TY - JOUR
T1 - Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial
AU - Ploumen, Eline Hubertina
AU - Buiten, Rosaly Anne
AU - Zocca, Paolo
AU - Doggen, Carine
AU - Jessurun, Gillian A.J.
AU - Schotborgh, Carl E.
AU - Roguin, Ariel
AU - Danse, Peter W.
AU - Benit, Edouard
AU - Aminian, Adel
AU - Anthonio, Rutger L.
AU - Somi, Samer
AU - Linssen, Gerard C.M.
AU - Hartmann, Marc
AU - Kok, Marlies M.
AU - von Birgelen, Clemens
N1 - Funding Information:
CvB reports that Thoraxcentrum Twente received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. The other authors have no conflicts of interest to declare. In patients with acute myocardial infarction (MI), percutaneous coronary intervention (PCI) with drug-eluting stents (DES) have resulted in higher event rates than seen with other clinical syndromes (i.e., stable and unstable angina).1-3 While the early DES had substantial safety issues,4,5 newer devices have more biocompatible durable polymer coatings.6,7 In addition, the designs of most contemporary DES are further refined and utilize thin or ultrathin stent struts. Yet, it is unclear, whether PCI with such novel DES is still associated with a higher event risk in patients with acute MI. The thin composite-wire-strut durable polymer-coated zotarolimus-eluting Resolute Onyx stent (RO-ZES, Medtronic, Santa Rosa, CA)8 is a recently introduced new-generation DES. The device was assessed in the randomized BIONYX trial, which is the first trial to examine the RO-ZES in all-comers and the first study to report 2-year clinical outcomes.9,10 The trial compares RO-ZES with the ultrathin-strut biodegradable polymer-coated sirolimus-eluting Orsiro stent (O-SES, Biotronik, B?lach, Switzerland), which is the only contemporary DES with proven superiority over another thin-strut new-generation DES in patients with ST-segment elevation MI (STEMI).11 As of now, no outcome data beyond 1?year have been reported for PCI with RO-ZES in the setting of STEMI or non-ST-segment elevation MI (NSTEMI). In this secondary analysis of the BIONYX trial, we examined the 2-year clinical outcome of patients treated for acute MI (i.e., STEMI or NSTEMI) versus all other clinical syndromes (non-MI), and performed a stent-level analysis among the acute MI patients.
Publisher Copyright:
© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
PY - 2021/8
Y1 - 2021/8
N2 - 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; p
log-rank = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, p
log-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%; p
log-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.
AB - 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; p
log-rank = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, p
log-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%; p
log-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.
KW - UT-Hybrid-D
U2 - 10.1002/ccd.29594
DO - 10.1002/ccd.29594
M3 - Article
SN - 1522-1946
VL - 98
SP - E188-E196
JO - Catheterization and cardiovascular interventions
JF - Catheterization and cardiovascular interventions
IS - 2
ER -