After a year of follow-up, patients with STEMI who received thrombus aspiration during PCI had similar results in the primary outcome of cardiovascular death, recurrent MI, cardiogenic shock or class IV heart failure compared with patients undergoing PCI alone, according to a prospective, randomized trial.
In each group, 8 percent of patients had a primary outcome and 4 percent experienced cardiovascular death within a year. In addition, 1.2 percent of patients in the thrombectomy group and 0.7 percent of patients in the PCI alone group had a stroke within a year.
Lead author Sanjit S. Jolly, MD, an interventional cardiologist at Hamilton Health Sciences in Canada, presented the findings on Oct. 13 in a late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.
Results of the TOTAL trial were simultaneously published online in The Lancet. It was the largest study of routine manual thrombectomy in STEMI patients.
Medtronic, the Canadian Institutes of Health Research, Canadian Network and the Centre for Trials Internationally funded the study with a research grant.
“Based on these data, manual thrombectomy can no longer be recommended as a routine strategy during primary PCI for ST elevation MI,” Jolly said.
The researchers randomized 10,064 patients between Aug. 5, 2010, and July 25, 2014, at 87 hospitals in 20 countries to receive manual thrombectomy with Medtronic’s Export catheter followed by PCI or PCI alone within 12 hours of symptom onset. Patients were excluded if they had undergone previous CABG or received fibrinolytic therapy.
At the American College of Cardiology scientific session in March, the researchers released results that showed no difference at 180 days within the groups with regards to the primary outcome of cardiovascular death, MI, cardiogenic shock or class IV heart failure. However, patients who received thrombectomy had significant improvements in the surrogate outcomes of distal embolism and ST segment resolution.
Despite those results, cardiologists continued using thrombus aspiration, although the one-year results could lead fewer cardiologists to use that approach.
“It often takes time for the evidence to get translated into clinical practice,” Jolly said. “A number of colleagues have said to me that they are using less thrombus aspiration based on the results. It’s causing them to pause. The other thing is, as an interventional cardiologist, we’re very visually driven. When we see something, we want to take it out. I think over time, practice shifts based on the evidence, but it may take more time.”
After a year, recurrent MI, cardiogenic shock or heart failure as well as all-cause death, stent thrombosis, definite stent thrombosis, target vessel revascularization and major bleeding were similar between the groups. In addition, a landmark analysis showed no significant difference in strokes beyond 180 days.
The findings were similar in subgroup analyses of patients based on thrombus burden, age, symptom onset duration, location of the infarct, initial TIMI flow and site primary PCI volume.
The researchers also conducted an updated meta-analysis of 20,000 patients with STEMI who were randomized to receive thrombectomy or PCI alone. They found no difference with regards to all-cause mortality, although the thrombectomy group had a significant increase in stroke (0.9 percent of patients) compared with the PCI alone group (0.6 percent of patients).