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Coronary Artery Disease: HELP
Articles by Elisabeth Ståhle
Based on 16 articles published since 2010
(Why 16 articles?)
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Between 2010 and 2020, Elisabeth Ståhle wrote the following 16 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
1 Article Higher Preoperative Plasma Thrombin Potential in Patients Undergoing Surgery for Aortic Stenosis Compared to Surgery for Stable Coronary Artery Disease. 2018

Dimberg, Axel / Alström, Ulrica / Ståhle, Elisabeth / Christersson, Christina. ·1 Section of Thoracic Surgery, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden. · 2 Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. ·Clin Appl Thromb Hemost · Pubmed #29768939.

ABSTRACT: Aortic stenosis (AS) and coronary artery disease (CAD) influence the coagulation system, potentially affecting hemostasis during cardiac surgery. Our aim was to evaluate 2 preoperative global hemostasis assays, plasma thrombin potential and thromboelastometry, in patients with severe aortic valve stenosis compared to patients with CAD. A secondary aim was to test whether the assays were associated with postoperative bleeding. Calibrated automated thrombogram (CAT) in platelet-poor plasma and rotational thromboelastometry (ROTEM) in whole blood were analyzed in patients scheduled for elective surgery due to severe AS (n = 103) and stable CAD (n = 68). Patients with AS displayed higher plasma thrombin potential, both thrombin peak with median 252 nmol/L (interquartile range 187-319) and endogenous thrombin potential (ETP) with median 1552 nmol/L/min (interquartile range 1340-1838), when compared to patients with CAD where thrombin peak was median 174 nmol/L (interquartile range 147-229) and ETP median 1247 nmol/L/min (interquartile range 1034-1448; both P < .001). Differences persisted after adjustment for age, gender, comorbidity, and antithrombotic treatment. Differences observed in thromboelastometry between the groups did not persist after adjustment for baseline characteristics. Bleeding amount showed no relationship with plasma thrombin potential but weakly to thromboelastometry ( R

2 Article High incidence of atrial fibrillation after coronary surgery. 2016

Thorén, Emma / Hellgren, Laila / Ståhle, Elisabeth. ·Department of Cardiothoracic Surgery, Uppsala University Hospital, Uppsala, Sweden emma.thoren@akademiska.se. · Department of Cardiothoracic Surgery, Uppsala University Hospital, Uppsala, Sweden. ·Interact Cardiovasc Thorac Surg · Pubmed #26598007.

ABSTRACT: OBJECTIVES: Postoperative atrial fibrillation (POAF) affects a third of all patients after coronary artery bypass surgery (CABG), but short-term follow-up of heart rhythm after discharge has been sporadic and shown varied results. The aim of this study was to examine the incidence of post-discharge atrial fibrillation (AF) for 30 days following hospital discharge after CABG. METHODS: A total of 67 patients, 19 (28%) with POAF during the initial hospitalization and 48 (72%) without POAF were included. Patients recorded intermittent electrocardiogram registrations three times daily, and additionally in case of arrhythmia symptoms. Presence of post-discharge AF was compared between the groups. All patients were in sinus rhythm at discharge. RESULTS: Twenty of 67 patients (30%) were diagnosed with post-discharge AF. Overall, 35% of them were entirely asymptomatic. POAF patients had a higher incidence of post-discharge AF (11 of 19, 58%) than non-POAF patients (9 of 48, 19%), with six times the odds of developing post-discharge AF compared with non-POAF patients [odds ratio (OR) 6.0; 95% CI 1.9-19, P = 0.002]. Patients with POAF registered episodes of post-discharge AF earlier during the follow-up period (mean Day 3 after discharge, range 1-9 days) than non-POAF patients (Day 10, range 7-14 days, P < 0.001). CONCLUSIONS: A high incidence of both symptomatic and asymptomatic AF was recorded during 30 days following hospital discharge after CABG. The incidence was highest among patients with POAF, of whom more than half experienced post-discharge AF.

3 Article Prognostic implications of severe coronary calcification in patients undergoing coronary artery bypass surgery: an analysis of the SYNTAX study. 2015

Bourantas, Christos V / Zhang, Yao-Jun / Garg, Scot / Mack, Michael / Dawkins, Keith D / Kappetein, Arie Pieter / Mohr, Friedrich W / Colombo, Antonio / Holmes, David R / Ståhle, Elisabeth / Feldman, Ted / Morice, Marie-Claude / de Vries, Ton / Morel, Marie-Angèle / Serruys, Patrick W. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, the Netherlands. ·Catheter Cardiovasc Interv · Pubmed #24824456.

ABSTRACT: OBJECTIVES: To investigate the prognostic implications of the presence of severe lesion calcification in patients undergoing coronary artery bypass graft (CABG) operation. BACKGROUND: There is robust evidence that lesion calcification is a predictor of worse prognosis in patients undergoing percutaneous coronary intervention; however, there is limited data about the prognostic implication of lesion calcium in patients treated with CABG. METHODS: We retrospectively analyzed data from 1,545 patients who underwent CABG and were recruited in the SYNTAX study and CABG registry. Two experts reviewed the angiographic data and classified patients in two groups: those with severely calcified coronary arteries and those without severe lesion calcification. Clinical outcomes at 5-year follow-up were collected and compared in the two groups. RESULTS: One out of three patients exhibited severe lesion calcification (n = 588). Patients with calcified coronaries had an increased mortality at 5-year follow-up (17.1% vs. 9.9%, P < 0.001) and a higher event rate of death-myocardial infarction (MI) compared with those without (19.4% vs. 13.2%, P = 0.003), but there was no statistical significant difference between the two groups for major adverse cardiovascular events (MACE, 26.8% vs. 21.8%, P = 0.057). In multivariate Cox regression analysis severe lesion calcification was an independent predictor of an increased all-cause mortality (hazard ratio: 1.39, 95% confidence interval: 1.02-1.89; P = 0.037) but it was not an independent predictor of the combined end-points death-MI or MACE. CONCLUSIONS: Severe lesion calcification is associated with an increased mortality in patients undergoing CABG, but it is not an independent predictor of death-MI or MACE. This paradox can be attributed to the fact that CABG allows perfusion of the healthy coronaries bypassing the diseased arteries and thus it minimizes the risk of coronary events due to progressive atherosclerosis.

4 Article Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial. 2014

Head, Stuart J / Davierwala, Piroze M / Serruys, Patrick W / Redwood, Simon R / Colombo, Antonio / Mack, Michael J / Morice, Marie-Claude / Holmes, David R / Feldman, Ted E / Ståhle, Elisabeth / Underwood, Paul / Dawkins, Keith D / Kappetein, A Pieter / Mohr, Friedrich W. ·Erasmus University Medical Center, Rotterdam, The Netherlands. · Herzzentrum Universität Leipzig, Strumpelstrasse 39, Leipzig 4289, Germany. · Guy's and St. Thomas' Hospital, London, UK. · San Raffaele Scientific Institute, Milan, Italy. · Medical City Hospital, Dallas, TX, USA. · Institut Hospitalier Jacques Cartier, Générale de santé, Massy, France. · Maro Clinic Rochester, Rochester, MN, USA. · Evanston Hospital, Evanston, IL, USA. · University Hospital Uppsala, Uppsala, Sweden. · Boston Scientific Corporation, Natick, MA, USA. · Herzzentrum Universität Leipzig, Strumpelstrasse 39, Leipzig 4289, Germany mohrf@medizin.uni-leipzig.de. ·Eur Heart J · Pubmed #24849105.

ABSTRACT: AIMS: Coronary artery bypass grafting (CABG) has been considered the standard of care for patients with three-vessel disease (3VD), but long-term comparative results from randomized trials of CABG vs. percutaneous coronary intervention (PCI) using drug-eluting stents (DES) remain limited. METHODS AND RESULTS: Patients with de novo 3VD or left main disease were randomly assigned to PCI with the paclitaxel-eluting first-generation stent or CABG in the SYNTAX trial. This pre-specified analysis presents the 5-year outcomes of patients with 3VD (n = 1095). The rate of major adverse cardiac and cerebrovascular events (MACCE) was significantly higher in patients with PCI compared with CABG (37.5 vs. 24.2%, respectively; P < 0.001). Percutaneous coronary intervention as opposed to CABG resulted in significantly higher rates of the composite of death/stroke/myocardial infarction (MI) (22.0 vs. 14.0%, respectively; P < 0.001), all-cause death (14.6 vs. 9.2%, respectively; P = 0.006), MI (9.2 vs. 4.0%, respectively; P = 0.001), and repeat revascularization (25.4 vs. 12.6%, respectively; P < 0.001); however, stroke was similar between groups at 5 years (3.0 vs. 3.5%, respectively; P = 0.66). Results were dependent on lesion complexity (P for interaction = 0.12); in patients with a low (0-22) SYNTAX score, PCI vs. CABG resulted in similar rates of MACCE (33.3% vs. 26.8%, respectively; P = 0.21) but significantly more repeat revascularization (25.4% vs. 12.6%, respectively; P = 0.038), while in intermediate (23-32) or high (≥ 33) SYNTAX score terciles, CABG demonstrated clear superiority in terms of MACCE, death, MI, and repeat revascularization. Differences in MACCE between PCI and CABG were larger in diabetics [hazard ratio (HR) = 2.30] than non-diabetics (HR = 1.51), although the P for interaction failed to reach significance for MACCE (P for interaction = 0.095) or any of the other endpoints. CONCLUSION: Five-year results of patients with 3VD treated with CABG or PCI using the first-generation paclitaxel-eluting DES suggest that CABG should remain the standard of care as it resulted in significantly lower rates of death, MI, and repeat revascularization, while stroke rates were similar. For patients with low SYNTAX scores, PCI is an acceptable revascularization strategy, although at a price of significantly higher rates of repeat revascularization. CLINICAL TRIAL REGISTRATION: NCT00114972.

5 Article Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial. 2014

Morice, Marie-Claude / Serruys, Patrick W / Kappetein, A Pieter / Feldman, Ted E / Ståhle, Elisabeth / Colombo, Antonio / Mack, Michael J / Holmes, David R / Choi, James W / Ruzyllo, Witold / Religa, Grzegorz / Huang, Jian / Roy, Kristine / Dawkins, Keith D / Mohr, Friedrich. ·From the Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Générale de santé, Massy, France (M.-C.M.) · Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands (P.W.S., A.P.K.) · Evanston Hospital, Evanston, IL (T.E.F.) · University Hospital Uppsala, Uppsala, Sweden (E.S.) · San Raffaele Scientific Institute, Milan, Italy (A.C.) · Medical City Hospital, Dallas, TX (M.J.M.) · Mayo Clinic, Rochester, MN (D.R.H.) · Baylor Heart and Vascular Hospital, Dallas, TX (J.W.C.) · Institute of Cardiology, Warsaw, Poland (W.R., G.R.) · Boston Scientific Corporation, Natick, MA (J.H., K.R., K.D.D.) · University of Leipzig Heart Center, Leipzig, Germany (F.M.). ·Circulation · Pubmed #24700706.

ABSTRACT: BACKGROUND: Current guidelines recommend coronary artery bypass graft surgery (CABG) when treating significant de novo left main coronary artery (LM) stenosis; however, percutaneous coronary intervention (PCI) has a class IIa indication for unprotected LM disease in selected patients. This analysis compares 5-year clinical outcomes in PCI- and CABG-treated LM patients in the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial, the largest trial in this group to date. METHODS AND RESULTS: The SYNTAX trial randomly assigned 1800 patients with LM or 3-vessel disease to receive either PCI (with TAXUS Express paclitaxel-eluting stents) or CABG. The unprotected LM cohort (N=705) was predefined and powered. Major adverse cardiac and cerebrovascular event rates at 5 years was 36.9% in PCI patients and 31.0% in CABG patients (hazard ratio, 1.23 [95% confidence interval, 0.95-1.59]; P=0.12). Mortality rate was 12.8% and 14.6% in PCI and CABG patients, respectively (hazard ratio, 0.88 [95% confidence interval, 0.58-1.32]; P=0.53). Stroke was significantly increased in the CABG group (PCI 1.5% versus CABG 4.3%; hazard ratio, 0.33 [95% confidence interval, 0.12-0.92]; P=0.03) and repeat revascularization in the PCI arm (26.7% versus 15.5%; hazard ratio, 1.82 [95% confidence interval, 1.28-2.57]; P<0.01). Major adverse cardiac and cerebrovascular events were similar between arms in patients with low/intermediate SYNTAX scores but significantly increased in PCI patients with high scores (≥33). CONCLUSIONS: At 5 years, no difference in overall major adverse cardiac and cerebrovascular events was found between treatment groups. PCI-treated patients had a lower stroke but a higher revascularization rate versus CABG. These results suggest that both treatments are valid options for LM patients. The extent of disease should accounted for when choosing between surgery and PCI, because patients with high SYNTAX scores seem to benefit more from surgery compared with those in the lower tertiles. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00114972.

6 Article Incidence, correlates, and significance of abnormal cardiac enzyme rises in patients treated with surgical or percutaneous based revascularisation: a substudy from the Synergy between Percutaneous Coronary Interventions with Taxus and Cardiac Surgery (SYNTAX) Trial. 2013

Farooq, Vasim / Serruys, Patrick W / Vranckx, Pascal / Bourantas, Christos V / Girasis, Chrysafios / Holmes, David R / Kappetein, Arie Pieter / Mack, Michael / Feldman, Ted / Morice, Marie Claude / Colombo, Antonio / Morel, Marie-angèle / de Vries, Ton / Dawkins, Keith D / Mohr, Friedrich W / James, Stefan / Ståhle, Elisabeth. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. ·Int J Cardiol · Pubmed #23993326.

ABSTRACT: AIMS: The aim of the present investigation was to determine the long-term prognostic association of post-procedural cardiac enzyme elevation within the randomised Synergy between Percutaneous Coronary Intervention (PCI) with TAXUS and Cardiac Surgery (SYNTAX) Trial. METHODS: 1800 patients with unprotected left main or de novo three-vessel coronary artery disease were randomised to undergo coronary artery bypass graft (CABG) surgery or PCI. Per protocol patients underwent post-procedural blood sampling with creatine kinase (CK), and the cardiac specific MB iso-enzyme (CK-MB) only if the preceding CK ratio was ≥ 2 × the upper limit of normal (ULN). An independent chemistry laboratory evaluated all collected blood samples. RESULTS: Post-procedural CK sampling was available in 1629 of 1800 patients (90.5%). As per protocol, CK-MB analyses were undertaken in 474 of 491 patients (96.5%) in the CABG arm, and 53 of 61 patients (86.9%) in the PCI arm. Within the CABG arm, despite the limitations of incomplete data, a post-procedural CK-MB ratio <3/≥3 ULN separated 4-year mortality into low- and high-risk groups (2.3% vs. 9.5%, p=0.03). Additionally, in the CABG arm, a post-procedural CK-MB ratio ≥3 ULN was associated with an increased frequency of a high SYNTAX Score (≥33) tertile (high [≥33] SYNTAX Score: 39.5%, intermediate [23-32] SYNTAX Score 31.0%, low [≤22] SYNTAX Score 29.5%, p=0.02). Within the PCI arm, a post-procedural CK ratio of <2 or ≥2 ULN separated 4-year mortality into low- and high-risk groups (10.8% vs. 23.3%, p=0.001). Notably, there was an early (within 6 months) and late (after 2 years) peak in mortality in patients with a post-PCI CK ratio of ≥2 ULN. Lack of pre-procedural thienopyridine, carotid artery disease, type 1 diabetes, and presence of coronary bifurcations were independent correlates of a CK ratio ≥2 ULN post-PCI. CONCLUSION: Cardiac enzyme elevations post-CABG or post-PCI are associated with an adverse long-term mortality; the causes of which are multifactorial.

7 Article The CABG SYNTAX Score - an angiographic tool to grade the complexity of coronary disease following coronary artery bypass graft surgery: from the SYNTAX Left Main Angiographic (SYNTAX-LE MANS) substudy. 2013

Farooq, Vasim / Girasis, Chrysafios / Magro, Michael / Onuma, Yoshinobu / Morel, Marie Angèle / Heo, Jung Ho / Garcia-Garcia, Hector / Kappetein, Arie Pieter / van den Brand, Marcel / Holmes, David R / Mack, Michael / Feldman, Ted / Colombo, Antonio / Ståhle, Elisabeth / James, Stefan / Carrié, Didier / Fournial, Gerard / van Es, Gerrit-Anne / Dawkins, Keith D / Mohr, Friedrich W / Morice, Marie-Claude / Serruys, Patrick W. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #23537954.

ABSTRACT: AIMS: The SYNTAX Score (SXscore) has established itself as an important prognostic tool in patients undergoing percutaneous coronary intervention (PCI). A limitation of the SXscore is the inability to differentiate outcomes in patients who have undergone prior coronary artery bypass graft (CABG) surgery. The CABG SXscore was devised to address this limitation. METHODS AND RESULTS: In the SYNTAX-LE MANS substudy 115 patients with unprotected left main coronary artery disease (isolated or associated with one, two or three-vessel disease) treated with CABG were prospectively assigned to undergo a 15-month coronary angiogram. An independent core laboratory analysed the baseline SXscore prior to CABG. The 15-month CABG SXscore was calculated by a panel of three interventional cardiologists. The CABG SXscore was calculated by determining the standard SXscore in the "native" coronary vessels ("native SXscore") and deducting points based on the importance of the diseased coronary artery segment (Leaman score) that have a functioning bypass graft anastomosed distally. Points relating to intrinsic coronary disease, such as bifurcation disease or calcification, remain unaltered. The mean 15-month CABG SXscore was significantly lower compared to the mean baseline SXscore (baseline SXscore 31.6, SD 13.1; 15-month CABG SXscore 21.2, SD 11.1; p<0.001). Reproducibility analyses (kappa [k] statistics) indicated a substantial agreement between CABG SXscore measurements (k=0.70; 95% CI [0.50-0.90], p<0.001), with the points deducted to calculate the CABG SXscore the most reproducible measurement (k=0.74; 95% CI [0.53-0.95], p<0.001). Despite the limited power of the study, four-year outcome data (Kaplan-Meier curves) demonstrated a trend towards reduced all-cause death (9.1% vs. 1.8%, p=0.084) and death/CVA/MI (16.4% vs. 7.0%, p=0.126) in the low compared to the high CABG SXscore group. CONCLUSIONS: In this pilot study the calculation of the CABG SXscore appeared feasible, reproducible and may have a long-term prognostic role in patients with complex coronary disease undergoing surgical revascularisation. Validation of this new scoring methodology is required.

8 Article Analysis of stroke occurring in the SYNTAX trial comparing coronary artery bypass surgery and percutaneous coronary intervention in the treatment of complex coronary artery disease. 2013

Mack, Michael J / Head, Stuart J / Holmes, David R / Ståhle, Elisabeth / Feldman, Ted E / Colombo, Antonio / Morice, Marie-Claude / Unger, Felix / Erglis, Andrejs / Stoler, Robert / Dawkins, Keith D / Serruys, Patrick W / Mohr, Friedrich W / Kappetein, A Pieter. ·Division of Cardiothoracic Surgery, Baylor Healthcare System, The Heart Hospital, Plano, Texas 75075, USA. michaema@baylorhealth.edu ·JACC Cardiovasc Interv · Pubmed #23523456.

ABSTRACT: OBJECTIVES: This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial's randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease. BACKGROUND: The SYNTAX trial compared PCI to CABG in patients with de novo 3-vessel and/or left main coronary disease. METHODS: The SYNTAX randomized trial was conducted at 85 U.S. and European sites (n = 1,800). All strokes (up to 4 years) were independently adjudicated by a clinical events committee that included a neurologist. An additional 1,077 (of which 644 were followed for 5 years) and 198 patients were included in the CABG and PCI registries, respectively. RESULTS: In the randomized cohort, 31 CABG and 19 PCI patients experienced 33 and 20 strokes post-randomization at 4-year follow-up, respectively (p = 0.062). Three strokes occurred pre-procedurally but following randomization in CABG-treated patients. After CABG, a large proportion of strokes occurred acutely (0 to 30 days: 9 of 33), whereas in the PCI arm, most strokes occurred >30 days after the procedure (18 of 20). Stroke resulted in death in 3 patients in both the PCI and CABG groups. Of the patients who developed stroke, 68% (21 of 31) in the CABG group had residual deficits at discharge; in the PCI group, 47% (9 of 19) had residual deficits. In a multivariate analysis, treatment with CABG was not significantly associated with increased stroke rates (odds ratio: 1.67, 95% confidence interval: 0.93 to 3.01, p = 0.089). The incidence and outcomes of stroke were similar in the randomized trial and registries. CONCLUSIONS: There is a higher risk of periprocedural stroke in patients undergoing CABG versus PCI; however, the risk converges over the first 4 years of follow-up. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972).

9 Article Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. 2013

Farooq, Vasim / van Klaveren, David / Steyerberg, Ewout W / Meliga, Emanuele / Vergouwe, Yvonne / Chieffo, Alaide / Kappetein, Arie Pieter / Colombo, Antonio / Holmes, David R / Mack, Michael / Feldman, Ted / Morice, Marie-Claude / Ståhle, Elisabeth / Onuma, Yoshinobu / Morel, Marie-angèle / Garcia-Garcia, Hector M / van Es, Gerrit Anne / Dawkins, Keith D / Mohr, Friedrich W / Serruys, Patrick W. ·Thoraxcenter, Erasmus University Medical Center, Rotterdam, Netherlands. ·Lancet · Pubmed #23439103.

ABSTRACT: BACKGROUND: The anatomical SYNTAX score is advocated in European and US guidelines as an instrument to help clinicians decide the optimum revascularisation method in patients with complex coronary artery disease. The absence of an individualised approach and of clinical variables to guide decision making between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) are limitations of the SYNTAX score. SYNTAX score II aimed to overcome these limitations. METHODS: SYNTAX score II was developed by applying a Cox proportional hazards model to results of the randomised all comers SYNTAX trial (n=1800). Baseline features with strong associations to 4-year mortality in either the CABG or the PCI settings (interactions), or in both (predictive accuracy), were added to the anatomical SYNTAX score. Comparisons of 4-year mortality predictions between CABG and PCI were made for each patient. Discriminatory performance was quantified by concordance statistics and internally validated with bootstrap resampling. External validation was done in the multinational all comers DELTA registry (n=2891), a heterogeneous population that included patients with three-vessel disease (26%) or complex coronary artery disease (anatomical SYNTAX score ≥33, 30%) who underwent CABG or PCI. The SYNTAX trial is registered with ClinicalTrials.gov, number NCT00114972. FINDINGS: SYNTAX score II contained eight predictors: anatomical SYNTAX score, age, creatinine clearance, left ventricular ejection fraction (LVEF), presence of unprotected left main coronary artery (ULMCA) disease, peripheral vascular disease, female sex, and chronic obstructive pulmonary disease (COPD). SYNTAX score II significantly predicted a difference in 4-year mortality between patients undergoing CABG and those undergoing PCI (p(interaction) 0·0037). To achieve similar 4-year mortality after CABG or PCI, younger patients, women, and patients with reduced LVEF required lower anatomical SYNTAX scores, whereas older patients, patients with ULMCA disease, and those with COPD, required higher anatomical SYNTAX scores. Presence of diabetes was not important for decision making between CABG and PCI (p(interaction) 0·67). SYNTAX score II discriminated well in all patients who underwent CABG or PCI, with concordance indices for internal (SYNTAX trial) validation of 0·725 and for external (DELTA registry) validation of 0·716, which were substantially higher than for the anatomical SYNTAX score alone (concordance indices of 0·567 and 0·612, respectively). A nomogram was constructed that allowed for an accurate individualised prediction of 4-year mortality in patients proposing to undergo CABG or PCI. INTERPRETATION: Long-term (4-year) mortality in patients with complex coronary artery disease can be well predicted by a combination of anatomical and clinical factors in SYNTAX score II. SYNTAX score II can better guide decision making between CABG and PCI than the original anatomical SYNTAX score. FUNDING: Boston Scientific Corporation.

10 Article Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. 2013

Mohr, Friedrich W / Morice, Marie-Claude / Kappetein, A Pieter / Feldman, Ted E / Ståhle, Elisabeth / Colombo, Antonio / Mack, Michael J / Holmes, David R / Morel, Marie-angèle / Van Dyck, Nic / Houle, Vicki M / Dawkins, Keith D / Serruys, Patrick W. ·Herzzentrum Universität Leipzig, Leipzig, Germany. mohrf@medizin.uni-leipzig.de ·Lancet · Pubmed #23439102.

ABSTRACT: BACKGROUND: 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. METHODS: 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. FINDINGS: 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 (p<0·0001). Estimates of myocardial infarction (3·8% in the CABG group vs 9·7% in the PCI group; p<0·0001) and repeat revascularisation (13·7%vs 25·9%; p<0·0001) 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%; p<0·0001). INTERPRETATION: 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. FUNDING: Boston Scientific.

11 Article The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. 2013

Farooq, Vasim / Serruys, Patrick W / Garcia-Garcia, Hector M / Zhang, Yaojun / Bourantas, Christos V / Holmes, David R / Mack, Michael / Feldman, Ted / Morice, Marie-Claude / Ståhle, Elisabeth / James, Stefan / Colombo, Antonio / Diletti, Roberto / Papafaklis, Michail I / de Vries, Ton / Morel, Marie-Angèle / van Es, Gerrit Anne / Mohr, Friedrich W / Dawkins, Keith D / Kappetein, Arie-Pieter / Sianos, Georgios / Boersma, Eric. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, the Netherlands. ·J Am Coll Cardiol · Pubmed #23265332.

ABSTRACT: OBJECTIVES: The study sought to evaluate the clinical impact of angiographic complete (CR) and incomplete (ICR) revascularization and its association with the presence of total occlusions (TO), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the "all-comers" SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. BACKGROUND: In patients with complex coronary artery disease undergoing PCI or CABG, the long-term prognostic implications of CR versus ICR is unsettled. METHODS: In this post hoc study, consisting of randomized (n = 1,800) and nested PCI (n = 198) and CABG (n = 649) registries, 4-year clinical outcomes were compared in groups, with and without angiographic CR, in the PCI and CABG arms. Clinical outcomes were analyzed with Kaplan-Meier estimates, log-rank comparisons, and Cox regression analyses. Multivariate predictors of ICR were determined. Similar analyses were undertaken in the TO and non-TO treated groups of both study arms. RESULTS: Angiographic CR was achieved in 52.8% of the PCI arm and 66.9% of the CABG arm. Within the PCI and CABG arms, ICR (compared with CR) seemed to be a surrogate marker of a greater burden of anatomical coronary complexity and clinical comorbidity and was associated with significantly higher frequencies of 4-year mortality, all-cause revascularization, stent thrombosis (PCI arm), and major adverse cardiac and cerebrovascular events. The presence of a TO was the strongest independent predictor of ICR after PCI (hazard ratio: 2.70, 95% confidence interval: 1.98 to 3.67, p < 0.001). Eight hundred and forty patients (PCI: 26.3%, CABG: 36.4%, p < 0.001) were identified to have 1,007 TOs, with 68.1% of TOs located in the proximal-mid coronary vasculature. The findings associating ICR (compared with CR) with higher frequencies of 4-year mortality and major adverse cardiac and cerebrovascular events remained consistent in the TO-treated groups in the PCI and CABG arms. CONCLUSIONS: Within the PCI and CABG arms of the all-comers SYNTAX trial, angiographically determined ICR has a detrimental impact on long-term clinical outcomes, including mortality. This effect remained consistent in patients with and without TOs.

12 Article Incidence and multivariable correlates of long-term mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial. 2012

Farooq, Vasim / Serruys, Patrick W / Bourantas, Christos / Vranckx, Pascal / Diletti, Roberto / Garcia Garcia, Hector M / Holmes, David R / Kappetein, Arie-Pieter / Mack, Michael / Feldman, Ted / Morice, Marie Claude / Colombo, Antonio / Morel, Marie-angèle / de Vries, Ton / van Es, Gerrit Anne / Steyerberg, Ewout W / Dawkins, Keith D / Mohr, Friedrich W / James, Stefan / Ståhle, Elisabeth. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, s-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands. ·Eur Heart J · Pubmed #23103663.

ABSTRACT: AIMS: The aim of this investigation was to determine the incidence and multivariable correlates of long-term (4-year) mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention (PCI) with TAXUS Express and Cardiac Surgery (SYNTAX) trial. METHODS AND RESULTS: A total of 1800 patients were randomized to undergo coronary artery bypass graft (CABG) surgery (n = 897) or PCI (n = 903). Prospectively collected baseline and peri- and post-procedural data were used to determine independent correlates of 4-year all-cause death in the CABG and the PCI arms (Cox proportional hazards model). Four-year mortality rates in the CABG and the PCI arms were 9.0% [74 deaths (12 in-hospital)] and 11.8% [104 deaths (16 in-hospital)], respectively (log-rank P-value = 0.063). Censored data comprised 78 patients (8.7%) in the CABG arm, and 24 patients (2.7%) in the PCI arm (log-rank P-value < 0.001). Within the CABG arm, the strongest independent correlates of 4-year mortality were lack of discharge aspirin [hazard ratio (HR) 3.56; 95% CI: 2.04, 6.21; P < 0.001], peripheral vascular disease (PVD) (HR: 2.65; 95% CI: 1.49, 4.72; P = 0.001), chronic obstructive pulmonary disease, age, and serum creatinine. Within the PCI arm, the strongest independent correlate of 4-year mortality was lack of post-procedural anti-platelet therapy (HR: 152.16; 95% CI: 53.57, 432.22; P < 0.001), with 10 reported early (within 45 days) in-hospital deaths secondary to multifactorial causes precluding administration of anti-platelet therapy. Other independent correlates of mortality in the PCI arm included amiodarone therapy on discharge, pre-procedural poor left ventricular ejection fraction, a 'history of gastrointestinal bleeding or peptic ulcer disease', PVD (HR: 2.13; 95% CI: 1.26, 3.60; P = 0.005), age, female gender (HR: 1.60; 95% CI: 1.01, 2.56; P = 0.048), and the SYNTAX score (Per increase in 10 points: HR: 1.25; 95% CI: 1.06, 1.47; P = 0.007). CONCLUSION: Independent correlates of 4-year mortality in the SYNTAX trial were multifactorial. Lack of discharge aspirin and lack of post-procedural anti-platelet therapy were the strongest independent correlates of mortality in the CABG and the PCI arms, respectively. Peripheral vascular disease is a common independent correlate of 4-year mortality and may be a marker of the severity of baseline coronary disease and risk of future native coronary disease (and extra-cardiac disease) progression.

13 Article A global risk approach to identify patients with left main or 3-vessel disease who could safely and efficaciously be treated with percutaneous coronary intervention: the SYNTAX Trial at 3 years. 2012

Serruys, Patrick W / Farooq, Vasim / Vranckx, Pascal / Girasis, Chrysafios / Brugaletta, Salvatore / Garcia-Garcia, Hector M / Holmes, David R / Kappetein, Arie-Pieter / Mack, Michael J / Feldman, Ted / Morice, Marie-Claude / Ståhle, Elisabeth / James, Stefan / Colombo, Antonio / Pereda, Peggy / Huang, Jian / Morel, Marie-Angèle / Van Es, Gerrit-Anne / Dawkins, Keith D / Mohr, Friedrich W / Steyerberg, Ewout W. ·Department of Interventional Cardiology, Erasmus University, Medical Centre, Thoraxcenter, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nl ·JACC Cardiovasc Interv · Pubmed #22721655.

ABSTRACT: OBJECTIVES: The aim of this study was to assess the additional value of the Global Risk--a combination of the SYNTAX Score (SXscore) and additive EuroSCORE--in the identification of a low-risk population, who could safely and efficaciously be treated with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI). BACKGROUND: PCI is increasingly acceptable in appropriately selected patients with left main stem or 3-vessel coronary artery disease. METHODS: Within the SYNTAX Trial (Synergy between PCI with TAXUS and Cardiac Surgery Trial), all-cause death and major adverse cardiac and cerebrovascular events (MACCE) were analyzed at 36 months in low (GRC(LOW)) to high Global Risk groups, with Kaplan-Meier, log-rank, and Cox regression analyses. RESULTS: Within the randomized left main stem population (n = 701), comparisons between GRC(LOW) groups demonstrated a significantly lower mortality with PCI compared with CABG (CABG: 7.5%, PCI: 1.2%, hazard ratio [HR]: 0.16, 95% confidence interval [CI]: 0.03 to 0.70, p = 0.0054) and a trend toward reduced MACCE (CABG: 23.1%, PCI: 15.8%, HR: 0.64, 95% CI: 0.39 to 1.07, p = 0.088). Similar analyses within the randomized 3-vessel disease population (n = 1,088) demonstrated no statistically significant differences in mortality (CABG: 5.2%, PCI: 5.8%, HR: 1.14, 95% CI: 0.57 to 2.30, p = 0.71) or MACCE (CABG: 19.0%, PCI: 24.7%, HR: 1.35, 95% CI: 0.95 to 1.92, p = 0.10). Risk-model performance and reclassification analyses demonstrated that the EuroSCORE-with the added incremental benefit of the SXscore to form the Global Risk-enhanced the risk stratification of all PCI patients. CONCLUSIONS: In comparison with the SXscore, the Global Risk, with a simple treatment algorithm, substantially enhances the identification of low-risk patients who could safely and efficaciously be treated with CABG or PCI.

14 Article Angiographic outcomes following stenting or coronary artery bypass surgery of the left main coronary artery: fifteen-month outcomes from the synergy between PCI with TAXUS express and cardiac surgery left main angiographic substudy (SYNTAX-LE MANS). 2011

Morice, Marie-Claude / Feldman, Ted E E / Mack, Michael J / Ståhle, Elisabeth / Holmes, David R / Colombo, Antonio / Morel, Marie-Angèle / van den Brand, Marcel / Serruys, Patrick W / Mohr, Friedrich / Carrié, Didier / Fournial, Gérard / James, Stefan / Leadley, Katrin / Dawkins, Keith D / Kappetein, A Pieter. ·Institut Hospitalier Jacques Cartier, Massy, France. mc.morice@icps.com.fr ·EuroIntervention · Pubmed #21959312.

ABSTRACT: AIMS: The SYNTAX-LE MANS substudy prospectively evaluated 15-month angiographic and clinical outcomes in patients with treated left main (LM) disease. METHODS AND RESULTS: In the SYNTAX trial, 1,800 patients with three-vessel and/or LM disease were randomised to either CABG or PCI; of these, 271 LM patients were prospectively assigned to receive a 15-month angiogram. The primary endpoint for the CABG arm was the ratio of ≥50% to <100% obstructed/occluded grafts bypassing LM lesions to the number placed. The primary endpoint for the PCI arm was the proportion of patients with ≤50% diameter stenosis ('patent' stents) of treated LM lesions. Per protocol, no formal comparison between CABG and PCI arms was intended based on the differing primary endpoints. Available 15-month angiograms were analysed for 114 CABG and 149 PCI patients. At 15 months, 9.9% (26/263) of CABG grafts were 100% occluded and an additional 5.7% (15/263) were ≥50% to <100% occluded. Overall, 27.2% (31/114) of patients had ≥1 obstructed/occluded graft. The 15-month CABG MACCE rate was 8.8% (10/114) and MACCE at 15 months was not significantly associated with graft obstruction/occlusion (p=0.85). In the PCI arm, 92.4% (134/145) of patients had ≤50% diameter LM stenosis at 15 months (89.7% [87/97] distal LM lesions and 97.9% [47/48] non-distal LM lesions). The 15-month PCI MACCE rate was 12.8% (20/156) and this was significantly associated with lack of stent patency at 15 months (p<0.001), mainly due to repeat revascularisation. CONCLUSIONS: At 15 months, 15.6% (41/263) of grafts were at least 50% obstructed but this was not significantly associated with MACCE; 92.4% (134/145) of patients had stents that remained patent at 15 months, and stent restenosis was significantly associated with MACCE, predominantly due to revascularisation.

15 Article 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. 2011

Kappetein, Arie Pieter / Feldman, Ted E / Mack, Michael J / Morice, Marie-Claude / Holmes, David R / Ståhle, Elisabeth / Dawkins, Keith D / Mohr, Friedrich W / Serruys, Patrick W / Colombo, Antonio. ·Department of Thoracic Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands. a.kappetein@erasmusmc.nl ·Eur Heart J · Pubmed #21697170.

ABSTRACT: 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.

16 Article Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial. 2010

Morice, Marie-Claude / Serruys, Patrick W / Kappetein, A Pieter / Feldman, Ted E / Ståhle, Elisabeth / Colombo, Antonio / Mack, Michael J / Holmes, David R / Torracca, Lucia / van Es, Gerrit-Anne / Leadley, Katrin / Dawkins, Keith D / Mohr, Friedrich. ·Institut Hospitalier Jacques Cartier, 6 Avenue du Noyer Lambert, Massy, France. mc.morice@icps.com.fr ·Circulation · Pubmed #20530001.

ABSTRACT: BACKGROUND: The prospective, multinational, randomized Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial was designed to assess the optimal revascularization strategy between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), for patients with left main (LM) and/or 3-vessel coronary disease. METHODS AND RESULTS: This observational hypothesis-generating analysis reports the results of a prespecified powered subgroup of 705 randomized patients who had LM disease among the 1800 patients with de novo 3-vessel disease and/or LM disease randomized to PCI with paclitaxel-eluting stents or CABG in the SYNTAX trial. Major adverse cardiac and cerebrovascular event rates at 1 year in LM patients were similar for CABG and PCI (13.7% versus 15.8%; Delta2.1% [95% confidence interval -3.2% to 7.4%]; P=0.44). At 1 year, stroke was significantly higher in the CABG arm (2.7% versus 0.3%; Delta-2.4% [95% confidence interval -4.2% to -0.1%]; P=0.009]), whereas repeat revascularization was significantly higher in the PCI arm (6.5% versus 11.8%; Delta5.3% [95% confidence interval 1.0% to 9.6%]; P=0.02); there was no observed difference between groups for other end points. When patients were scored for anatomic complexity, those with higher baseline SYNTAX scores had significantly worse outcomes with PCI than did patients with low or intermediate SYNTAX scores; outcomes for patients with CABG did not correlate with baseline SYNTAX score, but baseline EuroSCORE significantly predicted outcomes for both treatments. CONCLUSIONS: Patients with LM disease who had revascularization with PCI had safety and efficacy outcomes comparable to CABG at 1 year; longer follow-up is required to determine whether these 2 revascularization strategies offer comparable medium-term outcomes in this group of complex patients.