Search

We report the 5-year results of the SYNTAX trial, which compared coronary artery bypass graft surgery (CABG) with percutaneous coronary intervention (PCI) for the treatment of patients with left main coronary disease or three-vessel disease, to confirm findings at 1 and 3 years.The randomised, clinical SYNTAX trial with nested registries took place in 85 centres in the USA and Europe. A cardiac surgeon and interventional cardiologist at each centre assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments. Eligible patients suitable for either treatment were randomly assigned (1:1) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG. Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries. We analysed a composite rate of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT00114972.1800 patients were randomly assigned to CABG (n=897) or PCI (n=903). More patients who were assigned to CABG withdrew consent than did those assigned to PCI (50 vs 11). After 5 years' follow-up, Kaplan-Meier estimates of MACCE were 26·9% in the CABG group and 37·3% in the PCI group (p0·0001). Estimates of myocardial infarction (3·8% in the CABG group vs 9·7% in the PCI group; p0·0001) and repeat revascularisation (13·7%vs 25·9%; p0·0001) were significantly increased with PCI versus CABG. All-cause death (11·4% in the CABG group vs 13·9% in the PCI group; p=0·10) and stroke (3·7%vs 2·4%; p=0·09) were not significantly different between groups. 28·6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32·1% of patients in the PCI group (p=0·43) and 31·0% in the CABG group with left main coronary disease had MACCE versus 36·9% in the PCI group (p=0·12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25·8% of the CABG group vs 36·0% of the PCI group; p=0·008; high score, 26·8%vs 44·0%; p0·0001).CABG should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For patients with less complex disease (low SYNTAX scores) or left main coronary disease (low or intermediate SYNTAX scores), PCI is an acceptable alternative. All patients with complex multivessel coronary artery disease should be reviewed and discussed by both a cardiac surgeon and interventional cardiologist to reach consensus on optimum treatment.Boston Scientific.

Background Percutaneous coronary intervention (PCI) involving drug-eluting stents is increasingly used to treat complex coronary artery disease, although coronary-artery bypass grafting (CABG) has been the treatment of choice historically. Our trial compared PCI and CABG for treating patients with previously untreated three-vessel or left main coronary artery disease (or both). Methods We randomly assigned 1800 patients with three-vessel or left main coronary artery disease to undergo CABG or PCI (in a 1: 1 ratio). For all these patients, the local cardiac surgeon and interventional cardiologist determined that equivalent anatomical revascularization could be achieved with either treatment. A noninferiority comparison of the two groups was performed for the primary end point - a major adverse cardiac or cerebrovascular event (i.e., death from any cause, stroke, myocardial infarction, or repeat revascularization) during the 12-month period after randomization. Patients for whom only one of the two treatment options would be beneficial, because of anatomical features or clinical conditions, were entered into a parallel, nested CABG or PCI registry. Results Most of the preoperative characteristics were similar in the two groups. Rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P = 0.002), in large part because of an increased rate of repeat revascularization (13.5% vs. 5.9%, P

International audience; Background High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease. Methods We did a prospective, multicentre, non-randomised, open-label intervention study of an implantable DBS device (the VANTAGE study) at six specialist DBS centres at universities in six European countries. Patients were judged eligible if they were aged 21–75 years, had been diagnosed with bilateral idiopathic Parkinson's disease with motor symptoms for more than 5 years, had a Hoehn and Yahr score of 2 or greater, and had a Unified Parkinson's disease rating scale part III (UPDRS III) score in the medication-off state of more than 30, which improved by 33% or more after a levodopa challenge. Participants underwent bilateral implantation in the subthalamic nucleus of a multiple-source, constant-current, eight-contact, rechargeable DBS system, and were assessed 12, 26, and 52 weeks after implantation. The primary endpoint was the mean change in UPDRS III scores (assessed by site investigators who were aware of the treatment assignment) from baseline (medication-off state) to 26 weeks after first lead implantation (stimulation-on, medication-off state). This study is registered with ClinicalTrials.gov, number NCT01221948. Findings Of 53 patients enrolled in the study, 40 received a bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis. Improvement was noted in the UPDRS III motor score 6 months after first lead implantation (mean 13·5 [SD 6·8], 95% CI 11·3–15·7) compared with baseline (37·4 [8·9], 34·5–40·2), with a mean difference of 23·8 (SD 10·6; 95% CI 20·3–27·3; p

Aims: The SYNTAX™ score has been designed to better anticipate the risks of percutaneous or surgical revascularisation, taking into account the functional impact of the coronary circulation with all its anatomic components including the presence of bifurcations, total occlusions, thrombus, calcification, and small vessels. The purpose of this paper is to describe the baseline assessment of the SYNTAX™ score in the Syntax randomised trial, the corelab reproducibility, the potential difference in score assessment between the investigator and the corelab, and to ascertain the impact on one-year outcome after either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) in patients with complex coronary artery disease. Methods and results: To assess the reliability of Syntax™ scoring, 100 diagnostic angiograms from the Syntax trial were randomly selected and assessed independently by two observers. Intra-observer variability was assessed by analysing 91 sets of angiograms after an interval of at least eight weeks by one of the observers. Clinical outcomes in the randomised cohort of the Syntax trial up to one year are presented with stratification by tertile group of the SYNTAX™ score. The weighted kappa value for the inter-observer reproducibility on the global score was 0.45, while the intra-observer weighted kappa value was 0.59. The SYNTAX™ score as calculated by investigators consistently underscored the corelab score by 3.4 points. When the Syntax randomised cohort was stratified by tertiles of the SYNTAX™ score, there were similar or nonsignificantly different MACCE rates in those with low or intermediate scores; however in the top tertile the MACCE rate was greater in those receiving PCI compared to CABG. Conclusions: The SYNTAX™ score is a visual coronary score with an acceptable corelab reproducibility that has an impact on the one-year outcome of those having PCI, whereas it has no effect on the one-year outcome following surgical revascularisation. The SYNTAX™ score tool is likely to be useful in a wide range of patients with complex coronary disease.