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

Charite University, Berlin, Germany84 enrolled

Overview

Intracoronary optical coherence tomography (OCT) imaging allows for high-resolution characterization of coronary lesions. Difficulties in matching cross-sectional OCT-images with angiographic lesion localization, however, may limit its clinical utilization. The investigators sought to prospectively assess the impact of a novel system of real-time OCT-coregistration with angiography (ACR) compared to OCT alone and to the clinical standard proceeding (angiographic guided-PCI) all used for coronary lesion evaluation before percutaneous coronary interventions (PCI). The investigators hypothesize that the use of ACR will lead to less incidence of insufficient covered coronary lesions (geographical mismatch) and/or a less rate of edge dissections after PCI (combined primary study endpoint)

In this randomized blinded pilot-study the effect of pre-PCI planning by angiographic-co-registered OCT (ACR) compared to OCT or angiographic evaluation alone with respect to the entire result after PCI will be investigated. A special focus (primary endpoint) will be on the incidence of geographical mismatch (GM) and/or major edge dissections. Eligible patients will be randomized in three groups. Group 1 Pre-PCI-OCT: Patients underwent OCT-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on OCT findings. Group 2: Pre-PCI-ACR: Patients underwent ACR-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on ACR-findings. Group 3:OCT-Blinded/Angiographic guided PCI: Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators only based on angiographic lesion evaluation (standard care). For outcome analysis all study groups underwent post-PCI-OCT imaging as soon as investigators assume angiographic justiciable PCI-results (TIMI III, no residual stenosis \> 50%; no angiographic definable or suspicious edge dissections, angiographic acceptable stent expansion without evidence for malapposition). OCT imaging analysis will be performed within a OCT core-lab by two investigators blinded for the randomization group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with indication for coronary angiography for angina (stable or unstable), silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive invasive or non-invasive test must be present), or NSTE-ACS * male or non pregnant female patient * Signed written informed consent Exclusion Criteria: * Known neoplasia on treatment / without a curative therapeutic approach * Presence of one or more co-morbidities which reduces life expectancy to less than 24 months * Estimated creatinine clearance \<40 ml/min * Cardiogenic shock * Hemodynamic instability because of arrhythmia * Known left ventricular ejection fraction (LVEF) \<30%. * Therapy requiring psychiatric disorder * Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint. * Women who are pregnant or breastfeeding * Refusal of study participation

Outcomes

Primary Outcomes

Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%]

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: 1. the segment of the lesion is fully covered AND 2. the stent protrudes maximal 5mm beyond the predetermined landing zone. If one of these criteria is not fulfilled, it is considered as geographical mismatch