Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of ACS Patients With Multi-Vessel Disease
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|ClinicalTrials.gov Identifier: NCT03138473|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment|
|STEMI - ST Elevation Myocardial Infarction Multi Vessel Coronary Artery Disease NSTEMI - Non-ST Segment Elevation MI ACS - Acute Coronary Syndrome||Diagnostic Test: Residual SYNTAX Score Diagnostic Test: SYNTAX Revascularization Index|
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 (6 months to 1 year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of STEMI or NSTEACS.
|Study Type :||Observational|
|Estimated Enrollment :||108 participants|
|Official Title:||Impact of Residual Syntax Score and Syntax Revascularization Index on Outcomes of Acute Coronary Syndrome Patients With Multi-Vessel Disease|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Acute Coronary Syndrome Patients With Multi-Vessel Disease. The Residual SYNTAX score (rSS) and the SYNTAX Revascularization Index (SRI) will be calculated in this group and its relationship with patient outcomes either in hospital or in 6 months to 1 year follow-up will be evaluated.
Diagnostic Test: Residual 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, glomerular filtration rate (GFR) and left ventricular ejection fraction (LVEF), using the formula age/LVEF +1 point for every 10 ml/min/1.73 m2 reduction of GFR below 60 ml/min/1.73 m2 (1 point for GFR between 59 and 50, 2 points for GFR between 49 and 40 and 3 points for GFR between 39 and 30 ml/min/1.73 m2). The GFR 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 Test: SYNTAX 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.
- In-hospital major adverse cardiac events (MACE) [ Time Frame: 1 Year ]A 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).
- The individual components of the primary end-point [ Time Frame: 1 Year ]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)
- Major Bleeding [ Time Frame: 1 Year ]ACUITY defined major bleeding (Stone et al, 2004)
- Acute kidney injury (AKI) [ Time Frame: 1 Year ]a 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. [ Time Frame: 1 Year ]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),and a composite of these components.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138473
|Contact: Amr A. Othman, MBBChfirstname.lastname@example.org|
|Assiut University Heart Hospital||Recruiting|
|Assiut, Egypt, 71515|
|Contact: Hosam H. El-Araby, MD email@example.com|
|Study Chair:||Salwa R. Dimitry, MD||Department of Cardiology, Assiut University Faculty of Medicine|
|Study Director:||Tarek A. Nagib, MD||Department of Cardiology, Assiut University Faculty of Medicine|
|Study Director:||Khaled M. Elmaghraby, MD||Department of Cardiology, Assiut University Faculty of Medicine|