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Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial.
Ge, Zhen; Kan, Jing; Gao, Xiaofei; Raza, Afsar; Zhang, Jun-Jie; Mohydin, Bilal S; Gao, Fentang; Shao, Yibing; Wang, Yan; Zeng, Hesong; Li, Feng; Khan, Hamid Sharif; Mengal, Naeem; Cong, Hongliang; Wang, Mingliang; Chen, Lianglong; Wei, Yongyue; Chen, Feng; Stone, Gregg W; Chen, Shao-Liang.
Afiliación
  • Ge Z; Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
  • Kan J; Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
  • Gao X; Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
  • Raza A; Airdale General Hospital, West Yorkshire, UK.
  • Zhang JJ; Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
  • Mohydin BS; Punjab Institute of Cardiology, Lahore, Pakistan.
  • Gao F; Gansu Provincial People's Hospital, Lanzhou, China.
  • Shao Y; Qingdao Municipal Hospital, Qingdao, China.
  • Wang Y; Xiamen Heart Center, Xiamen University, Xiamen, China.
  • Zeng H; Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
  • Li F; Affiliated Oriental Huainan General Hospital, Anhui University of Science and Technology, Huainan, China.
  • Khan HS; Rawalpindi Institute of Cardiology, Rawalpindi, Pakistan.
  • Mengal N; National Institute of Cardiovascular Diseases of Pakistan, Karaqi, Pakistan.
  • Cong H; Tianjin Chest Hospital, Tianjin University, Tianjin, China.
  • Wang M; Puto People's Hospital, Tongji University, Shanghai, China.
  • Chen L; Fujian Medical University Union Hospital, Fuzhou, China.
  • Wei Y; Center for Public Health and Epidemic Preparedness & Response, Peking University, Beijing, China.
  • Chen F; School of Public Health, Center of Global Health, Nanjing Medical University, Nanjing, China.
  • Stone GW; The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: gregg.stone@mountsinai.org.
  • Chen SL; Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.
Lancet ; 403(10439): 1866-1878, 2024 May 11.
Article en En | MEDLINE | ID: mdl-38599220
ABSTRACT

BACKGROUND:

Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE).

METHODS:

In this randomised, placebo-controlled, double-blind clinical trial, patients aged 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and who had no major ischaemic or bleeding events after 1-month treatment with dual antiplatelet therapy were randomly assigned to receive oral ticagrelor (90 mg twice daily) plus oral aspirin (100 mg once daily) or oral ticagrelor (90 mg twice daily) plus a matching oral placebo, beginning 1 month and ending at 12 months after percutaneous coronary intervention (11 months in total). Recruitment took place at 58 centres in China, Italy, Pakistan, and the UK. Patients were required to remain event-free for 1 month on dual antiplatelet therapy following percutaneous coronary intervention with contemporary drug-eluting stents. Randomisation was done using a web-based system, stratified by acute coronary syndrome type, diabetes, IVUS-ACS randomisation, and site, using dynamic minimisation. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (defined as the composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically driven target vessel revascularisation), with an expected event rate of 6·2% in the ticagrelor plus aspirin group and an absolute non-inferiority margin of 2·5 percentage points between 1 month and 12 months after percutaneous coronary intervention. The two co-primary endpoints were tested sequentially; the primary superiority endpoint had to be met for hypothesis testing of the MACCE outcome to proceed. All principal analyses were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03971500, and is completed.

FINDINGS:

Between Sept 21, 2019, and Oct 27, 2022, 3400 (97·0%) of the 3505 participants in the IVUS-ACS study were randomly assigned (1700 patients to ticagrelor plus aspirin and 1700 patients to ticagrelor plus placebo). 12-month follow-up was completed by 3399 (>99·9%) patients. Between month 1 and month 12 after percutaneous coronary intervention, clinically relevant bleeding occurred in 35 patients (2·1%) in the ticagrelor plus placebo group and in 78 patients (4·6%) in the ticagrelor plus aspirin group (hazard ratio [HR] 0·45 [95% CI 0·30 to 0·66]; p<0·0001). MACCE occurred in 61 patients (3·6%) in the ticagrelor plus placebo group and in 63 patients (3·7%) in the ticagrelor plus aspirin group (absolute difference -0·1% [95% CI -1·4% to 1·2%]; HR 0·98 [95% CI 0·69 to 1·39]; pnon-inferiority<0·0001, psuperiority=0·89).

INTERPRETATION:

In patients with an acute coronary syndrome who had percutaneous coronary intervention with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin. Along with the results from previous studies, these findings show that most patients in this population can benefit from superior clinical outcomes with aspirin discontinuation and maintenance on ticagrelor monotherapy after 1 month of dual antiplatelet therapy.

FUNDING:

The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. TRANSLATION For the Mandarin translation of the abstract see Supplementary Materials section.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Inhibidores de Agregación Plaquetaria / Aspirina / Quimioterapia Combinada / Síndrome Coronario Agudo / Intervención Coronaria Percutánea / Ticagrelor / Hemorragia Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Lancet Año: 2024 Tipo del documento: Article País de afiliación: China

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Inhibidores de Agregación Plaquetaria / Aspirina / Quimioterapia Combinada / Síndrome Coronario Agudo / Intervención Coronaria Percutánea / Ticagrelor / Hemorragia Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Lancet Año: 2024 Tipo del documento: Article País de afiliación: China