Target Lesion Failure With Current Drug-Eluting Stents

Taglieri, Nevio; Bruno, Antonio Giulio; Ghetti, Gabriele; Marrozzini, Cinzia; Saia, Francesco; Galiè, Nazzareno; Palmerini, Tullio

doi:10.1016/j.jcin.2020.09.014

Cited by 26 publications

(19 citation statements)

References 34 publications

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“…19 Furthermore, the BIOFLOW-V trial showed consistency in superiority of the O-SES to the durable polymer DESs at 1-and 3-years follow-up with significantly lower TLF, MI, TLR, and late and very late stent thrombosis. 20 A meta-analysis 11 comparing efficacy and safety among newer generation DESs showed no difference in TLF at long-term follow-up (varied from 24 through 60 months in the pooled studies), when comparing the O-SES to the N-BES (0.85 [0.72-1.01]). However, TLF rates for the O-SES were significantly lower within the first year of follow-up compared to the N-BES (0.81 [0.67-0.98]).…”

Section: Discussionmentioning

confidence: 99%

“…A meta-analysis 11 comparing efficacy and safety among newer generation DESs showed no difference in TLF at long-term follow-up (varied from 24 through 60 months in the pooled studies), when comparing the O-SES to the N-BES (0.85 [0.72–1.01]). However, TLF rates for the O-SES were significantly lower within the first year of follow-up compared to the N-BES (0.81 [0.67–0.98]).…”

Section: Discussionmentioning

confidence: 99%

“…According to large metaanalysis, long-term comparisons among recent generation of DESs have revealed conflicting results. 10,11 The SORT OUT VII trial (Scandinavian Organization for Randomized Trials With Clinical Outcome) 12 showed noninferiority of the biodegradable polymer ultrathin strut Orsiro sirolimus-eluting stent (O-SES) as compared to the biodegradable polymer biolimus-eluting Nobori stent (N-BES) in the composite safety and efficacy target lesion failure (TLF) end point at 1-year follow-up and a lower risk of definite stent thrombosis. The follow-up has been extended to 5 years.…”

mentioning

confidence: 99%

“…According to large meta-analysis, long-term comparisons among recent generation of DESs have revealed conflicting results. 10,11…”

mentioning

confidence: 99%

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Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial

Hansen

Jensen

Mæng

et al. 2023

Circ: Cardiovascular Interventions

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Background: Biodegradable polymer drug-eluting stents were developed to improve safety and efficacy outcomes for patients undergoing percutaneous coronary intervention. However, few long-term follow-up efficacy studies are available. The study sought to investigate 5-year results from the SORT OUT VII trial (Scandinavian Organization for Randomized Trials With Clinical Outcome) comparing the biodegradable polymer ultrathin-strut sirolimus-eluting Orsiro stent (O-SES) versus the biodegradable polymer biolimus-eluting Nobori stent (N-BES). Methods: This registry-based, randomized, multicenter, single-blinded, noninferiority trial compared O-SES and N-BES in an all-comer population. The composite primary end point, target lesion failure, consisted of cardiac death, myocardial infarction related to the target lesion, or target lesion revascularization within 1 year. Follow-up was extended to 5 years. Results: Five-year follow-up was completed for 2521 patients (99.8%). Five-year target lesion failure did not differ between O-SES (12.4%) and N-BES (13.1%; rate ratio [RR], 0.94 [95% CI, 0.75–1.18]). Cardiac death (RR, 0.95 [95% CI, 0.67–1.34]), target myocardial infarction (RR, 1.14 [95% CI, 0.76–1.71]), target lesion revascularization (RR, 0.90 [95% CI, 0.67–1.21]), and definite stent thrombosis rates (RR, 0.73 [95% CI, 0.41–1.33]) did not differ significantly between the 2 stents. Within the first year, definite ST was significantly lower for O-SES (0.4%) compared to N-BES (1.2%; RR, 0.33 [95% CI, 0.12–0.92]), but no difference was from 1 through 5 years: O-SES 1.2% and N-BES 0.9% (RR, 1.28 [95% CI, 0.58–2.82]). Conclusions: Five years after treatment with biodegradable polymer stents, target lesion failure did not differ among O-SES and N-BES. Definite stent thrombosis was less often seen within the first year in the O-SES but the difference was not maintained after 5 years. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT01879358.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

“…According to large meta-analysis, long-term comparisons among recent generation of DESs have revealed conflicting results. 10,11…”

mentioning

confidence: 99%

See 2 more Smart Citations

Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial

Hansen

Jensen

Mæng

et al. 2023

Circ: Cardiovascular Interventions

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“…1 The risk of in-stent restenosis (ISR) has been reported in the low single digits. 2 These encouraging results led to an increase in interventional treatment of complex multivessel disease including long and multiple stents. As a result, clinical restenosis rate is often significantly higher than reported in randomized trials (RCT).…”

mentioning

confidence: 99%

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions

Scheller

Kader

Ahmad

et al. 2022

Circ: Cardiovascular Interventions

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Background: Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. Methods: One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Results: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. Conclusions: This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02996318, NCT03242096.

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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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Target Lesion Failure With Current Drug-Eluting Stents

Cited by 26 publications

References 34 publications

Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial

Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions

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

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