Data from ARGENTO Study Published in International Journal of Cardiology Show No Differences in Stent Thrombosis and Other Clinical Outcomes for Patients Who Discontinue DAPT Prior to and After 15 Days

HONG KONG. -- New clinical data published in the International Journal of Cardiology supports that OrbusNeich's Genous Stent is safe and effective in patients who discontinue DAPT within 15 days of stent placement. Specifically, no differences in rates of stent thrombosis (ST) and other clinical outcomes were observed between patients who discontinued DAPT prior to and after 15 days, according to the results of ARGENTO, a consecutive, prospective study in 384 patients undergoing single or multivessel percutaneous coronary intervention (PCI) with the Genous Stent.

In the study, the rate of major adverse cardiac events (MACE) in all patients at follow up (22.8 +/- 13.6 months) was 8.6 percent. The rate of cardiac death was 3.4 percent, and myocardial infarction (MI) similarly occurred in 3.4 percent of patients. In addition, the rate of target vessel revascularization (TVR) was 4.7 percent. The overall rate of definite or probable stent thrombosis (ST) was 1.3 percent.

Although not statistically significant, the rates of MACE (4.4 percent for discontinued DAPT; 9.9 percent for continued DAPT) and TVR (1.1 percent for discontinued DAPT; 5.8 percent for continued DAPT) were lower in the patient group that received a shorter duration of DAPT. Definite or probable ST occurred in 1.1 percent of patients who discontinued DAPT prior to or at 15 days and in 1.3 percent of patients who received DAPT beyond 15 days.

"In patients treated with the Genous Stent, DAPT duration does not appear to predict risk for fatal events, such as ST or MI, typically associated with the premature discontinuation of antiplatelet agents following treatment with a stent," said Federico Piscione, M.D., of the Federico II University in Naples, Italy, and corresponding author of the publication. "In fact, we observe a trend toward improved outcomes for patients who discontinue DAPT within 15 days of stenting. Taken together, these data suggest that the Genous Stent is a safe and effective option for patients with expected or known low compliance to long-term DAPT."

The consecutive, prospective study enrolled 384 patients who underwent single or multivessel percutaneous coronary intervention (PCI) with Genous Stent implantation; a total of 423 lesions were treated. Ninety-one patients discontinued DAPT within 15 days, while 293 received DAPT for more than 15 days. Of the patients treated, 30.5 percent were diabetics, 37.5 percent had history of previous MI, and 58.8 percent had a history of acute coronary syndrome (ACS), including unstable angina, non ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI).

Paolo Scacciatella, M.D., of the Department of Cardiovascular and Thoracic Diseases, S. Giovanni Battista University Hospital, Turin, Italy, and a co-author of the publication, said, "The ARGENTO results confirm the safety and efficacy of the Genous Stent when combined with a very short duration of DAPT. These data are similar to those in previous studies that suggest that the Genous Stent may also be an important alternative for high-risk patients and for those undergoing undeferrable non-cardiac surgery."

Source: OrbusNeich