Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina

Verheye, Stefan; Jolicœur, E. Marc; Behan, Miles; Pettersson, Thomas; Sainsbury, Paul; Hill, Jonathan; Vrolix, Mathias; Agostoni, Pierfrancesco; Engstrøm, Thomas; Labinaz, Marino; Silva, Ranil de; Schwartz, Marc; Meyten, Nathalie; Uren, Neal; Doucet, Serge; Tanguay, Jean François; Lindsay, Steven; Henry, Timothy D.; White, Christopher J.; Edelman, Elazer R.; Banai, Shmuel

doi:10.1056/nejmoa1402556

Cited by 229 publications

(220 citation statements)

References 37 publications

(26 reference statements)

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“…15 One reason for the dearth of real placebo trials in device studies is the incidence of procedure related complications and the ORBITA study illustrates the inherent risks. Of the 95 patients in the 'placebo' arm, 4 had wire related complications, necessitating bail out PCI, while 2 sustained post procedural major bleeding -a clinically signifi cant complication rate requiring intervention of 6.3%.…”

Section: Ischaemia Versus Symptom Guided Revascularisationmentioning

confidence: 99%

Orbita – Much Ado about Nothing?

Zaman

2018

Journal of the Royal College of Physicians of Edinburgh

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SummaryORBITA was a placebo-controlled, multicentre, randomised trial of percutaneous coronary intervention (PCI) conducted in the UK. It enrolled patients with stable angina or equivalent symptoms and at least one angiographically severe lesion ≥ 70% in at least one vessel and vulnerable to PCI. Notable exclusions were patients admitted with an acute coronary syndrome, previous coronary artery bypass surgery and presence of disease in the left main stem. After enrolment there were two distinct phases to the trial that differentiated it from previous PCI trials. For the fi rst 6 weeks all patients underwent an intensive medical optimisation phase during which antianginal therapy was titrated. All patients had (telephone) access to a study doctor who was responsible for optimising therapy based on patient history. The second phase, after this 6 week period, was a pre-randomisation assessment followed by the randomised (wire across lesion only vs. PCI) blinded procedure with both groups being treated with identical duration of dual antiplatelet therapy. During the intervention procedure, patients had auditory isolation with headphones playing music throughout. The outcome measures were angina (measured using Seattle Angina Questionnaire), quality of life (quantifi ed using the 5 level EuroQol 5 dimensions), functional capacity using cardiopulmonary exercise testing and myocardial ischaemic burden with dobutamine stress echocardiography. Importantly, the clinical team including all staff present at the randomised blinded procedure were blinded to the results of the symptom burden and quality of life assessments.The interventional procedure for all enrolled patients involved an invasive procedure consisting of intubation of the coronary artery with a guiding catheter (from either the radial or femoral artery) and crossing the lesion with an intracoronary wire to make a physiological assessment of the culprit vessel. The numerical result of the physiology display was not visible to the operator who followed the randomisation code to which the patient was allocated. For patients randomised to PCI, standard PCI procedure was followed with the use of drugeluting stents optimised with post-dilatation. After stent deployment, the physiology measurement was repeated with the operator also being blinded to this fi gure.After a follow up period of 6 weeks, patients had all prerandomisation tests repeated. Once complete, patients and physicians were unblinded, with patients free to choose PCI after consultation with their physician.The pre-specifi ed primary endpoint of the study was the difference in exercise time between the groups. There were several secondary endpoints: change in peak oxygen uptake, change in exercise to 1 mm ST segment depression, angina severity based on Canadian Cardiovascular Society class, physical limitation, angina stability, angina severity (Seattle Angina Questionnaire), quality of life (EQ-5D-SL), Duke treadmill score and change in dobutamine stress echocardiography wall motion score.Of 368 pati...

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Section: Ischaemia Versus Symptom Guided Revascularisationmentioning

confidence: 99%

Orbita – Much Ado about Nothing?

Zaman

2018

Journal of the Royal College of Physicians of Edinburgh

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“…Despite the use of newer antianginal therapy (ranolazine), a large number of patients remain highly symptomatic with impaired quality of life. Verheye et al recently reported the use of a novel balloon-expandable device placed within the coronary sinus to cause of a focal narrowing, thereby increasing pressure within the coronary sinus and theoretically redistributing blood flow to ischaemic myocardium 22 23. In a small clinical trial of 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina, use of the device relative to a sham procedure was associated with a marked improvement in CCS angina class.…”

Section: Stable Cadmentioning

confidence: 99%

Almanac 2015: coronary artery disease

Shavelle

2016

Heart

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Recent years have seen major advances in the evaluation and treatment of patients with coronary artery disease. These include assessment of novel biomarkers and imaging methods for patients at risk for coronary artery disease, care of patients with ST-segment elevation myocardial infarction, a novel device to treat medical refractory angina, use of non-statin lipid-lowering agents, a better understanding of the risks and benefits of long-term dual antiplatelet therapy and the use of the newer antiplatelet agents. This article summarises research related to coronary artery disease published in Heart in 2014 and 2015, within the context of other major cardiovascular journals.

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“…In a recent randomized, controlled trial, the coronary sinus restrictor significantly reduced the angina class vs. the control group at 6 months. 54 Clearly, this intervention requires more evaluation.…”

Section: Transmyocardial Revascularizationmentioning

confidence: 99%

Angina treatments and prevention of cardiac events: an appraisal of the evidence: Table 1

Winchester

Pepine

2015

Eur Heart J Suppl

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Angina pectoris is the symptomatic manifestation of transient myocardial ischaemia. At the most fundamental level, angina arises when myocardial oxygen demand exceeds the ability of the coronary circulation to provide adequate oxygen delivery to maintain normal myocardial metabolic function. In vivo, the balance of oxygen demand and delivery is a complex physiological process that can be altered by a variety of interventions. Lifestyle modification is a cornerstone of cardiovascular disease management, with or without angina. Additional pharmaceutical and physical interventions are usually applied to patients with angina. Mechanisms of action for these interventions include heart rate modulation, vascular smooth muscle relaxation, metabolic manipulation, revascularization, and others. A number of these interventions have overlapping mechanisms that target angina. Additionally, some interventions may directly or indirectly prevent or delay adverse outcomes such as myocardial infarction or death. This review summarizes current evidence for many applied ischaemia treatments documented to modify angina and comments on available evidence relating to improvement in cardiovascular outcomes.

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Efficacy of a Device to Narrow the Coronary Sinus in Refractory Angina

Abstract: T h e ne w e ngl a nd jou r na l o f m e dicine n engl j med 372;6 nejm.org february 5, 2015

Cited by 229 publications

References 37 publications

Orbita – Much Ado about Nothing?

Orbita – Much Ado about Nothing?

Almanac 2015: coronary artery disease

Angina treatments and prevention of cardiac events: an appraisal of the evidence: Table 1

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