Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial.

AIMS Long-term randomized comparisons of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in left main coronary (LM) disease and/or three-vessel disease (3VD) patients have been limited. This analysis compares 3-year outcomes in LM and/or 3VD patients treated with CABG or PCI with TAXUS Express stents. METHODS AND RESULTS SYNTAX is an 85-centre randomized clinical trial (n= 1800). Prospectively screened, consecutive LM and/or 3VD patients were randomized if amenable to equivalent revascularization using either technique; if not, they were entered into a registry. Patients in the randomized cohort will continue to be followed for 5 years. At 3 years, major adverse cardiac and cerebrovascular events [MACCE: death, stroke, myocardial infarction (MI), and repeat revascularization; CABG 20.2% vs. PCI 28.0%, P< 0.001], repeat revascularization (10.7 vs. 19.7%, P< 0.001), and MI (3.6 vs. 7.1%, P= 0.002) were elevated in the PCI arm. Rates of the composite safety endpoint (death/stroke/MI 12.0 vs. 14.1%, P= 0.21) and stroke alone (3.4 vs. 2.0%, P= 0.07) were not significantly different between treatment groups. Major adverse cardiac and cerebrovascular event rates were not significantly different between arms in the LM subgroup (22.3 vs. 26.8%, P= 0.20) but were higher with PCI in the 3VD subgroup (18.8 vs. 28.8%, P< 0.001). CONCLUSIONS At 3 years, MACCE was significantly higher in PCI- compared with CABG-treated patients. In patients with less complex disease (low SYNTAX scores for 3VD or low/intermediate terciles for LM patients), PCI is an acceptable revascularization, although longer follow-up is needed to evaluate these two revascularization strategies.

[1]  P. Serruys,et al.  Impact of completeness of revascularization on the five-year outcome in percutaneous coronary intervention and coronary artery bypass graft patients (from the ARTS-II study). , 2010, The American journal of cardiology.

[2]  M. Kutner,et al.  A randomized trial comparing coronary angioplasty with coronary bypass surgery. Emory Angioplasty versus Surgery Trial (EAST) , 1994, The New England journal of medicine.

[3]  P. Serruys,et al.  Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents. , 2010, Journal of the American College of Cardiology.

[4]  Patrick W Serruys,et al.  The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design, rationale, and run-in phase. , 2006, American heart journal.

[5]  Seung‐Jung Park,et al.  Validation of SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score for prediction of outcomes after unprotected left main coronary revascularization. , 2010, JACC: Cardiovascular Interventions.

[6]  F Unger,et al.  Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. , 2001, The New England journal of medicine.

[7]  P. Shah,et al.  Comparison of coronary artery bypass surgery with percutaneous coronary intervention with drug-eluting stents for unprotected left main coronary artery disease. , 2006, Journal of the American College of Cardiology.

[8]  M. Kutner,et al.  A Randomized Trial Comparing Coronary Angioplasty with Coronary Bypass Surgery , 1994 .

[9]  J. Ornato,et al.  2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST‐Elevation Myocardial Infarction (Updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (Updating the 2005 Guideline and 2007 Focused Update) , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[10]  G. Biondi-Zoccai,et al.  Management of multivessel coronary disease after ST-elevation myocardial infarction treated by primary coronary angioplasty. , 2010, American heart journal.

[11]  P. Serruys,et al.  The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. , 2005, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[12]  A. Kiss,et al.  Impact of Patient and Target-Vessel Characteristics on Arterial and Venous Bypass Graft Patency: Insight From a Randomized Trial , 2007, Circulation.

[13]  A. Kaider,et al.  2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study. , 2009, JACC. Cardiovascular interventions.

[14]  Patrick W Serruys,et al.  Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. , 2005, Journal of the American College of Cardiology.

[15]  Antonio Colombo,et al.  Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. , 2009, The New England journal of medicine.

[16]  Patrick W Serruys,et al.  Coronary-artery stents. , 2006, The New England journal of medicine.

[17]  Volkmar Falk,et al.  Guidelines on Myocardial Revascularization the Task Force on Myocardial Revascularization of the European Society of Cardiology (esc) and the European Association for Cardio-thoracic Surgery (eacts) Developed with the Special Contribution of the European Association for Percutaneous Cardiovascular I , 2022 .

[18]  D. Capodanno,et al.  Usefulness of SYNTAX score to select patients with left main coronary artery disease to be treated with coronary artery bypass graft. , 2009, JACC. Cardiovascular interventions.

[19]  Reza Ardehali,et al.  Systematic Review: The Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Graft Surgery , 2007, Annals of Internal Medicine.

[20]  M. Mack,et al.  Complex coronary anatomy in coronary artery bypass graft surgery: impact of complex coronary anatomy in modern bypass surgery? Lessons learned from the SYNTAX trial after two years. , 2011, The Journal of thoracic and cardiovascular surgery.

[21]  A. Natarajan,et al.  Right heart complications of ventriculoatrial shunt. , 2011, European Heart Journal.

[22]  B. Gersh,et al.  Angiographic Versus Functional Severity of Coronary Artery Stenoses in the FAME Study: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation , 2011 .

[23]  F. Eberli,et al.  Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. , 2010, Journal of the American College of Cardiology.

[24]  P. Serruys,et al.  Cyphering the complexity of coronary artery disease using the syntax score to predict clinical outcome in patients with three-vessel lumen obstruction undergoing percutaneous coronary intervention. , 2007, The American journal of cardiology.

[25]  G. Angelini,et al.  Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial. , 2010, Journal of the American College of Cardiology.

[26]  J. Forrester,et al.  Comparison of bypass surgery with drug-eluting stents for diabetic patients with multivessel disease. , 2007, International journal of cardiology.

[27]  G. Stone,et al.  Comparison between the NERS (New Risk Stratification) score and the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score in outcome prediction for unprotected left main stenting. , 2010, JACC. Cardiovascular interventions.

[28]  V. Fuster,et al.  Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial. , 2008, American heart journal.

[29]  P. Teirstein,et al.  Revascularization for unprotected left main disease: evolution of the evidence basis to redefine treatment standards. , 2009, Journal of the American College of Cardiology.

[30]  F. Mohr,et al.  Does Reasonable Incomplete Surgical Revascularization Affect Early or Long-Term Survival in Patients With Multivessel Coronary Artery Disease Receiving Left Internal Mammary Artery Bypass to Left Anterior Descending Artery? , 2009, Circulation.

[31]  L. Mauri,et al.  The conundrum of late and very late stent thrombosis following drug-eluting stent implantation , 2007, Current opinion in cardiology.

[32]  P. Serruys,et al.  Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions , 2007, Circulation.

[33]  M. Mack,et al.  Assessment of the SYNTAX score in the Syntax study. , 2009, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.