Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes

Trial details

Who runs it

Assiut University

Trial code

NCT07916701

Record updated

4 November 2026

Original description

Coronary artery disease (CAD) remains the top cause of death worldwide . While guideline-directed medical therapy forms the foundation of CAD treatment , revascularization via percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery is critical for complex cases, such as multivessel disease or acute coronary syndromes (ACS). Post-procedure, patients are classified as having achieved complete revascularization (CR) or incomplete revascularization (ICR). The residual SYNTAX score (rSS) objectively quantifies this leftover stenosis, where higher scores predict worse long-term outcomes .Read full original descriptionShow less

Coronary artery disease (CAD) remains the top cause of death worldwide . While guideline-directed medical therapy forms the foundation of CAD treatment , revascularization via percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery is critical for complex cases, such as multivessel disease or acute coronary syndromes (ACS). Post-procedure, patients are classified as having achieved complete revascularization (CR) or incomplete revascularization (ICR). The residual SYNTAX score (rSS) objectively quantifies this leftover stenosis, where higher scores predict worse long-term outcomes .

Concurrently, inflammation heavily drives ACS pathogenesis, plaque instability, and residual cardiovascular risk . Complete blood count (CBC)-derived inflammatory indices - specifically NLR, PLR, SII, and MLR - offer inexpensive, accessible markers of this systemic inflammatory status .

The Knowledge Gap: Most research evaluates rSS alongside traditional risk factors, ignoring systemic inflammation in a unified prognostic framework. Existing studies on these CBC indices often focus broadly on STEMI or general PCI populations, rather than isolated ICR patients. Furthermore, they rely on single measurements, failing to evaluate the incremental value or dynamic changes (baseline vs. post-procedural) of these indices over rSS alone.

Study Hypotheses: This study hypothesizes that baseline, 24-hour post-PCI, and dynamic changes in NLR, PLR, SII, and MLR are independently associated with major adverse cardiovascular events (MACE) in angiographically documented ICR patients. Ultimately, adding these inflammatory indices to the rSS will significantly improve MACE prognostic discrimination, yielding superior AUC, NRI, and IDI values compared to using rSS alone.

Primary aim: To determine whether the addition of baseline and post-PCI CBC-derived inflammatory indices (NLR and SII) to rSS improves discrimination for MACE compared with rSS alone.

Secondary aims:

1. To determine whether the addition of baseline and post-PCI PLR and MLR to rSS improves discrimination for MACE compared with rSS alone. 2. To assess the correlation between baseline and post-PCI NLR, PLR, SII, MLR and rSS as a continuous variable. 3. To determine whether inflammatory indices are independently associated with MACE after adjustment for demographic, clinical, laboratory, angiographic, and procedural variables. 4. To assess whether changes in NLR, PLR, SII, and MLR from baseline to 24 h post-PCI provide incremental prognostic information beyond static values and rSS.

Patients .

* Patients presenting with STEMI or high risk NSTEMI undergoing Primary PCI and with incomplete revascularization will be included in the study. * Eligible patients will be subjected to the following:

I- History taking and examination 2-After completion of the index PCI, Incomplete revascularization will be defined as the presence of significant residual coronary artery disease, resulting in a rSS >0 . .

3-A baseline CBC will be obtained immediately after admission, before coronary angiography/PCI . second CBC will be obtained (24±2 hours) after PCI, the interval between PCI and 2nd CBC sampling will be recorded The following indices will be calculated: NLR = absolute Neutrophil count\ Absolute Lymphocyte count, PLR = Platelet count\Absolute Lymphocyte count, SII = Platelets count x neutrophils count \ lymphocytes count and MLR = Monocytes count \lymphocytes count.

4-Peak troponin or CK-MB will be recorded after 12-24 hours of onset of symptoms and used as a surrogate measure of infarct size and included as a covariate in the multivariable analysis.

5-Transthoracic echocardiography will be performed by cardiologists blinded to the study within the first 24hr after PCI according to current practice guidelines 5-Patients will be followed for 12 months after the index PCI. 6-The primary endpoint will be the occurrence of major adverse cardiovascular events (MACE) during follow-up in the form of Cardiovascular death due to new ischemic event, Non-fatal myocardial infarction and Unplanned ischemia-driven repeat coronary revascularization.

Secondary end point: Onset of new ischemic events (UA, worsening of chest pain or ischemic induced heart failure)

Inclusion: Age ≥18 years; Patients presenting with STEMI or high risk NSTEMI undergoing primary PCI; Successful PCI of the intended target lesion(s); Evidence of incomplete coronary revascularization after PCI, defined as residual coronary disease resulting in an rSS >0; Availability of adequate pre and post -PCI CBC parameters.

Exclusion: Recent major surgery or major trauma; Active infection or systemic inflammatory disease; Known hematological malignancy or major hematological disorder; Active malignancy; Advanced liver disease with significant hematological abnormalities; End-stage renal disease requiring dialysis; Current treatment known to markedly affect leukocyte or platelet counts, such as chronic systemic corticosteroid therapy or cytotoxic therapy; Severe thrombocytopenia or leukopenia which make CBC-derived indices unreliable.

ClinicalTrials.gov NCT07916701