Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From the DUTCH PEERS (TWENTE II) Randomized Trial

Houwelingen, K. Gert van; Lam, Ming Kai; Löwik, Marije M.; Danse, Peter W.; Jessurun, Gillian A.J.; Anthonio, Rutger L.; Sen, Hanim; Linssen, Gerard C.M.; IJzerman, Maarten Joost; Doggen, Carine J.M.; Birgelen, Clemens von

doi:10.1016/j.rec.2016.05.029

Cited by 3 publications

(5 citation statements)

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“…Yet, when interpreting clinical event rates, it is important to consider the study design, completeness of follow‐up, source of the data, years of enrolment, and the respective in‐ and exclusion criteria of the study. Many randomized DES trials excluded patients who were unable to provide informed consent or had a life expectancy of less than 12 months 1,2,7,20‐22 . This applies even to randomized “all‐comer” trials, such as the BIONYX, and it may be most relevant for patients with an acute MI – in particular with STEMI, as these patients present much more often in critical condition than patients with stable or unstable angina.…”

Section: Discussionmentioning

confidence: 99%

“…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%

“…Many randomized DES trials excluded patients who were unable to provide informed consent or had a life expectancy of less than 12 months. 1 , 2 , 7 , 20 , 21 , 22 This applies even to randomized “all‐comer” trials, such as the BIONYX, and it may be most relevant for patients with an acute MI – in particular with STEMI, as these patients present much more often in critical condition than patients with stable or unstable angina. As a consequence, the use of these (more or less unavoidable) exclusion criteria will result in somewhat more favorable event rates in DES trial participants as compared to everyday clinical practice or DES registries in consecutive patients.…”

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%

Section: Discussionmentioning

confidence: 99%

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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“…Secondary endpoints showed no significant between-DES difference, and longitudinal deformation was only seen in a few patients treated with the angiographically more visible Promus Element EES (1.0% vs. 0%, p = 0.002); however, this was not associated with adverse events [48]. Subgroup analyses in patients treated for bifurcation lesions and for MI [49,50], and the trial's 5-year follow-up underlined the favourable findings of these two DES [51].…”

Section: All-comers Trials To Assess New Durable Polymers Desmentioning

confidence: 95%

The 2010s in clinical drug-eluting stent and bioresorbable scaffold research: a Dutch perspective

et al. 2020

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Dutch researchers were among the first to perform clinical studies in bare metal coronary stents, the use of which was initially limited by a high incidence of in-stent restenosis. This problem was greatly solved by the introduction of drug-eluting stents (DES). Nevertheless, enthusiasm about firstgeneration DES was subdued by discussions about a higher risk of very-late stent thrombosis and mortality, which stimulated the development, refinement, and rapid adoption of new DES with more biocompatible durable polymer coatings, biodegradable polymer coatings, or no coating at all. In terms of clinical DES research, the 2010s were characterised by numerous The authors H. Kawashima and P. Zocca contributed equally to the manuscript.

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Seguridad y eficacia de nuevos modelos de stents liberadores de sirolimus con polímero biodegradable en el modelo preclínico

Prado

Pérez-Martínez

Ramón

et al. 2017

Revista Española de Cardiología

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Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From the DUTCH PEERS (TWENTE II) Randomized Trial

Cited by 3 publications

References 45 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

The 2010s in clinical drug-eluting stent and bioresorbable scaffold research: a Dutch perspective

Seguridad y eficacia de nuevos modelos de stents liberadores de sirolimus con polímero biodegradable en el modelo preclínico

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