TOTAL: Manual Thrombectomy Does Not Benefit STEMI Patients at 1 Year
Performing manual thrombectomy routinely prior to primary PCI in STEMI patients does not reduce the composite of CV death, HF, recurrent MI or cardiogenic shock at 1 year, according to data from the TOTAL trial presented at TCT 2015 and simultaneously published in The Lancet. Moreover, the adjunctive treatment may increase risk for stroke
Sanjit S. Jolly, MD, MSc, of McMaster University, Hamilton, Canada, and colleagues randomized 10,064 STEMI patients within 12 hours of symptom onset to receive upfront manual thrombus aspiration followed by PCI (n = 5,035) or PCI alone (n = 5,029).
At 1 year, the composite rate of CV death, HF, recurrent MI or cardiogenic shock (primary outcome) was 7.8% in both groups (Figure).
Individual components of the primary outcome were also similar. The rate of CV death was 3.6% with manual thrombectomy and 3.8% with PCI alone (P = .48); class IV HF was 2.1% and 1.9%, respectively (P = .5); recurrent MI was 2.5% and 2.3%, respectively (P = .68) and cardiogenic shock was 1.9% and 2.1%, respectively (P = .47).
However, the rate of stroke at 1 year was 1.2% with manual thrombectomy and 0.7% with PCI alone (HR 1.66; 95% CI 1.1-2.51; P = .015). Combined stroke or transient ischemic attack also was more common with manual thrombectomy (1.4% vs. 0.9%; HR 1.65; 95% CI, 1.14-2.4; P = .008).
Additional analyses failed to find benefit of manual thrombectomy in any patient subgroup, even those with the highest thrombus burden, Jolly said.
Ending the thrombectomy debate
Based on TOTAL’s 1-year outcomes, “manual thrombectomy can no longer be recommended as a routine strategy” for STEMI patients, Jolly concluded.
Two other large trials, TAPAS and TASTE, showed contradictory results for manual thrombectomy in this population. TAPAS, published in 2008, found that manual thrombectomy reduced cardiac death, whereas the TASTE trial, published in 2013, found no clinical benefit to the adjunctive therapy. Longer-term follow-up of TOTAL was obtained because data from the trial at 180 days showed no difference in the primary outcome but suggested some improvement in surrogate markers of ST-segment resolution and distal embolization. The researchers wanted to determine whether the findings related to surrogate outcomes would translate into benefit at 1 year.
In a discussion after the presentation, Stefan K. James, MD, of Uppsala Clinical Research Center, Sweden, said it is important to “rely on the TOTAL findings and take them seriously.” However, in certain cases, “it’s OK to still use thrombectomy,” said James, who was an investigator for the TASTE trial.
Jolly reports no relevant conflicts of interest.