News in brief from the world of cardiology
SAPIEN valve positive results
Clinicians have achieved successful one-year outcomes in high-risk or inoperable patients undergoing transcatheter aortic valve replacement during the first two years since release of the valve (Sapien®, Edwards) commercially, according to results presented at the Euro PCR 2001 meeting in Paris, France.
Despite high predicted mortality and multiple co-morbidities in many of these patients, survival at one year was 76% in the 1,038 patients treated as part of Cohort I (first year of commercialisation), and 77% in the 1,269 patients treated as part of Cohort II (second year of commercialisation). Since November 2007, over 2,300 patients were enrolled in the post-market European SOURCE Registry.
Clinical outcomes improved by biodegradable stent
Drug-eluting stents (DES) using a biodegradable polymer significantly improve clinical outcomes and reduce stent thrombosis by 50% compared with those using a durable polymer, according to findings from an independent patient-level meta-analysis involving over 4,000 patients announced at the Euro PCR 2011 meeting in Paris, France, recently.
The incidence of the composite primary end point (cardiac death, myocardial infarction or clinically-indicated target vessel revascularisation) at three years was significantly lower in the biodegradable polymer DES-treated group than in the durable polymer DES-treated group. Rates of definite stent thrombosis at three years were also significantly lower in the biodegradable polymer DES-treated group than in the durable polymer DES-treated group.
NICE updates on bivalirudin and ticagrelor
Bivalirudin therapy (Angiox®, The Medicines Company), in combination with aspirin and clopidogrel, has been recommended by the National Institute for Health and Clinical Excellence (NICE) for the treatment of adults with ST-segment-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
In its review the Appraisal Committee noted “the robustness of the clinical data, in which treatment with bivalirudin dominated treatment with a glycoprotein IIb/IIIa inhibitor plus heparin (that is, was less costly and more effective) and that the results of the model are robust to the various sensitivity analyses”. Full guidance is available at http://guidance.nice.org.uk/TA230
In an appraisal consultation document, NICE has concluded that ticagrelor (Brilique®, AstraZeneca) is a cost-effective treatment option in adult patients with acute coronary syndromes (ACS) in England and Wales. It has recommended its use in combination with aspirin as a treatment for adult patients with ACS. Final guidance is expected later this year.
Dronedarone safety review
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have announced that results from the PALLAS trial will be considered in their safety reviews of dronedarone (Multaq,® Sanofi-Aventis).
The PALLAS study investigating high-risk patients with permanent atrial fibrillation was prematurely stopped after first results indicated that there was a 2.3 fold increase in the combined end point of stroke, systemic arterial embolism, myocardial infarction or cardiovascular death in the dronedarone arm compared to the placebo arm.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to shortly finalise its review of the overall benefit-risk balance of the drug.
The FDA currently considers that the PALLAS study results are preliminary because the data have not undergone quality assurance procedures and have not been completely adjudicated. They advise, however, that Multaq® should not be prescribed to patients with permanent atrial fibrillation.
Sanofi-Aventis have reminded doctors that the current indication for dronedarone in the UK is in adult clinically stable patients with a history of, or current non-permanent AF to prevent recurrence of AF or to lower ventricular rate.
Dabigatran licensed in the UK
Dabigatran (Pradaxa®, Boehringer Ingelheim) has now been licensed by the EU for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors. It is the first new oral anticoagulant for over 50 years.
Its licence follows results from the RE-LY study which showed that dabigatran, at the recommended dose (150 mg twice daily), reduced the relative risk of stroke or systemic embolism by 35% in eligible AF patients compared to warfarin (1.71 % versus 1.11 %, respectively, p = < 0.001). The RE-LY study involved 18,113 patients in 44 countries.
AF is the most common heart rhythm condition in the UK affecting 1.2 million people, and is a leading cause of stroke.
EMA recommends new pioglitazone labelling
The European Medicines Agency (EMA) has recommended labelling changes for medicines containing pioglitzone (Actos®, Takeda), as a result of the small increased risk of bladder cancer seen in patients taking these medicines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommends new contraindications and warnings regarding appropriate patient selection, and periodic review of the efficacy and safety of treatment, to reduce risk.
The CHMP’s European review of pioglitazone-containing medicines, initiated in March 2011, reviewed all available data on the occurrence of bladder cancer, finding that the benefit/risk balance remained positive in limited populations of patients with type-2 diabetes. The EMA’s recommendation will be forwarded to the European Commission for a final decision.
SMC recommendation for intravenous iron in anaemia
Intravenous iron (Ferinject®, Vifor) has been recommended by the Scottish Medicines Consortium (SMC) for the treatment of iron deficiency anaemia when oral iron preparations are ineffective or non-applicable.
Intravenous iron has also received approval for a simplified dosing regimen to treat iron deficiency from the Medicine and Healthcare products Regulatory Agency (MHRA). The new regimen means the treatment can be delivered in standardised doses depending on a given patient’s body weight and haemoglobin level.
New lipid management guidelines
Clinicians should aim for low-density lipoprotein (LDL) cholesterol levels below <3.0 mmol/L in moderate-risk patients with dyslipidaemia, <2.5 mmol/L in high- risk patients, and <1.8 mmol/L and/or at least a 50% reduction in levels if this target cannot be reached in very high risk patients, according to new guidelines from the European Atherosclerosis Society (EAS) and the European Society of Cardiology (Eur Heart J 2011 doi: 10.1093/eurheartj/her158)
In addition to LDL cholesterol as the key target, two other options have been introduced: non-high-density lipoprotein (HDL) cholesterol and apolipoprotein B.
Digital stethoscope to aid early diagnosis
Earlier diagnosis of heart disease could be aided by a digital stethoscope currently in development by a Queen Mary, University of London team. The technology synchronises the sounds of a human heartbeat, representing the beat and any anomalies in graph-form.
The ‘DigiScope’ system is designed to be used in the same way as a normal stethoscope to collect the four separate sounds of a heartbeat. These are then transmitted wirelessly to a laptop or desktop and synchronised into one combined signal, which can be processed by independent component analysis.
Readings will produce visual graphs that can be compared with ‘normal’ readings while the patient is present, studied at a later time, or transmitted to peers via the internet for a second opinion.
Smoking cessation drug linked to CV events
A smoking cessation treatment varenicline may increase the risk of serious cardiovascular (CV) events, resulting in hospitalisation, disability or death, according to a study by the University of East Anglia and two US universities. The systematic review and meta-analysis (CMAJ 2011 doi:10.1503/cmaj.110218) used data from 14 double-blind randomised controlled trials lasting between one and 52 weeks, finding serious heart problems of around 1%.
While the US Food and Drug Administration has revised the medication’s labelling after finding it to be associated with an increase in adverse cardiovascular events, the European Medicines Agency (EMA) has confirmed that the treatment’s proven efficacy for smoking cessation means its benefit-risk balance remains positive, despite the side effects.
Statins reduce atherosclerosis in patients with CKD
A lipid-lowering medicine has been shown to reduce major atherosclerotic events in patients with chronic kidney disease (CKD) for the first time, according to a study published recently in The Lancet (doi:10.1016/S0140-6736(11)60739-3).
Ezetimibe/simvastatin (10/20 mg) reduced the risk of major atherosclerotic events (non-fatal myocardial infarction (MI) or coronary death, non-haemorrhagic stroke or revascularisation procedures) by a statistically significant 17% compared with placebo (p = 0.0021) in the SHARP (The Study of Heart and Renal Protection) study, which randomised 9,270 patients with CKD (3,023 on dialysis and 6,247 not) with no known history of MI or coronary revascularisation to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo.
The combination also reduced low-density lipoprotein cholesterol by an average of 0.85 mmol/L more than placebo at study midpoint of 2.5 years. Patients were followed up for a median of 4.9 years.
Professor Michael Kirby, University of Hertfordshire, said of the results: “Chronic kidney disease is a prevalent condition estimated to affect up to one in ten and it was added to the Quality and Outcomes Framework in 2006. Traditionally blood pressure has been a focus in these patients but this study highlights the importance of cholesterol as well. It is important that we continue to monitor for and understand CKD, a condition which brings risk of serious cardiovascular repercussions”.
EHRA prize for London doctor
Dr Tarvinder Dhanjal, a trainee in electrophysiology at Guy’s and St Thomas’ Hospital, London, has won the European Heart Rhythm Association’s electrophysiology case college prize after describing how he diagnosed and cured his patient’s two different arrhythmias, one of which masked the other. The case was in a patient who had undergone transcatheter aortic valve implantation (TAVI) surgery but retained a very rapid heartbeat that was unresponsive to drug treatment. After a surface electrocardiogram (ECG) showed atrial flutter, the patient underwent an electrical catheter study to diagnose and destroy the aberrant region but his elevated heart rate did not decrease. Dr Dhanjal then diagnosed and treated a second arrhythmia, an atrioventricular nodal re-entry tachycardia, which had been masked because, at 180 beats per minute, it was exactly half the speed of the flutter