The data safety monitoring board (DSMB) has recommended that the TASTE trial, which is evaluating thrombus aspiration in MI, move forward passed its prespecified patient mark to continue enrollment, after a "scrutiny of the figures."
Inclusion in the TASTE (Thrombus Aspiration in ST-Elevation MI in Scandinavia) trial has passed the prespecified 5,000 patients mark. Because of lower than expected 30-day mortality in the study cohort the steering committee earlier amended to the protocol that an interim analysis should be carried out, according to a press release from the researchers. The interim comprised 4,802 patients with a minimum of 45 days follow-up.
The DSMB has recommended continued inclusion in TASTE to a total of 7,300 patients.
“The recommendation to continue the trial was exciting news but also somewhat surprising for us,” said TASTE's principal investigator Ole Fröbert, MD, PhD, and Stefan K. James, MD, PhD, chair of the steering committee and head of the Swedish angiography and angioplasty registry, in the release. Fröbert practices out of the department of cardiology at Örebro University Hospital in Örebro, Sweden, and James is an assistant professor of cardiology at Uppsala University Hospital in Uppsala, Sweden.
TASTE is the largest prospective randomized trial of a medical device for primary PCI and the first-ever randomized clinical trial using a national registry as a platform for randomization follow-up.
According to the trial design at ClinicalTrials.gov, in patients who are referred to Scandinavian hospitals for MI, the researchers will randomize treatment with thrombus aspiration before conventional angioplasty. They hypothesize that these patients will have a reduced risk of death, fewer rehospitalizations, fewer new MIs, reduced risk of heart failure, better coronary artery flow after angioplasty and greater reduction of infarct size compared with patients randomized to conventional angioplasty alone.
The investigators said they hope to finalize inclusion early 2013.