[Healio] Reducing prasugrel dose 1 month after PCI for ACS improves outcomes_200909admin
Among patients who underwent PCI for ACS and then had dual antiplatelet therapy with aspirin and prasugrel, halving the prasugrel dose after 1 month conferred reduced risk for net adverse clinical events, researchers reported.
For the HOST-REDUCE-POLYTECH-ACS trial, 2,338 patients who underwent PCI for ACS and received aspirin and 10 mg prasugrel (Effient, Daiichi Sankyo/Eli Lilly) daily after the procedure were assigned to continue their regimen or de-escalate to a daily regimen of aspirin and 5 mg prasugrel at 1 month. The findings were presented at the European Society of Cardiology Congress and published in The Lancet.
At 1 year, the primary endpoint of net adverse clinical events, defined as all-cause death, nonfatal MI, stent thrombosis, repeat revascularization, stroke and BARC grade 2 or higher bleeding, occurred in 7.2% of the de-escalation group compared with 10.1% of the control group (absolute risk difference, –2.9 percentage points; HR = 0.7; 95% CI, 0.52-0.92; number needed to treat with de-escalation strategy to prevent one event = 34), according to the researchers.
“In this trial, we were able to confirm the safety and efficacy of prasugrel-based de-escalating DAPT after PCI in patients with ACS,” Hyo-Soo Kim, MD, PhD, from the Cardiovascular Center at Seoul National University Hospital in South Korea, said during a presentation.
Risk for BARC 2 or higher bleeding events was lower in the de-escalation group (HR = 0.48; 95% CI, 0.32-0.73), whereas there was no difference between the groups in risk for ischemic events, defined as cardiac death, MI, stent thrombosis or ischemic stroke (HR = 0.76; 95% CI, 0.4-1.45), Kim said.
“This is very important: Even though we de-escalate prasugrel, ischemic events did not increase,” he said, noting that these were numerically lower in the de-escalation group (1.4% vs. 1.8%).
Subgroup analyses did not find any differences in the treatment effect by age, sex, diabetes, kidney disease, STEMI vs. non-STEMI or unstable angina diagnosis, left ventricular ejection fraction, presence of multivessel disease or total stent length, Kim said.
All patients had their procedure done at one of 35 hospitals in South Korea. The mean age was 59 years and 11% were women. Approximately 15% had STEMI, 25% had non-STEMI and the rest had unstable angina.
“These results may not be generalizable to all ethnicities undergoing PCI, given that our study was performed in East Asians, who are known to have higher bleeding risk,” Kim said.
The trial had a 2×2 factorial design and patients were also assigned to PCI with a durable-polymer drug-eluting stent or a bioabsorbable DES. The DES-related findings have not yet been published or presented.