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

STEMI - ST Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138473
• Other study ID #: 17100078
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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, 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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University Heart Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (19)

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Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, Jørgensen E, Pedersen F, Saunamäki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aarøe J, Jensen SE, Raungaard B, Køber L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. — View Citation

Farooq V, Serruys PW, Bourantas CV, Zhang Y, Muramatsu T, Feldman T, Holmes DR, Mack M, Morice MC, Ståhle E, Colombo A, de Vries T, Morel MA, Dawkins KD, Kappetein AP, Mohr FW. Quantification of incomplete revascularization and its association with five-year mortality in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial validation of the residual SYNTAX score. Circulation. 2013 Jul 9;128(2):141-51. doi: 10.1161/CIRCULATIONAHA.113.001803. Epub 2013 Jun 13. — View Citation

Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30. Review. — View Citation

Garg S, Sarno G, Garcia-Garcia HM, Girasis C, Wykrzykowska J, Dawkins KD, Serruys PW; ARTS-II Investigators. A new tool for the risk stratification of patients with complex coronary artery disease: the Clinical SYNTAX Score. Circ Cardiovasc Interv. 2010 Aug;3(4):317-26. doi: 10.1161/CIRCINTERVENTIONS.109.914051. Epub 2010 Jul 20. — View Citation

Généreux P, Campos CM, Yadav M, Palmerini T, Caixeta A, Xu K, Francese DP, Dangas GD, Mehran R, Leon MB, Serruys PW, Stone GW. Reasonable incomplete revascularisation after percutaneous coronary intervention: the SYNTAX Revascularisation Index. EuroIntervention. 2015 Oct;11(6):634-42. doi: 10.4244/EIJY14M10_05. — View Citation

Généreux P, Palmerini T, Caixeta A, Rosner G, Green P, Dressler O, Xu K, Parise H, Mehran R, Serruys PW, Stone GW. Quantification and impact of untreated coronary artery disease after percutaneous coronary intervention: the residual SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) score. J Am Coll Cardiol. 2012 Jun 12;59(24):2165-74. doi: 10.1016/j.jacc.2012.03.010. Epub 2012 Apr 4. — View Citation

Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038. — View Citation

Hoebers LP, Vis MM, Claessen BE, van der Schaaf RJ, Kikkert WJ, Baan J Jr, de Winter RJ, Piek JJ, Tijssen JG, Dangas GD, Henriques JP. The impact of multivessel disease with and without a co-existing chronic total occlusion on short- and long-term mortality in ST-elevation myocardial infarction patients with and without cardiogenic shock. Eur J Heart Fail. 2013 Apr;15(4):425-32. doi: 10.1093/eurjhf/hfs182. Epub 2012 Nov 12. — View Citation

Khan R, Al-Hawwas M, Hatem R, Azzalini L, Fortier A, Joliecoeur EM, Tanguay JF, Lavoie-L'Allier P, Ly HQ. Prognostic impact of the residual SYNTAX score on in-hospital outcomes in patients undergoing primary percutaneous coronary intervention. Catheter Cardiovasc Interv. 2016 Nov;88(5):740-747. doi: 10.1002/ccd.26413. Epub 2016 Feb 1. — View Citation

Lee JH, Park HS, Chae SC, Cho Y, Yang DH, Jeong MH, Kim YJ, Kim KS, Hur SH, Seong IW, Hong TJ, Cho MC, Kim CJ, Jun JE, Park WH; Korea Acute Myocardial Infarction Registry Investigators. Predictors of six-month major adverse cardiac events in 30-day survivors after acute myocardial infarction (from the Korea Acute Myocardial Infarction Registry). Am J Cardiol. 2009 Jul 15;104(2):182-9. doi: 10.1016/j.amjcard.2009.03.010. — View Citation

Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. Review. Erratum in: J Am Coll Cardiol. 2016 Mar 29;67(12):1506. — View Citation

Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, van den Brand M, Van Dyck N, Russell ME, Mohr FW, Serruys PW. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005 Aug;1(2):219-27. — View Citation

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Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC), Steg PG, James SK, Atar D, Badano LP, Blömstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. — View Citation

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Wykrzykowska JJ, Garg S, Onuma Y, de Vries T, Goedhart D, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial. Circ Cardiovasc Interv. 2011 Feb 1;4(1):47-56. doi: 10.1161/CIRCINTERVENTIONS.110.958389. Epub 2011 Jan 4. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital major adverse cardiac events (MACE)	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).	2 Years
Secondary	The individual components of the primary end-point	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)	2 Years
Secondary	Major Bleeding	ACUITY defined major bleeding (Stone et al, 2004)	2 Years
Secondary	Acute kidney injury (AKI)	a 25% relative or 0.5mg/dL (44.2µmol/L) absolute increase in presenting serum creatinine after PPCI.	2 Years
Secondary	6 months- 1 year MACE, and its individual components.	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.	2 Years