Medtronic touts early vessel healing in independent 1-month Resolute Onyx DES trial
Medtronic (NYSE:MDT) today released data from an independent study of its Resolute Onyx drug-eluting stent, touting strong early vessel healing at one month in a patient population with a high percentage of patients with complex coronary artery disease.
Data from the study was presented at the EuroPCR Annual Meeting in Paris, the Fridley, Minn.-based company said.
The study included data from 15 patients, including 13 with acute coronary syndrome, evaluated using optical coherence tomography, Medtronic said. At one month, patients implanted with the Resolute Onyx DES indicated an average of 88% of struts covered by neointimal formation and 92.3% of the total stented area showing complete strut overage, including areas between the struts.
“We are committed to generating meaningful clinical evidence to help inform physician decision making and guidelines around the use of newer-generation DES in complex patients. These results reinforce our commitment to studying one-month DAPT in studies like the Global Onyx ONE Study which is currently enrolling around the world,” coronary and renal denervation biz GM Dave Moeller said in a prepared statement.
“The signal of early healing is crucial for patients who may need to interrupt or discontinue dual anti-platelet therapy within a short period of time after receiving a stent. These data help expand the growing body of clinical evidence that may support physicians in tailoring DAPT regimens for complex patients,” Onyx 1-month OCT study principal investigator Dr. Elvin Kedhi said in a press release.
In a separate presentation, Medtronic presented an analysis of new data from the DAPT-StemI trial of patients treated with the Resolute Integrity DES.
The company reported that at six months, the patient oriented composite primary endpoint of all-cause mortality, myocardial infarction, revascularization, stroke and TIMI major bleeding occurred in only 4.2%Q of patients. Results also indicated a 1.1% rate of target lesion revascularization and 0.7% rate of stent thrombosis.
Medtronic won CE Mark approval for Resolute Onyx in November 2014 and added FDA approval last April. The device launched in Japan last July.