Safety and efficacy of biodegradable polymer-coated thin strut sirolimus-eluting stent vs. durable polymer-coated everolimus-eluting stent in patients with acute myocardial infarction

Gierlotka, Marek; Szczurek-Katański, K; Osuch, Marcin; Roleder-Dylewska, Magda; Hawranek, Michał; Gąsior, Paweł; Wojakowski, Wojciech; Poloński, Lech

doi:10.5114/aic.2018.79194

Cited by 4 publications

(6 citation statements)

References 41 publications

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“…There is considerable clinical evidence supporting the use of new‐generation DES in patients with acute MI, including STEMI 20‐22,28‐31 . Yet, up to now, clinical outcome data >1 year after treatment with RO‐ZES in patients with acute MI are scarce.…”

Section: Discussionmentioning

confidence: 99%

“…There is considerable clinical evidence supporting the use of new‐generation DES in patients with acute MI, including STEMI. 20 , 21 , 22 , 28 , 29 , 30 , 31 Yet, up to now, clinical outcome data >1 year after treatment with RO‐ZES in patients with acute MI are scarce. The Korean Acute MI Registry 32 assessed the short‐term clinical outcome of 1,486 acute MI patients who were treated with either RO‐ZES ( n = 402) or everolimus‐eluting stents ( n = 1,084).…”

Section: Discussionmentioning

confidence: 99%

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Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial

Ploumen

Buiten

Zocca

et al. 2021

Cathet Cardio Intervent

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Objectives To compare 2‐year outcome following treatment with drug‐eluting stents (DES) for acute myocardial infarction (MI) versus non‐MI clinical syndromes. In acute MI patients, a stent‐level comparison was performed, comparing Resolute Onyx versus Orsiro stents. Background In patients presenting with acute MI, higher adverse event rates have been reported. So far, no clinical results >1 year have been published of acute MI patients treated with Resolute Onyx. Methods This post‐hoc analysis of the randomized BIONYX trial(NCT02508714) assessed the main outcome target vessel failure (TVF: cardiac death, target vessel MI, or target vessel revascularization) with Kaplan–Meier methods. Results Of all 2,488 trial participants, acute MI patients (n = 1,275[51.2%]) were significantly younger and had less comorbidities than non‐MI patients (n = 1,213[48.8%]). TVF rates were lower in acute MI patients (77/1,275[6.1%] vs. 103/1,213[8.6%], HR:0.70, 95%‐CI 0.52–0.94; plog‐rank = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, plog‐rank = 0.03). Multivariate analysis showed no independent association of clinical syndrome with TVF (adjusted‐HR: 0.81, 95%‐CI 0.60–1.10; p = .17). In MI patients treated with Resolute Onyx (n = 626) versus Orsiro (n = 649), there was no difference in TVF (6.2 vs. 6.1%; plog‐rank = 0.97) and its components. There was only 1(0.2%) definite‐or‐probable stent thrombosis in RO‐ZES and 8(1.2%) in O‐SES (p = .053). Conclusions Two years after treatment with thin‐strut DES in this randomized trial, patients treated for acute MI had lower adverse event rates than non‐MI patients. Yet, these findings were mainly attributable to between‐group differences in patient and lesion characteristics. In patients who underwent PCI for acute MI, both Resolute Onyx and Orsiro showed favorable and similar 2‐year outcomes.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial

Ploumen

Buiten

Zocca

et al. 2021

Cathet Cardio Intervent

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“…The expectation from DES is a decrease in ISR through inhibition of smooth muscle and endothelial proliferation. Although experience described in the coronary literature largely supports such practice, DES I in cardiac procedures have been found to be associated with clot formation in some cases, resulting in thrombosis at the stent site [10, 19]. Recently, second generation DES were introduced with the scope to overcome the limitations of the first generation DES.…”

Section: Discussionmentioning

confidence: 99%

Comparison of drug-eluting and bare metal stents for extracranial vertebral artery stenting

Maciejewski¹,

Pienia̦żek²,

Tekieli³

et al. 2019

pwki

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Introduction: Drug-eluting stents of the first (DES I) and second generation (DES II) proved superior to bare metal stents (BMS) in the coronary territory. However, there are limited data on whether they have any advantage over BMS in vertebral artery stenosis (VAS). Aim: To compare outcomes of DES (DES I, DES II) and BMS in the treatment of symptomatic extracranial VAS. Material and methods: During 13-year study period (2003-2016), 392 consecutive patients underwent VAS angioplasty in 428 arteries, including implantation of 148 DES (DES I: 21; DES II: 127 lesions), and 280 BMS. Results: The technical success rates for DES and BMS groups were 96.7% and 94.6% (p = 0.103), with similar periprocedural complication rates (1.4% vs. 2.2%; p = 0.565). VAS degree was reduced from 86 ±9.7 to 2.7 ±5.0% in DES (p < 0.001) and from 84.1 ±9.4 to 4.3 ±6.9% in BMS (p < 0.001). Angiography confirmed in-stent restenosis/occlusion (ISR/ISO) 50-99% in 53 (14.2%) and 21 (5.6%) out of 373 patients (409 arteries) with at least 6-month follow-up. ISR/ISO rates were similar in DES vs. BMS (22.8% vs. 19.4%; p = 0.635), as well as in DES I vs. DES II (6/19; 31.6% vs. 25/92; 27.2%, p = 0.325). Stainless steel (24/135; 17.8%) and cobalt-chromium (23/121;19%) BMS had significantly lower incidence of ISR/ISO, as compared to platinum-chromium (7/18; 38.9%), p = 0.034. ISR/ISO was associated with age (p = 0.01) and CRP level > 5 mg/l (p = 0.043), while greater stent length was associated with ISR only in the DES group (p = 0.024). Conclusions: Our results do not support significant differences in ISR/ISO rates between DES and BMS, although differences between particular stent types and ISR rates require further investigation.

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“…The BP-SES used in this study is a Conformité Européenne (CE)-approved balloon expandable cobalt-chromium stent with a 71 microns strut thickness covered with a biodegradable copolymer of poly-lactic and glycolic acid together with sirolimus. In a previously published study, BP-SES demonstrated comparable safety and efficacy in all-comers and acute myocardial infarction (MI) patient population when compared to the benchmark balloon-expandable cobalt-chromium DP-EES [15,16]. DP-EES was previously granted the specific indication for DM patients from the Food and Drug Administration of the United States and CE mark from the European Commission.…”

Section: Stent System Descriptionmentioning

confidence: 99%

Biodegradable polymer-coated thin strut sirolimus- -eluting stent versus durable polymer-coated everolimus-eluting stent in the diabetic population

et al. 2021

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Background: The number of patients with diabetes mellitus (DM) presenting with coronary artery disease is increasing and accounts for more than 30% of patients undergoing percutaneous coronary interventions (PCI). The biodegradable polymer drug-eluting stents were developed to improve vascular healing. It was sought herein, to determine 1-year clinical follow-up in patients with DM treated with the thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus durable coating everolimus-eluting stent (DP-EES). Methods: Patients were retrospectively analyzed with DM were treated with either a BP-SES (ALEX™, Balton, Poland, n = 670) or a DP-EES (XIENCE™, Abbott, USA, n = 884) with available 1 year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes. Results: After propensity score matching 527 patients treated with BP-SES and 527 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. In-hospital mortality was 3.23% in BP-SES vs. 2.09% in DP-EES group (p = 0.25). One-year followup demonstrated comparable efficacy outcome TVR (BP-SES 6.64% vs. DP-EES 5.88%; p = 0.611), as well as similar safety outcomes of all-cause death p = 0.158), p = 0.813), and definite/probable stent thrombosis (BP-SES 1.14% vs. DP-EES 0.76%; p = 0.525). Conclusions: The thin-strut biodegradable polymer coated, sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to DP-EES. These data support the relative safety and efficacy of BP-SES in diabetic patients undergoing PCI.

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Safety and efficacy of biodegradable polymer-coated thin strut sirolimus-eluting stent vs. durable polymer-coated everolimus-eluting stent in patients with acute myocardial infarction

Cited by 4 publications

References 41 publications

Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial

Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial

Comparison of drug-eluting and bare metal stents for extracranial vertebral artery stenting

Biodegradable polymer-coated thin strut sirolimus- -eluting stent versus durable polymer-coated everolimus-eluting stent in the diabetic population

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