TOTAL: Manual thrombectomy with PCI does not improve outcomes, increases short-term stroke rate
SAN DIEGO — Manual thrombectomy with primary PCI did not benefit patients with STEMI and was associated with an increased rate of stroke at 30 days, according to findings from the TOTAL trial.
Previously, the small TAPAS study suggested manual thrombectomy may improve outcomes by reducing distal embolization and improving microvascular perfusion, but the TASTE trial did not show a difference in all-cause mortality at 30 days or 1 year between patients who had manual thrombectomy followed by PCI and those who had PCI alone, Sanjit S. Jolly, MD, MSc, associate professor of medicine and interventional cardiologist at McMaster University, Hamilton, Ontario, Canada, said during a press conference at the American College of Cardiology Scientific Sessions.
Sanjit S. Jolly
Jolly and colleagues randomly assigned 10,732 patients with STEMI undergoing primary PCI to routine upfront manual thrombectomy in conjunction with PCI, or PCI alone. Approximately 7% of patients from the PCI-alone group required manual thrombectomy after PCI alone failed, he said.
The primary outcome was a composite of CV death, recurrent MI, cardiogenic shock or NYHA class IV HF within 180 days. The key safety outcome was stroke at 30 days.
The primary outcome occurred in 6.9% of the thrombectomy group vs. 7% in the PCI-only group (HR = 0.99; 95% CI, 0.85-1.15).
The researchers also reported no differences between the groups in CV death (thrombectomy group, 3.1%; PCI-only group, 3.5%; HR = 0.9; 95% CI, 0.73-1.12) or the primary outcome plus stent thrombosis and target vessel revascularization (9.9% vs. 9.8%, respectively; HR = 1; 95% CI, 0.89-1.14).
However, Jolly said, stroke within 30 days occurred in 0.7% of those in the thrombectomy group vs. 0.3% of those in the PCI-only group (HR = 2.06; 95% CI, 1.13-3.75).
“The stroke findings were unexpected and require confirmation in other studies,” Jolly said. “Detailed analyses are ongoing to understand the etiology of these strokes.”
A lesson from the study is that benefits seen in small studies may not turn out to be true in larger ones, Jolly said.
“As an interventional cardiologist who believed that early trial, and in fact followed the guidelines of using thrombectomy routinely, the TOTAL and TASTE trials have now shown us the truth, and we need these [larger] trials to determine what the true effect of interventions are in order to move the field forward and help patients,” he said. – by Erik Swain
Jolly SS, et al. Late-Breaking Clinical Trials V: TCT@ACC-i2 Interventional Cardiology. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.
Disclosure: The study was funded by Medtronic, the Canadian Network and Centre for Trials Internationally (CANNeCTIN) and the Canadian Institutes of Health Research. Jolly reports receiving grant support from the Canadian Institutes of Health Research, CANNeCTIN and Medtronic, and receiving personal fees from AstraZeneca and St. Jude Medical.