ACC.26: Heart Pump Trial Finds No Benefit in High-Risk Angioplasty

A randomized trial presented at the American College of Cardiology's Annual Scientific Session (ACC.26) in New Orleans found no benefit from using a temporary heart pump to support patients with severe heart failure during complex coronary angioplasty, and recorded more cardiovascular deaths among those who received it, the ACC said on March 29.

The meeting, held March 28-30, also featured device and procedure trials in chronic total occlusions of the coronary arteries and in failed mitral valve replacements.

BCIS-3: heart pump support during PCI

The UK trial, known as CHIP-BCIS3, enrolled 300 patients at 21 UK sites who had extensive coronary disease and severe left ventricular impairment, with hearts pumping out on average 27 percent of the blood in the left ventricle per beat, according to the ACC. Half underwent percutaneous coronary intervention with left-ventricular unloading using a miniaturized pump; half had PCI alone. The support device was a micro-axial pump, SOLACI reported, with a mean follow-up of 22 months.

On the primary endpoint, a hierarchical composite of death, disabling stroke, heart attack, cardiovascular hospitalization and procedural heart injury, outcomes were better with standard care in 43 percent of patient-pair comparisons and with unloading in 36.6 percent, a difference that was not statistically significant, the ACC said. In a secondary analysis, all-cause death was 32.6 percent with unloading versus 23.4 percent with standard care, and cardiovascular death was 26.7 percent versus 14.5 percent.

"Our findings strongly suggest that we shouldn't be using this device routinely without more evidence of benefit," said Divaka Perera of King's College London, the study's first author. The ACC said Perera described bleeding and blood-vessel injury rates as low in both groups; SOLACI reported major bleeding of 10.8 percent versus 7.3 percent and vascular complications of 16.9 percent versus 10.6 percent. The trial was funded by the UK's National Institute for Health and Care Research and published in the New England Journal of Medicine, the ACC said.

ORBITA-CTO and SURVIV

In ORBITA-CTO, a blinded trial of 50 patients with a single chronic total occlusion, angioplasty improved angina beyond a placebo procedure, according to an ACC summary. Patients who had the procedure averaged 31 more angina-free days over 168 days of follow-up. "Our results demonstrate in a randomized, double-blinded study design that coronary angioplasty and stenting is an effective treatment for patients who have a chronic total occlusion and chronic anginal chest pain," said principal investigator John Davies. The ACC noted the trial was small and excluded the most complex occlusions. Results were published in JACC.

The SURVIV study randomized 150 patients at seven hospitals in Brazil with failing mitral bioprosthetic valves to transcatheter valve-in-valve treatment or repeat surgery. At one year, death or disabling stroke occurred in 5.3 percent of the transcatheter group and 20.8 percent of the surgical group, a difference driven largely by early postoperative events, according to the ACC. Its limitations include small size and a single-country population with many rheumatic heart disease patients.

Next steps

Perera's group plans to present a cost-benefit analysis of left-ventricular unloading later this year, and said follow-up studies are needed to understand the higher death and blood-vessel injury rates, the ACC said. Further research is needed to determine which chronic total occlusion patients benefit most from angioplasty, Davies said.