OCT Versus Angiography for Culprit Lesion Revascularization in Acute Myocardial Infarction PatiEnts

Condition(s) studied

Investigational drug(s) / intervention(s)

Angiography-guided PCI group: The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 10% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended.

Optical coherence tomography-guided PCI group: \[Stent Optimization\] 1. Stent Expansion: Visually assess residual angiographic diameter stenosis \<10% "AND" ① In non-LM lesions: In-stent minimal lumen area (MSA) \>80% of the average reference lumen area "OR" \>4.5 mm2 ② In LM lesion: MSA\>7 mm2 for distal LM and \>8 mm2 for proximal LM 2. Stent Apposition: No major malapposition (defined as a distance from stent strut to adjacent intima ≥400 um and \< 1mm length) of the stent over its entire length against the vessel wall 3. Edge Dissection: No major edge dissection in the proximal or distal reference segments, defined as 5 mm from the edge of the stent, extended to media layer with potential to provoke flow disturbances (defined as \>60° of the circumference of the vessel at site of dissection and/or \>2 mm in length of dissection flap)

Study summary

The aim of the study is to compare clinical outcomes between optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).

Eligibility

Primary outcome measure(s)

• Target vessel failure — 2 years after last patient enrollment
  a composite of cardiac death, target-vessel myocardial infarction, clinically-driven target-vessel repeat revascularization, definite or probable stent thrombosis

Trial sites (18)

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