New Study Results Reported at TCT 2015 and Published in JACC: Cardiovascular Interventions
SAN FRANCISCO – October 13, 2015 – Results from a new study show no significant benefit of thrombus aspiration during percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) presenting between 12 and 48 hours after symptom onset.
Findings were reported today at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The study was also published in the Journal of the American College of Cardiology: Cardiovascular Interventions.
Although current guidelines recommend thrombus aspiration, recent trials in STEMI patients with early symptom onset (between 0 and 12 hours) have reported disappointing results with no reduction in mortality and possibly an increase in stroke.
The trial was designed as a prospective, randomized, controlled, single-blind, single-center study. Patients with subacute STEMI presenting between 12 and 48 hours after symptom onset were randomized in a 1:1 ratio to manual thrombus aspiration (n=70) or standard PCI alone (n=74). The primary endpoint was the extent of microvascular obstruction (MVO) assessed by cardiac magnetic resonance imaging (CMR) one to four days after randomization. Secondary endpoints included measures of CMR (infarct size, myocardial salvage, left ventricular ejection fraction and volumes), angiography (TIMI flow post-PCI and myocardial blush grade post-PCI), enzymatic infarct size (high-sensitivity troponin T after 24 and 48 hours) and clinical outcomes after 30 days.
The extent of MVO was not significantly different between patients assigned to thrombus aspiration and PCI alone (2.5 ± 4.0% vs.3.1 ± 4.4%, p=.47, respectively). There were also no significant differences in infarct size, left ventricular ejection fraction, or angiographic and clinical endpoints between groups.
“In patients with subacute STEMI, routine manual thrombus aspiration before PCI failed to show a significant reduction in the primary endpoint of microvascular obstruction assessed by cardiac magnetic imaging compared to conventional PCI alone,” said lead investigator, Steffen Desch, MD. Dr. Desch is a Professor at the University of Schleswig-Holstein, Campus Lübeck in Lübeck, Germany.
“This finding is further supported by a lack of benefit in angiographic, enzymatic, and clinical secondary endpoints.”
The study was funded by a research grant from Medtronic. Dr. Desch reported grant/research support from Medtronic.