OUP user menu

How much of the world do you need for meaningful clinical trials?Christmas Greetings 2011Book review: ‘Cardiovascular catheterization and intervention’A Textbook of Coronary, Peripheral, and Structural Heart DiseaseThe Brazilian Archives of Cardiology is the only cardiology journal in Latino America and the Southern hemisphere with an impact factorThe Mediterranean Diet, Part IIThe TIMI story

DOI: http://dx.doi.org/10.1093/eurheartj/ehr417 3057-3063 First published online: 14 December 2011

In the clinical trials business, where bigger is often better, the Duke Clinical Research Institute of Duke University is well placed to ride out declining health budgets, according to its director, Robert A. Harrington MD, speaking with Barry Shurlock, PhD

Embedded Image

Durham Centre, Duke Clinical Research Institute

In the wake of the downgrading of US debt, there can be few biomedical researchers who are not uneasy about the future. Turmoil in international finance, uncertain futures and growing demands on statistical power mean that pharmaceutical companies seeking partners to carry out large-scale clinical trials are increasingly facing difficult decisions. Do they ramp up their in-house facilities for trial coordination and data management and work with a network of external research centres? Do they sign a contract with a commercial contract research company? Or do they turn to a major academic research centre that has everything in place to fita trial into its ongoing programme? Someone who is certain that the academic partnering option has much to commend it is Robert A. Harrington, MD, the Director of the Duke Clinical Research Institute (DCRI), and Richard S. Slack, MD, Distinguished Professor in the Division of Cardiology, at Duke University Medical Center, Durham, NC, USA.

Like most major institutions, DCRI has a history driven by certain individuals who recognized the opportunities of the times they lived in. First, there was Dr Eugene Stead Jr, MD, whom Dr Harrington describes as ‘one of the giants of US medicine’. In the late 1960s, at a time when it was becoming clear that computers had much to offer, he had the visionary idea of aggregating clinical data to create what became the Duke Databank for Cardiovascular Disease. It became a key resource in a country where health-care systems are less coordinated and populations are generally more mobile than in Europe. Then, in the late 1980s, Dr Robert M. Califf, who was Dr Harrington's predecessor, gave another crank to the machine. Like all medical students at Duke, he had spent his 3rd year doing research. He chose to work on the databank and during this time became keenly aware of its value for giving quantitative answers to key questions. After a spell at the University of California, San Francisco, he returned to Duke as a fellow, and then a faculty member, and with colleagues developed the infrastructure to carry out large-scale clinical trials, working in areas such as fibrinolysis and angioplasty. In 1996, this capability was formally recognized by the creation of DCRI, which claims to deliver ‘credible study results that change clinical practice’.

Under Dr Califf's leadership, DCRI grew and grew and now claims to be the ‘largest academic research organization in the world’. Dr Harrington gives the figures. At any one time about 100 trials are in progress. The largest patient group recruited, numbering more than 41 000 (41 021), was in a study of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO-1). With a budget of about $170 million, it involves about 220 Duke Faculty members, all of whom have appointments elsewhere in various academic departments, though 50% carry out ‘sizeable amounts’ of research at the institute. Here, they draw on the support of 1200 employees, including 300 in clinical operations and research coordination, about 100 in biostatistics, the same number in IT and a further 130 in data management and informatics. This truly huge facility is housed in two buildings, one opposite to the Duke University Medical Center and another about 3 miles (5 km) away. Its research is financed about 60% by industry, about 40% by the National Institutes of Health (NIH), Bethesda, Maryland, together with small streams from such bodies as the American College of Cardiology, the American Heart Association, and private sources.

Embedded Image

Dr Robert Harrington

Although founded on outstanding success in cardiovascular research, DCRI now embraces other specialties. Dr Harrington is himself an interventional cardiologist, with strong interests in the mechanisms of acute coronary syndromes, and antithrombotic therapy, especially in the context of percutaneous interventions. Outlining the development of DCRI, he said: ‘In the mid-90s, we had done really well in clinical trials in cardiology, using the continuing legacy of the databank as a research tool to become a major coordinating centre for multicentre studies. Subsequently, Ralph Snyderman, Dean of the medical school at the time, charged Rob Califf to go beyond cardiology into different [clinical] areas to utilise the skills that had been acquired’.

Speaking of the thousands of centres worldwide involved in DCRI trials, he said: ‘Over the years we have built up close relationships with many other countries, particularly since the 1980s with the [Catholic University of] Leuven, Belgium, and since more than 10 years ago with Uppsala [University, Sweden]. We share leadership on the scientific side, and in operational matters, working with “people like us” in these and many other places. These include Edmonton and Toronto in Canada, many centres in South America and South-East Asia, and in Australia and New Zealand. Of course, we need these global networks to get an adequate sample size. Many of the trials in cardiology [and other specialities] need data on 15–20 000 patients, over a reasonable timeframe—say 18–24 months—and this can only be done by drawing on 35–40 countries. But there are other reasons for going global. In this way we get different patient pools, and we develop close intellectual and friendly relationships with the people we work with. We also benefit from the different ideas and different ways of treatment used in various countries’.

Typical of the products of the institute is a key comparative trial reported recently (28 August 2011) at the ESC 2011 Congress, Paris, by Dr Christopher B. Granger, Professor of Medicine at Duke University Medical Center, who directed the study jointly with Professor Lars C. Wallentin of Uppsala University, Sweden. Based on outcomes with the oral direct Factor Xa inhibitor apixaban vs. warfarin for the prevention of stroke and systemic embolism in more than 18 000 (18 202) atrial fibrillation patients from centres around the world, it showed that apixaban resulted in less bleeding and lower mortality rates.

More than 750 original papers are published each year by DCRI staff, about 20% of them in high-profile journals (impact factor >10). Faculty members generate many of the clinical questions put to trial and then seek support from industry or government, though pharmaceutical, device and biotechnology companies also approach DCRI directly. Acknowledging that times are harder than they were, Dr Harrington said: ‘There is a decline in real dollars for healthcare in the US. Funds doubled under Clinton, were pretty flat with some allowance for inflation under Bush, and during the last few years under Obama there has been a decline. Although the kind of work we do in the US, and in Europe, requires large sample sizes, [and is therefore costly], during a period when funds have been declining our funding stream has been pretty favourable. A factor that has worked in our favour is that the pharma industry, anticipating reduced profits as patents expire, want to reduce the number of employees and are therefore outsourcing more. So far we have done well, though there's no doubt that there are big forces that make the future uncertain’.

Although Dr Harrington is ‘cautiously optimistic’ about the fortunes of DCRI, some strategic changes have been made. Thus, the institute is diversifying even more into other specialities, including oncology. Smaller trials are also of greater interest, such as ‘first in man’ studies, and major investments are being made in informatics and the management and analysis of data. This, after all, is how DCRI started and how it has thrived.

Christmas Greetings 2011

Embedded Image

Christmas 2011, courtesy Sam Rogers

The year 2011 ends with CardioPulse in its third year and the EHJ impact factor exceeding 10.

The editor wishes to thank all contributing writers, publishing staff, and readers for their efforts in making CardioPulse successful and wishes them happy days for the coming Christmas holiday season.

2012 will be a new year, with new hopes and aspirations for everyone, which I hope will be fulfilled.

Andros Tofield, managing editor CardioPulse

Book review: ‘Cardiovascular catheterization and intervention’
A Textbook of Coronary, Peripheral, and Structural Heart Disease

Editors: Debabrata Mukherjee, Eric R. Bates, Marco Roffi, David J. Moliterno

ISBN – 13: 978-1-84184-664-4

First published in 2010 by Informa Health Care

Embedded Image

As the editors state in their introduction, interventional cardiovascular medicine continues to rapidly evolve in both diagnostic and therapeutic arenas. I would add that the progress continues at such a rapid pace that editing and printing a book on cardiovascular interventions engages a certain risk. It may well be that once a book of this kind is available in bookstores; some subjects discussed may be overtaken by developments.

The authors knew about this risk and have taken it with, fortunately, rather positive results. They cover the different subjects ‘from head to toe’ in about 700 pages giving the reader a detailed insight into different techniques related to cardiovascular interventions.

The book covers some subjects which are not found in other volumes of this kind. The book has 54 chapters written by 100

authors from Europe and the USA whereby the USA takes a clear lead; also among the authors, there are one Australian, two from South America, and two from Georgia.

The subjects cover general themes (history, equipment, radiation, safety, contrast media, etc.) as well as rather detailed descriptions of ‘how to do’ for particular interventions. I was impressed to see the subject of sedation taken up as an impressive piece, as well as a chapter on the use of vasodilators in pulmonary hypertension. Intravascular imaging and physiology is very well covered. Importance is rightly given to the question of vascular access which is thoroughly discussed. Catheter treatment of valvular heart disease is covered in sufficient detail, although the latest developments, predictably, have not been incorporated.

A definitely positive aspect is the addition of subjects which cross borders to other fields of vascular medicine. There is, for instance, a chapter on acute stoke interventions and the treatment of intra cranial stenoses. The subject of carotid and vertebral artery intervention is thoroughly discussed and, from a

didactic point of view, highly valuable. I am also impressed by general remarks on the logistics of management of acute coronary syndromes (pre-hospital and hospital care) as well as the outline of training programmes and maintenance of certification.

On the other hand, I searched in vain for a description of renal artery denervation in drug-resistant hypertension. Possibly, it may have been put aside as being too close to electrophysiology, or simply, arrived too late on stage. The book might benefit from a logical disposition of chapter headlines to allow readers a more efficient search. If ever a new edition is planned, this ought to be incorporated.

All in all this is a highly useful textbook on most aspects of transcatheter therapy. It should be available to all interventional cardiologists.

Ulrich Sigwart, MD, FACC, EFESC, FRCP

Professor Emeritus

University of Geneva

The Brazilian Archives of Cardiology is the only cardiology journal in Latino America and the Southern hemisphere with an impact factor

The Brazilian Archives of Cardiology was founded 63 years ago in 1948 by the Brazilian Society of Cardiology. It was the first cardiology journal in South America and one of the first in Latin America. The founding editor, Jairo Ramos, held the post until 1953.

The Society had been planning a journal since 1943, initially to publish scientific papers from Brazil. But it was an international journal from the beginning. The first year saw papers originate from Brazil and wider Latin America, Mexico, and the USA.

‘It was not the intention at the beginning but in reality it started as an international journal’, says Editor-in-chief Luiz Felipe Moreira, associate professor of cardiovascular surgery at Sao Paolo University Medical School and director of surgical research at the Heart Institute, Sao Paolo University, Brazil.

Embedded Image

Luiz Felipe Moreira

Moreira took up the position in 2010 for 4 years. He was previously an associate editor for cardiovascular surgery. It is the first time in the journal's history that a surgeon has been editor-in-chief.

Moreira has a team of around 10 associate editors from Brazil who are specialists in different areas: clinical cardiology, surgical cardiology, interventional cardiology, paediatric cardiology/congenital heart diseases, arrhythmias/pacemakers, non-invasive diagnostic techniques, basic or experimental research, epidemiology/statistics, and hypertension.

The editorial board houses people mainly from Brazil, but there are 14 members from other countries (Portugal, the USA, Argentina, Spain, Italy, the UK, and Belgium). The group includes important players from the European Society of Cardiology (ESC) such as Fausto Pinto (Portugal) and Pedro Brugada (Belgium).

The journal's readership comprises researchers and clinical cardiologists. It is a free access journal so readers are based all over the world. While the Brazilian Archives of Cardiology has been indexed in Index Medicus for decades, it was only last year that it gained its first impact factor which currently stands at 1.3. It's a similar impact factor to other national journals. The journal is published in three languages—Portuguese, English, and Spanish.

Submissions come primarily from Brazil (90%), but papers are also sent from European countries and from Korea, Japan, and India. The journal receives around 500 manuscripts each year in the different subject categories, and most are original research. Last year, it received more than 400 original contributions, about 70 review articles and 120 case reports. It publishes about 30% of submissions.

The journal has reached a turning point, says Moreira. While it has been an international journal from the start, receiving papers from other countries especially in Latin America, it is mainly a journal that publishes Brazilian scientific research in cardiology. He wants to receive more submissions from other countries.

To that end he is looking to improve relationships with other societies, particularly those related to Latino America and Ibero America including Portugal and Spain. He participates in a group of Latin American editors in cardiology which was set to gather at the American College of Cardiology meeting in New Orleans in April. And last year, he met European cardiology contacts at the ESC Congress. He is working to establish commitments with journals such as the Portuguese Journal of Cardiology and the Revista Española de Cardiología which would see joint publication of certain editorials and papers and access links to the other journals.

Under Moreira's editorship, the journal is undergoing changes in the basic layout and improvements are being made to the scientific aspects of papers so that there are strict guidelines for publication on statistics and methodology. This should help increase its profile as an international journal.

The Brazilian Archives of Cardiology remains the only cardiology journal in Latino America and in the Southern hemisphere that has achieved an impact factor, says Moreira. He adds: ‘Therefore I think we have a great possibility to really grow as one of the most important journals from countries which are achieving more and more great developments in science’.

Jennifer Taylor, MPhil

The Mediterranean Diet, Part II

Food: a culture and a medicine all in one. The second and final story.

In the previous edition of CardioPulse, we explored the Mediterranean diet, concentrating mainly on the dietary aspects of the concept behind it. However, I believe that there are other cultural aspects of possible interest to the reader. For example, the modern cardiologist should not ignore the fact that all epidemics of the past were eradicated not by medicine or drugs but rather by changes in lifestyle (Figure 1). According to the INTERHEART Study1 we could resolve 98% of the current epidemics of cardiovascular disease by changing our behaviour (including our eating habits) and controlling simple risk factors. Perhaps, the cardiologists of tomorrow should prescribe an appropriate diet and regular exercise instead of pills or devices and this concept has already captured the attention of the White House.2 If this is the case, we have a clear advantage in Europe as cuisine is considered a serious matter on this continent!

But, what is European cuisine? Interestingly, it doesn't exist as a single entity due to a unique culinary and cultural fusion that occurred in Europe. Table 1 illustrates the great opposites of food and its culture between Europe and the USA.

View this table:
Table 1

The ‘historical’ great opposites

Olive oilLard, butter

It all started in Mesopotamia 10 000 BC, when, in response to demographic expansion, agriculture took root and food began to be exported worldwide: to Africa, (sogo), Europe (grain), America (corn), and Asia (rice)—the first example of globalization! Anthropologically, agriculture also marks the onset of civilization—mankind distancing himself from animals! The farmer is no longer a simple picker or a hunter. He is now a producer and, in a way, has separated himself from nature as he seeks to own and dominate it. Agriculture (which now seems to be so natural) is actually violent towards nature: the ground is ploughed, sown, flooded, and transformed.3 This concept is illustrated in the Jewish tradition where in Leviticus 25, there is mention of the Sabbath Year:

  • 1. The LORD said to Moses on Mount Sinai,

  • 2. ‘Speak to the Israelites and say to them: When you enter the land I am going to give you, the land itself must observe a Sabbath to the LORD.

  • 3. For six years sow your fields, and for six years prune your vineyards and gather their crops.

  • 4. But in the seventh year the land is to have a Sabbath of rest, a Sabbath to the LORD. Do not sow your fields or prune your vineyards.

  • 5. Do not reap what grows of itself or harvest the grapes of your untended vines. The land is to have a year of rest’.

Bread is the symbolic product of agriculture and of human civilization. In Christianity (John, 6:35), Jesus says. ‘I am the bread of life; he who comes to me will never go hungry. But, bread does not exist in nature and is manmade with sophisticated technology! Bread, olive oil, and wine are the basis of the Greek and Roman diets (Table 1). In Christianity, the holistic meaning of the olive is well known: peace. Equally, bread and wine are important in the Christian religion. Jesus became human and said ‘You will eat of my flesh (bread) and drink my blood (wine)’. This represented a clear reversal from previous Mediterranean religions, in which animals were sacrificed and offered to the ‘table’ of the divinity. In Christianity, it was Jesus who sacrificed himself (a clear example of from bottom-up to top-down?).

When the peoples of the North (Table 1, the Vikings) invaded and dominated the Roman Empire, two opposing cultures contaminated each other. The Viking invaders were hunters, not farmers like the Romans. They accepted and used nature and the forest as it was without transforming it. Pork and other meats, butter, and beer were important for them and were cooked by direct contact with fire—the modern concept of a barbecue. This may indirectly explain why it is the man (the ‘hunter’) who is generally in charge of the barbecue, and why the meat is preferably consumed in groups (the hunting community). Opulence was important to the invading tribes, because bigger meant stronger. In contrast, the Romans were frugal farmers. Their different approach to nature was also evident in cooking: The Romans preferred boiling (as in soups) to roasting. We should consider a sense of guilt to the violence against nature, boiling is more subtle: a complementary element—water—mediates between food and the fire.3

A typical modern feature of fusion between these two underlying cultures is the simple sandwich or Panini: bread, pork, butter, and vegetables all in one (Figure 2). This sort of mixture explains why there is no true ‘European cuisine’, but rather a constant evolution of different cuisines characterized by multiple intermixing. It also explains many of the differences between Northern and Southern European cuisines and the lack of a unified concept.

Different cultural behaviours are also present in the modern opposites between Europe and the USA (Table 2): big (power) vs. small, fast vs. slow, global vs. regional, industrial vs. organic, and preserved vs. fresh. So … the story continues, but … . As always is the case, common sense prevails and the existing campaign against obesity from the American Heart Association is a typical example (Figure 3).

View this table:
Table 2

The ‘modern’ great opposites

EquilibriumKing Size
Slow foodFast food
Mediterranean dietMcDonalds

Roberto Ferrari, FESC, Department of Cardiology and LTTA Centre, University Hospital of Ferrara and Salvatore Maugeri Foundation, IRCCS, Lumezzane, Italy


The TIMI story

Nearly 30 years on, TIMI is still asking the crucial questions in cardiovascular disease

Now in its 57th trial, TIMI (Thrombolysis in Myocardial Infarction) is an academic research organization that is part of Brigham and Women's Hospital and Harvard Medical School and was founded by Dr Eugene Braunwald in 1984. It started as a confederation of experienced investigators brought together and sponsored by the National Heart, Lung and Blood Institute of the USA, with the notion that multicentre clinical trials were needed to adequately address and answer important questions in the treatment of acute myocardial infarction which was then entering the fibrinolytic era.

The first trial compared a new fibrin-specific fibrinolytic (recombinant tissue plasminogen activator) vs. non-fibrin-specific streptokinase, which had been around for many decades. The trial was a huge success and showed superiority of the new drug for achieving infarct-related artery patency.1 ‘In fact the trial was stopped early by the independent data monitoring board because of overwhelming efficacy,’ says Dr Marc S. Sabatine, now the chairman of the TIMI Study Group and an associate professor of medicine at Harvard Medical School in Boston.

Embedded Image

Dr Marc S. Sabatine

It was decided that the excellent collaboration would continue and, after a journalist asked Dr Braunwald what they were going to study in TIMI 2, it was decided to keep the ‘TIMI’ prefix as well. TIMI 2 investigated whether acute MI patients who had been treated with a fibrinolytic needed to go to the cardiac catheterization lab urgently or not.

TIMI 3 branched out from acute MI to patients with non-ST elevation acute coronary syndromes and investigated two questions: whether these patients would benefit from a fibrinolytic and whether they needed to go to the cardiac catheterization lab rapidly or could be managed conservatively.

Subsequent trials in the first decade of TIMI studied novel fibrinolytics and anticoagulants in patients with acute MI and patients with non-ST elevation acute coronary syndromes.

Today, there are 10 TIMI trials ongoing, in various phases from starting up to winding down.

The scope of the research has broadened considerably over time. Whereas TIMI 1 studied patients with ST-elevation MI, other trials have looked at patients with non-ST elevation acute coronary syndromes, stable vascular disease, cardiovascular risk factors such as diabetes and hypercholesterolaemia, and other cardiovascular conditions including atrial fibrillation.

The TIMI investigators have expanded the range of experimental therapies that they study, which now includes novel anticoagulants (both intravenous and oral), novel antiplatelet drugs (again, both intravenous and oral), lipid-lowering agents, anti-ischaemic drugs, anti-inflammatory compounds, renin–angiotensin axis inhibitors, and glucose-lowering agents to treat diabetes.

The size and scope of the trials has increased dramatically over time. TIMI 1 enrolled 316 patients in about a dozen hospitals over the course of 6 months and the primary endpoint was an angiographic one ascertained after 90 min. Today TIMI trials, can enrol more than 20 000 patients in over 1000 hospitals across more than 40 countries. The primary endpoints are typically hard cardiovascular outcomes that are often assessed over many years after the start of the trial.

The TIMI investigators have consistently incorporated ancillary studies to improve understanding of the underlying biology. These studies have examined coronary angiograms, static and continuous electrocardiograms, and echocardiograms. Dr David Morrow leads the Biomarker Core Laboratory, which has contributed landmark studies involving troponin (including when measured with new, highly sensitive assays), C-reactive protein, and B-type natriuretic peptide. Proteomics and metabolomics are now being used to discover biomarkers that can provide insights into disease states. Dr Jessica Mega leads the Pharmacogenetics Core Laboratory that is investigating the impact of genetic variants on outcomes and response to pharmacotherapy.

TIMI trials have fundamentally changed clinical practice. A few illustrative examples are provided below. TACTICS-TIMI 18, led by Dr Christopher Cannon, showed that an early invasive approach for patients with non-ST elevation acute coronary syndromes significantly reduced the risk of major adverse cardiovascular outcomes,2 an approach that is now recommended by the professional society practice guidelines.

In PROVE IT-TIMI 22, also led by Dr Cannon, acute coronary syndrome patients were given standard lipid lowering with pravastatin 40 mg or intensive lipid lowering with atorvastatin 80 mg. Achieved LDL cholesterol was 95 mg/dL with pravastatin and 62 mg/dL with atorvastatin, and the atorvastatin arm had a significantly lower rate of death or major cardiovascular events.3 Prior to the study, acute coronary syndrome patients were sent home with a goal of only achieving an LDL cholesterol of <100 mg/dL but now professional society practice guidelines state a goal of <70 mg/dL based on PROVE IT-TIMI 22 and subsequent trials.

TRITON-TIMI 38, led by Dr Elliott Antman and Dr Stephen Wiviott, compared clopidogrel, the standard of care for patients undergoing planned percutaneous coronary intervention (PCI) for an acute coronary syndrome, to prasugrel, a new P2Y12 ADP receptor blocker that is a more potent platelet inhibitor. Treatment with prasugrel resulted in a decrease in ischaemic events and an increase in bleeding events.4

Dr Sabatine says: ‘In addition to these trials being a success for achieving their primary endpoints and showing that a particular drug was better, they also support fundamental biological hypotheses in terms of targeting lower LDL cholesterol levels and greater platelet inhibition in the setting of an acute coronary syndrome’.

Results of ancillary studies have also changed clinical practice. For example, when troponin emerged as a new biomarker to replace CK-MB, there was uncertainty about whether patients with an elevated troponin but a normal CK-MB merited the same intensity of care as traditional MI patients with an elevated CK-MB. Data from TACTICS-TIMI 18 was used to show that patients with even minor elevations of troponin were at increased risk and would benefit from an early invasive strategy.5

A pharmacogenetics ancillary study from TRITON-TIMI 38 showed that patients undergoing PCI treated with clopidogrel who had loss-of-function genetic variants in CYP2C19, an enzyme responsible for metabolizing clopidogrel, have much higher ischaemic event rates including stent thrombosis than patients without the variant. These findings led to a label change for the drug.6

The TIMI Study Group continues to grow with a large number of trials that are currently ongoing (Table 1). Dr Braunwald continues to provide intellectual input to all major scientific issues and remains heavily operationally involved in the trials that started when he was chairman.

View this table:
Table 1

Ongoing TIMI trials (as of 22 June 2011)

IMPROVE-IT (TIMI 40)Simvastatin + ezetimibe vs. simvastatinPost-ACS
ENGAGE AF-TIMI 48Edoxaban (Factor Xa inhibitor) vs. warfarinAF
TRA 2P-TIMI 50Vorapaxar (thrombin receptor antagonist) vs. placeboStable atherosclerosis
ATLAS ACS2-TIMI 51Rivaroxaban (Factor Xa inhibitor) vs. placeboPost-ACS
SOLID-TIMI 52Darapladib (Lp-PLA2 inhibitor) vs. placeboPost-ACS
SAVOR-TIMI 53Saxagliptin (DPP-4 inhibitor) vs. placeboDiabetes
PEGASUS-TIMI 54Ticagrelor (P2Y12 ADP receptor blocker) vs. placeboStable post-MI
REVEAL-HPS3/TIMI 55Anacetrapib (CETP inhibitor) vs. placeboStable atherosclerosis
ELEVATE-TIMI 56Clopidogrel dose-ranging based on geneticsStable CAD
LAPLACE-TIMI 57PCSK9 inhibitor vs. placeboHypercholesterolaemia

Dr Sabatine was appointed vice chair in June 2010 and became chairman in January 2011. He relishes his new role as chairman as advances in molecular biology have yielded promising new drug classes that can have a major impact on patient outcomes. He notes that TIMI is continuing to evolve as the design and execution of clinical trials are becoming increasingly complex. Moreover, with the duration of follow-up increasing and society becoming increasingly more mobile, new tools are needed to ensure that subjects remain engaged in and compliant with long-term trials. He says: ‘The ultimate goal is having the TIMI Study Group in the best position possible to ask and answer the next round of important questions in cardiovascular disease’.

Jennifer Taylor, MPhil

CardioPulse contact: Andros Tofield, MD, FRCS, FACEP, Managing Editor CardioPulse, EHJ. Email: docandros{at}bluewin.ch


View Abstract