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From the News Editor
ESC: Not All News is Good News
 From across the proverbial pond, the annual congress of the 2008 European Society of Cardiology (ESC), which took place in Munich, Germany, this week, issued forth a series of surprising clinical findings. Caveats abound from much of the researchers’ data, with very few conclusive methods for new approaches to cardiovascular care.
In an ambitious and costly endeavor, Boston Scientific undertook the SYNTAX trial in the first head-to-head comparison of PCI compared to surgery, with the hopes that the value of its stents would be conclusively confirmed. Unfortunately, for Boston Scientfic, the trial failed to meet its primary endpoint, and the results indicated that CABG is the preferable method for the sickest patients.
However, on a positive note for the vendor, the SYNTAX trial found that stents and surgery performed fairly equally for adverse events, except for stroke. The researchers noted the significant decrease in the rate of stroke for patients treated with PCI as compared to CABG.
In the GISSI-HF trial, nature outperformed pharmaceuticals. The Italian researchers found that omega-3 fatty acids have the ability to reduce mortality and hospital admissions in symptomatic heart failure patients better than the popular statin, Crestor.
The TRANSCEND trial was designed to evaluate blood pressure drug telmisartan, compared to the gold-standard ACE inhibitors. The trial sponsor and drug-maker Boehringer-Ingelheim may have been disappointed to learn that the outcomes cannot justify the drug as a replacement for the standard treatment. However, the researchers did suggest that telmisartan could be a viable alternative for patients who cannot tolerate ACE inhibitors.
In mid-stage data from the APPRAISE-1 trial, more negative news emerged for Bristol-Myers Squibb and Pfizer’s experimental anticoagulant apixaban. At ESC, the researchers reported results of the trial, comparing a combination of apixaban and standard treatments, such as aspirin and Plavix, to standard treatments alone. The drug showed that despite unacceptable high rates of bleeding, a non-statistically significant trend suggested that the patients on the lowest dose had a lower risk of heart attack or stroke. The APPRAISE-1 investigators said that their results warrant more research.
Bristol-Myers Squibb and Pfizer do not plan to pursue FDA approval for apixaban, as previously planned.
As conference season swings into high gear, many more clinical studies will undoubtedly continue to issue new and exciting data about the treatment of cardiovascular diseases.
If you are curious about attending any upcoming association meetings, please visit our Healthcare TechGuide for the online calendar of cardiovascular conferences.
On these topics, or any others, please feel free to contact me.
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Justine Cadet, News Editor
jcadet@cardiovascularbusiness.com |
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| Top Stories |
ESC: Surgery bests stenting in sickest patients, Boston Scientific trial finds
 The SYNTAX trial that Boston Scientific undertook to prove the worth of drug-eluting stent (DES) procedures has conversely failed to meet its primary endpoint at one year, and shown that CABG is a preferable method for the sickest patients, according to results presented this week at the European Society of Cardiology (ESC) in Munich, Germany. |
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Heart editors: Class of diabetes drugs carries significant heart failure risks
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BMJ: Direct-to-consumer drug ads are a waste of money
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Cardiologist error may have spread hepatitis C through nuclear stress tests
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ESC Conference News
Omega-3 fatty acids surpasses Crestor in reducing heart failure
A simple, one-a-day capsule of omega-3 polyunsaturated fatty acids (PUFA) can reduce mortality and admission to hospital for cardiovascular reasons in patients with heart failure, while statin treatment with rosuvastatin had no effect in patients with chronic heart failure, according to two studies based on the GISSI-HF trial presented at the European Society of Cardiology (ESC) congress in Munich, Germany.
Medtronic pacemaker may be safe to use in MRI scans
Medtronic’s investigational EnRhythm MRI SureScan pacing system shows promise as a potential solution for patients receiving their first pacemaker and needing an MRI scan, according to initial safety and efficacy data presented Sunday at the European Society of Cardiology (ESC) Congress in Munich, Germany.
Telmisartan could be an alternative for patients who can’t tolerate ACE inhibitors
Telmisartan, designed to lower blood pressure, reduced the incidence of cardiovascular death, heart attack or stroke in people who are unable to tolerate the standard treatment, according to the TRANSCEND trial presented at this week’s European Society of Cardiology (ESC) congress in Munich, Germany.
Apixaban falls short compared to standard blood-clotting drugs
When apixaban is added to the current standard of care for acute coronary syndrome (ACS), including aspirin and clopidogrel, it did not show a statistically significant difference in ischemic events, according to a trial presented Tuesday at the European Society of Cardiology (ESC) congress in Munich, Germany.
Ivabradine benefits patients with high heart rates, two studies say
Use of the heart-rate lowering drug ivabradine can reduce the incidence of cardiovascular disease and death in patients with coronary artery disease (CAD) and those who have a high heart rate, according to two studies presented this week at the European Society of Cardiology (ESC) Congress in Munich, Germany.
Lp-PLA2 yields mixed results for Glaxo as coronary plaque stabilizer
The selective Lp-PLA2 (lipoprotein-associated phospholipase A2) inhibitor darapladib, in addition to standard of care treatment, prevented expansion of the necrotic core, a region associated with a high risk of rupture, according to the results of the IBIS-2 trial presented Tuesday at the European Society of Cardiology (ESC) congress in Munich, Germany.
ESC updates guidelines for heart failure, STEMI, acute pulmonary embolism
The European Society of Cardiology (ESC) has released three new sets of updated guidelines in three areas of cardiovascular care: STEMI patients; acute and chronic heart failure; and the management of acute pulmonary embolism during their annual congress, which took place in Munich, Germany, this week.
Industry News
Docs, payors say ICD-10 timetable is recipe for disaster
While the ICD-10 code set has the potential to transform the healthcare system, the three-year timeframe proposed by the Department of Health and Human Services (HHS) is not long enough to make a successful transition, according to physicians and health insurers.
Whistleblowers helped DoJ collect nearly $10B in healthcare fraud cases
The U.S. Department of Justice (DoJ) closed 379 healthcare fraud cases and recovered $9.3 billion from defendants from 1996 to 2005, according to a study in the Sept. 2 issue of the Annals of Internal Medicine.
Judge gives Boston Scientific $200M break on Medtronic payout
Boston Scientific scored a major victory in an ongoing patent dispute with Medtronic involving balloon catheters and stent delivery systems, when the judge reduced the award from $250 million to $19 million.
CMS qualifies ACC national cardiovascular data registry for 2008 PQRI
The Centers for Medicare & Medicaid Services (CMS) has qualified the American College of Cardiology's (ACC) National Cardiovascular Data Registry (NCDR) to submit aggregate data for the 2008 Physician Quality Reporting Initiative (PQRI).
Terumo fires back against Maquet patent infringe suit
Terumo Cardiovascular Systems filed a patent infringement complaint Aug. 21 in the Northern District of California against Maquet Cardiovascular, alleging that Maquet's Vasoview endoscopic vessel harvesting system infringes on of its patents.
Denmark court defends Pfizer Lipitor patent
The Eastern Division of the High Court in Copenhagen, Denmark, has ruled in Pfizer’s favor regarding challenges to two of its patents covering atorvastatin, the active ingredient in Lipitor.
Intel enters healthcare arena with patient-monitoring device
Intel has made its foray into the medical market with the release of a care management system that allows physicians to monitor patients with congestive heart failure and chronic obstructive pulmonary disease from their homes.
Financial News
BMJ: Will screening those at high risk for cardiovascular events be cost effective?
As the British government closed its consultation on the effectiveness of vascular checks for high-risk individuals aged 40 to 74, experts debated the value of the strategy in the Aug. 28 issue of British Medical Journal.
Clinical Studies
JAMA: Use of sodium bicarbonate does not reduce contrast risk
The use of sodium bicarbonate for hydration during coronary angiography for patients with kidney disease did not reduce the risk of developing serious kidney problems related to the use of contrast agents, compared with the use of sodium chloride, according to a study in the Sept. 3 issue of the Journal of the American Medical Association.
NEJM: ICDs do not hinder quality of life in patients with heart failure
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New Releases
Philips launches dual-axis rotational coronary angiography technology at ESC
Philips Healthcare unveiled its XperSwing dual-axis rotational functionality for coronary angiography at the European Society of Cardiology (ESC) congress this week in Munich, Germany.
TomTec debuts 2D cardiac performance package
TomTec launched its 2D Cardiac Performance Analysis package as part of its CardioArena multimodality imaging solution at the European Society of Cardiology (ESC) Congress 2008 in Munich, Germany, this week.
Regulatory News
FDA clears new Edwards mitral heart valve device
Edwards Lifesciences, a heart valves company, has received approval from the FDA for the Carpentier-Edwards Perimount Magna mitral heart valve.
Stereotaxis nets FDA guidewire clearance to treat CTO in peripheral arteries
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United Therapeutics submits NDA for pulmonary arterial hypertension drug
The FDA has accepted the new drug application (NDA) for inhaled treprostinil for the treatment of pulmonary arterial hypertension from United Therapeutics and its wholly-owned subsidiary Lung Rx.
Partnerships & Alliances
MD Buyling to provide VHA hospitals with info on technology, pricing
MD Buyline, a research, information and consulting organization for healthcare providers, and VHA, a healthcare alliance, have entered a multi-year agreement to provide VHA’s 1,400 member hospitals with access to expert analysts and reports on technology, pricing and performance.
Executive Announcement
3mensio hires new CEO, Wessels named as CTO
3mensio Medical Imaging, an advanced visualization software company, has appointed Paul Sysmans as CEO; Frank Wessels, founding CEO, is taking on a new role as the company’s chief technology officer. The new executive appointments are effective immediately.
Former ev3, Boston Scientific exec appointed as new Stentys CMO
Stentys, a next-generation drug-eluting bifurcation stent company, has appointed René Spaargaren, MD, as its chief medical officer (CMO). |
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