Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

New hemodynamic device improved outcomes for high-risk PCI patients

Society for Cardiovascular Angiography and Interventions 2011 Scientific Sessions

BALTIMORE — An analysis of data showed that the Abiomed Impella 2.5 device offered better hemodynamic support than the intra-aortic balloon pump traditionally used in high-risk percutaneous coronary intervention patients.
William O’Neill, MD, executive dean for clinical affairs at the University of Miami Miller School of Medicine, presented data from the aborted PROTECT II trial during the Society for Cardiovascular Angiography and Interventions 2011 Scientific Sessions. After the trial was halted, investigators continued to follow the population for 90 days. They determined that in the Impella arm (n=213), 21.6% experienced major adverse events compared with 31% in the balloon device arm (n=210).

Between November 2007 and November 2010, 452 of an intended 654 patients were prospectively enrolled in a multicenter, randomized trial to determine the type of hemodynamic support that provides the best clinical outcomes during high-risk PCI. Patients with three-vessel disease and left ventricular ejection fraction <30% or with unprotected left main or last patent conduit and LVEF <35% during PCI were included. Prophylactic support was initiated before the intervention and halted as soon as it was efficacious after the procedure. The revascularization procedure was at the discretion of the clinician. The primary endpoint was a composite of major adverse events at 30 days; the primary endpoint follow-up was assessed at 90 days.

Due to futility on the primary analysis at the first interim mark, the Data Safety Monitoring Board recommended the study be terminated. The patient population (n=452) at interim was 66 ± 10 years of age and included those with diabetes (52%), active angina (66%) and renal insufficiency (25%). Class NYHA III/IV patients numbered 56%; 67% were not candidates for surgery. Patients had syntax scores of 31 ± 14 and their LVEF was 24 ± 6%.

O’Neill also presented data on the effect of operator learning curve: 90-day outcomes in the intent-to-treat population (n=447) saw a major adverse event rate for the Impella device of 47.8% in 2008; 39.1% in 2009; and 37.3% in 2010. “I can’t fault the Data Safety Monitoring Board for halting the trial,” O’Neill said. “The thing we didn’t take into full consideration was the learning curve of the trial.”
__________________________________________________ _________________________
Prevalence of wake-up strokes found in large population
Mackey J. Neurology. 2011;76:1662–1667.

Almost 15% of all strokes that occurred in a recent study were found to be wake-up strokes. This study, according to researchers, was the first large and population-based study to examine the event rate of wake-up strokes.

Jason Mackey, MD, and fellow colleagues studied all first-time and recurrent ischemic strokes among 1.3 million residents of the Cincinnati/northern Kentucky region in 2005. Only patients aged at least 18 years who were evaluated in an ED were included in the analysis.

Overall, 1,778 residents were identified with 1,854 first-ever and recurrent ischemic strokes. Of these, 273 (14.3%) were wake-up strokes, resulting in an adjusted wake-up stroke event rate of 26 per 100,000 people. Among those who experienced a wake-up stroke, at least 35.9% would have been eligible for thrombolysis had arrival time not been a factor.

Additional analysis also revealed that those who had wake-up strokes tended to be older (72.3 ± 0.83 years vs. 70 ± 0.48 years; P=.01) and had a higher baseline retrospective NIH Stroke Scale score (median interquartile ratio,4 vs. 3; P=.004).

Despite these factors, study researchers said there were no obvious features distinguishing between wake-up and nonwake-up strokes.

In addition, they said: “Wake-up strokes constitute a significant percentage of ischemic strokes and are ineligible for thrombolytic therapy due to the current time-based restrictions, which is unfortunate because it is likely that some of these events occurred immediately prior to awakening. Efforts are ongoing to develop better methods of identifying those patients most likely to benefit from treatment while at the same time minimizing exposure to undue risk.”
__________________________________________________ ___________________________
FDA approves carotid stenting system in standard-risk patients

The FDA has recently approved the use of the RX Acculink carotid stenting system for patients at standard surgical risk for carotid endarterectomy, expanding the use of the system beyond the former indication of those who are at high risk with the procedure.

This approval follows the FDA advisory panel’s 7-3 vote in January that the benefits of an expanded indication of the RX Acculink system (Abbott Vascular) outweigh the risks. Both the advisory panel and the FDA’s vote were based on the findings of the 10-year Carotid Revascularization Endarterectomy Vs. Stenting Trial (CREST), which demonstrated similar results among patients treated with carotid stenting vs. carotid endarterectomy.

According to a press release, a condition of this approval is that Abbott will conduct a post-approval study on the device, following new patients treated with the system for at least 3 years to confirm the results of CREST. Also stated in the release, this upcoming study will be consistent with recommendations made by the panel and will evaluate how patients aged at least 80 years respond to the treatment, as well as whether success is affected by physician experience and whether those with symptoms before treatment have a different outcome compared with those who are asymptomatic.