CABG vs PCI in Patients With 3-Vessel Disease
CABG vs PCI in Patients With 3-Vessel Disease
The study design, methods as well as mid-term outcomes of the SYNTAX trial have been published previously. Briefly, SYNTAX was a prospective, multinational, randomized, clinical study in which 1800 patients with de novo LM and/or 3VD, in whom clinical equipoise was deemed with revascularization by either treatment, were randomly assigned to undergo PCI with TAXUS Express paclitaxel-eluting stents (Boston Scientific, Natick, MA, USA) or CABG. Patients in whom PCI or CABG was considered the treatment of choice by a multidisciplinary Heart Team were enrolled in a CABG-ineligible PCI registry (n = 198) or PCI-ineligible CABG registry (n = 1077), respectively. A yearly follow-up of all patients was performed by clinic visits or telephone contact up to 5 years.
Randomization was stratified by clinical site, the presence of LM disease, and medically treated diabetes mellitus. A separate analysis of patients with 3VD was pre-specified in the trial protocol, provided non-inferiority was met for the primary endpoint. However, since non-inferiority was not met, the current analysis should be interpreted as 'hypothesis generating'. The trial is registered at ClinicalTrials.gov with number NCT00114972.
The primary endpoint of the SYNTAX trial was the rate of MACCE at 12 months after allocation and is a composite of all-cause death, stroke, MI, and repeat revascularization. Secondary endpoints consisted of (i) a composite safety endpoint of death/stroke/MI, (ii) individual endpoints of all-cause death, cardiac death, stroke, MI, and repeat revascularization, and (iii) symptomatic graft occlusion and stent thrombosis (ST). These events were considered at 1 month post-procedure and yearly post-allocation. Definitions of these events have been reported previously. An independent clinical events committee adjudicated all primary clinical events.
The vessels (diameter ≥1.5 mm and significant stenosis >50%) deemed important to revascularize were determined by the Heart Team prior to randomization. The group of 3VD consists of patients with significant stenosis in vessels supplying all three major epicardial territories in the absence of LM disease, as determined by the site investigators. Incomplete revascularization (IR) was assessed by correlating this pre-operative documentation to the actual revascularization performed during the procedure and was recorded by the investigator.
Continuous variables are expressed as mean ± SD and compared using the Student t-test. Discrete data are presented as frequencies and compared with a χ or Fisher's exact tests, where appropriate. Analyses were performed according to intention to treat. Short-term outcomes were considered to be within 30 days post-procedure and were calculated as binary rates. Long-term event rates were estimated using Kaplan–Meier curves with a statistical comparison made by log-rank test. Patients lost to follow-up or who withdrew consent were non-assessable and were censored at the last available follow-up time, assumed to be event free. A sensitivity analysis was performed in which non-assessable patients were assumed to have had an event.
Subgroup analyses were performed according to SYNTAX score tercile, diabetic status, and IR, with P-values for interaction calculated using χ testing. Multivariable proportional hazard models with a P-value of 0.10 as entry and exit criteria were constructed to identify whether PCI treatment vs. CABG was an independent predictor of MACCE, the composite safety endpoint, and all-cause death during follow-up. Variables included in the model were believed to be clinically relevant, and PCI vs. CABG was forced in each model (see Supplementary material online, Appendix). A two-sided P-value of <0.05 was considered to indicate statistical significance. All statistical analyses were performed using the SPSS software, version 20 (IBM Corporation, Armonk, NY, USA).
Methods
Study Design
The study design, methods as well as mid-term outcomes of the SYNTAX trial have been published previously. Briefly, SYNTAX was a prospective, multinational, randomized, clinical study in which 1800 patients with de novo LM and/or 3VD, in whom clinical equipoise was deemed with revascularization by either treatment, were randomly assigned to undergo PCI with TAXUS Express paclitaxel-eluting stents (Boston Scientific, Natick, MA, USA) or CABG. Patients in whom PCI or CABG was considered the treatment of choice by a multidisciplinary Heart Team were enrolled in a CABG-ineligible PCI registry (n = 198) or PCI-ineligible CABG registry (n = 1077), respectively. A yearly follow-up of all patients was performed by clinic visits or telephone contact up to 5 years.
Randomization was stratified by clinical site, the presence of LM disease, and medically treated diabetes mellitus. A separate analysis of patients with 3VD was pre-specified in the trial protocol, provided non-inferiority was met for the primary endpoint. However, since non-inferiority was not met, the current analysis should be interpreted as 'hypothesis generating'. The trial is registered at ClinicalTrials.gov with number NCT00114972.
Definitions
The primary endpoint of the SYNTAX trial was the rate of MACCE at 12 months after allocation and is a composite of all-cause death, stroke, MI, and repeat revascularization. Secondary endpoints consisted of (i) a composite safety endpoint of death/stroke/MI, (ii) individual endpoints of all-cause death, cardiac death, stroke, MI, and repeat revascularization, and (iii) symptomatic graft occlusion and stent thrombosis (ST). These events were considered at 1 month post-procedure and yearly post-allocation. Definitions of these events have been reported previously. An independent clinical events committee adjudicated all primary clinical events.
The vessels (diameter ≥1.5 mm and significant stenosis >50%) deemed important to revascularize were determined by the Heart Team prior to randomization. The group of 3VD consists of patients with significant stenosis in vessels supplying all three major epicardial territories in the absence of LM disease, as determined by the site investigators. Incomplete revascularization (IR) was assessed by correlating this pre-operative documentation to the actual revascularization performed during the procedure and was recorded by the investigator.
Statistical Methods
Continuous variables are expressed as mean ± SD and compared using the Student t-test. Discrete data are presented as frequencies and compared with a χ or Fisher's exact tests, where appropriate. Analyses were performed according to intention to treat. Short-term outcomes were considered to be within 30 days post-procedure and were calculated as binary rates. Long-term event rates were estimated using Kaplan–Meier curves with a statistical comparison made by log-rank test. Patients lost to follow-up or who withdrew consent were non-assessable and were censored at the last available follow-up time, assumed to be event free. A sensitivity analysis was performed in which non-assessable patients were assumed to have had an event.
Subgroup analyses were performed according to SYNTAX score tercile, diabetic status, and IR, with P-values for interaction calculated using χ testing. Multivariable proportional hazard models with a P-value of 0.10 as entry and exit criteria were constructed to identify whether PCI treatment vs. CABG was an independent predictor of MACCE, the composite safety endpoint, and all-cause death during follow-up. Variables included in the model were believed to be clinically relevant, and PCI vs. CABG was forced in each model (see Supplementary material online, Appendix). A two-sided P-value of <0.05 was considered to indicate statistical significance. All statistical analyses were performed using the SPSS software, version 20 (IBM Corporation, Armonk, NY, USA).
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