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Good news for Renal Denervation

HTN improved with Renal Denervation

Heparin in HEAT-PPCI

Drug encapsulation reduces cardiac changes

Rheumatic Heart Disease neglected

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New analysis of the SYMPLICITY HTN-3 Trial

Key factors of renal denervation may have contributed to the unexpected outcome.

Results of the SYMPLICITY HTN-3 [1] trial sent shock waves through the cardiology community when they appeared to show that there was no significant difference in patient outcome between renal denervation and a sham procedure in patients with drug resistant HTN. As a result, renal denervation procedures came to a halt. Now, an analysis has shown that the results were probably affected by a number of confounding factors that partially explain the unexpected blood pressure responses.
The analysis, published in the European Heart Journal [2], identified factors in the SYMPLICITY HTN-3 trial, such as variations in the performed procedure and changes in patients’ medications and drug compliance, which may have had a significant impact on the results.
 
Professor Thomas Lüscher, editor-in-chief of the European Heart Journal, said: “SYMPLICITY HTN-3 resulted in referrals for the procedure drying up completely, making further trials almost impossible. However, in the analysis published in the European Heart Journal, David Kandzari and colleagues shed light for the first time on the interpretation of the results and suggest that in many patients the number of renal denervations was probably insufficient to achieve the proper degree of reduction in blood pressure that previous research had suggested was possible.”

Prof Lüscher, who has co-authored an editorial [3] to accompany Prof Kandzari’s paper, said: “Professor Kandzari’s analysis shows there were significant variations in the way that patients in SYMPLICITY HTN-3 were ablated. His sub-analysis now shows, for the first time, that if patients received 12 or more ablations in the trial, they experienced the same blood pressure reduction as in the earlier, SYMPLICITY HTN-2 trial and as reported by a large number of registries.”
With this new information, new trials can be performed that may provide the evidence needed to back up anecdotal and registry evidence.

A podcast of the editorial by Felix Mahfoud and Thomas Lüscher is available at eurheartj.oxfordjournals.org/podcast and on iTunes.

Refs:

[1] “A controlled trial of renal denervation for resistant hypertension”, by Deepak L. Bhatt et al. New England Journal of Medicine 2014; 370:1393-1401; April 10, 2014 http://www.nejm.org/toc/nejm/370/15/ ; doi: 10.1056/NEJMoa1402670

[2] “Predictors of blood pressure response in the SYMPLICITY HTN-3 trial”, by David E. Kandzari et al. European Heart Journal. doi:10.1093/eurheartj/ehu441. Published online: http://eurheartj.oxfordjournals.org/content/early/2014/11/13/eurheartj.ehu441

[3] “Renal denervation: simply trapped by complexity?”, by Felix Mahfoud and Thomas Felix Lüscher. European Heart Journal. doi:10.1093/eurheartj/ehu450. Published online: http://eurheartj.oxfordjournals.org/content/early/2014/11/13/eurheartj.ehu450

 

REDUCE-HTN shows blood pressure reductions with Renal Denervation

The 6 months results of the REDUCE-HTN trial have shown blood pressure reductions with renal denervation in patients with resistant hypertension. The prospective, multicentre, single-arm study tested the safety and efficacy of the balloon-based bipolar Vessix renal denervation system in 146 patients with office systolic blood pressure ≥160 mmHg despite three or more antihypertensive medications at maximally tolerated doses.

Patients receiving the intervention achieved reductions in both office and ambulatory blood pressure. Renal artery safety and renal function results were favourable. There were no acute events that indicated seriously compromised renal artery integrity or cardiovascular complications and less than 6% of patients had serious procedure related adverse events.

Mean eGFR was stable during the 6 months of follow up. The authors concluded that in addition to lifestyle modifications and antihypertensive medications, renal denervation may be a treatment option for some patients with hypertension.

The full paper is here.

 

HEAT-PPCI shows reduced incidence of major adverse ischaemic events with heparin

HEAT-PPCI was an open-label randomised controlled trial that compared antithrombotic therapy with bivalirudin or unfractionated heparin during primary percutaneous coronary intervention (PPCI). Before angiography, more than 1,800 patients were randomised 1:1 to heparin or bivalirudin then followed up for 28 days.
The use of GP IIb/IIIa inhibitors was reserved for selective bailout use as per European Society of Cardiology guidelines and the rate of use was much the same between groups.

The primary efficacy outcome was a composite of all-cause mortality, cerebrovascular accident, reinfarction, or unplanned target lesion revascularization. The primary safety outcome was incidence of major bleeding.

The primary efficacy outcome occurred in 8.7% of patients in the bivalirudin group and 5.7% of patients in the heparin group (p=0.01). The primary safety outcome occurred in 3.5% of patients in the bivalirudin group and 3.1% of patients in the heparin group (p=0.59).
The study showed that compared with bivalirudin, heparin reduced the incidence of major adverse ischaemic events - in particular acute stent thrombosis and associated reinfarction events – with no difference in bleeding.

The researchers concluded that systematic use of heparin rather than bivalirudin would substantially reduce drug costs.

The full paper is here.

 

Encapsulation of cancer drugs reduces cardiac damage

Austrian researchers have shown that a new technique which wraps chemotherapy drugs in a fatty cover (liposome) reduces heart damage, in a study presented at EuroEcho-Imaging 2014 in Vienna.

Cardiotoxicity can occur acutely or up to 30 years after chemotherapy and is the second most common cause of death in cancer patients, after secondary malignancy in childhood cancer survivors.

Liposomal encapsulation is a new technique which enables more of the drug to reach the cancer cells because there is less degradation. There are fewer side effects on healthy cells because the fat cover acts as a barrier. The drug stays in the bloodstream longer, allowing higher cumulative doses to be given.
Researchers tested whether non-pegylated liposome encapsulation of the anthracycline doxorubicin (called Myocet) could decrease its cardiotoxicity compared to conventional doxorubicin or epirubicin, another anthracycline.

The study included 24 pigs that were randomised to receive the human dose-equivalent of either Myocet, conventional doxorubicin, or epirubicin in 3 cycles. Cardiac function was assessed by echocardiography and magnetic resonance imaging (MRI) at baseline and follow up (after about 3 months). Laboratory follow up included haematology, renal function, and measurement of troponin and BNP. The epirubicin group was excluded from the final analyses because of low survival levels.
The group receiving Myocet had better diastolic and systolic function in the left and right ventricles, compared to conventional doxorubicin. The Myocet group also had less fibrosis development in the myocardium as shown by MRI and histology staining.

 

‘Utter neglect’ of rheumatic heart disease revealed by results from global study

Rheumatic heart disease (RHD) – the most common acquired heart disease in children in many countries of the world – is being neglected and poorly treated, according to new findings from the Global Rheumatic Heart Disease Registry (the REMEDY study), just published online in the European Heart Journal [1].

RHD accounts for up to 1.4 million deaths every year, with the highest numbers of people affected by it and dying occurring in low and middle-income countries.
Results from the pilot phase of the REMEDY study, which looked at 3,343 RHD patients attending one of 25 hospitals in 12 African countries, India and Yemen between January 2010 and November 2012, found that:

  • Only 55% of RHD patients were receiving penicillin (or another antibiotic);
  • Oral anti-coagulants were prescribed in 70% of patients with heart problems that would benefit from it, but less than a third of them were receiving the correct therapeutic levels and 20% of pregnant women were on warfarin;
  • Among the 1,825 women of child-bearing age, only 4 % were taking contraceptive measures,

Professor Bongani Mayosi, Professor of Medicine and head of the Department of Medicine at Groote Schuur Hospital and University of Cape Town, South Africa, who led the research, said: “Our findings reflect the utter neglect of RHD in affected countries. Most of the interventions that are not applied, are available and cheap in the countries concerned, and their application will provide the greatest benefit.”

“At present, the primary healthcare systems are not prioritising these simple, but effective measures. RHD is a disease of poverty, neglected by the health ministries in affected countries and by the international community in general.”

The REMEDY study found that the majority of patients with RHD were young, predominantly female and unemployed. The majority had moderate to severe valvular heart disease, further complicated by congestive heart failure, pulmonary hypertension, atrial fibrillation, stroke and infective endocarditis.

Co-author, Professor Salim Yusuf, said: “The World Health Organization has called upon countries of the world to reduce mortality associated with RHD and other non-communicable diseases by 25% by the year 2025 – known as the 25x25 target. The findings of this study not only set the baseline by which to judge progress, but also point to the need to close the gap in the use of evidence-based interventions if the 25x25 target will be achieved for RHD.”

Prof Mayosi concluded: “We plan to launch the full study of 30,000 patients with RHD from 166 endemic countries from 2015 onwards. The full REMEDY study, which will involve contributors from all inhabited continents of the world, will serve as a platform not only for monitoring progress to the achievement of the 25x25 target, but also for trialling new and novel strategies, such as new oral anti-coagulants, for reducing morbidity and mortality in RHD. REMEDY seeks to put an end to rheumatic heart disease in our own lifetime through the application of preventive measures.”

Notes:

[1] “Characteristics, complications, and gaps in evidence-based interventions in rheumatic heart disease: the Global Rheumatic Heart Disease Registry (the Remedy study)”, by Liesl Zühlke et al. European Heart Journal. doi:10.1093/eurheartj/ehu449

 

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