PARIS — A strategy guided by CYP2C19 genotyping conferred reduced bleeding risk and similar thrombotic risk compared with standard treatment in patients needing oral P2Y12 inhibitor therapy after PCI with stenting for STEMI, according to findings from the POPular Genetics trial presented at the European Society of Cardiology Congress.
For the randomized, open-label, assessor-blinded trial, among patients assigned the genotyping strategy, carriers of CYP2C19*2 or CYP2C19*3 loss-of-function alleles received ticagrelor (Brilinta, AstraZeneca) or prasugrel (Effient, Daiichi Sankyo/Eli Lilly) and noncarriers received clopidogrel. Patients assigned standard treatment received ticagrelor or prasugrel in accordance with ESC guidelines.
The results were simultaneously published in The New England Journal of Medicine.
The primary bleeding outcome of PLATO major or minor bleeding at 12 months occurred in 9.8% of the genotyping group and 12.5% of the standard group (HR = 0.78; 95% CI, 0.61-0.98), according to Jurrien M. ten Berg, MD, PhD, director of the St Antonius Center of Platelet Function Research in Nieuwegein, the Netherlands, and colleagues.
The primary combined outcome of net adverse clinical events, defined as all-cause death, MI, stroke, definite stent thrombosis or PLATO major bleeding, was similar in both groups (genotyping, 5.1%; standard, 5.9%; absolute difference, 0.7 percentage points; 95% CI, 2 to 0.7; P for noninferiority < .001).
“Physicians can reduce bleeding complications by using a genotype-guided strategy for selecting oral P2Y12 inhibitors in patients with STEMI without increasing the thrombotic risk,” ten Berg said during a press conference.
All patients had signs and symptoms of STEMI lasting 30 minutes to 12 hours. The mean age was 62 years and 25% were women.
“Genotyping is easy to use — it can be done in the cath lab — and has fast results,” ten Berg said during the press conference. “Almost two-thirds of the patients could be treated with clopidogrel.” – by Erik Swain
ten Berg JM, et al. Hot Line Session 6. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019; Paris.
Claassens DMF, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1907096.
Disclosures: ten Berg reports he has research contracts with AstraZeneca and ZonMw and receives consultant and speaker fees from AstraZeneca, Bayer, Boehringer Ingelheim, Ferrer, Isoria, Merck Sharpe & Dohme and Pfizer.