

confidence: 99%

“…Participation in another clinical research within 12 months of the index surgery, PCI during the previous six months for a lesion different than the index procedure's target lesion, and a life expectancy of less than two years. Ellert-Gregersen et al (2022) [ 36 ] Multi-RCT PF-BES BP-SES Eighteen years old with chronic stable coronary artery disease or acute coronary syndrome and at least one coronary lesion with >50% diameter stenosis, requiring treatment with a DES. If multiple lesions were treated, the allocated study stent must be used in all lesions.…”

Section: Tablementioning

confidence: 99%

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Clinical Outcomes of Polymer-Free Versus Polymer-Coated Drug-Eluting Stents in Patients With Coronary Artery Disease: A Systematic Review and Meta-Analysis

Khatri¹,

Kumar²,

Mahfooz³

et al. 2023

Cureus

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Drug-eluting stents have transformed the treatment of coronary artery disease (CAD), and there are two types: polymer-free and polymer-coated stents. Polymer-free stents have a coating that is quickly absorbed by the body, whereas polymer-coated stents have a coating that remains on the stent surface. This meta-analysis and systematic review aimed to compare the clinical outcomes of these two stent types in patients with coronary artery disease. The literature and abstracts from significant databases were reviewed to compare polymer-free drug-eluting stents (PF-DES) and polymer-coated drug-eluting stents (PC-DES) for the treatment of coronary artery disease (CAD). The primary efficacy endpoints of the study were all-cause mortality and deaths from cardiovascular and non-cardiovascular causes. Among the secondary outcomes were incidences of myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis, stroke, and major adverse cardiovascular events (MACEs). In terms of the primary outcomes, the combined analysis revealed a marginally lower risk of all-cause mortality (relative risk, RR (95% CI) = 0.92 (0.85, 1.00), p = 0.05, I 2 = 0%) with the use of PF-DES versus PC-DES. Nonetheless, there was no significant difference in cardiovascular mortality (RR (95% CI) = 0.97 (0.87, 1.08)) or non-cardiovascular mortality (RR (95% CI) = 0.87 (0.69, 1.10), p = 0.25, I 2 = 9%) between the groups. Furthermore, univariate meta-regression revealed that male gender and prior myocardial infarction were independently associated with an increased risk of all-cause mortality and cardiovascular disease. According to the current meta-analysis, no statistically significant differences existed in PF-DES and PC-DES outcomes. More extensive research is needed to investigate these findings further and establish their validity.

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Real‐World Clinical Performance of a Novolimus‐Eluting Stent Versus a Sirolimus‐Eluting Stent

Chang,

Sung,

et al. 2024

Clinical Cardiology

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IntroductionThe DESyne novolimus‐eluting coronary stent (NES) is a new‐generation drug‐eluting stent (DES) that is widely used, but clinical data are rarely reported for this stent. We compared the safety and effectiveness of the DESyne NES and the Orsiro bioresorbable polymer sirolimus‐eluting stent (SES) in patients undergoing percutaneous coronary intervention (PCI).MethodsThis was a retrospective, single‐center, observational study. Between July 2017 and December 2022, patients who presented with chronic or acute coronary syndrome undergoing PCI with DESyne NES or Orsiro SES were consecutively enrolled in the present study. The primary endpoint, major adverse cardiovascular event (MACE), was a composite of cardiovascular death, target‐vessel myocardial infarction, or clinically driven target‐lesion revascularization.ResultsA total of 776 patients (age 68.8 ± 12.2; 75.9% male) undergoing PCI were included. Overall, 231 patients with 313 lesions received NES and 545 patients with 846 lesions received SES. During a follow‐up duration of 784 ± 522 days, the primary endpoint occurred in 10 patients (4.3%) in the NES group and in 36 patients (6.6%) in the SES group. After multivariate adjustment, the risk of MACE did not significantly differ between groups (NES vs. SES, hazard ratio 0.74, 95% CI, 0.35–1.55, p = 0.425). The event rate of individual components of the primary endpoint was comparable between the two groups.ConclusionsFavorable and similar clinical outcomes were observed in patients undergoing PCI with either NES or SES in a medium‐term follow‐up duration. Future studies with adequately powered clinical endpoints are required for further evaluation.

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Polymer-free biolimus-coated stents versus ultrathin-strut biodegradable polymer sirolimus-eluting stents: two-year outcomes of the randomised SORT OUT IX trial

Cited by 11 publications

References 29 publications

Ultrathin bioresorbable polymer sirolimus‐eluting stents in US patients undergoing coronary revascularization: 1‐Year outcomes from the BIOFLOW VII trial

Ultrathin bioresorbable polymer sirolimus‐eluting stents in US patients undergoing coronary revascularization: 1‐Year outcomes from the BIOFLOW VII trial

Clinical Outcomes of Polymer-Free Versus Polymer-Coated Drug-Eluting Stents in Patients With Coronary Artery Disease: A Systematic Review and Meta-Analysis

Real‐World Clinical Performance of a Novolimus‐Eluting Stent Versus a Sirolimus‐Eluting Stent

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