Routine percutaneous coronary interventions with manual thrombectomies increase the risk of stroke compared to PCI alone, according to a new substudy published last month.
The substudy, published online already and set to go to print in the European Heart Journal, examined a 10,058-patient cohort from the earlier Total study of PCI and manual thrombectomies to better understand the increase in stroke rate.
The new analysis reported that the stroke difference was evident in as little as 48 hours, with 15 thrombectomy patients reporting an event versus 5 treated with only PCI. The overall risk was still low however, with a 0.3% risk associated with thrombectomy treatment and a 0.1% risk from PCI alone, according to the study.
At 30-days, stroke rates in thrombectomy patients were more than double that of those treated with PCI alone, though the risks were again below 1% for both groups, with thrombectomy patients having a 0.7% risk and PCI only patients having a 0.3% risk. The difference in stroke rate continued to grow between 90 and 180 days. Stroke rates at 180 days were 1% for thrombectomy patients versus 0.5% for PCI-only patients.
The rate of fatal strokes and strokes that led to major disabilities had double the rate in thrombectomy patients compared to PCI patients at 180 days, with 0.7% and 0.3% respectively. The study reported that both ischemic stroke and primary hemorrhagic strokes also occurred at higher rates in thrombectomy patients.
There was no difference in the rate of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class IV heart failure within 180 days between the 2 patient groups, according to the study.
However, in patients who received bailout thrombectomy, no strokes occurred. This led study authors to recommend the treatment only for bailouts.
“A strategy of routine manual thrombectomy was associated with an increased risk of stroke compared with a strategy of PCI alone with thrombectomy reserved for only bailout. Future thrombectomy trials need to carefully collect stroke outcomes to determine their safety in addition to efficacy,” study authors wrote.
Thrombectomy treatments during the trial were administered with Medtronic‘s (NYSE:MDT) Export catheter.
Late last month, the American Heart Association/American Stroke Association updated its treatment guidelines for patients suffering from ischemic stroke to include endovascular treatments, such as thrombectomy, for patients who have obstructions in the large arteries supplying blood to the brain.
