SAN DIEGO—TOTAL may not totally spell the end of routine manual thrombectomy with PCI, but it should make interventional cardiologists think twice about using it with STEMI patients. The large, international trial showed no clinical benefit and possible harm.
TOTAL (The Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI) was billed a potentially game-changing clinical trial in previews of the American College of Cardiology’s scientific session. The trial’s results unveiled March 16 were among the closers for the three-day conference.
TOTAL was inspired by the conflicting results of two trials, TAPAS and TASTE, both designed to evaluate the effectiveness of manual thrombectomy. The first found a reduction in risk with routine thrombectomy and the second detected no difference in outcomes, presenter Sanjit Jolly, MD, of McMaster University, Hamilton, Ontario, explained at a press conference.
Between 2010 and 2014, researchers from 87 hospitals in 20 countries randomized 10,732 patients with STEMI to routine thrombectomy or PCI alone. The protocol allowed bailout thrombectomy in the PCI alone group. The primary outcome was death from cardiovascular causes, recurrent MI, cardiogenic shock or New York Heart Association class IV heart failure at 180 days. For safety, they assessed stroke at 180 days.
The rate of the primary outcome was similar for both groups, at 6.9 percent with thrombectomy and 7 percent with PCI alone. The individual components also were similar. Stroke was more common in the thrombectomy group, though. At 30 days, the rate of stroke with thrombectomy was 0.7 percent vs. 0.3 percent with PCI alone. Those rates increased to 1 percent and 0.5 percent, respectively, at 180 days.
A total of 7 percent of patients in the PCI alone group required thrombectomy bailout. “That is an important take-home message,” Jolly said. He added that the stroke finding surprised the researchers.
Panelist David Kandzari, MD, of the Piedmont Heart Institute in Atlanta, suggested the results answered the question about any survival advantage. He added that interventional cardiologists likely would continue to use thrombectomy selectively, despite with no clinical benefit, “unless there is a safety hazard.”
Kandzari supported Jolly in the TOTAL team’s plans to continue to study the stroke data. He noted that early stroke didn’t seem to be different in the bailout patients. “I think there is still much we are going to learn from you and the group about this procedure and if there remains any particular role.”
Jolly said that an ACC National Cardiovascular Data Registry analysis showed about 20 percent of physicians use routine thrombectomy and, based on a survey by his research group, about 30 percent internationally.
“My estimate would be that number would decline moderately after these results,” Kandzari said. “But considering bailout use we would continue to see some use of thrombectomy.”