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Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of ACS Patients With Multi-Vessel Disease

Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of Acute Coronary Syndrome Patients With Multi-Vessel Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03138473
Enrollment
149
Registered
2017-05-03
Start date
2018-07-01
Completion date
2021-06-30
Last updated
2022-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACS - Acute Coronary Syndrome, Multi Vessel Coronary Artery Disease, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction

Keywords

SYNTAX Score, residual SYNTAX score, SYNTAX Revascularization Index

Brief summary

The investigators want to assess the use of the residual SYNTAX score and the SYNTAX Revascularization Index as predictors for in-hospital outcomes and mid-term (6 months to 1 year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of STEMI or NSTEACS. Both values will be calculated in a number of patients over one year, and the relationship between both values and patient outcomes will be evaluated.

Detailed description

Significant non-culprit coronary stenosis is noted in 40-70% of patients with ST-elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). Presence of multivessel disease (MVD) has been associated with poorer clinical outcomes. MVD in STEMI may confer an increased risk of recurrent ischemia and mortality. However, the impact of MVD on prognosis in STEMI may vary depending on the characteristics of coronary artery disease (CAD) present. Current guidelines recommend that only the infarct-related artery should be treated. However, RCTs have suggested that a strategy of multivessel PCI, either at the time of primary PCI or as a planned, staged procedure, may be beneficial and safe in selected patients with STEMI. On the basis of these findings, the prior Class III (Harm) recommendation with regard to multivessel primary PCI in hemodynamically stable patients with STEMI has been upgraded and modified to a Class IIb recommendation to include consideration of multivessel PCI, either at the time of primary PCI or as a planned, staged procedure. Early invasive treatment in high-risk patients with non-ST-elevation acute coronary syndrome (NSTEACS) has been shown to improve their prognosis in terms of cardiovascular death and reinfarction. The prevalence of multivessel disease in these patients stands at about 50% and experts agree that performing complete revascularization is beneficial in such patients. Accordingly, the SYNergy between PCI with TAXus and cardiac surgery (SYNTAX) score has been developed in 2005 in Erasmus Medical Center in the Netherlands to evaluate the severity of coronary artery disease in the settings of left main or MVD. The investigators have observed a growing interest in residual disease burden after PCI. The residual SYNTAX score (rSS), described by Genereux and colleagues is a strong prognostic factor of coronary events and all-cause death in patients who have undergone PCI. This score has subsequently been validated by other groups and been shown to have good prognostic accuracy for adverse ischemic outcomes after PCI. The SYNTAX Revascularisation Index (SRI), which takes into account the severity and extent of baseline CAD (as assessed by the baseline SYNTAX score \[bSS\]) and the residual CAD after PCI (as assessed by the rSS) has been used in determining the proportion of CAD that has been treated, and has been shown to have prognostic utility in PCI for MVD. Here, the investigators want to assess the use of the residual SYNTAX score and the SYNTAX Revascularization Index as predictors for in-hospital outcomes and mid-term (up to two year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of STEMI or NSTEACS.

Interventions

DIAGNOSTIC_TESTResidual SYNTAX Score

The baseline SYNTAX score and the residual SYNTAX score (rSS) are calculated by summing up the individual scores for each lesion with a diameter stenosis ≥50% in vessels with a diameter ≥ 1.5 mm in the angiography obtained before and after the procedure. The SYNTAX algorithm of scoring is fully described elsewhere. The modified Age, Creatinine, and Ejection Fraction (ACEF) score is calculated based on the age, creatinine clearance (CrCl) and left ventricular ejection fraction (LVEF), using the formula age/LVEF +1 point for every 10 ml/min/1.73 m2 reduction of CrCl below 60 ml/min/1.73 m2 (1 point for CrCl between 59 and 50, 2 points for CrCl between 49 and 40 and 3 points for CrCl between 39 and 30 ml/min/1.73 m2). The CrCl is calculated via the Cockroft-Gault equation using age, gender weight and serum creatinine before PCI. The baseline SYNTAX score was then multiplied by the modified ACEF score to obtain the baseline clinical SYNTAX score.

DIAGNOSTIC_TESTSYNTAX Revascularization Index

The SYNTAX Revascularization Index (SRI), representing the proportion of CAD burden treated by PCI, was calculated using the following formula: SRI= (1-\[rSS/bSS\]) ×100.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All ACS (STEMI and NSTEACS) patients undergoing PCI in the setting of MVD.

Exclusion criteria

* Patients receiving fibrinolytic therapy. * Patients with cardiogenic shock * Post-CABG patients * Patients with severe renal impairment

Design outcomes

Primary

MeasureTime frameDescription
In-hospital major adverse cardiac events (MACE)2 YearsA composite of cardiac death (including periprocedural), non-fatal myocardial infarction, congestive heart failure, unplanned revascularization including target vessel revascularization (TVR), target lesion revascularization (TLR) and Coronary artery bypass graft (CABG).

Secondary

MeasureTime frameDescription
The individual components of the primary end-point2 YearsCardiac death (including periprocedural), non-fatal myocardial infarction, congestive heart failure, unplanned revascularization including target vessel revascularization (TVR), target lesion revascularization (TLR) and Coronary artery bypass graft (CABG)
Major Bleeding2 YearsACUITY defined major bleeding (Stone et al, 2004)
Acute kidney injury (AKI)2 Yearsa 25% relative or 0.5mg/dL (44.2µmol/L) absolute increase in presenting serum creatinine after PPCI.
6 months- 1 year MACE, and its individual components.2 YearsCardiac death (including periprocedural), non-fatal myocardial infarction, congestive heart failure, unplanned revascularization including target vessel revascularization (TVR), target lesion revascularization (TLR) and Coronary artery bypass graft (CABG),and a composite of these components.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026