Clinical trials, imaging lead busy agenda for cardiologists

Europe’s largest medical conference got under way at the Messe München over the weekend, with in excess of 25,000 physicians attending and another 7,000 industry representatives participating from more than 130 countries. Organized by the European Society of Cardiology (ESC; Sophia Antipolis, France), a key focus for the four-day congress is cardiovascular imaging, with 77 sessions dedicated to the topic out of the 400 presentations on the program. According to ESC Congress Program Committee chairman Jeroen Bax, “We have witnessed a revolution in terms of imaging equipment and software. Cardiovascular imaging is now fully integrated in patient care and it unthinkable to manage patients with cardiovascular disease without the use of echocardiography, nuclear cardiology, magnetic resonance imaging or the most recent addition to the diagnostic armamentarium, cardiac CT.”

Ten live cases demonstrating innovations for imaging intervention will be transmitted from five centers in Berlin, Munich and Rotterdam, the Netherlands, along with Liège, Belgium, and Katowice, Poland. Also on the agenda for cardiologists at the congress this week are special sessions each day presenting clinical trial updates, with three late-breaking trial sessions in the spotlight as part of a new feature for ESC 2008 called “Meet the Trialists.”

Interactive discussion with presenters of the following trials are scheduled: the GISSI-HF test of the effects of statins in patients with symptomatic chronic heart failure, the BEAUTIFUL study of the efficacy of ivabradine in reducing cardiovascular events for patients with stable coronary artery disease and left ventricular dysfunction, and the SYNTAX trial comparing percutaneous coronary intervention with Boston Scientific‘s (Natick, Massachusetts) Taxus drug-eluting stent (DES) and cardiac surgery.

The strong role Europe plays in the fierce competition over DES was to be the topic of a Sunday session, as the chairmen of the leading cardiology intervention event bring to Munich the “Best of EuroPCR 2008” with a focus on safety and long-term results of dozens of clinical trials.

Detailed results from the controversial SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study will be presented in a special “Hot Line” session.

Top-line results from the SEAS trial first disclosed at a press conference in July in London set off a heated reaction. The early release of the data was due to reporting requirements for the study’s sponsors, Merck (Whitehouse Station, New Jersey) and Schering-Plough (Kenilworth, New Jersey), to both regulatory agencies and financial markets.

The released results showed that reducing levels of LDL cholesterol with a proprietary combination of simvastatin and ezetimibe in patients with aortic stenosis had no more effect on major cardiovascular events, the study’s primary endpoint, than with placebo.

However, concentrations of LDL cholesterol fell by 61% in the simvastatin/ezetimibe treatment group when compared with the placebo group, suggesting that a large proportion of the patients who received the cholesterol-lowering treatment benefited from less complicated surgery and less atherosclerotic disease.

The SEAS study is the first large-scale randomized trial to measure the effect of lowering LDL-cholesterol in patients with aortic stenosis.

Carried out at 173 clinical centers in Norway, Denmark, Sweden, Finland, Germany, the UK and Ireland, the trial included 1,873 patients with mild to moderate aortic stenosis without symptoms who were not considered to have a clear indication for treatment with cholesterol-lowering drugs.

Press reports seized on safety concerns due to the high incidence of cancers among patients in the trial while the others took the top-line results as further bad news for the efficacy of simvastatin/ezetimibe in the prevention of major cardiovascular conditions. “The audience will be much different from our press conference in London, where I focused on just the main findings,” said Professor Terje Pedersen, who chaired the study’s steering committee. “When the primary endpoint of a trial is not significant, we have to be cautious about secondary endpoints,” he said adding that taking the results of 25 other randomized trials into consideration, “it seems valid when we find a reduction in coronary bypass surgery in our treated patients, the evidence from other trials gives plausibility to our secondary endpoint findings.”

Prevention of heart disease remains the primary mission for ESC and the congress will revisit the conclusions of the EUROACTION study that were published in June. The single largest research project to be undertaken by the European Society of Cardiology, EUROACTION matched six pairs of hospitals and six pairs of general practices in eight European countries and show a multidisciplinary, family-based program made a significant difference in reducing cardiovascular risk.

“EUROACTION provides practical support to initiatives promoted by ESC together with the European Commission to raise awareness of cardiovascular disease prevention goals throughout Europe,” said Kim Fox, ESC president. The Members of the European Parliament Heart Group was created by an overwhelming majority vote late in 2007 and began working officially this year with the European Heart Network and ESC to push initiatives across Europe on cardiovascular disease prevention. “As cardiologists, we get to see people when the damage is done,” said Dr. William Wijns of ESC. “To see members of the European Parliament actually focus on cardiovascular health is extremely important, as they can help Europe take further action, in particular in the field of prevention.”

Cardiovascular disease remains the leading cause of death in the European Union, killing over 2 million citizens each year at a cost of more than 1192 billion ($282 billion) for the 27 governments who are the primary payers of health services.

The 2008 ESC congress follows last year’s record-breaking event in Vienna, which was attended by 29,423 physicians and total participation of 35,618. ESC also reported “a record financial year” for operations in 2007, with revenue of €38 million ($56 million) and a €4 million profit after taxes ($5.8 million). The congress in 2006, the most recent reported, produced a €7.5 million ($11 million) contribution to the society, based on revenue of €21 million ($31 million). More than 10,000 abstracts were submitted for this year’s congress, with some 3,000 accepted.

ESC also will update during the congress its 32 Clinical Practice Guidelines, covering areas such as valvular heart disease, myocardial disease, acute coronary syndromes, diabetic heart disease, arrhythmias and hypertension. For the first time, ESC will issue guidelines at this week’s gathering on the management of acute myocardial infarction in patients presenting with ST-segment, along with new versions of guidelines for diagnosis and treatment of heart failure and pulmonary arterial hypertension, as well as an update of guidelines for pulmonary embolism.


- in: Categories

Share your thoughts

Your email address will not be published. Required fields are marked *