A Medical Device Daily

At the EuroPCR meeting held this week in Barcelona, Spain, Abbott (Abbott Park, Illinois) reported one-year results from the SPIRIT V international, post-approval, single-arm study of Xience V. Results showed a very low 1.8% rate of repeat procedure (target lesion revascularization), a 0.7% rate of stent thrombosis and a 5.1% rate of major adverse cardiac events (MACE) at one year in patients treated with Abbott's Xience V drug eluting stent.

The 2,663-patient SPIRIT V trial is the first look at the performance of Xience V in a diverse, "real world" population of patients and lesion types, including diabetics, patients with multi-vessel disease and patients with highly complex lesions. The data from this real-world study is valuable because it reflects a broad patient population that is more representative of the spectrum of disease seen in a typical interventional cardiology practice, the company said. The SPIRIT V data is also the largest complex patient population Abbott has reported data on for Xience V.

Additionally, the one-year results from SPIRIT V indicate that even in a patient population with challenging anatomy, Xience V exhibits low event rates, similar to what was seen when Xience V was studied in controlled, randomized studies.

"The data from real-world studies are valuable because they reflect a broad patient population that is more representative of the spectrum of disease seen in a typical interventional cardiology practice," said Eberhard Grube, MD, chief of the department of cardiology and angiology at Heart Center Sieburg (Sieburg, Germany) and principal investigator of the SPIRIT V study. "The one-year results from SPIRIT V indicate that even in a patient population with a high percentage of complex lesions, Xience V exhibits remarkably low event rates, similar to what was seen when Xience V was studied in controlled, randomized SPIRIT studies."

SPIRIT V is an international, post-approval study of 2,663 patients. About 100 clinical sites throughout Europe, Asia-Pacific and Canada are participating in the study, ensuring a patient population composed of multiple ethnic groups.

In other news from the EuroPCR meeting:

• Results show percutaneous mitral repair using the MitraClip system from Evalve (Menlo Park, California) in symptomatic high-risk surgical patients with either functional mitral regurgitation (FMR) or degenerative mitral regurgitation (DMR) improves patient clinical status. The results from the 78 patient EVEREST II High Risk Registry demonstrated improvement in left ventricular function and reduced hospitalization for congestive heart failure for both MR groups at 12 months. Additionally, a reduction in mortality compared to the predicted mortality risk of surgery was reported for the registry.

The data were presented by Saibal Kar, MD, director of interventional cardiac research at Cedars-Sinai Medical Center (Washington) and the lead enrolling investigator of the EVEREST trials.

"The High Risk Registry data support our belief that the MitraClip therapy is a safe and clinically beneficial treatment alternative for select patients suffering from significant functional or degenerative MR," said Kar. "Patients otherwise unable to withstand more invasive treatments can benefit from the MitraClip therapy while avoiding the risk of increased morbidity and mortality often associated with surgical treatment."

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

The High Risk Registry data showed similar 30-day mortality, as well as improved 12-month mortality among patients treated with the MitraClip therapy compared to a concurrent control group who was managed medically or underwent mitral valve surgery.

At 12 months, 74% of FMR patients with matched data were in NYHA functional class I or II, compared to only 9% at baseline. Similarly, at 12 months, 75% of DMR patients with matched data were in NYHA functional class I or II, compared to only 15% at baseline. This sustained improvement in functional class was accompanied by improved LV function for both groups. The rate of hospitalization for congestive heart failure in the year after treatment with the MitraClip system was reduced by 55% and significantly lower compared to the year prior to treatment.

• InspireMD (Tel Aviv, Israel) reported the completion of enrollment for the MAGICAL trial (MGuard in Acute Myocardial). The trial was designed to confirm the clinical feasibility, safety and performance of MGuard when used during primary PCI in STEMI patients.

The MAGICAL trial is a multicenter, prospective, single arm, 60-patient study. The primary endpoints of the study are incidence of complete ST segment resolution measured 60 minutes post procedure and incidence of TIMI 3 flow after PCI. Main secondary endpoints are myocardial blush grade (MBG) and MACE at discharge, 30 days and 6 months.

"I am very pleased and excited we reached this milestone" said Dariusz Dudek, MD, of Jagiellonian University (Krakow, Poland). "From the data collected so far, primary PCI for STEMI patients using MGuard seems highly safe and effective."

To date, TIMI flow 3 is 91%, MBG 3 is 74%, complete ST resolution is 63%. MACE at discharge is 0% and 30 days MACE to date is 0% as well.