Boston Scientific and Medtronic shared clinical trial data on their stents in patients who received relatively short regimens of dual antiplatelet therapy (DAPT).
On Thursday, Medtronic shared results showing its polymer stent Resolute Onyx performed comparably to Biosensors' BioFreedom in high-bleeding risk (HBR) patients who received one month of DAPT.
- At the same Transcatheter Cardiovascular Therapeutics symposium, Boston Scientific showed giving three months of DAPT rather than 12 had no effect on key outcomes.
DAPT regimens featuring aspirin and a P2Y12 inhibitor such as cangrelor or clopidogrel are given to patients who receive coronary stents to cut the risk of stent thrombosis. A 12-month DAPT duration became the standard but that standard has been debated and challenged, with some studies suggesting three or six-month regimens are safer.
The latest data Boston Scientific and Medtronic presented help inform that debate. Medtronic's clinical trial randomized almost 2,000 HBR patients undergoing percutaneous coronary interventions to receive either Resolute Onyx or BioFreedom. Patients in both arms received one month of DAPT.
Resolute Onyx and BioFreedom performed comparably against the primary safety endpoint of cardiac death, myocardial infarction or stent thrombosis at one year, posting rates of 17.1% and 16.9%, respectively.
The devices also performed comparably against most of the other endpoints. Resolute Onyx had an edge in two areas. The trial found the rate of device success was statistically higher among patients who received Medtronic's Resolute Onyx. And the rate of myocardial infarction was lower in the Resolute Onyx cohort.
Medtronic framed the data as supporting the use of shortened DAPT courses with its stent.
"With these new data presented today, the evidence provides greater confidence in treating complex patients with Resolute Onyx and a shortened course of DAPT," Dave Moeller, general manager of the coronary and renal denervation business at Medtronic, said in a statement.
Boston Scientific's trial enrolled 2,009 HBR patients and treated them with Synergy, a thin-strut platinum-chromium stent, and a three-month course of DAPT. The researchers compared results in those patients to a historical control group that received DAPT for 12 months.
The rates of death or myocardial infarction between three and 15-months were nearly identical in the two cohorts, resulting in the trial meeting one of its co-primary endpoints. The study also met its second co-primary endpoint. That endpoint required less than 1% of patients to experience stent thrombosis.
"This is critically important information because the required duration of DAPT following implantation of current generation drug-eluting stent platforms was previously unknown," Ajay Kirtane, the cardiologist who presented the data, said in a statement.