Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study

Analysis of primary endpoint will be assessed by evaluation of proximal and/or distal stent end.

I) Major edge dissection (MED):

Major: ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length

II) Geographical mismatch (GM):

Untreated plaque with a minimal lumen area <4,5mm2 within 5mm of the reference segment.

In the postPCI-OCT analysis it is considered as no geographical mismatch, if:

• the segment of the lesion is fully covered AND
• the stent protrudes maximal 5mm beyond the predetermined landing zone.

If one of these criteria is not fulfilled, it is considered as geographical mismatch

All secondary endpoints of OCT will be assessed by evaluation of proximal and/or distal stent end/segment.

(I) ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length (II) Any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length

see primary endpoint

Defined by the MSA achieved relative to the proximal or distal reference segments.

The stent length is divided into 2 equal segments (proximal and distal), and the MSA is determined in each segment.

• Optimal stent expansion: The MSA of the segment is ≥95% of the related reference lumen area
• Acceptable stent expansion: The MSA of the segment is ≥90% and <95% of the related reference lumen area
• Unacceptable stent expansion: The MSA of the segment is <90% of the related lumen area

see outcome 5

Incompletely apposed stent struts in at least 5 consecutive OCT-frames (defined as stent struts clearly separated from the vessel wall (lumen border/plaque border) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch).

Malapposition will be further classified as:

A) Major: If associated with stent underexpansion (unacceptable stent expansion as defined above) B) Minor: If not associated with significant underexpansion (optimal or acceptable stent expansion as defined above) C) Major and minor

Defined as the distance between target landing zone and actual landing zone of stent location (proximal and distal end). Therefore, the lesion is divided in two equal halves, so that every segment (proximal and distal) can be analyzed for itself.

Minimal lumen area covered by stent.

Gain of Minimal Lumen Diameter (MLD) between prePCI- and postPCI-OCT

Time from reaching the ostium with the guide catheter until pullback of the last one.

Total time required for diagnostic angiography and PCI.

Total amount of contrast used for entire intervention (including OCT-pullbacks)

Addition of each stent length which were used for target lesion

Number of stents which were used for target lesion

Maximal stent diameter used for target lesion

Complications between advancing and pullback of OCT catheter

Defined as: new ACS; stent thrombosis of study culprit lesion; new unplaned coronary angiography; new revascularization (PCI/CABG); apoplex/TIA; pacemaker implantation; anaphylactic shock; contrast-induced nephropathy; bleeding; death

Device-oriented composite endpoint within the target lesion. Defined as cardiovascular death, myocardial infarction OR target-lesion revascularization. This composite endpoint will be checked during a follow up after 1 and 3 months.