ArticleCardiovascular diabetology2016
Combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) prospective study. Rationale and design.
Article in Cardiovascular diabetology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02989740 (Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients. COMBINE), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients. COMBINE (OCT-FFR) Prospective Register
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparison of adverse cardiovascular event endpoints between patients with diabetes and patients without diabetes based on coronary artery plaques: a systematic review and meta-analysis.Journal of cardiothoracic surgery · 2024Pooled it
- Long-term outcomes of patients with normal fractional flow reserve and thin-cap fibroatheroma.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023Trial
- Discordance in the diagnostic assessment of vulnerable plaques between radiofrequency intravascular ultrasound versus optical coherence tomography among patients with acute myocardial infarction: insights from the IBIS-4 study.The international journal of cardiovascular imaging · 2021Trial
- Diabetes does not impact the diagnostic performance of contrast-based fractional flow reserve: insights from the CONTRAST study.Cardiovascular diabetology · 2017Trial
- Vessel fractional flow reserve (vFFR) vs. optical coherence tomography in chronic coronary syndromes (VISION-FFR).Clinical research in cardiology : official journal of the German Cardiac Society · 2026Article
- Impact of clinical risk characteristics on the prognostic value of high-risk plaques.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025Observational
- Role of OCT in Assessing Vasa Vasorum in Chronic Coronary Syndrome: Insights from Long-Term Follow-Up.Journal of clinical medicine · 2025Article
- Intracoronary Imaging for Changing Therapeutic Decisions in Patients with Multivascular Coronary Artery Disease.Medicina (Kaunas, Lithuania) · 2024Article
- Vulnerable plaque features and adverse events in patients with diabetes mellitus: a post hoc analysis of the COMBINE OCT-FFR trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Article
- Renal Dysfunction Increases Risk of Adverse Cardiovascular Events in 5-Year Follow-Up Study of Intermediate Coronary Artery Lesions.Medical science monitor : international medical journal of experimental and clinical research · 2024Article
- Medically Treated Nonischemic Thin-Cap Fibroatheroma Lesions Versus Fractional Flow Reserve-Guided Complete Revascularization in Diabetic Patients.Journal of the Society for Cardiovascular Angiography & Interventions · 2024Article
- Role of intravascular ultrasound and optical coherence tomography in intracoronary imaging for coronary artery disease: a systematic review.Journal of geriatric cardiology : JGC · 2024Article
- Current Role of Intracoronary Imaging for Implementing Risk Stratification and Tailoring Culprit Lesion Treatment: A Narrative Review.Journal of clinical medicine · 2023Review
- Multimodality OCT, IVUS and FFR evaluation of coronary intermediate grade lesions in women vs. men.Frontiers in cardiovascular medicine · 2023Article
- Optical coherence tomography in coronary atherosclerosis assessment and intervention.Nature reviews. Cardiology · 2022Review
- Morphometric Assessment for Functional Evaluation of Coronary Stenosis with Optical Coherence Tomography and the Optical Flow Ratio in a Vessel with Single Stenosis.Journal of clinical medicine · 2022Article
- Comparative efficacy and safety of adenosine and regadenoson for assessment of fractional flow reserve: A systematic review and meta-analysis.World journal of cardiology · 2022Article
- Contemporary Management of Stable Coronary Artery Disease.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2022Review
- Risk factor management and OCT characteristics of plaque vulnerability: the Holy Grail of plaque and patient vulnerability.The international journal of cardiovascular imaging · 2022Article
- The Role of Coronary Physiology in Contemporary Percutaneous Coronary Interventions.Current cardiology reviews · 2022Review
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFractional flow reserve (FFR) is a widely used tool for the identification of ischaemia-generating stenoses and to guide decisions on coronary revascularisation. However, the safety of FFR-based decisions in high-risk subsets, such as patients with Diabetes Mellitus (DM) or vulnerable stenoses presenting thin-cap fibro-atheroma (TCFA), is unknown. This study will examine the impact of optical coherence tomography (OCT) plaque morphological assessment and the identification of TCFA, in combination with FFR to better predict clinical outcomes in DM patients.
methodsCOMBINE (OCT-FFR) is a prospective, multi-centre study investigating the natural history of DM patients with ≥1 angiographically intermediate target lesion in three subgroups of patients; patients with FFR negative lesions without TCFA (group A) and patients with FFR negative lesions with TCFA (group B) as detected by OCT and to compare these two groups with each other, as well as to a third group with FFR-positive, PCI-treated intermediate lesions (group C). The study hypothesis is that DM patients with TCFA (group B) have a worse outcome than those without TCFA (group A) and also when compared to those patients with lesions FFR ≤0.80 who underwent complete revascularisation. The primary endpoint is the incidence of target lesion major adverse cardiac events (MACE); a composite of cardiac death, myocardial infarction or rehospitalisation for unstable/progressive angina in group B vs. group A.
conclusionCOMBINE (OCT-FFR) is the first prospective study to examine whether the addition of OCT plaque morphological evaluation to FFR haemodynamic assessment of intermediate lesions in DM patients will better predict MACE and possibly lead to new revascularisation strategies. Trial Registration Netherlands Trial Register: NTR5376.
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