At this year’s Transcatheter Cardiovascular Therapeutics meeting, companies presented work comparing shortened durations of dual anti-platelet therapy with the standard 1-year regimen in patients treated with a drug-eluting stent.
Among those companies were Medtronic (NYSE:MDT) and OrbusNeich. Here’s a look at what they found.
Medtronic’s DAPT-STEMI trial
Yesterday, investigators presented data from Medtronic’s independently-run DAPT-STEMI trial, which found that six- and 12-month dual anti-platelet therapy bring result in the same outcomes in ST-elevation myocardial infarction patients treated with Medtronic’s Resolute Integrity drug-eluting stent.
Guidelines suggest that STEMI patients receive 12 months of DAPT following percutaneous coronary intervention.
The DAPT-STEMI trial enrolled 1,100 STEMI patients and 870 of them were randomized to either stop dual anti-platelet therapy after six months or continue DAPT for a full-year.
The study’s primary non-inferiority endpoint, which was a composite of all-cause mortality, myocardial infarction, revascularization, stroke or major bleeding, was met at two years.
“These data help expand the growing body of clinical evidence that may support physicians in tailoring DAPT regimens for patients,” principal investigator Dr. Elvin Kedhi said in prepared remarks. “We believe the results from DAPT-STEMI, in addition to the future outcomes from the Resolute Onyx One study, will help to inform DAPT guidelines for newer-generation DES.”
“Physicians are the ultimate DAPT decision-makers, therefore it’s critical that we invest in providing relevant and clinically meaningful evidence around DAPT duration,” Dr. Martin Rothman, VP of medical affairs for Medtronic’s cardiac & vascular group’s coronary and structural heart division added. “We look forward to continuing this important research with the upcoming enrollment initiation of our Onyx One study that will evaluate one-month DAPT with the Resolute Onyx DES in patients at a high bleeding risk.”
OrbusNeich’s Reduce trial
In OrbusNeich’s study, investigators hypothesized that they could reduce the duration of DAPT by using the company’s Combo dual therapy stent, which combines a luminal anti-CD34 antibody with sirolimus.
The study enrolled 1,496 patients with acute coronary syndrome and treated them with the Combo dual therapy stent and either three months or 12 months of DAPT. The trial’s primary endpoint was a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target-vessel revascularization and bleeding at 12 months.
There was no difference in the primary endpoint between three and 12 months DAPT, the company reported and bleeding rates were similar among both treatment groups.
“The Reduce trial shows that among ACS patients treated with a Combo stent, three months of DAPT is non-inferior to 12 months of DAPT, and this is consistent for all pre-specified subgroups” Dr. Harry Suryapranata, professor of interventional cardiology at Radboud University Medical Center, said in prepared remarks. “Therefore, this strategy could be considered if needed, even in ACS population. Future larger trials are needed to further investigate and confirm the safety of short-term DAPT regimen in ACS patients in the era of new ADP antagonists and new generation DES.”