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Comparison of MECHANISM of early and late vascular responses following treatment of ST-elevation Acute Myocardial Infarction with two different everolimus-eluting stents: Randomized controlled trial between biodegradable polymer and durable polymer stent (MECHANISM-AMI-RCT)

Comparison of MECHANISM of early and late vascular responses following treatment of ST-elevation Acute Myocardial Infarction with two different everolimus-eluting stents: Randomized controlled trial between biodegradable polymer and durable polymer stent (MECHANISM-AMI-RCT)

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Patients with STEMI (ST-elevation acute myocardial infarction) who have consent for the study, coronary angiography confirming the lesion responsible for AMI (acute myocardial infarction), and who are deemed to require primary PCI with DES (drug-eluting stent) and who will require a cardiac catheterization procedure in 2 weeks (staged PCI in another branch or confirmatory contrast of the treated site).

End of research

1 death (non-cardiac death), 2 cerebrovascular events, 2 hemorrhagic complications, 1 other (ventricular fibrillation) 1 other (ventricular fibrillation), 1 target lesion revascularization (TLR)Target vessel revascularization (TVR): 2, Non-target vessel revascularization (non-TVR): 1

The early and mid-term arterial healing profile of biodegradable polymer-coated everolimus-eluting stents (BP-EES) is unclear, especially in ST-segment elevation myocardial infarction (STEMI) culprit lesions. This study aimed to compare early- and mid-term arterial healing between durable polymer-coated everolimus-eluting stents (DP-EES) and BP-EES in STEMI patients. In a prospective, multicenter, non-inferiority trial, STEMI patients were randomized to receive BP-EES (n=60) or DP-EES (n=60). The primary endpoint of this study was the mean percentage of covered struts (%covered struts) on FD-OCT at 2 weeks. Key secondary endpoints included the percentage of uncovered struts, frequency of abnormal intra-stent tissue, and percentage of malapposed struts by FD-OCT at 2 weeks and at 12 months. They underwent serial FD-OCT evaluations immediately after percutaneous coronary intervention, and at 2 weeks and at 12 months after the procedure. The primary endpoint of %covered struts at 2 weeks was 71.4% in BP-EES and 72.3% in DP-EES (risk difference 0.94%, lower limit of one-sided 95% confidence interval (CI) 5.6; Pnon-inferiority = 0.0756). At 12 months, the mean percentage of uncovered struts was significantly lower (1.73% (95%CI: 0.28-3.17) vs. 4.81% (95% CI: 3.52-6.09); p=0.002)), and the average malapposed volume was significantly smaller in the BP-EES group than in the DP-EES group (p=0.002). At 12 months, BP-EES had a significantly larger average neointimal area with a significantly smaller average intra-stent tissue unevenness score than DP-EES, suggesting more uniform neointimal coverage with BP-EES. Strut coverage was comparable between BP-EES and DP-EES at 2 weeks. Non-inferiority could not be proven because of an insufficient sample size. The significantly better arterial healing with BP-EES at 12 months suggests a safer profile for STEMI culprit lesions.

Detailed FD-OCT analysis showed comparable strut coverage rates between BP-EES and DP-EES and failed to demonstrate the non-inferiority of BP-EES to DP-EES regarding %covered struts at 2 weeks. Differences in malapposed struts, tissue protrusion, and evaginations between the groups post-PCI and at 2 weeks are potentially related to stent design. Twelve-month follow-up FD-OCT analysis showed significantly better arterial healing in lesions treated with BP-EES, suggesting that it has a safer stent profile.

July. 22, 2022

July. 22, 2022

https://link.springer.com/article/10.1007/s12928-022-00879-7

No

No Plans

https://jrct.niph.go.jp/latest-detail/jRCTs022180024

MORINO YOSHIHIRO

Iwate Medical University Hospital

2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture

ymorino@iwate-med.ac.jp

Omiya Kanako

Iwate Medical University Hospital

2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture

+81-19-613-7111

komiya@iwate-med.ac.jp

Complete

Nov. 08, 2018

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1)Patients with ST-elevation acute myocardial infarction
2)Patients with existence of coronary culprit lesions that should be treated with drug-eluting stents
3)Patients with planned cardiac catheterization procedure after 2 weeks

1)Hemodynamically shock
2)Culprit lesion of left main coronary artery
3)Chronic renal failure with serum creatinine levels = or > 2.0mg/dl(including hemodialysis)
4)Cancer patients with life prognosis shorter than 2 years or scheduled surgery within 3 months

Both

ST elevation acute myocardial infarction (STEMI)

revascularization of culprit lesions of ST-elevation myocardial infarction with either bioabsorbable polymer-based everolimus-eluting stent or durable polymer-based everolimus-eluting stent (1:1 randomization)

Strut coverage rate evaluated by optical coherence tomography 2 weeks after stent implantation

Evaluation by optical coherence tomography at post-procedure, 2 weeks, 1 year
1) strut coverage rate
2) maximum area of in-stent thrombus
3) mal-apposition rates of struts
4) minimal limen area

+81-19-651-5111

Mar. 07, 2019

none