Understanding the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) Trial Implications for current and future clinical practice

__Abstract__ The landmark Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) Trial1-4 has aided in reducing the area of uncertainty in decision making between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery in patients with complex coronary artery disease.5-8 As part of the SYNTAX Trial, quantification of the coronary artery disease burden was undertaken with the anatomical SYNTAX Score (www.syntaxscore.com),9-11 and has since been implemented in international revascularisation guidelines.5-8 In addition, recognising the importance of quantifying coronary artery disease burden in decision-making between CABG and PCI, the US Food and Drugs Association mandates the SYNTAX Score as entry criteria in ongoing contemporary stent and structural heart disease trials. Namely, the EXCEL (Evaluation of XIENCE PRIME™ or XIENCE V® Everolimus Eluting Stent System Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) Trial (ClinicalTrials.gov identifier: NCT01205776), and SURTAVI (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) Trial (ClinicalTrials.gov identifier: NCT01586910). The SYNTAX Trial was conceived in an era when the potential benefits of drug eluting stents were first being realised between 2002-2006.12-19 After multiple prior attempts comparing CABG against PCI using older technologies – namely plain ‘old’ balloon angioplasty (POBA) and bare metal stents (BMS) – in over 20 randomised trials,20, 21 including the Bypass Angioplasty Revascularization Investigation (BARI)22 and Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI)23 trials, the time had once again come to rechallenge the cardiac surgeons in the management of complex coronary artery disease. Historically one of the major criticisms of randomised trial design comparing CABG against PCI was that the trials enrolled highly selected, “cherry-picked,” patients, with approximately 2-12% of screened subjects actually randomised in most trials, and thus being largely unrepresentative of conventional clinical practice.20, 24 At the time of the SYNTAX Trial design, one of the key requirements put forth by seven cardiac surgeons, dubbed the “magnificent seven,” and fully endorsed by the clinical and interventional cardiologists at the time, was the need for an ‘all-comers’ trial design, free from selection bias

Hierarchies of conditional beliefs and interactive epistemology in dynamic games

Digitised version produced by the EUI Library and made available online in 2020

The impact of coronary perforation in percutaneous interventions involving the left main stem coronary artery in the United Kingdom 2007-2014: Insights from the British Cardiovascular Intervention Society database

Background Percutaneous coronary intervention (PCI) is increasingly utilized for treatment of coronary disease involving the unprotected left main stem (ULMS). However, no studies to date have examined the outcomes of such interventions when complicated by coronary perforation (CP). Methods Using the British Cardiovascular Intervention society (BCIS) database, data were analyzed on all ULMS‐PCI procedures complicated by CP in England and Wales between 2007 and 2014. Multivariate logistic regressions were used to identify predictors of ULMS CP and to evaluate the association between this complication and outcomes. Results During 10,373 ULMS‐PCI procedures, CP occurred more frequently than in non‐ULMS‐PCI (0.9 vs. 0.4%, p < .001) with a stable annual incidence. Covariates associated with CP included number of stents used, female gender, use of rotational atherectomy and chronic total occlusion (CTO) intervention. Adjusted odds of adverse outcomes for ULMS‐PCI complicated by CP were higher for peri‐procedural complications including cardiogenic shock, tamponade, side‐branch loss, DC cardioversion, in‐hospital major bleeding, transfusion requirement, and peri‐procedural myocardial infarction. There were also significantly increased odds for in‐hospital major adverse cardiac events (MACCE, OR 8.961, 95% CI [4.902–16.383]) and 30‐day mortality (OR 5.301, 95% CI [2.741–10.251]). Conclusions CP is an infrequent event during ULMS‐PCI and is predicted by female gender, rotational atherectomy, CTO interventions or number of stents used. CP was associated with significantly higher odds of mortality and morbidity, but at rates similar to previously published all‐comer PCI complicated by CP

Evaluation with in vivo optical coherence tomography and histology of the vascular effects of the everolimus-eluting bioresorbable vascular scaffold at two years following implantation in a healthy porcine coronary artery model: implications of pilot results for future pre-clinical studies

To quantify with in vivo OCT and histology, the device/vessel interaction after implantation of the bioresorbable vascular scaffold (BVS). We evaluated the area and thickness of the strut voids previously occupied by the polymeric struts, and the neointimal hyperplasia (NIH) area covering the endoluminal surface of the strut voids (NIHEV), as well as the NIH area occupying the space between the strut voids (NIHBV), in healthy porcine coronary arteries at 2, 3 and 4 years after implantation of the device. Twenty-two polymeric BVS were implanted in the coronary arteries of 11 healthy Yucatan minipigs that underwent OCT at 2, 3 and 4 years after implantation, immediately followed by euthanasia. The areas and thicknesses of 60 corresponding strut voids previously occupied by the polymeric struts and the size of 60 corresponding NIHEV and 49 NIHBV were evaluated with both OCT and histology by 2 independent observers, using a single quantitative analysis software for both techniques. At 3 and 4 years after implantation, the strut voids were no longer detectable by OCT or histology due to complete polymer resorption. However, analysis performed at 2 years still provided clear delineation of these structures, by both techniques. The median [ranges] areas of these strut voids were 0.04 [0.03–0.16] and 0.02 [0.01–0.07] mm2 by histology and OCT, respectively. The mean (±SD) thickness by histology and OCT was 220 ± 40 and 120 ± 20 μm, respectively. The median [ranges] NIHEV by histology and OCT was 0.07 [0.04–0.20] and 0.03 [0.01–0.08] mm2, while the mean (±SD) NIHBV by histology and OCT was 0.13 ± 0.07 and 0.10 ± 0.06 mm2. Our study indicates that in vivo OCT of the BVS provides correlated measurements of the same order of magnitude as histomorphometry, and is reproducible for the evaluation of certain vascular and device-related characteristics. However, histology systematically gives larger values for all the measured structures compared to OCT, at 2 years post implantation

Combined anatomical and clinical factors for the long-term risk stratification of patients undergoing percutaneous coronary intervention: the Logistic Clinical SYNTAX score

Background The SYNTAX score (SXscore), an anatomical-based scoring tool reflecting the complexity of coronary anatomy, has established itself as an important long-term prognostic factor in patients undergoing percutaneous coronary intervention (PCI). The incorporation of clinical factors may further augment the utility of the SXscore to longer-term risk stratify the individual patient for clinical outcomes. Methods and results Patient-level merged data from >6000 patients in seven contemporary coronary stent trials was used to develop a logistic regression model—the Logistic Clinical SXscore—to predict 1-year risk for all-cause death and major adverse cardiac events (MACE). A core model (composed of the SXscore, age, creatinine clearance, and left ventricular ejection fraction) and an extended model [incorporating the core model and six additional (best performing) clinical variables] were developed and validated in a cross-validation procedure. The core model demonstrated a substantial improvement in predictive ability for 1-year all-cause death compared with the SXscore in isolation [area under the receiver operator curve (AUC): core model: 0.753, SXscore: 0.660]. A minor incremental benefit of the extended model was shown (AUC: 0.791). Consequently the core model alone was retained in the final the Logistic Clinical SXscore model. Validation plots confirmed the model predictions to be well calibrated. For 1-year MACE, the addition of clinical variables did not improve the predictive ability of the SXscore, secondary to the SXscore being the predominant determinant of all-cause revascularization. Conclusion The Logistic Clinical SXscore substantially enhances the prediction of 1-year mortality after PCI compared with the SXscore, and allows for an accurate personalized assessment of patient ris

The impact of intracoronary imaging on PCI outcomes in cases utilising rotational atherectomy: an analysis of 8,417 rotational atherectomy cases from the British Cardiovascular Intervention Society Database

Introduction. There is increasing evidence supporting the use of intracoronary imaging to optimize the outcomes of percutaneous coronary intervention (PCI). However, there are no studies examining the impact of imaging on PCI outcomes in cases utilising rotational atherectomy (RA-PCI). Our study examines the determinants and outcomes of using intracoronary imaging in RA-PCI cases including 12-month mortality. Methods. Using the British Cardiac Intervention Society database, data were analysed on all RA-PCI procedures in the UK between 2007 and 2014. Descriptive statistics and multivariate logistic regressions were used to examine baseline, procedural, and outcome associations with intravascular imaging. Results. Intracoronary imaging was used in 1,279 out of 8,417 RA-PCI cases (15.2%). Baseline covariates associated with significantly more imaging use were number of stents used, smoking history, previous CABG, pressure wire use, proximal LAD disease, laser use, glycoprotein inhibitor use, cutting balloons, number of restenosis attempted, off-site surgery, and unprotected left main stem (uLMS) PCI. Adjusted rates of in-hospital major adverse cardiac/cerebrovascular events (IH-MACCE), its individual components (death, peri-procedural MI, stroke, and major bleed), or 12-month mortality were not significantly altered by the use of imaging in RA-PCI. However, subgroup analysis demonstrated a signal towards reduction in 12-month mortality in uLMS RA-PCI cases utilising intracoronary imaging (OR 0.67, 95% CI 0.44–1.03). Conclusions. Intracoronary imaging use during RA-PCI is associated with higher risk of baseline and procedural characteristics. There were no differences observed in IH-MACCE or 12-month mortality with intracoronary imaging in RA-PCI

Assessment of plaque evolution in coronary bifurcations located beyond everolimus eluting scaffolds: Serial intravascular ultrasound virtual histology study

Purpose. To evaluate the atherosclerotic evolution in coronary bifurcations located proximally and distally to a bioresorbable scaffold. Methods. Thirty bifurcations located >5 mm beyond the scaffolded segment, being investigated with serial intravascular ultrasound virtual histology (IVUS-VH) examinations, at baseline and 2-years, in patients enrolled in the ABSORB cohort B1 study were included in this analysis. In each bifurcation, the frames portraying the proximal rim, in-bifurcation, and distal rim of the ostium of the side branch were analyzed. The geometric parameters and plaque types were evaluated at baseline and 2-years follow-up. Results: There were no significant differences in the geometrical parameters such as lumen, vessel and plaque areas as well as in the composition of the atheroma between baseline and 2-years follow-up.When we separately examined the bifurcations located proximally and distally to the scaffolded segment, no changes were found at the distal bifurcations, while at the proximal bifurcations there was a statistical significant decrease in the plaque burden (36.67 ± 13.33% at baseline vs. 35.06 ± 13.20% at 2 years follow-up, p = 0.04).Ten necrotic core rich plaques were found at baseline, of which 2 regressed to either fibrotic plaque or to intimal thickening at 2 years follow-up. The other 8 did not change. Disease progression was noted in 3 plaques (1 adaptive intimal thickening, 1 fibrotic and 1 fibroca

Usefulness of the updated logistic clinical SYNTAX score after percutaneous coronary intervention in patients with prior coronary artery bypass graft surgery: Insights from the GLOBAL LEADERS trial

Objectives: We aimed to investigate the prognostic utility of the anatomical CABG SYNTAX and logistic clinical SYNTAX scores for mortality after percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafts (CABG). Background: The anatomical SYNTAX score evaluated the anatomical complexity of coronary artery disease and helped predict the prognosis of patients undergoing PCI. The anatomical CABG SYNTAX score was derived from the anatomical SYNTAX score in patients with prior CABG, whilst the logistic clinical SYNTAX score was developed by incorporating clinical factors into the anatomical SYNTAX score. Methods: We calculated the anatomical CABG SYNTAX score and logistic clinical SYNTAX score in 205 patients in the GLOBAL LEADERS trial. The predictive abilities of these scores for 2-year all-cause mortality were evaluated. Results: Using the median scores as categorical thresholds between low and high score groups, the logistic clinical SYNTAX score was able to discriminate the risk of 2-year mortality, unlike the anatomical CABG SYNTAX score. The logistic clinical SYNTAX was significantly better at predicting 2-year mortality, compared to the anatomical CABG SYNTAX score, as evidenced by AUC values in receiver-operating characteristic curve analysis (0.806 vs. 0.582, p <.001) and integrated discrimination improvement (0.121, p <.001). Conclusions: The logistic clinical SYNTAX score was superior to the anatomical CABG SYNTAX score in predicting 2-year mortality