For patients with a high bleeding risk (HBR) who undergo percutaneous coronary intervention (PCI), a dual antiplatelet therapy (DAPT) regimen of one month may be more effective than one that lasts three months, according to new data published in the Journal of the American College of Cardiology.
Researchers analyzed a total of 3,652 patients who participated in the XIENCE Short DAPT study. This included 1,605 patients who participated in XIENCE 28 and underwent one month of DAPT and 2,047 patients who participated in XIENCE 90 and underwent DAPT for three months. Patients underwent PCI from July 2017 to February 2020. The mean patient age was 75 years old, and 67.5% of patients were men.
According to the authors, the primary endpoint of the study was the composite of all-cause death or MI between one and 12 months after index procedure, and the key secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2-5 bleeding.
In the XIENCE 28 group, 90.0% of patients did not have ischemic events and were adherent to treatment at one month. Ninety-eight percent of patients had complete follow-up at 12 months.
The equivalent rates among patients enrolled in XIENCE 90 were 96.3% at one month, with 94.7% completing 12-month follow-up.
The final study group was made up of 3,364 patients, with 41.4% coming from one-month DAPT group and 58.6% coming from the three-month DAPT group.
From one to 12 months after index PCI, 103 (7.5%) primary endpoint [ischemic] events were observed in patients on one-month DAPT compared with 145 (7.6%) in the three-month DAPT cohort.
The mean rate of death or MI, meanwhile, was 7.3% in patients who stopped taking DAPT at 1 month, and 7.5% in patients who stopped taking DAPT at three months.
The authors emphasized that "there were no notable differences in the individual propensity score stratified mean rates of all-cause death, or in other secondary ischemic endpoints, such as definite or probable stent thrombosis, cardiovascular death, and target lesion failure."
Overall, a total of 103 (7.7%) secondary endpoint events [bleeding outcomes] were reported in patients on one-month DAPT and 184 (10%) in patients who were on a three-month DAPT regimen.
The mean rate of BARC type 2-5 bleeding was lower in patients who stopped DAPT at one month compared with those who discontinued DAPT at three months.
Researchers also found that mean rates of the primary ischemic endpoint were nearly identical among patients on one- and three-month DAPT between 31 and 90 days and from 91 to 365 days.
On the other hand, the key secondary bleeding endpoint was considerably lower in patients who received one-month DAPT before 90 days, but not afterwards.
“The present study was the first to demonstrate the bleeding-related benefits and absence of ischemic harm associated with a DAPT duration of one month as compared with three months among HBR patients,” wrote lead author Marco Valgimigli, MD, PhD, a specialist at Bern University Hospital in Switzerland, and colleagues. “Although treatment arms were not randomized, both XIENCE 90 and 28 studies were developed with almost identical protocols, as shown by the very similar prevalence and distribution of HBR criteria."
The team also noted that, among HBR patients, "discontinuation of DAPT at one month after PCI with drug-eluting stents is a safe and effective strategy to avoid bleeding."
Read the full study here.