Cardiovascular disease (CVD) is now the most prevalent disease to affect the Chinese population. This study describes how 30% of the population sample had ≥3 CV risk factors, and as such prevention strategies must now be employed to help manage the rapid increase in CVD prevalence in the Chinese population, or face an ‘epidemiological transition’ that will develop faster than anything known in the west.

The western world has been facing a growing CVD epidemic, and it is evident that the Chinese population is beginning to follow suit.

The increase in CV risk factors in the Chinese population – smoking, obesity and hypertension, to name but a few – correlate to the modernization of Chinese society, and is similar to the epidemiological transition that western societies have experienced since the Industrial Revolution.

Although western countries have various CVD prevention strategies and programmes, these must be applied in the context of Chinese culture in order to meet the needs of this population. Furthermore, Visscher notes that changes in western governments towards a more right-wing school of thought may negatively impact on current global CVD prevention strategies.

Ultimately, unless this issue is dealt with, the increase in CVD risk factors in the Chinese population will result in a major epidemic that will have implications and consequences that reach far beyond China’s borders.

Read the full editorial here.

In a recent editorial published in the European Heart Journal, Zahi A. Fayad and Venkatesh Mani from the Mount Sinai School of Medicine, New York, USA, and Valentin Fuster from the Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid Spain outline the need for more clinical trials, such as The Rotterdam Study, that use plaque characterisation as an endpoint.

Conventional CV risk factors and the Framingham risk score do not fully account for CV events in asymptomatic patients. Techniques such as MR have allowed detailed information regarding plaque characteristics to be determined, which will undoubtedly help screen asymptomatic patients at risk of CV events, and who would benefit from early therapies or aggressive treatment.

The authors of this editorial state that although studies such as the Multi-Ethnic Study of Atherosclerosis (MESA) study and the Atherosclerosis Risk in Communities (ARIC) carotid MRI study have helped identify risk factors and shown the correlation between carotid thickness and various plaque characteristics such as Lipid Rich Necrotic Centres (LRNC) – more studies are needed that employ standardised methodologies for plaque characterisation, and that quantitatively measure high-risk plaque features as an endpoint.

Read the full editorial here.

The paper outlines how previous studies exploring drug-gene interactions have led to the FDA adapting recommendations so they take into account the possible effects of heritable genetic polymorphisms have on drug therapy.

This paper summarises the current knowledge on the pharmacogenomics of all major drug classes used to treat cardiovascular diseases, providing a body of evidence that suggests we are on the verge of a radical overhaul in our approach towards cardiovascular pharmacotherapy.

Read the abstract here.

An analysis of more than 100,000 patients, published in Archives of Internal Medicine, concluded the risk of internal bleeding was too high.

The UK-led study said only people with a history of heart problems or stroke should take the tablets. Prof Kausik Ray, from St George’s, University of London, tells the BBC: “If you treat 73 people for about six years you will get one of these non-trivial bleeds. If you treat about 160 people for the same period of time, you’re preventing one heart attack that probably wouldn’t have been fatal anyway.

“It suggests that the net benefit for aspirin is not there, it certainly doesn’t prolong life. If you think about it the net benefit, actually there is net harm.”

Further reading:

Sreenivasa Rao Kondapally Seshasai, MD, MPhil; Shanelle Wijesuriya, MA, MBBChir; Rupa Sivakumaran, MA, MBBChir; Sarah Nethercott, MA, MBBChir; Sebhat Erqou, MD, PhD;Naveed Sattar, MD, PhD; Kausik K. Ray, MD. Effect of aspirin on vascular and nonvascular outcomes: Meta-analysis of randomized controlled trials. Arch Intern Med Published online January 9, 2012. doi:10.1001/archinternmed.2011.628.

Click here to visit the event website.

During this live webcast, participants can watch the forum sessions live online and ask the moderator questions during the sessions.

CVCT Forum takes place from 2-3 December 2011 in Paris, if you cannot attend the CVCT Forum, with the webcast you will still be able to discuss the latest clinical trials issues directly with an impressive list of Key Opinion Leaders and clinical trial coordinators, regulatory authorities, as well as research and development staff from pharmaceutical companies.

Download the CVCT Forum Programme

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Here we provide you with an overview of the late breaking clinical trials on the first day of the AHA Scientific Sessions 2011.

AIDA STEMI

This trial, presented by Holger Thiele, MD, from Herzzentrum Leipzig, Leipzig, Germany, compared intracoronary (IC) and intravenous (IV) bolus abciximab during primary percutaneous coronary intervention (PCI) in STEMI patients.

This phase II, interventional, randomized efficacy study showed that the primary end point – a composite of death, new myocardial infacrction (MI) and new heart failure (HF) – was no different between the two groups. Therefore, although IC abciximab is safe, it does not add any further benefit when compared to standard IV abciximab bolus.

Furthermore, the event rate was less than anticipated in both groups – 7.0% IC and 7.6% IV (p=0.58) compared to the predicted event rate of 12%. These results were not expected, especially in the light of previous studies. However, as Thiele explained, many centres only included low-risk patients, which may have influenced these results.

The outcome of AIDA STEMI does not support a change in current clinical practice.

ISAR REACT4

Bivalirudin may be the preferable drug of choice when treating STEMI and NSTEMI patients undergoing PCI, according to the findings of the ISAR REACT 4 trial, presented by Adnan Kastrati, MD, Deutsches Herzzentrum, Munich, Germany. [1]

This randomized, double-blind, multicentre study involved 17,000 patients who were enrolled within 48 hours of presentation of NSTEMI acute coronary syndrome (ACS). All patients were treated with clopidogrel 600mg, before being randomized to an abciximab plus unfractionated heparin (UFH) infusion for 12 hours, or a bivalirudin bolus for the duration of PCI.

The primary end point was a composite of death, large MI or revascularization within 30 days of PCI.

Abciximab plus UFH did not reach this primary end point, and it increased the risk of bleeding in patients with NSTEMI undergoing PCI.

So is ISAR REACT 4 a ‘practice changing trial’?

During the presentation discussion, the consensus was that this may well be the case. Deepak L Bhatt MD, VA Boston Healthcare System, US, discussed the results, stating that in the light of results from trials such as ACUITY and HORIZON, “ISAR REACT 4 completes the puzzle of the role of bivalirudin in PCI.”

References

1. Kastrati A, Neumann FJ, Schulz S, et al., Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction. NEJM 2011; November 13: 10.1056/NEJMoa1109596.

Here we provide you with an overview of the late breaking clinical trials on the first day of the AHA Scientific Sessions 2011.

ADOPT

The Apixaban Dosing to Optimize Protection from Thrombosis (ADOPT) trial was presented by Samuel Z Goldhaber, MD from Brigham and Women’s Hospital, Harvard Medical School, US.

This randomized, double-blind, double-dummy trial tested the hypothesis that the extended use of apixaban would be more effective than the short term use of enoxaparin for venous thromboembolism (VTE) prophylasis in medically ill patients.

The outcome of the ADOPT trial revealed that 30-day prophylaxis with apixaban was not superior to 6-14 days of treatment with enoxaparin. Apixaban was also associated with an increase in major bleeding events compared to enoxaparin.

That the risk of VTE increases after hospital discharge is well-established; however the results of ADOPT do not provide justification for policy change in this treatment, although they do highlight the need to identify subgroups that would benefit from targeted extended prophylaxis.

TRACER

The TRACER trial provided an overview of the use of vorapaxar in the for treatment of acute coronary artery syndromes (ACS).

This large, multinational, double-blind, randomized trial compared vorapaxar with placebo in 12,994 patients with ACS without ST-segment-elevation. The primary endpoint was a composite of death from CV causes, MI or stroke. However, the TRACER trial was halted earlier this year after an increase in intercranial haemorrage was reported in patients with a history of stroke.

As the novel oral antithombotic agent had reached all primary and secondary end points, the researchers were able to present their findings at the AHA 2011.

There were no benefits in terms of primary end points, and vorapaxar significantly increased the risk of major bleeding, especially intercranial hemorrhage.

During the discussion, Dr Keith Fox from Edinburgh, UK noted that in the placebo population of the trail, patients had a 6.1% risk of death and a 12.1% risk of stroke at two years, and approximately half of these occurred at 4 months, stating that TRACER has “missed the sweet spot between efficacy and safety.”

ATLAS ACS2 TIMI 51

The results of the ATLAS ACS2 TIMI 51 trial was big news at the AHA Scientific Sessions 2011, showing that very low dose rivaroxaban (2.5 mg, and 5 mg, respectively) in combination with other antiplatelet therapies significantly lowers the effects of cardiac events in patients with symptoms across the ACS spectrum compared with the current standard of care.

The results of this trial were presented by C Michael Gibson, MD, Beth Isreal Deaconess Medicine Center, Boston, Mass. Us.

Rivaroxaban 5.0 mg produced a significant reduction in the primary end points, although the rates of CV death were not reduced. However, rivaroxaban 2.5 mg produced a 32% relative risk reduction in all cause mortality and a 34% risk reduction of CV death.

These benefits were consistent across all sub-groups, there was no evidence of rebound ischaemic events and no difference in the risk of fatal bleeding.

As Gibson stated during the presentation, the results of ATLAS ACS2 TIMI 51 represent “a new era in secondary prevention after acute coronary syndrome.” [1, 2]

References

1. Mega J, Braunwald E, Wiviott, et al., Rivaroxaban in patients with a recent acute coronary syndrome. NEJM 2011; November 13: 10.1056/NEJMoa1112277

2. Roe MT, Ohman EM. A new era in secondary prevention after coronary syndrome. NEJM 2011; November 13: 10.1056/NEJMe1112770

The book, edited by Professor JC Kaski and associate editors Stuart Baker, Carl Hayward, Teck K. Khong, Saagar Mahida and Juan Tamargo, provides a comprehensive A-Z formulary of cardiovascular drugs and drug groups and up-to-date information on cardiovascular management guidelines and clinical trials.

“We are proud of this achievement and delighted that the BMA Medical Book Award judges selected our book among the very many excellent books that were shortlisted,” says Professor Kaski. “The BMA award represents a truly prestigious distinction and we are delighted with the First Prize!”

The book comprehensively addresses the issue of cardiovascular pharmacotherapy in a practical fashion. As Professor Kaski explains: “It has two sections; the first one devoted to the most prevalent cardiovascular conditions, where we briefly discuss the clinical presentation of these cardiovascular conditions, and provide diagnostic algorithms and management guidelines.”

“Management is approached from an evidence-based perspective.  Section two is presented as an A to Z of cardiovascular drugs . Here we provide pharmacological information including pharmacokinetic data, indications and contraindications, dosages, interactions and undesirable effects.”

The various chapters of the book were written by teams comprising clinical consultants, pharmacologists, academic cardiologists, specialist registrars and junior doctors.  The rationale for this multidisciplinary and “multi-layered” approach has been to provide scientifically solid but practical information to the the potential readers, who are likely to represent an heterogeneous audience.

“A very large proportion of the co-editors and chapter authors belong to St George’s University and the NHS Trust,” he adds. “This reveals the excellent cardiovascular knowledge and clinical expertise available in our Institution.  The BMA award can viewed as a reward to all those who teamed up to produce this excellent work.”

Drugs in Cardiology: A Comprehensive Guide to Cardiovascular Pharmacotherapy.
Juan Carlos Kaski; associate editors, Stuart Baker, Carl Hayward, Teck K. Khong, Saagar Mahida and Juan Tamargo.
Oxford University Press, 2011. ISBN: 9780199557462.