Trials of short duration DAPT
LEADERS-FREE 2015 ACS+stable angina | 2466 HBR patients BioFreedom (DES) vs BMS | 1 month of DAPT followed by aspirin alone | 12-month follow-up | Target lesion revascularisation: 5.1% BioFreedom 9.8% BMS P<0.001 | Death, MI, stent thrombosis 9.4% BioFreedom vs 12.9% BMS P<0.001 |
ONYX-ONE 2020 ACS+stable angina | 1996 HBR patients Resolute Onyx (DES) vs BioFreedom (DES) | 1 month DAPT (aspirin+mostly clopidogrel) After 2 months 92% on single APT Aspirin : 55.9% P2Y12 : 44.1% | 12-month follow-up | Primary safety endpoint: Cardiac death/MI/stent thrombosis 17.1 vs 16.9% P=0.011 for non-inferiority | Stent thrombosis 0.9% at 12 months for both arms P=0.99 Bleeding, BARC 2–5 P=0.4 |
SENIOR 2018 ACS+stable angina | 1200 patients>75 years Synergy (DES) vs BMS | 1 month DAPT for stable angina 6 months DAPT for ACS | 12-month follow-up | Primary endpoint: all-cause mortality, MI, stroke or ischaemia-driven target lesion revascularisation DES 11.6% vs BMS 16.4% P=0.02 | Stent thrombosis 1% for both arms Bleeding: 5% in both arms |
TWILIGHT 2019 ACS+stable angina | 7119 patients at HBR or high ischaemic risk | Ticagrelor+Aspirin for 3 months then Ticagrelor+Aspirin vs Ticagrelor+placebo | 12-month follow-up | Primary endpoint : BARC 2, 3, 5 Ticagrelor+Aspirin=7.1% Ticagrelor+placebo = 4.0% P<0.001 | Death from any cause, non-fatal MI, or non-fatal stroke 3.9% in both arms P<0.001 for non-inferiority |
A, aspirin; BARC, bleeding academic research collaboration; BMS, bare metal stent; DAPT, dual antiplatelet therapy; DES, drug eluting stent; HBR, high bleeding risk; T, ticagrelor.