A Medical Device Daily

As the annual meeting of the American College of Cardiology (Washington) got underway this past weekend in Orlando, a flood of new clinical trial data was presented, along with a vast number of new product and partnership agreement announcements.

In one interesting new piece of news at the ACC meeting, ProSolv CardioVascular (Indianapolis), a Fujifilm company, and the Cardiovascular Ultrasound unit of GE Healthcare's (Waukesha, Wisconsin) reported an affiliation in which the companies will collaborate to develop an integrated solution aimed at improving workflow for echocardiography departments.

Specifically, the organizations hope to expand user access to the advanced quantitative analysis packages currently offered through GE Healthcare by offering workflow and diagnostic reporting efficiencies.

GE Healthcare currently provides an advanced analysis and quantification software module, EchoPAC, designed for the analysis of raw data image sets from GE Healthcare cardiovascular ultrasound systems. Through the new affiliation, the companies said they intend to help make information more universally accessible by cardiologists and other clinical staff by assuring that, no matter where the information is accessed, users have virtually the same level of advanced diagnostic functionality. In doing so, the companies believe users could benefit from a quicker diagnostic process and enhanced diagnostic confidence.

"We're pleased to be working with GE with the aim to deliver advanced integrations that will provide diagnostic and workflow efficiency improvements to our mutual customers," said Aaron Waitz, president/CEO of ProSolv CardioVascular. "There is a definite need for more open access to data throughout cardiovascular departments and healthcare systems as a whole.

"By providing our ProSolv customers access to raw data analysis and quantitative features of EchoPAC, we could help more customers improve their diagnostic and analysis capabilities and improve patient care," said Al Lojewski, VP and GM of GE's Cardiovascular Ultrasound unit.

In other ACC news:

Medtronic (Minneapolis) reported that new data released at the meeting demonstrated "exceptional" long-term safety and effectiveness results for its Endeavor drug-eluting coronary stent (DES) in a large multicenter, real-world study, in which no defined patient selection criteria were specified, and angioplasty was used at medical discretion. Two-year results for more than 2,000 patients in the international, E-Five study showed that the Endeavor stent was associated with a low rate of both overall (0.7%) and very late stent thrombosis (VLAST) at 0.1%.

Long-term controlled clinical studies of other approved DES devices reveal a small but consistent (0.3%/year) increase in the frequently-fatal VLAST complication. The E-Five findings run counter to expectations based upon these prior studies of other DES which have also reported an approximate doubling (0.6%/year) in the rate of VLAST when these devices are used in real-world patient populations.

On other safety endpoints, the two-year results for this pre-specified subset of E-Five patients were similarly favorable, with low and stable rates of cardiac death (1.2% vs. 1.5%) and myocardial infarction (1.2% vs. 1.5%) at one and two years, respectively.

Duration of dual-antiplatelet therapy (DAPT) for these E-Five patients underscores the safety benefits of the Endeavor stent: 52.6% of the patients were on DAPT at one year and 22.1% at two years.

E-Five originally enrolled more than 8,000 patients at more than 200 sites in Europe, Asia Pacific, the Middle East and South America. Extended two-year follow-up was planned for a pre-specified subset of about 2,000 patients at 26 centers in 14 countries to determine the durability of the Endeavor stent's safety and efficacy in a "real-world" population, which reflects the variability of patient types and lesion characteristics in standard clinical practice.

• Long-term data presented from the SPIRIT II clinical trial by Abbott (Abbott Park, Illinois) demonstrated that the clinical advantages of the Xience V everolimus-eluting coronary stent system continued to increase between two and three years compared to the Taxus Express2 paclitaxel-eluting DES and the Taxus Liberté paclitaxel-eluting DES, both manufactured by Boston Scientific (Natick, Massachusetts).

Both Taxus Express2 (73% of lesions) and Taxus Liberté (27% of lesions) were used as controls in the SPIRIT II trial. The data also showed that patients treated with Xience V continue to experience fewer heart attacks, deaths or repeat procedures at the target lesion compared to patients treated with Taxus out to three years, Abbott said.

Between two and three years, Abbott's Xience V maintained a low cardiac death rate of 0.5%, while the observed cardiac death rate for Taxus more than tripled during the same time period (1.3% at two years vs. 4.2% at three years). Similarly, Xience V maintained a low, single-digit rate of major adverse cardiac events (MACE) between two and three years (6.4% at two years vs. 6.4% at three years), while the observed MACE rate with Taxus increased about 40% between two and three years (10.5% at two years vs. 14.9% at three years).

In addition, the SPIRIT II results demonstrated that Xience V continues to outperform Taxus, with Xience V showing continued clinical benefits at three years, including an 88% reduction in the risk of cardiac death and a 57% reduction in the risk of MACE.

"In the clinical outcomes that matter most, such as heart attack, repeat procedure at the target lesion or death, Xience V demonstrated a consistent reduction compared to Taxus out to three years," said Patrick Serruys, MD, PhD, professor of Interventional Cardiology at Thoraxcentre, of the Erasmus University Hospital (Rotterdam, the Netherlands), and principal investigator of the SPIRIT II clinical trial. "What's even more impressive is that the clinical differences between Xience V and Taxus continue to widen between two and three years, confirming the long-term safety and efficacy of Xience V."

Abbott supplies a private-label version of Xience V to Boston Scientific called the Promus everolimus-eluting DES. The Promus is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.

Percutaneous mitral valve repair using the MitraClip system, developed by Evalve (Menlo Park, California), in symptomatic high-risk surgical patients with functional mitral regurgitation (FMR) improves patient clinical status, and left ventricular function, according to 12-month data from the high-risk registry arm of the Endovascular Valve Edge-to-Edge REpair Study (EVEREST II) study

The data were presented at the meeting by Ted Feldman, MD, director of the cardiac catheterization lab at Evanston North Shore Hospital (Evanston, Illinois) and co-principal investigator of the EVEREST trials.

Patients considered at high-risk for surgery are those with increased likelihood of mortality following surgery, usually because of advanced age and co-morbidities, which limit their treatment options. Without MR reduction, these symptomatic patients have a poor quality of life, are frequently hospitalized for heart failure and have reduced survival.

The FMR high-risk registry cohort was composed of 46 symptomatic patients with grade 3 or 4 MR and at least a 12% predicted risk of surgical mortality. Mortality risk was determined by either the Society of Thoracic Surgery Mortality Risk Model, or by a cardiac surgeon's determination that one or more specifically defined risk factors resulted in a predicted mortality risk of at least 12%. The average age was 73 years and most patients had several co-morbidities.

At 12 months, 73% of patients with matched data were in NYHA functional class I or II, compared to only 9% at baseline. This improvement in functional class was accompanied by improved LV function. The rate of hospitalization for heart failure in the year after treatment with the MitraClip system was significantly (p=0.02) lower than the rate in the year prior to treatment.

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