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Coronary Artery Disease: HELP
Articles by Rodney H. Stables
Based on 20 articles published since 2008

Between 2008 and 2019, Rod Stables wrote the following 20 articles about Coronary Artery Disease.
+ Citations + Abstracts
1 Review Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. 2018

Head, Stuart J / Milojevic, Milan / Daemen, Joost / Ahn, Jung-Min / Boersma, Eric / Christiansen, Evald H / Domanski, Michael J / Farkouh, Michael E / Flather, Marcus / Fuster, Valentin / Hlatky, Mark A / Holm, Niels R / Hueb, Whady A / Kamalesh, Masoor / Kim, Young-Hak / Mäkikallio, Timo / Mohr, Friedrich W / Papageorgiou, Grigorios / Park, Seung-Jung / Rodriguez, Alfredo E / Sabik, Joseph F / Stables, Rodney H / Stone, Gregg W / Serruys, Patrick W / Kappetein, Arie Pieter. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. Electronic address: s.head@erasmusmc.nl. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, Netherlands. · Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Icahn School of Medicine at Mount Sinai, New York, NY, USA; Peter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, ON, Canada. · Norwich Medical School University of East Anglia and Norfolk and Norwich University Hospital, Norwich, UK. · Icahn School of Medicine at Mount Sinai, New York, NY, USA. · Stanford University School of Medicine, Stanford, CA, USA. · Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil. · Richard L Roudebush VA Medical Center, Indianapolis, IN, USA. · Department of Cardiology, Oulu University Hospital, Oulu, Finland. · Department of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biostatistics, Erasmus University Medical Center, Rotterdam, Netherlands. · Cardiac Unit, Otamendi Hospital, Buenos Aires, Argentina. · Department Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. · Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Liverpool, UK. · Columbia University Medical Center and the Center for Clinical Trials, Cardiovascular Research Foundation, New York, NY, USA. · Imperial College London, London, UK. ·Lancet · Pubmed #29478841.

ABSTRACT: BACKGROUND: Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies. METHODS: We did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics. FINDINGS: We included 11 randomised trials involving 11 518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06-1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09-1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19-1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86-1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87-1·33; p=0·52), regardless of diabetes status and SYNTAX score. INTERPRETATION: CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies. FUNDING: None.

2 Clinical Trial Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study. 2017

Escaned, Javier / Collet, Carlos / Ryan, Nicola / De Maria, Giovanni Luigi / Walsh, Simon / Sabate, Manel / Davies, Justin / Lesiak, Maciej / Moreno, Raul / Cruz-Gonzalez, Ignacio / Hoole, Stephan P / Ej West, Nick / Piek, J J / Zaman, Azfar / Fath-Ordoubadi, Farzin / Stables, Rodney H / Appleby, Clare / van Mieghem, Nicolas / van Geuns, Robert Jm / Uren, Neal / Zueco, Javier / Buszman, Pawel / Iñiguez, Andres / Goicolea, Javier / Hildick-Smith, David / Ochala, Andrzej / Dudek, Dariusz / Hanratty, Colm / Cavalcante, Rafael / Kappetein, Arie Pieter / Taggart, David P / van Es, Gerrit-Anne / Morel, Marie-Angèle / de Vries, Ton / Onuma, Yoshinobu / Farooq, Vasim / Serruys, Patrick W / Banning, Adrian P. ·Hospital Cliinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain; Calle Profesor Martín Lagos s/n, 28040 Madrid, Spain. · Department of Cardiology, Academic Medical Center of Amsterdam, Cardiology, Amsterdam, the Netherlands; Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, the Netherlands. · Department of Cardiology, John Radcliffe Hospital, Cardiology, Oxford, UK; Headley Way, Headington, Oxford OX3 9DU, UK. · Department of Cardiology Belfast Health & Social Care Trust, Belfast, UK; Knockbracken Healthcare Park, Saintfield Rd, Belfast BT8 8BH, UK. · Hospital Clinic I Provincial de Barcelona, Barcelona, Spain; Carrer de Villarroel, 170, 08036 Barcelona, Spain. · Department of Cardiology, Imperial College London, London, UK; Kensington, London SW7 2AZ, UK. · 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland; Collegium Maius, Fredry 10, 61-701 Poznan, Poland. · Department of Cardiology, Hospital Universitario la Paz, Madrid, Spain; Paseo de la Castellana, 261, 28046 Madrid, Spain. · Department of Cardiology, Hospital Universitario de Salamanca, IBSAL, Salamanca, Spain; Paseo de San Vicente, 58, 37007 Salamanca, Spain. · Department of Cardiology, Papworth Hospital NHS Foundation Trust, Cambridge, UK; Papworth Everard, Cambridge CB23 3RE, UK. · Department of Cardiology, Freeman Hospital and Newcastle University, Newcastle-upon-Tyne, UK; High Heaton, Newcastle upon Tyne NE7 7DN, UK. · Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, UK; Oxford Rd, Manchester M13 9WL, UK. · Liverpool Heart and Chest Hospital, Liverpool, UK; Thomas Dr, Liverpool L14 3PE, UK. · Thoraxcenter, Erasmus MC, the Netherlands; 's-Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands. · The Royal Infirmary of Edinburgh, Edinburgh, UK; 51 Little France Dr, Edinburgh EH16 4SA, UK. · Department of Cardiology, Hospital Universitario Valdecilla, Cantabria, Spain; Av. Valdecilla, 25, 39008 Santander, Cantabria, Spain. · American Heart of Poland (PAK), Ustrón, Poland; Sanatoryjna 1, 43-450 Ustrón, Poland. · Department of Cardiology, Hospital Meixoeiro, Pontevedra, Spain; Camiño Meixoeiro, s/n, 36214 Vigo, Pontevedra, Spain. · Brighton & Sussex University Hospitals NHS Trust, Brighton, UK; Barry Building, Eastern Rd, Brighton BN2 5BE, UK. · Gornoslaskie Centrum Medycnze, Poland; 45/47, 40-635 Katowice, Poland. · Department of Interventional Cardiology, Jagiellonian University, Krakow, Poland; Gol?bia 24, 31-007 Kraków, Poland. · Cardialysis BV, Rotterdam, the Netherlands; Westblaak 98, 3012 KM, Rotterdam, the Netherlands. · European Cardiovascular Research Institute, Westblaak 98, 3012 KM, Rotterdam, the Netherlands. ·Eur Heart J · Pubmed #29020367.

ABSTRACT: Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07-0.97, P = 0.045). Conclusion: At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted. ClinicalTrials.gov Identifier: NCT02015832.

3 Article Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. 2016

Behan, Miles W / Holm, Niels R / de Belder, Adam J / Cockburn, James / Erglis, Andrejs / Curzen, Nicholas P / Niemelä, Matti / Oldroyd, Keith G / Kervinen, Kari / Kumsars, Indulis / Gunnes, Paal / Stables, Rodney H / Maeng, Michael / Ravkilde, Jan / Jensen, Jan Skov / Christiansen, Evald H / Cooter, Nina / Steigen, Terje K / Vikman, Saila / Thuesen, Leif / Lassen, Jens Flensted / Hildick-Smith, David. ·Department of Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Edinburgh EH16 4SA, UK milesbehan@hotmail.com. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK. · Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia. · Southampton University Hospitals & Faculty of Medicine, University of Southampton, Southampton, UK. · Division of Cardiology, Department of Medicine, Oulu University Hospital, Oulu, Finland. · Golden Jubilee National Hospital, Glasgow, UK. · Feiring Heart Centre, Feiring, Norway. · Liverpool Heart and Chest Hospital, Liverpool, UK. · Aalborg University Hospital, Aalborg, Denmark. · Gentofte University Hospital, Gentofte, Denmark. · University Hospital of Tromsoe, Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway. · Heart Center, Tampere University Hospital, Tamper University, Finland. ·Eur Heart J · Pubmed #27161619.

ABSTRACT: AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data from two large bifurcation coronary stenting trials with similar methodology: the Nordic Bifurcation Study (NORDIC I) and the British Bifurcation Coronary Study: old, new, and evolving strategies (BBC ONE). METHODS AND RESULTS: Both multicentre randomized trials compared simple (provisional T-stenting) vs. complex (culotte, crush, and T-stenting) techniques, using drug-eluting stents. We analysed all-cause death at 5 years. Data were collected from phone follow-up, hospital records, and national mortality tracking. Follow-up was complete for 890 out of 913 patients (97%). Both Simple and Complex groups were similar in terms of patient and lesion characteristics. Five-year mortality was lower among patients who underwent a simple strategy rather than a complex strategy [17 patients (3.8%) vs. 31 patients (7.0%); P = 0.04]. CONCLUSION: For coronary bifurcation lesions, a provisional single-stent approach appears to be associated with lower long-term mortality than a systematic dual stenting technique.

4 Article Adverse events following percutaneous and surgical coronary revascularisation: Analysis of non-MACE outcomes in the Stent or Surgery (SoS) Trial. 2016

Roberts, Elved B / Perry, Raphael / Booth, Jean / Sigwart, Ulrich / Stables, Rod H. ·University Hospitals of Leicester and Leicester NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester LE3 9QP, United Kingdom. Electronic address: elved.roberts@uhl-tr.nhs.uk. · Liverpool Heart and Chest Hospital NHS Foundation Trust, Thomas Drive, Liverpool L14 3PE, United Kingdom. · Clinical Trials and Evaluation Unit, Royal Brompton Hospital, Sydney Street, London SW3 6NP, United Kingdom. · Cardiology Center, University Hospital of Geneva, 24 Rue Micheli du Crest, 1211 Geneva, Switzerland. ·Int J Cardiol · Pubmed #26372883.

ABSTRACT: OBJECTIVES: To analyse adverse events requiring or prolonging hospitalisation in the Stent or Surgery (SoS) trial. BACKGROUND: Many adverse events following coronary revascularisation are non-major adverse cardiovascular events (non-MACE). Trials comparing percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) have reported rates of mortality and MACE only. MATERIAL AND METHODS: Comparisons between PCI and CABG groups in the SOS trial were by intention to treat. For patients with non-fatal/non-MACE, number of events per 100 patient years follow-up and duration of hospital stay were assessed. Competing risk analysis was used to illustrate temporal pattern of adverse outcomes. RESULTS: During 2 y median follow up, 1 one or more adverse event occurred in 47.3% (231) of the PCI group and 53% (265) of the CABG group (p=0.086). Non-fatal/non-MACE occurred in 11.9% of the PCI group and 38.6% of the CABG group (p<0.001). Non-fatal/non-MACE per 100 patient years follow-up was 17.49 (PCI) and 35.04 (CABG), rate ratio 2.0, 95% CI 1.7 to 2.4, p<0.001. Cumulative non-fatal/non-MACE associated hospital stays were 1387 and 3287 days in PCI and CABG groups respectively. Median duration of hospitalisation per non-fatal/non-MACE was 5 days (interquartile range 2 to 11.75 days) in the PCI group and 6 days (interquartile range 2 to 12 days) in the CABG group, p=0.245. CONCLUSIONS: CABG had lower cumulative incidence of fatal or MACE outcomes, higher cumulative incidence of non-fatal/non-MACE outcomes, and longer cumulative hospitalisation periods compared to the PCI group.

5 Article Validation of high temporal resolution spiral phase velocity mapping of temporal patterns of left and right coronary artery blood flow against Doppler guidewire. 2015

Keegan, Jennifer / Raphael, Claire E / Parker, Kim / Simpson, Robin M / Strain, Stephen / de Silva, Ranil / Di Mario, Carlo / Collinson, Julian / Stables, Rod H / Wage, Ricardo / Drivas, Peter / Sugathapala, Malindie / Prasad, Sanjay K / Firmin, David N. ·Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. j.keegan@rbht.nhs.uk. · Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. c.raphael@rbht.nhs.uk. · Department of Bioengineering, Imperial College London, London, UK. k.parker@imperial.ac.uk. · Radiological Physics, University Medical Centre, Freiburg, Germany. robin.simpson@uniklinik-freiburg.de. · Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. stephen.strain@yahoo.co.uk. · National Heart and Lung Institute, Imperial College London, London, UK. r.desilva@imperial.ac.uk. · Department of Cardiology, Royal Brompton and Harefield NHS Foundation Trust, London, UK. r.desilva@imperial.ac.uk. · Department of Cardiology, Royal Brompton and Harefield NHS Foundation Trust, London, UK. c.dimario@rbht.nhs.uk. · Department of Cardiology, Chelsea and Westminster Hospital, London, UK. Julian.collinson@chelwest.nhs.uk. · Institue of Cardiovascular Science and Medicine, Liverpool Heart and Chest Hospital, Liverpool, UK. rod.stables@lhch.nhs.uk. · Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. r.wage@rbht.nhs.uk. · Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. p.drivas@rbht.nhs.uk. · Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. msugathapala@gmail.com. · Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. s.prasad@rbht.nhs.uk. · Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. d.firmin@imperial.ac.uk. · National Heart and Lung Institute, Imperial College London, London, UK. d.firmin@imperial.ac.uk. ·J Cardiovasc Magn Reson · Pubmed #26428627.

ABSTRACT: BACKGROUND: Temporal patterns of coronary blood flow velocity can provide important information on disease state and are currently assessed invasively using a Doppler guidewire. A non-invasive alternative would be beneficial as it would allow study of a wider patient population and serial scanning. METHODS: A retrospectively-gated breath-hold spiral phase velocity mapping sequence (TR 19 ms) was developed at 3 Tesla. Velocity maps were acquired in 8 proximal right and 15 proximal left coronary arteries of 18 subjects who had previously had a Doppler guidewire study at the time of coronary angiography. Cardiovascular magnetic resonance (CMR) velocity-time curves were processed semi-automatically and compared with corresponding invasive Doppler data. RESULTS: When corrected for differences in heart rate between the two studies, CMR mean velocity through the cardiac cycle, peak systolic velocity (PSV) and peak diastolic velocity (PDV) were approximately 40 % of the peak Doppler values with a moderate - good linear relationship between the two techniques (R(2): 0.57, 0.64 and 0.79 respectively). CMR values of PDV/PSV showed a strong linear relationship with Doppler values with a slope close to unity (0.89 and 0.90 for right and left arteries respectively). In individual vessels, plots of CMR velocities at all cardiac phases against corresponding Doppler velocities showed a consistent linear relationship between the two with high R(2) values (mean +/-SD: 0.79 +/-.13). CONCLUSIONS: High temporal resolution breath-hold spiral phase velocity mapping underestimates absolute values of coronary flow velocity but allows accurate assessment of the temporal patterns of blood flow.

6 Article A Single-Center Randomized Trial of Intraoperative Zero-Balanced Ultrafiltration During Cardiopulmonary Bypass for Patients With Impaired Kidney Function Undergoing Cardiac Surgery. 2015

Matata, Bashir M / Scawn, Nigel / Morgan, Maureen / Shirley, Sarah / Kemp, Ian / Richards, Sarah / Lane, Steven / Wilson, Keith / Stables, Rodney / Jackson, Mark / Haycox, Alan / Mediratta, Neeraj. ·Liverpool Heart and Chest Hospital NHS Foundation Trust. Electronic address: matata_bashir@hotmail.com. · Liverpool Heart and Chest Hospital NHS Foundation Trust. · School of Management. · Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom. ·J Cardiothorac Vasc Anesth · Pubmed #26119403.

ABSTRACT: OBJECTIVES: The authors investigated whether zero-balance ultrafiltration (Z-BUF) during bypass significantly improves clinical and cost outcomes or biomarkers of kidney injury for patients with preoperative kidney impairment (estimated glomerular filtration rate [eGFR]<60 mL/minute) undergoing cardiac surgery. DESIGN: A single-center randomized controlled trial recruited, patients between 2010 and 2013, with a 12-months follow-up. SETTING: Hospital. PARTICIPANTS: One hundred ninety-nine patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). INTERVENTIONS: Patients were assigned randomly to receive zero-balance ultrafiltration (Z-BUF) or not, with stratification for degree of kidney dysfunction and diabetes. MEASUREMENTS AND MAIN RESULTS: The authors assessed clinical efficacy and kidney function biomarkers. Cumulative probability of discharge from the intensive care unit (ICU) was assessed by Kaplan-Meier plots and was found not to be significantly different between the two trial arms (p = 0.61). After adjusting for EuroSCORE, diabetes, eGFR, cardioplegia types and type of surgery in a Cox proportional hazard model, hazard ratios (HR) for ICU length of stay between the Z-BUF and no-Z-BUF groups was not significantly different: HR (95% CI): 0.89 (0.66, 1.20; p = 0.44). In contrast, significant reductions in postoperative chest infections and the composite of clinical endpoints (death, strokes, and myocardial infarctions) in the Z-BUF group were observed. In addition, Z-BUF significantly abrogated the rise in the kidney damage markers urinary NGAL/creatinine ratio, urea, creatinine and eGFR during CPB and adverse events risks. CONCLUSIONS: Z-BUF during bypass surgery is associated with significant reductions in morbidity and biomarkers of CPB-induced acute kidney injury soon after CPB, which are indicative of clearance of inflammatory/immune mediators from the circulation.

7 Article Construction and validation of a plaque discrimination score from the anatomical and histological differences in coronary atherosclerosis: the Liverpool IVUS-V-HEART (Intra Vascular UltraSound-Virtual-Histology Evaluation of Atherosclerosis Requiring Treatment) study. 2014

Murray, Scott W / Stables, Rodney H / Garcia-Garcia, Hector M / Grayson, Antony D / Shaw, Matthew A / Perry, Raphael A / Serruys, Patrick W / Palmer, Nicholas D. ·Institute for Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom. ·EuroIntervention · Pubmed #24472736.

ABSTRACT: AIMS: New markers to help stratify coronary atherosclerosis are needed. Although attempts have been made to differentiate active lesions from those that are stable, none of these has ever been formalised into a discriminatory score. The aim of this study was to analyse the differences between culprit ACS lesions and culprit stable angina lesions with intravascular ultrasound-derived virtual histology and to construct and validate a plaque score. METHODS AND RESULTS: Prior to percutaneous coronary intervention (PCI), we performed volumetric, intravascular ultrasound-derived virtual histology (IVUS-VH) analysis in acute coronary syndrome (ACS) culprit lesions (AC - n=70) and stable angina culprit lesions (SC - n=35). A direct statistical comparison of IVUS-VH data and multiple logistic regression analysis was undertaken. Four main factors were found to be associated (p<0.05) with an AC lesion phenotype: necrotic core/dense calcium (NC/DC) ratio; minimum lumen area <4 mm2 (MLA <4); remodelling index @MLA >1.05 and VH-TCFA presence. Calculation of each logistic regression coefficient and the equation produces an active plaque discrimination score with an AUC of 0.96 on receiver operating characteristics (ROC) analysis. Validation of the score in 50 independent plaques from the Thoraxcenter in Rotterdam revealed an AUC of 0.71, confirming continued diagnostic ability. CONCLUSIONS: We have found four features on IVUS and VH that can predict and discriminate ACS culprit lesion phenotypes from those that are clinically stable. Subsequently, we have constructed and validated the Liverpool Active Plaque Score based upon these features. It is hoped this score may help diagnose active coronary plaques, in the future, to help prevent major adverse cardiac events.

8 Article Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. 2013

Meredith, Ian T / Verheye, Stefan / Weissman, Neil J / Barragan, Paul / Scott, Douglas / Valdés Chávarri, Mariano / West, Nick E J / Kelbæk, Henning / Whitbourn, Robert / Walters, Darren L / Kubica, Jacek / Thuesen, Leif / Masotti, Monica / Banning, Adrian / Sjögren, Iwar / Stables, Rod H / Allocco, Dominic J / Dawkins, Keith D. ·MonashHeart, Clayton, Victoria, Australia. ian.meredith@myheart.id.au ·EuroIntervention · Pubmed #23872647.

ABSTRACT: AIMS: The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial. METHODS AND RESULTS: EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40 ± 5.06% for PROMUS Element (PE) vs. 2.68 ± 4.60% for SYNERGY (p=0.34) and 3.09 ± 4.29% for SYNERGY ½ dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY ½ dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years. CONCLUSIONS: At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.

9 Article The impact of coronary bifurcation stenting strategy on health-related functional status: a quality-of-life analysis from the BBC One (British Bifurcation Coronary; Old, New, and Evolving Strategies) study. 2013

Sirker, Alex / Sohal, Manav / Oldroyd, Keith / Curzen, Nick / Stables, Rod / de Belder, Adam / Hildick-Smith, David. ·Heart Hospital, London, United Kingdom. ·JACC Cardiovasc Interv · Pubmed #23428004.

ABSTRACT: OBJECTIVES: This study sought to assess the impact of coronary bifurcation stenting on health-related functional status, using the Seattle Angina Questionnaire (SAQ), for participants in the BBC ONE (British Bifurcation Coronary; Old, New, and Evolving Strategies) trial and to compare simple versus complex bifurcation stenting strategies in this regard. BACKGROUND: Large randomized studies have examined outcomes from bifurcation stenting with drug-eluting stents. They have reported on major adverse cardiovascular events and angiographic follow-up. However, a principal goal of percutaneous coronary intervention is symptom control and improvement in quality of life, yet there are no published data from these trials on this aspect. Furthermore, it is unknown whether simple versus complex stenting strategies have different effects on angina control and quality of life. METHODS: The BBC ONE study randomized 500 subjects to bifurcation stenting using either a simple (provisional T) or complex (crush or culotte) approach. Subjects completed the SAQ at baseline and at 9 months after percutaneous coronary intervention. Canadian Cardiovascular Society class and antianginal drug use were also evaluated. RESULTS: Bifurcation stenting was associated with significant improvements on SAQ scales and in Canadian Cardiovascular Society class (baseline: 5.3% subjects were class 0; follow-up: 64.0% were class 0; p < 0.001) and a significant reduction in the number of antianginal drugs used (median decrease: 1; p < 0.001). Simple and complex strategies did not differ significantly for changes in the SAQ, actual SAQ scores, or use of antianginal drugs. CONCLUSIONS: Regardless of chosen strategy, bifurcation stenting produced significant functional improvements in angina-related health. No significant difference between simple and complex strategies was found in this regard.

10 Article Long-term mortality data from the balloon pump-assisted coronary intervention study (BCIS-1): a randomized, controlled trial of elective balloon counterpulsation during high-risk percutaneous coronary intervention. 2013

Perera, Divaka / Stables, Rod / Clayton, Tim / De Silva, Kalpa / Lumley, Matthew / Clack, Lucy / Thomas, Martyn / Redwood, Simon / Anonymous3180744. ·Cardiovascular Division, St. Thomas' Hospital Campus, Kings College London, London SE1 7EH, UK. Divaka.Perera@kcl.ac.uk ·Circulation · Pubmed #23224207.

ABSTRACT: BACKGROUND: There is conflicting evidence on the utility of elective intra-aortic balloon pump (IABP) use during high-risk percutaneous coronary intervention (PCI). Observational series have indicated a reduction in major in-hospital adverse events, although randomized trial evidence does not support this. A recent study has suggested a mortality benefit trend early after PCI, but there are currently no long-term outcome data from randomized trials in this setting. METHODS AND RESULTS: Three hundred one patients with left ventricular impairment (ejection fraction <30%) and severe coronary disease (BCIS-1 jeopardy score ≥8; maximum possible score=12) were randomized to receive PCI with elective IABP support (n=151) or without planned IABP support (n=150). Long-term all-cause mortality was assessed by tracking the databases held at the Office of National Statistics (in England and Wales) and the General Register Office (in Scotland). The groups were balanced in terms of baseline characteristics (left ventricular ejection fraction, 23.6%; BCIS-1 jeopardy score, 10.4) and the amount and type of revascularization performed. Mortality data were available for the entire cohort at a median of 51 months (interquartile range, 41-58) from randomization. All-cause mortality at follow-up was 33% in the overall cohort, with significantly fewer deaths occurring in the elective IABP group (n=42) than in the group that underwent PCI without planned IABP support (n=58) (hazard ratio, 0.66; 95% confidence interval, 0.44-0.98; P=0.039). CONCLUSIONS: In patients with severe ischemic cardiomyopathy treated with PCI, all-cause mortality was 33% at a median of 51 months. Elective IABP use during PCI was associated with a 34% relative reduction in all-cause mortality compared with unsupported PCI. CLINICAL TRIAL REGISTRATION: URL: http://www.isrctn.org. Unique identifier: ISRCTN40553718; and http://www.clinicaltrials.gov. Unique identifier: NCT00910481.

11 Article Defining the magnitude of measurement variability in the virtual histology analysis of acute coronary syndrome plaques. 2013

Murray, Scott W / Stables, Rodney H / Hart, George / Palmer, Nicholas D. ·Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Liverpool, UK. scottmurray@doctors.org.uk ·Eur Heart J Cardiovasc Imaging · Pubmed #22782956.

ABSTRACT: BACKGROUND: Previous intravascular ultrasound-based virtual histology (IVUS-VH) measurement variability studies have been confined to single-frame or short-segment analysis in stable patients with minimal disease. We sought to determine the magnitude of human measurement variability in acute coronary syndrome (ACS) plaques. METHODS AND RESULTS: Prior to percutaneous coronary intervention, we performed IVUS-VH analysis in troponin-positive ACS culprit lesions. A total of 3840 IVUS-VH frames were analysed by two operators to determine intra- and inter-observer variability. The plaque constituent area and volumes were compared using intra-class correlation coefficient (ICC); within-subjects standard deviation (WSSD, mm(2) or mm(3)) and the repeatability coefficient (RCO) to quantify the magnitude of operator error that 95% of future measurements should not exceed. The majority of intra- and inter-observer measurements had ICC of >0.92 confirming excellent agreement. Only the fibrous area (0.86), fibro-fatty (FF) area (0.72) and FF volume (0.87) had ICC levels suggesting an operator error >10%. However, the mean RCO and the percentage this represents in single-frame analysis (area error) varied across the plaque subtypes: fibrous area = 1.64 mm(2) (59%); FF area = 0.49 mm(2) (140%); necrotic core (NC) area = 0.39 mm(2) (21.3%); dense calcium (DC) area = 0.29 mm(2) (33.7%). For full lesion pullbacks (volume error): fibrous volume = 8.14 mm(3) (9.9%); FF volume = 5.63 mm(3) (53.8%); NC volume = 3.78 mm(3) (6.9%) and DC = 2.4 mm(3) (9.6%) CONCLUSION: As in previous studies, intra- and inter-observer ICC suggests good agreement between observers. However, this can still represent large measurement error values and percentages. These findings could impact on the interpretation of previous studies and influence future studies using IVUS-VH measurements as endpoints.

12 Article The effect of age on outcomes of coronary artery bypass surgery compared with balloon angioplasty or bare-metal stent implantation among patients with multivessel coronary disease. A collaborative analysis of individual patient data from 10 randomized trials. 2012

Flather, Marcus / Rhee, June-Wha / Boothroyd, Derek B / Boersma, Eric / Brooks, Maria Mori / Carrié, Didier / Clayton, Tim C / Danchin, Nicholas / Hamm, Christian W / Hueb, Whady A / King, Spencer B / Pocock, Stuart J / Rodriguez, Alfredo E / Serruys, Patrick / Sigwart, Ulrich / Stables, Rodney H / Hlatky, Mark A. ·University of East Anglia, Norwich, United Kingdom. ·J Am Coll Cardiol · Pubmed #23153843.

ABSTRACT: OBJECTIVES: This study sought to assess whether patient age modifies the comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI). BACKGROUND: Increasingly, CABG and PCI are performed in older patients to treat multivessel disease, but their comparative effectiveness is uncertain. METHODS: Individual data from 7,812 patients randomized in 1 of 10 clinical trials of CABG or PCI were pooled. Age was analyzed as a continuous variable in the primary analysis and was divided into tertiles for descriptive purposes (≤56.2 years, 56.3 to 65.1 years, ≥65.2 years). The outcomes assessed were death, myocardial infarction and repeat revascularization over complete follow-up, and angina at 1 year. RESULTS: Older patients were more likely to have hypertension, diabetes, and 3-vessel disease compared with younger patients (p < 0.001 for trend). Over a median follow-up of 5.9 years, the effect of CABG versus PCI on mortality varied according to age (interaction p < 0.01), with adjusted CABG-to-PCI hazard ratios and 95% confidence intervals (CI) of 1.23 (95% CI: 0.95 to 1.59) in the youngest tertile; 0.89 (95% CI: 0.73 to 1.10) in the middle tertile; and 0.79 (95% CI: 0.67 to 0.94) in the oldest tertile. The CABG-to-PCI hazard ratio of less than 1 for patients 59 years of age and older. A similar interaction of age with treatment was present for the composite outcome of death or myocardial infarction. In contrast, patient age did not alter the comparative effectiveness of CABG and PCI on the outcomes of repeat revascularization or angina. CONCLUSIONS: Patient age modifies the comparative effectiveness of CABG and PCI on hard cardiac events, with CABG favored at older ages and PCI favored at younger ages.

13 Article Use of troponin to diagnose periprocedural myocardial infarction: effect on composite endpoints in the British Bifurcation Coronary Study (BBC ONE). 2012

Cockburn, James / Behan, Miles / de Belder, Adam / Clayton, Tim / Stables, Rod / Oldroyd, Keith / Curzen, Nick / Hildick-Smith, David. ·Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK. ·Heart · Pubmed #22851684.

ABSTRACT: BACKGROUND: Periprocedural myocardial infarction (PMI; ESC/ACC type 4a) is diagnosed on the basis of elevation of cardiac enzymes more than three times the 99th centile upper reference limit. Recent guidelines recommend the use of troponin instead of creatine kinase (CK) to diagnose PMI, but this assay increases diagnostic sensitivity, while the clinical significance of small increases in troponin remains undetermined. We examined the effects of using the new definition on the incidence of a composite endpoint (previously defined by CK) in a contemporary clinical randomised trial-the British Bifurcation Coronary Study (BBC ONE). METHODS: The BBC ONE trial randomly allocated 500 patients with coronary bifurcation lesions to either a simple or complex stenting strategy. The composite primary endpoint (CPEP) included death, myocardial infarction (MI) (PMI plus subsequent MI) and target vessel failure, at 9 months. RESULTS: In BBC ONE the CPEP occurred in 8% versus 15.2% in the simple and complex groups, respectively (HR 2.02, 95% CI 1.17 to 3.47, p=0.009). This difference was largely driven by PMI, which occurred in nine (3.6%) versus 28 (11.2%) patients (HR 3.24, 95% CI 1.53 to 6.86, p=0.001). Using troponin, PMI would have occurred in 71 (28.4%) versus 114 (45.6%) patients, respectively (HR 1.61, 95% CI 1.27 to 2.05, p=0.001), and the CPEP in 32% versus 48% of patients (HR 1.50, 95% CI 1.2 to 1.87, p=0.001). Use of troponin increased MI detection fivefold, from 7.4% to 37.0% overall. CONCLUSIONS: Use of troponin would have led to a fivefold increase in diagnosis of PMI in the BBC ONE trial. Incorporation of PMI into a composite endpoint may no longer be justified in many interventional trials.

14 Article Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial. 2010

Perera, Divaka / Stables, Rodney / Thomas, Martyn / Booth, Jean / Pitt, Michael / Blackman, Daniel / de Belder, Adam / Redwood, Simon / Anonymous330669. ·Cardiovascular Division, King's College London, London SE1 7EH, UK. ·JAMA · Pubmed #20736470.

ABSTRACT: CONTEXT: Observational studies have previously reported that elective intra-aortic balloon pump (IABP) insertion may improve outcomes following high-risk percutaneous coronary intervention (PCI). To date, this assertion has not been tested in a randomized trial. OBJECTIVE: To determine whether routine intra-aortic balloon counterpulsation before PCI reduces major adverse cardiac and cardiovascular events (MACCE) in patients with severe left ventricular dysfunction and extensive coronary disease. DESIGN, SETTING, AND PATIENTS: The Balloon Pump-Assisted Coronary Intervention Study, a prospective, open, multicenter, randomized controlled trial conducted in 17 tertiary referral cardiac centers in the United Kingdom between December 2005 and January 2009. Patients (n = 301) had severe left ventricular dysfunction (ejection fraction < or = 30%) and extensive coronary disease (Jeopardy Score > or = 8/12); those with contraindications to or class I indications for IABP therapy were excluded. INTERVENTION: Elective insertion of IABP before PCI. MAIN OUTCOME MEASURES: Primary end point was MACCE, defined as death, acute myocardial infarction, cerebrovascular event, or further revascularization at hospital discharge (capped at 28 days). Secondary end points included all-cause mortality at 6 months, major procedural complications, bleeding, and access-site complications. RESULTS: MACCE at hospital discharge occurred in 15.2% (23/151) of the elective IABP and 16.0% (24/150) of the no planned IABP groups (P = .85; odds ratio [OR], 0.94 [95% confidence interval {CI}, 0.51-1.76]). All-cause mortality at 6 months was 4.6% and 7.4% in the respective groups (P = .32; OR, 0.61 [95% CI, 0.24-1.62]). Fewer major procedural complications occurred with elective IABP insertion compared with no planned IABP use (1.3% vs 10.7%, P < .001; OR, 0.11 [95% CI, 0.01-0.49]). Major or minor bleeding occurred in 19.2% and 11.3% (P = .06; OR, 1.86 [95% CI, 0.93-3.79]) and access-site complications in 3.3% and 0% (P = .06) of the elective and no planned IABP groups, respectively. CONCLUSIONS: Elective IABP insertion did not reduce the incidence of MACCE following PCI. These results do not support a strategy of routine IABP placement before PCI in all patients with severe left ventricular dysfunction and extensive coronary disease. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN40553718; clinicaltrials.gov Identifier: NCT00910481.

15 Article Predicting angiographic outcome in contemporary percutaneous coronary intervention: a lesion-specific logistic model. 2010

Roberts, Elved B / Grayson, Anthony D / Alahmar, Albert E / Andron, Mohammed / Perry, Raphael / Stables, Rodney H. ·Department of Cardiology, Glenfield Hospital, University Hospitals of Leicester, United Kingdom. elvedroberts@gmail.com ·J Interv Cardiol · Pubmed #20642482.

ABSTRACT: BACKGROUND: Previous angiographic lesion classification systems were derived from analysis of outcomes and lesion complexity in the early stent era. Advances in equipment design and techniques have altered the association between lesion and target vessel characteristics and procedural outcome in modern percutaneous coronary intervention (PCI). We evaluated the precise relationship between lesion characteristics and technical outcome on a lesion by lesion basis in a large dataset. We developed a multivariate model to predict technical failure in PCI. METHODS: Analysis of prospectively collected data on 10,800 lesions in 6,719 consecutive PCI cases between January 2000 and December 2004. Multivariate logistic regression was undertaken to identify predictors of angiographic outcome at each treated lesion (success/failure). Statistical model validation was carried out using data from a further 3,340 treated lesions in 1,940 consecutive cases. RESULTS: Independent variables associated with an increased risk of technical failure included total occlusion, severe calcification, proximal vessel tortuosity >90 degrees, lesion in a degenerate vein graft, and lesion angulation > or =90 degrees. The receiver operating characteristics (ROC) curve for the predicted probability of technical failure was 0.85. Failure occurred in 2.2% of treated lesions in the validation set (ROC curve 0.82, model predicted 2.5%). CONCLUSIONS: We have re-evaluated the association between lesion characteristics and technical outcome in modern PCI. We have thereby developed a contemporary prediction model for angiographic outcome at each treated lesion.

16 Article Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. 2010

Hildick-Smith, David / de Belder, Adam J / Cooter, Nina / Curzen, Nicholas P / Clayton, Tim C / Oldroyd, Keith G / Bennett, Lorraine / Holmberg, Steve / Cotton, James M / Glennon, Peter E / Thomas, Martyn R / Maccarthy, Philip A / Baumbach, Andreas / Mulvihill, Niall T / Henderson, Robert A / Redwood, Simon R / Starkey, Ian R / Stables, Rodney H. ·Sussex Cardiac Centre, Royal Sussex County Hospital, Brighton, BN8 5QH, UK. david.hildick-smith@bsuh.nhs.uk ·Circulation · Pubmed #20194880.

ABSTRACT: BACKGROUND: The optimal strategy for treating coronary bifurcation lesions remains a subject of debate. With bare-metal stents, single-stent approaches appear to be superior to systematic 2-stent strategies. Drug-eluting stents, however, have low rates of restenosis and might offer improved outcomes with complex stenting techniques. METHODS AND RESULTS: Patients with significant coronary bifurcation lesions were randomized to either a simple or complex stenting strategy with drug-eluting stents. In the simple strategy, the main vessel was stented, followed by optional kissing balloon dilatation/T-stent. In the complex strategy, both vessels were systematically stented (culotte or crush techniques) with mandatory kissing balloon dilatation. Five hundred patients 64+/-10 years old were randomized; 77% were male. Eighty-two percent of lesions were true bifurcations (>50% narrowing in both vessels). In the simple group (n=250), 66 patients (26%) had kissing balloons in addition to main-vessel stenting, and 7 (3%) had T stenting. In the complex group (n=250), 89% of culotte (n=75) and 72% of crush (n=169) cases were completed successfully with final kissing balloon inflations. The primary end point (a composite at 9 months of death, myocardial infarction, and target-vessel failure) occurred in 8.0% of the simple group versus 15.2% of the complex group (hazard ratio 2.02, 95% confidence interval 1.17 to 3.47, P=0.009). Myocardial infarction occurred in 3.6% versus 11.2%, respectively (P=0.001), and in-hospital major adverse cardiovascular events occurred in 2.0% versus 8.0% (P=0.002), respectively. Procedure duration and x-ray dose favored the simple approach. CONCLUSIONS: When coronary bifurcation lesions are treated, a systematic 2-stent technique results in higher rates of in-hospital and 9-month major adverse cardiovascular events. This difference is largely driven by periprocedural myocardial infarction. Procedure duration is longer, and x-ray dose is higher. The provisional technique should remain the preferred strategy in the majority of cases. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00351260.

17 Article Percutaneous versus surgical revascularization for multivessel coronary artery disease: a single center 10 year follow-up of SOS trial patients. 2009

Buszman, Pawel / Wiernek, Szymon / Szymanski, Radoslaw / Bialkowska, Bozena / Buszman, Piotr / Fil, Wojciech / Stables, Rodney / Bochenek, Andrzej / Martin, Jack / Tendera, Michal. ·Upper Silesian Medical Center, 45-47 Ziolowa, 40-635 Katowice, Poland. pbuszman@ka.onet.pl ·Catheter Cardiovasc Interv · Pubmed #19360866.

ABSTRACT: OBJECTIVES: To compare 10 year outcomes including death, left ventricular ejection fraction (LVEF), major adverse cardiovascular and cerebrovascular events (MACCE), repeat revascularization (RR), and severity of angina (CCS) after randomization to stent supported percutaneous coronary intervention (PCI) or surgical revascularization (CABG) in a single center participating in the SOS trial. BACKGROUND: Randomized studies show increased RR following PCI, but otherwise similar results to CABG in selected mutlivessel disease patients with up to 5 year follow up. There is no 10 year data available. MATERIALS AND METHODS: The analysis involved 100 patients randomized into the SOS study in Poland. RESULTS: Patients were well matched for baseline demographic and angiographic characteristics. During 9.6 +/- 0.85 year observation, there was no significant difference between groups for survival, CCS, and LVEF. Increased RR occurred following PCI; 21 (42%) vs. 9 (18%), P < 0.05. As a consequence, the MACCE was also significantly higher following PCI; 36 (72%) vs. 28 (56%), P < 0.05. Excess RR predominantly occurred in the first year and diminished over time with numerically less RR following PCI from year 5 to 10; 2 (4%) vs. 7 (14%), P = ns. CONCLUSIONS: These findings suggest that patients with multivessel coronary artery disease technically suitable for either stent supported PCI or CABG have very similar 10 year outcomes with respect to mortality, angina class, LVEF, and MACCE other than RR. Excess RR following PCI predominantly occurs in early years and is numerically lower following PCI in years 5-10. This underscores the need for longer-term follow up from randomized trials.

18 Article Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease: a collaborative analysis of individual patient data from ten randomised trials. 2009

Hlatky, Mark A / Boothroyd, Derek B / Bravata, Dena M / Boersma, Eric / Booth, Jean / Brooks, Maria M / Carrié, Didier / Clayton, Tim C / Danchin, Nicolas / Flather, Marcus / Hamm, Christian W / Hueb, Whady A / Kähler, Jan / Kelsey, Sheryl F / King, Spencer B / Kosinski, Andrzej S / Lopes, Neuza / McDonald, Kathryn M / Rodriguez, Alfredo / Serruys, Patrick / Sigwart, Ulrich / Stables, Rodney H / Owens, Douglas K / Pocock, Stuart J. ·Stanford University School of Medicine, Stanford, CA, USA. ·Lancet · Pubmed #19303634.

ABSTRACT: BACKGROUND: Coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are alternative treatments for multivessel coronary disease. Although the procedures have been compared in several randomised trials, their long-term effects on mortality in key clinical subgroups are uncertain. We undertook a collaborative analysis of data from randomised trials to assess whether the effects of the procedures on mortality are modified by patient characteristics. METHODS: We pooled individual patient data from ten randomised trials to compare the effectiveness of CABG with PCI according to patients' baseline clinical characteristics. We used stratified, random effects Cox proportional hazards models to test the effect on all-cause mortality of randomised treatment assignment and its interaction with clinical characteristics. All analyses were by intention to treat. FINDINGS: Ten participating trials provided data on 7812 patients. PCI was done with balloon angioplasty in six trials and with bare-metal stents in four trials. Over a median follow-up of 5.9 years (IQR 5.0-10.0), 575 (15%) of 3889 patients assigned to CABG died compared with 628 (16%) of 3923 patients assigned to PCI (hazard ratio [HR] 0.91, 95% CI 0.82-1.02; p=0.12). In patients with diabetes (CABG, n=615; PCI, n=618), mortality was substantially lower in the CABG group than in the PCI group (HR 0.70, 0.56-0.87); however, mortality was similar between groups in patients without diabetes (HR 0.98, 0.86-1.12; p=0.014 for interaction). Patient age modified the effect of treatment on mortality, with hazard ratios of 1.25 (0.94-1.66) in patients younger than 55 years, 0.90 (0.75-1.09) in patients aged 55-64 years, and 0.82 (0.70-0.97) in patients 65 years and older (p=0.002 for interaction). Treatment effect was not modified by the number of diseased vessels or other baseline characteristics. INTERPRETATION: Long-term mortality is similar after CABG and PCI in most patient subgroups with multivessel coronary artery disease, so choice of treatment should depend on patient preferences for other outcomes. CABG might be a better option for patients with diabetes and patients aged 65 years or older because we found mortality to be lower in these subgroups.

19 Article Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: a meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials. 2008

Daemen, Joost / Boersma, Eric / Flather, Marcus / Booth, Jean / Stables, Rod / Rodriguez, Alfredo / Rodriguez-Granillo, Gaston / Hueb, Whady A / Lemos, Pedro A / Serruys, Patrick W. ·Thoraxcenter, Ba-583, Dr Molewaterplein 40, 3015 GD Rotterdam, Netherlands. ·Circulation · Pubmed #18725490.

ABSTRACT: BACKGROUND: Randomized trials that studied clinical outcomes after percutaneous coronary intervention (PCI) with bare metal stenting versus coronary artery bypass grafting (CABG) are underpowered to properly assess safety end points like death, stroke, and myocardial infarction. Pooling data from randomized controlled trials increases the statistical power and allows better assessment of the treatment effect in high-risk subgroups. METHODS AND RESULTS: We performed a pooled analysis of 3051 patients in 4 randomized trials evaluating the relative safety and efficacy of PCI with stenting and CABG at 5 years for the treatment of multivessel coronary artery disease. The primary end point was the composite end point of death, stroke, or myocardial infarction. The secondary end point was the occurrence of major adverse cardiac and cerebrovascular accidents, death, stroke, myocardial infarction, and repeat revascularization. We tested for heterogeneities in treatment effect in patient subgroups. At 5 years, the cumulative incidence of death, myocardial infarction, and stroke was similar in patients randomized to PCI with stenting versus CABG (16.7% versus 16.9%, respectively; hazard ratio, 1.04, 95% confidence interval, 0.86 to 1.27; P=0.69). Repeat revascularization, however, occurred significantly more frequently after PCI than CABG (29.0% versus 7.9%, respectively; hazard ratio, 0.23; 95% confidence interval, 0.18 to 0.29; P<0.001). Major adverse cardiac and cerebrovascular events were significantly higher in the PCI than the CABG group (39.2% versus 23.0%, respectively; hazard ratio, 0.53; 95% confidence interval, 0.45 to 0.61; P<0.001). No heterogeneity of treatment effect was found in the subgroups, including diabetic patients and those presenting with 3-vessel disease. CONCLUSIONS: In this pooled analysis of 4 randomized trials, PCI with stenting was associated with a long-term safety profile similar to that of CABG. However, as a result of persistently lower repeat revascularization rates in the CABG patients, overall major adverse cardiac and cerebrovascular event rates were significantly lower in the CABG group at 5 years.

20 Article Randomized, controlled trial of coronary artery bypass surgery versus percutaneous coronary intervention in patients with multivessel coronary artery disease: six-year follow-up from the Stent or Surgery Trial (SoS). 2008

Booth, Jean / Clayton, Tim / Pepper, John / Nugara, Fiona / Flather, Marcus / Sigwart, Ulrich / Stables, Rodney H / Anonymous6140602. ·Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London, United Kingdom. ·Circulation · Pubmed #18606919.

ABSTRACT: BACKGROUND: The Stent or Surgery Trial is a randomized, controlled trial comparing percutaneous coronary intervention with coronary artery bypass grafting (CABG) for patients with multivessel disease. Initial results at a median follow-up of 2 years showed a survival advantage for patients randomized to CABG. This article reports survival outcome at a median follow-up of 6 years. METHODS AND RESULTS: A total of 988 (n=488 percutaneous coronary intervention, n=500 CABG) patients were randomized at 53 centers during the period from 1996 to 1999. Investigators established survival status from hospital or community medical records or national databases or by direct contact with patients and their relatives. All-cause mortality was compared with hazard ratios and confidence intervals calculated from Cox proportional hazards models. Prespecified subgroup analyses for diabetes mellitus, angina grade, and angiographic severity of coronary disease at baseline were performed with tests for interaction. At a median follow-up of 6 years, 53 patients (10.9%) died in the percutaneous coronary intervention group compared with 34 (6.8%) in the CABG group (hazard ratio 1.66, 95% confidence interval 1.08 to 2.55, P=0.022). Little evidence was found that the treatment effect on mortality differed between subgroups according to baseline angina grade (interaction test P=0.52), the severity of coronary disease (P=0.92), or diabetic status (P=0.15). CONCLUSIONS: At a median follow-up of 6 years, a continuing survival advantage was observed for patients managed with CABG, which is not consistent with results from other stent-versus-CABG studies.