TOTAL: Stroke risk linked to manual thrombectomy during PCI evident within 48 hours

The increased stroke risk associated with manual thrombectomy during primary PCI detected in the TOTAL trial was evident within the first 48 hours after the procedure and still prominent at 180 days, according to new data from the TOTAL trial presented at EuroPCR.

The TOTAL trial of 10,732 patients with STEMI undergoing primary PCI, presented at the American College of Cardiology Scientific Sessions in March and published in The New England Journal of Medicine, found that patients assigned manual thrombectomy did not achieve a clinical benefit compared with patients assigned control treatment, but had a higher risk for stroke at 30 days (0.7% vs. 0.3%; HR = 2.06; 95% CI, 1.13-3.75).

Sanjit S. Jolly

At EuroPCR, Sanjit S. Jolly, MD, MSc, associate professor of medicine and interventional cardiologist at McMaster University, Hamilton, Ontario, presented additional data on stroke from the TOTAL cohort, including stroke timing, severity, subtypes and independent predictors.

The difference between the groups in stroke remained at 180 days (thrombectomy group, 1%; controls, 0.5%; HR = 2; 95% CI, 1.25-3.2), Jolly said.

Much of this difference occurred in those who had a fatal stroke or one resulting in major disability, defined as Rankin score of 3 to 6 (thrombectomy group, 0.7%; controls, 0.3%; HR = 2.69; 95% CI, 1.42-5.08), he said.

At 180 days, compared with controls, the thrombectomy group had a higher rate of both ischemic strokes (0.7% vs. 0.4%; HR = 1.71; 95% CI, 1.03-3) and primary hemorrhagic strokes (0.2% vs. 0.04%; HR = 4.98; 95% CI, 1.09-22.7), according to Jolly.

The time period in which the difference in stroke rate between the groups was most pronounced was 0 to 48 hours after the procedure (thrombectomy group, 0.3%; controls, 0.1%; HR = 3; 95% CI, 1.09-8.25). Jolly also noted that the differences during other time periods (more than 48 hours to less than 7 days, 7 to less than 30 days, 30 to less than 90 days and 90 to 180 days) were not significant.

Patients who had a stroke within 180 days were much more likely to die compared with those who did not have a stroke (30.8% vs. 3.4%; HR = 10.17; 95% CI, 6.7-15.45).

Independent predictors of stroke included assignment to thrombectomy (HR = 2; 95% CI, 1.24-3.24), age per 10 years (HR = 1.27; 95% CI, 1.04-1.55), female sex (HR = 2.1; 95% CI, 1.31-3.36), peripheral vascular disease (HR = 2.56; 95% CI, 1.09-6.03), previous stroke (HR = 2.54; 95% CI, 1.23-2.54), prior diabetes (HR = 2.41; 95% CI, 1.51-3.85) and use of intra-aortic balloon (HR = 2.98; 95% CI, 1.15-7.73), according to Jolly.

The researchers also performed a meta-analysis and found an increased risk for stroke in the thrombectomy group across 10 trials comparing thrombectomy plus PCI to PCI alone (0.8% vs. 0.5%; OR = 1.59; 95% CI, 1.11-2.27). However, when they performed a meta-analysis of risk for mortality across 20 trials comparing thrombectomy plus PCI to PCI alone, a trend toward a benefit for thrombectomy emerged (3.8% vs. 4.3%; OR = 0.87; 95% CI, 0.76-1).

“Routine thrombectomy compared to PCI alone (with only bailout thrombectomy) was associated with an increased risk of stroke that was evident within 48 hours,” Jolly said during a presentation. “Future trials of thrombectomy devices need to carefully collect stroke outcomes … to determine safety in addition to efficacy.” – by Erik Swain

Reference:

Jolly SS, et al. Hot Line: Primary PCI and STEMI in Practice. Presented at: EuroPCR; May 19-22, 2015; Paris.

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.