Publications
155 results found
Jones DA, Rathod KS, Pavlidis AN, et al., 2018, Outcomes after chronic total occlusion percutaneous coronary interventions: an observational study of 5496 patients from the Pan-London CTO Cohort., Coron Artery Dis
BACKGROUND: Chronic total occlusions (CTO) are commonly encountered in patients undergoing coronary angiography; however, percutaneous coronary intervention (PCI) is infrequently performed owing to technical difficulty, the perceived risk of complications and a lack of randomized data. The aim of this study was to analyse the frequency and outcomes of CTO-PCI procedures in a large contemporary cohort of successive patients. PATIENTS AND METHODS: We undertook an observational cohort study of 48 234 patients with stable angina of which 5496 (11.4%) procedures were performed for CTOs between 2005 and 2015 at nine tertiary cardiac centres across London, UK. Outcome was assessed by in-hospital major adverse cardiac events and all-cause mortality at a median follow-up of 4.8 years (interquartile range: 2.2-6.4 years). RESULTS: Over time, there was an increase in the proportion of elective PCI procedures performed for CTOs, but no increase in the absolute number. Overall success rates increased over time (74.3% in 2005 to 81.5% in 2015; P=0.0003) despite an increase in case complexity (previous myocardial infarction, diabetes, renal failure, previous coronary artery bypass grafting, peripheral vascular disease and left ventricular impairment) that correlated with procedural advancements. Successful CTO PCI was associated with lower mortality [9.5%, 95% confidence interval (CI): 8.1-11.6 vs. 15.3%, 95% CI: 13.7-20.6, P<0.0001] that persisted after multivariate cox analysis (hazard ratio: 0.37, 95% CI: 0.25-0.62) and propensity matching (hazard ratio=0.36, 95% CI: 0.18-0.73, P=0.0005). CONCLUSION: Successful procedures were associated with lower mortality suggesting that the greater uptake of CTO PCI may improve clinical outcomes in a wider population than are currently being offered therapy.
Cheng K, de Silva R, 2018, New Advances in the Management of Refractory Angina Pectoris, EUROPEAN CARDIOLOGY REVIEW, Vol: 13, Pages: 70-79, ISSN: 1758-3756
Poulsen CB, Pedrigi RM, Pareek N, et al., 2018, Plaque burden influences accurate classification of fibrous cap atheroma by in-vivo optical coherence tomography in a porcine model of advanced coronary atherosclerosis, EuroIntervention, ISSN: 1774-024X
AIMS: In-vivo validation of coronary optical coherence tomography (OCT) against histology and the effects of plaque burden (PB) on plaque classification remain unreported. We investigated this in a porcine model with human-like coronary atherosclerosis. METHODS AND RESULTS: Five female Yucatan D374Y-PCSK9 transgenic hypercholesterolemic mini-pigs were implanted with a coronary shear-modifying stent to induce advanced atherosclerosis. OCT frames (n=201) were obtained 34 weeks after implantation. Coronary arteries were perfusion-fixed, serially sectioned and co-registered with OCT using a validated algorithm. Lesions were adjudicated using the Virmani classification and PB assessed from histology. OCT had a high sensitivity, but modest specificity (92.9% and 74.6%), for identifying fibrous cap atheroma (FCA). The reduced specificity for OCT was due to misclassification of plaques with histologically defined pathological intimal thickening (PIT) as FCA (46.1% of the frames with histological PIT were misclassified). PIT lesions misclassified as FCA by OCT had a statistically higher PB than in other OCT frames (median 32.0% versus 13.4%; p<0.0001). Misclassification of PIT lesions by OCT occurred when PB exceeded approximately 20%. CONCLUSIONS: Compared with histology, in-vivo OCT classification of FCA had high sensitivity but reduced specificity due to misclassification of PITs with high PB.
Pareek N, Kosovitsas A, Rubens M, et al., 2018, Double Trouble: Two Types of Stent Fracture in a Drug-Eluting Stent Secondary to Traction From a Saphenous Vein Graft, JACC-CARDIOVASCULAR INTERVENTIONS, Vol: 11, Pages: 316-318, ISSN: 1936-8798
Sainsbury PA, Fisher M, de Silva R, 2017, Alternative interventions for refractory angina, HEART, Vol: 103, Pages: 1911-+, ISSN: 1355-6037
de Silva R, Steg PG, 2017, Identifying patients with acute total coronary occlusion in NSTEACS: finding the high-risk needle in the haystack, EUROPEAN HEART JOURNAL, Vol: 38, Pages: 3090-3093, ISSN: 0195-668X
Cheng K, Wright C, De Silva R, 2017, The effect of a multi-disciplinary care pathway for refractory angina on psychological outcomes, quality of life and medication use, Publisher: OXFORD UNIV PRESS, Pages: 450-450, ISSN: 0195-668X
Ferreira PF, Nielles-Vallespin S, Scott AD, et al., 2017, Evaluation of the impact of strain correction on the orientation of cardiac diffusion tensors with in vivo and ex vivo porcine hearts, Magnetic Resonance in Medicine, Vol: 79, Pages: 2205-2215, ISSN: 0740-3194
PurposeTo evaluate the importance of strain-correcting stimulated echo acquisition mode echo-planar imaging cardiac diffusion tensor imaging.MethodsHealthy pigs (n = 11) were successfully scanned with a 3D cine displacement-encoded imaging with stimulated echoes and a monopolar-stimulated echo-planar imaging diffusion tensor imaging sequence at 3 T during diastasis, peak systole, and strain sweet spots in a midventricular short-axis slice. The same diffusion tensor imaging sequence was repeated ex vivo after arresting the hearts in either a relaxed (KCl-induced) or contracted (BaCl2-induced) state. The displacement-encoded imaging with stimulated echoes data were used to strain-correct the in vivo cardiac diffusion tensor imaging in diastole and systole. The orientation of the primary (helix angles) and secondary (E2A) diffusion eigenvectors was compared with and without strain correction and to the strain-free ex vivo data.ResultsStrain correction reduces systolic E2A significantly when compared without strain correction and ex vivo (median absolute E2A = 34.3° versus E2A = 57.1° (P = 0.01), E2A = 60.5° (P = 0.006), respectively). The systolic distribution of E2A without strain correction is closer to the contracted ex vivo distribution than with strain correction, root mean square deviation of 0.027 versus 0.038.ConclusionsThe current strain-correction model amplifies the contribution of microscopic strain to diffusion resulting in an overcorrection of E2A. Results show that a new model that considers cellular rearrangement is required.
Cheng K, Wright C, de Silva R, 2017, THE IMPACT OF A MULTI-DISCIPLINARY CARE PATHWAY FOR PATIENTS WITH REFRACTORY ANGINA ON PSYCHOSOCIAL OUTCOMES, QUALITY OF LIFE AND MEDICATION, Annual Conference of the British-Cardiovascular-Society (BCS), Publisher: BMJ PUBLISHING GROUP, Pages: A70-A71, ISSN: 1355-6037
Poulsen CB, Pedrigi R, Holm N, et al., 2017, COMPARISON OF IN VIVO OPTICAL COHERENCE TOMOGRAPHY DERIVED PLAQUE PHENOTYPE AND BURDEN WITH HISTOLOGY IN A PORCINE MODEL OF ADVANCED CORONARY ATHEROSCLEROSIS, 66th Annual Scientific Session and Expo of the American-College-of-Cardiology (ACC), Publisher: ELSEVIER SCIENCE INC, Pages: 1072-1072, ISSN: 0735-1097
Nielles-Vallespin S, Khalique Z, Ferreira PF, et al., 2017, Assessment of myocardial microstructural dynamics by in vivo diffusion tensor cardiac magnetic resonance, Journal of the American College of Cardiology, Vol: 69, Pages: 661-676, ISSN: 0735-1097
BackgroundCardiomyocytes are organized in microstructures termed sheetlets that reorientate during left ventricular thickening. Diffusion tensor cardiac magnetic resonance (DT-CMR) may enable noninvasive interrogation of in vivo cardiac microstructural dynamics. Dilated cardiomyopathy (DCM) is a condition of abnormal myocardium with unknown sheetlet function.ObjectivesThis study sought to validate in vivo DT-CMR measures of cardiac microstructure against histology, characterize microstructural dynamics during left ventricular wall thickening, and apply the technique in hypertrophic cardiomyopathy (HCM) and DCM.MethodsIn vivo DT-CMR was acquired throughout the cardiac cycle in healthy swine, followed by in situ and ex vivo DT-CMR, then validated against histology. In vivo DT-CMR was performed in 19 control subjects, 19 DCM, and 13 HCM patients.ResultsIn swine, a DT-CMR index of sheetlet reorientation (E2A) changed substantially (E2A mobility ∼46°). E2A changes correlated with wall thickness changes (in vivo r2 = 0.75; in situ r2 = 0.89), were consistently observed under all experimental conditions, and accorded closely with histological analyses in both relaxed and contracted states. The potential contribution of cyclical strain effects to in vivo E2A was ∼17%. In healthy human control subjects, E2A increased from diastole (18°) to systole (65°; p < 0.001; E2A mobility = 45°). HCM patients showed significantly greater E2A in diastole than control subjects did (48°; p < 0.001) with impaired E2A mobility (23°; p < 0.001). In DCM, E2A was similar to control subjects in diastole, but systolic values were markedly lower (40°; p < 0.001) with impaired E2A mobility (20°; p < 0.001).ConclusionsMyocardial microstructure dynamics can be characterized by in vivo DT-CMR. Sheetlet function was abnormal in DCM with altered systolic conformation and reduced mobility, contrasting with HCM, which showed reduced mobility with alte
Pareek N, Serruys P, de Silva R, 2017, Shedding light on inflammation, EHJ Cardiovascular Imaging / European Heart Journal - Cardiovascular Imaging, Vol: 18, Pages: 519-520, ISSN: 2047-2412
Giavarini A, Kilic ID, Redondo Diéguez A, et al., 2017, Intracoronary Imaging., Heart, Vol: 103, Pages: 708-725
Giavarini A, Kilic ID, Redondo Dieguez A, et al., 2017, Chronic ischaemic heart disease: Intracoronary Imaging, HEART, Vol: 103, Pages: 708-725, ISSN: 1355-6037
Raphael CE, Keegan J, Parker KH, et al., 2016, Feasibility of cardiovascular magnetic resonance derived coronary wave intensity analysis, Journal of Cardiovascular Magnetic Resonance, Vol: 18, ISSN: 1532-429X
BackgroundWave intensity analysis (WIA) of the coronary arteries allows description of the predominant mechanisms influencing coronary flow over the cardiac cycle. The data are traditionally derived from pressure and velocity changes measured invasively in the coronary artery. Cardiovascular magnetic resonance (CMR) allows measurement of coronary velocities using phase velocity mapping and derivation of central aortic pressure from aortic distension. We assessed the feasibility of WIA of the coronary arteries using CMR and compared this to invasive data.MethodsCMR scans were undertaken in a serial cohort of patients who had undergone invasive WIA. Velocity maps were acquired in the proximal left anterior descending and proximal right coronary artery using a retrospectively-gated breath-hold spiral phase velocity mapping sequence with high temporal resolution (19 ms). A breath-hold segmented gradient echo sequence was used to acquire through-plane cross sectional area changes in the proximal ascending aorta which were used as a surrogate of an aortic pressure waveform after calibration with brachial blood pressure measured with a sphygmomanometer. CMR-derived aortic pressures and CMR-measured velocities were used to derive wave intensity. The CMR-derived wave intensities were compared to invasive data in 12 coronary arteries (8 left, 4 right). Waves were presented as absolute values and as a % of total wave intensity. Intra-study reproducibility of invasive and non-invasive WIA was assessed using Bland-Altman analysis and the intraclass correlation coefficient (ICC).ResultsThe combination of the CMR-derived pressure and velocity data produced the expected pattern of forward and backward compression and expansion waves. The intra-study reproducibility of the CMR derived wave intensities as a % of the total wave intensity (mean ± standard deviation of differences) was 0.0 ± 6.8%, ICC = 0.91. Intra-study reproducib
Cheng K, Sainsbury P, Fisher M, et al., 2016, Management of refractory angina pectoris, European Cardiology Review, Vol: 11, Pages: 69-76, ISSN: 1758-3756
With improvements in survival from coronary artery disease (CAD) and an ageing population, refractory angina (RA) is becoming an increasingly common clinical problem facing clinicians in routine clinical practice. These patients experience chronic symptoms in the context of CAD, characterised by angina-type pain, which is uncontrolled despite optimal pharmacological, interventional and surgical therapy. Although mortality rates are no worse in this cohort, patients experience a significantly impaired quality of life with disproportionately high utilisation of healthcare services. It has been increasingly recognised that the needs of RA patients are multifactorial and best provided by specialist multi-disciplinary units. In this review, we consider the variety of therapies available to clinicians in the management of RA and discuss the promise of novel treatments.
Pedrigi RM, Mehta VV, Bovens SM, et al., 2016, Influence of shear stress magnitude and direction on atherosclerotic plaque composition, Royal Society Open Science, Vol: 3, ISSN: 2054-5703
The precise flow characteristics that promote different atherosclerotic plaque types remain unclear. We previously developed a blood flow-modifying cuff for ApoE(-/-) mice that induces the development of advanced plaques with vulnerable and stable features upstream and downstream of the cuff, respectively. Herein, we sought to test the hypothesis that changes in flow magnitude promote formation of the upstream (vulnerable) plaque, whereas altered flow direction is important for development of the downstream (stable) plaque. We instrumented ApoE(-/-) mice (n = 7) with a cuff around the left carotid artery and imaged them with micro-CT (39.6 µm resolution) eight to nine weeks after cuff placement. Computational fluid dynamics was then performed to compute six metrics that describe different aspects of atherogenic flow in terms of wall shear stress magnitude and/or direction. In a subset of four imaged animals, we performed histology to confirm the presence of advanced plaques and measure plaque length in each segment. Relative to the control artery, the region upstream of the cuff exhibited changes in shear stress magnitude only (p < 0.05), whereas the region downstream of the cuff exhibited changes in shear stress magnitude and direction (p < 0.05). These data suggest that shear stress magnitude contributes to the formation of advanced plaques with a vulnerable phenotype, whereas variations in both magnitude and direction promote the formation of plaques with stable features.
Raphael CE, Cooper R, Parker KH, et al., 2016, Mechanisms of myocardial ischemia in hypertrophic cardiomyopathy: insights from wave intensity analysis and magnetic resonance, Journal of the American College of Cardiology, Vol: 68, Pages: 1651-1660, ISSN: 1558-3597
BACKGROUND: Angina is common in hypertrophic cardiomyopathy (HCM) and is associated with abnormal myocardial perfusion. Wave intensity analysis improves the understanding of the mechanics of myocardial ischemia. OBJECTIVES: Wave intensity analysis was used to describe the mechanisms underlying perfusion abnormalities in patients with HCM. METHODS: Simultaneous pressure and flow were measured in the proximal left anterior descending artery in 33 patients with HCM and 20 control patients at rest and during hyperemia, allowing calculation of wave intensity. Patients also underwent quantitative first-pass perfusion cardiac magnetic resonance to measure myocardial perfusion reserve. RESULTS: Patients with HCM had a lower coronary flow reserve than control subjects (1.9 ± 0.8 vs. 2.7 ± 0.9; p = 0.01). Coronary hemodynamics in HCM were characterized by a very large backward compression wave during systole (38 ± 11% vs. 21 ± 6%; p < 0.001) and a proportionately smaller backward expansion wave (27% ± 8% vs. 33 ± 6%; p = 0.006) compared with control subjects. Patients with severe left ventricular outflow tract obstruction had a bisferiens pressure waveform resulting in an additional proximally originating deceleration wave during systole. The proportion of waves acting to accelerate coronary flow increased with hyperemia, and the magnitude of change was proportional to the myocardial perfusion reserve (rho = 0.53; p < 0.01). CONCLUSIONS: Coronary flow in patients with HCM is deranged. Distally, compressive deformation of intramyocardial blood vessels during systole results in an abnormally large backward compression wave, whereas proximally, severe left ventricular outflow tract obstruction is associated with an additional deceleration wave. Perfusion abnormalities in HCM are not simply a consequence of supply/demand mismatch or remodeling of the intramyocardial blood vessels; th
Giavarini A, de Silva R, 2016, The Role of Ivabradine in the Management of Angina Pectoris, Cardiovascular Drugs and Therapy, Vol: 30, Pages: 407-417, ISSN: 0920-3206
Stable angina pectoris affects 2–4 % of the population in Western countries and entails an annual risk of death and nonfatal myocardial infarction of 1–2 % and 3 %, respectively. Heart rate (HR) is linearly related to myocardial oxygen consumption and coronary blood flow, both at rest and during stress. HR reduction is a key target for the prevention of ischemia/angina and is an important mechanism of action of drugs which are recommended as first line therapy for the treatment of angina in clinical guidelines. However, many patients are often unable to tolerate the doses of beta blocker or non-dihydropyridine calcium antagonists required to achieve the desired symptom control. The selective pacemaker current inhibitor ivabradine was developed as a drug for the management of patients with angina pectoris, through its ability to reduce HR specifically. The available data suggest that ivabradine is a well-tolerated and effective anti-anginal agent and it is recommended as a second-line agent for relief of angina in guidelines. However, recent clinical trials of ivabradine have failed to show prognostic benefit and have raised potential concerns about safety. This article will review the available evidence base for the current role of ivabradine in the management of patients with symptomatic angina pectoris in the context of stable coronary artery disease.
McGill L-A, Ferreira P, Scott A, et al., 2016, Non-invasive Interrogation of Myocardial Disarray in Hypertrophic Cardiomyopathy, Annual Conference of the British Cardiovascular Society (BCS) on Prediction and Prevention, Publisher: BMJ Publishing Group, Pages: A96-A96, ISSN: 1355-6037
Wright C, De Silva R, 2016, Management of refractory angina: The importance of winning over both hearts and minds Christine Wright, Ranil de Silva, British Journal of Cardiology, Vol: 23, Pages: 45-46, ISSN: 0969-6113
de Silva R, 2016, What is the role of interventional procedures in the management of refractory angina pectoris?, Dialogues in Cardiovascular Medicine, Vol: 21, Pages: 196-208, ISSN: 1272-9949
The population of patients with refractory angina pectoris is growing, with estimates of approximately 30 000 to 50 000 new cases in Europe each year. Patients with refractory angina pectoris often end up in a perpetual cycle of longterm visits to the outpatient and emergency departments. This cycle results in a disproportionately large consumption of health care resources, resulting in overinvestigation, polypharmacy, high attendance rates in primary and secondary care, hospitalization, and prolonged hospital stays. Much of this could be avoided by providing novel interventions and better models of care. This article aims to critically review the recent interventional approaches designed to improve symptoms and quality of life for patients with refractory angina pectoris.
McGill LA, Ferreira PF, Scott AD, et al., 2016, Relationship between cardiac diffusion tensor imaging parameters and anthropometrics in healthy volunteers, Journal of Cardiovascular Magnetic Resonance, Vol: 18, Pages: 2-2
Antonacci G, Pedrigi RM, Kondiboyina A, et al., 2015, Quantification of plaque stiffness by Brillouin microscopy in experimental thin cap fibroatheroma, JOURNAL OF THE ROYAL SOCIETY INTERFACE, Vol: 12, ISSN: 1742-5689
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Keegan J, Raphael CE, Parker K, et al., 2015, Validation of high temporal resolution spiral phase velocity mapping of temporal patterns of left and right coronary artery blood flow against Doppler guidewire, Journal of Cardiovascular Magnetic Resonance, Vol: 17, ISSN: 1532-429X
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<sup>2</sup>: 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<sup>2</sup> 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.
Pedrigi RM, Poulsen CB, Mehta VV, et al., 2015, Inducing persistent flow disturbances accelerates atherogenesis and promotes thin cap fibroatheroma development in D374Y-PCSK9 hypercholesterolemic minipigs, Circulation, Vol: 132, Pages: 1003-1012, ISSN: 0009-7322
BACKGROUND: -Although disturbed flow is thought to play a central role in the development of advanced coronary atherosclerotic plaques, no causal relationship has been established. We evaluated whether inducing disturbed flow would cause the development of advanced coronary plaques, including thin cap fibroatheroma (TCFA). METHODS AND RESULTS: -D374Y-PCSK9 hypercholesterolemic minipigs (N=5) were instrumented with an intracoronary shear-modifying stent (SMS). Frequency-domain optical coherence tomography was obtained at baseline, immediately post-stent, 19, and 34 weeks and used to compute shear stress metrics of disturbed flow. At 34 weeks, plaque type was assessed within serially-collected histological sections and co-registered to the distribution of each shear metric. The SMS caused a flow-limiting stenosis and blood flow exiting the SMS caused regions of increased shear stress on the outer curvature and large regions of low and multidirectional shear stress on the inner curvature of the vessel. As a result, plaque burden was ~3-fold higher downstream of the SMS compared to both upstream of the SMS and in the control artery (p<0.001). Advanced plaques were also primarily observed downstream of the SMS, in locations initially exposed to both low (p<0.002) and multidirectional (p<0.002) shear stress. TCFA regions demonstrated significantly lower shear stress that persisted over the duration of the study compared to other plaque types (p<0.005). CONCLUSIONS: -These data support a causal role for lowered and multidirectional shear stress in the initiation of advanced coronary atherosclerotic plaques. Persistently lowered shear stress appears to be the principal flow disturbance needed for the formation of TCFA.
Poulsen CB, Pedrigi RM, Mehta VV, et al., 2015, INDUCTION OF PERTURBED SHEAR STRESS LEADS TO FOCAL ADVANCED ATHEROSCLEROTIC PLAQUE FORMATION IN TRANSGENIC MINIPIGS WITH HYPERCHOLESTEROLEMIA, Scientific Session of the American-College-of-Cardiology (ACC), Publisher: ELSEVIER SCIENCE INC, Pages: A1927-A1927, ISSN: 0735-1097
Raphael CE, Cooper R, Keegan J, et al., 2015, IMPACT OF LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION AND MICROCIRCULATORY DYSFUNCTION ON CORONARY HAEMODYNAMICS IN HYPERTROPHIC CARDIOMYOPATHY, Scientific Session of the American-College-of-Cardiology (ACC), Publisher: ELSEVIER SCIENCE INC, Pages: A952-A952, ISSN: 0735-1097
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de Silva R, Tsujioka H, Gaze D, et al., 2015, Serial Changes in High-Sensitivity Cardiac Troponin, N-terminal Pro-B-Type Natriuretic Peptide, and Heart Fatty Acid Binding Protein during Exercise Echocardiography in Patients with Suspected Angina Pectoris and Normal Resting Left Ventricular Function, CLINICAL CHEMISTRY, Vol: 61, Pages: 554-556, ISSN: 0009-9147
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Verheye S, Jolicœur EM, Behan MW, et al., 2015, Efficacy of a device to narrow the coronary sinus in refractory Angina, New England Journal of Medicine, Vol: 372, Pages: 519-527, ISSN: 0028-4793
BACKGROUND: Many patients with coronary artery disease who are not candidates for revascularization have refractory angina despite standard medical therapy. The balloonexpandable, stainless steel, hourglass-shaped, coronary-sinus reducing device creates a focal narrowing and increases pressure in the coronary sinus, thus redistributing blood into ischemic myocardium. METHODS: We randomly assigned 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina (on a scale from I to IV, with higher classes indicating greater limitations on physical activity owing to angina) and myocardial ischemia, who were not candidates for revascularization, to implantation of the device (treatment group) or to a sham procedure (control group). The primary end point was the proportion of patients with an improvement of at least two CCS angina classes at 6 months. RESULTS: A total of 35% of the patients in the treatment group (18 of 52 patients), as compared with 15% of those in the control group (8 of 52), had an improvement of at least two CCS angina classes at 6 months (P=0.02). The device was also associated with improvement of at least one CCS angina class in 71% of the patients in the treatment group (37 of 52 patients), as compared with 42% of those in the control group (22 of 52) (P = 0.003). Quality of life as assessed with the use of the Seattle Angina Questionnaire was significantly improved in the treatment group, as compared with the control group (improvement on a 100-point scale, 17.6 vs. 7.6 points; P = 0.03). There were no significant between-group differences in improvement in exercise time or in the mean change in the wall-motion index as assessed by means of dobutamine echocardiography. At 6 months, 1 patient in the treatment group had had a myocardial infarction; in the control group, 1 patient had died and 3 had had a myocardial infarction. CONCLUSIONS: In this small clinical trial, implantation of the coronary-sinus reducing device was associate
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