Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://cr.elmerpub.com

Review

Volume 17, Number 5, October 2026, pages 379-393

Navigating Ischemic and Bleeding Risks in High Bleeding Risk Patients Undergoing Coronary Intervention

↓ **Table 1.** Key Clinical Trials of Antiplatelet Therapy Strategies for HBR Patients Undergoing PCI
Trial name	Published year	Enrolled population	Core antiplatelet therapy regimen & duration	Primary endpoint	Key clinical conclusions
BP-DES: biodegradable polymer drug-eluting stents; PF-DES: polymer-free drug-eluting stent; DCB: drug-coated balloon; PCI: percutaneous coronary intervention; HBR: high bleeding risk; ARC: Academic Research Consortium; DAPT: dual antiplatelet therapy; BARC: Bleeding Academic Research Consortium; BMS: bare-metal stent; MACCE: major adverse cardiac and cerebrovascular event; CAD: coronary artery disease; ACS: acute coronary syndrome; MI: myocardial infarction.
LEADERS FREE	2018	ARC-HBR PCI patients (n = 2,466)	PF-DES (BioFreedom) + 1-month DAPT vs. BMS + 1-month DAPT	1-year cardiac death/MI/stent thrombosis; clinically indicated target lesion revascularization	Short-term 1-month DAPT combined with PF-DES achieves superior ischemic protection and lower revascularization risk than BMS without increasing bleeding risk, supporting ultra-short DAPT feasibility in HBR patients.
MASTER DAPT	2021	Event-free ARC-HBR PCI patients (n = 4,579)	2-month abbreviated DAPT vs. standard 12-month DAPT	1-year net adverse clinical events (NACE: death/MI/stroke/BARC 3–5 bleeding)	Abbreviated 2-month DAPT reduced major bleeding risk by 44% in HBR patients, with non-inferior ischemic outcomes, validating the safety of shortened DAPT.
TWILIGHT	2019	High-risk PCI patients (including HBR subgroup, n = 9,006)	3-month DAPT followed by ticagrelor monotherapy vs. 12-month standard DAPT	1-year BARC 2–5 bleeding events	Early switch to ticagrelor monotherapy significantly reduced bleeding risk in HBR patients without increasing ischemic events, confirming the value of DAPT de-escalation strategy.
ONYX ONE	2020	ARC-HBR PCI patients (n = 1,943)	Resolute Onyx DES + 1-month DAPT	1-year target vessel failure and major bleeding	Modern thin-strut permanent polymer DES combined with 1-month ultra-short DAPT is safe and effective for HBR patients, expanding the optional stent types for short DAPT regimens.
ZEUS	2018	DES-ineligible patients (52% HBR, n = 1,606)	Zotarolimus-eluting DES + individualized short DAPT (median 1 month) vs. BMS + short DAPT	12-month MACCE	Short DAPT combined with new-generation DES yields better long-term ischemic outcomes than BMS in HBR patients without incremental bleeding risk.
SENIOR	2019	Elderly PCI patients (≥ 75 years, HBR-enriched, n = 1,200)	Biodegradable polymer DES + 1-month (stable CAD)/6-month (ACS) DAPT vs. BMS	1-year all-cause death/MI/stroke/target lesion revascularization	Short-duration DAPT combined with BP-DES significantly reduces ischemic adverse events in elderly HBR patients, superior to traditional BMS strategy.
EVOLVE Short DAPT	2021	HBR PCI patients (n = 2,005)	Synergy BP-DES + 3-month DAPT	1-year stent thrombosis and target vessel myocardial infarction	3-month abbreviated DAPT is safe for HBR patients treated with biodegradable polymer DES, providing an intermediate short-duration DAPT option.

↓ Table 1. Key Clinical Trials of Antiplatelet Therapy Strategies for HBR Patients Undergoing PCI

Trial name

Published year

Enrolled population

Core antiplatelet therapy regimen & duration

Primary endpoint

Key clinical conclusions

BP-DES: biodegradable polymer drug-eluting stents; PF-DES: polymer-free drug-eluting stent; DCB: drug-coated balloon; PCI: percutaneous coronary intervention; HBR: high bleeding risk; ARC: Academic Research Consortium; DAPT: dual antiplatelet therapy; BARC: Bleeding Academic Research Consortium; BMS: bare-metal stent; MACCE: major adverse cardiac and cerebrovascular event; CAD: coronary artery disease; ACS: acute coronary syndrome; MI: myocardial infarction.

LEADERS FREE

2018

ARC-HBR PCI patients (n = 2,466)

PF-DES (BioFreedom) + 1-month DAPT vs. BMS + 1-month DAPT

1-year cardiac death/MI/stent thrombosis; clinically indicated target lesion revascularization

Short-term 1-month DAPT combined with PF-DES achieves superior ischemic protection and lower revascularization risk than BMS without increasing bleeding risk, supporting ultra-short DAPT feasibility in HBR patients.

MASTER DAPT

2021

Event-free ARC-HBR PCI patients (n = 4,579)

2-month abbreviated DAPT vs. standard 12-month DAPT

1-year net adverse clinical events (NACE: death/MI/stroke/BARC 3–5 bleeding)

Abbreviated 2-month DAPT reduced major bleeding risk by 44% in HBR patients, with non-inferior ischemic outcomes, validating the safety of shortened DAPT.

TWILIGHT

2019

High-risk PCI patients (including HBR subgroup, n = 9,006)

3-month DAPT followed by ticagrelor monotherapy vs. 12-month standard DAPT

1-year BARC 2–5 bleeding events

Early switch to ticagrelor monotherapy significantly reduced bleeding risk in HBR patients without increasing ischemic events, confirming the value of DAPT de-escalation strategy.

ONYX ONE

2020

ARC-HBR PCI patients (n = 1,943)

Resolute Onyx DES + 1-month DAPT

1-year target vessel failure and major bleeding

Modern thin-strut permanent polymer DES combined with 1-month ultra-short DAPT is safe and effective for HBR patients, expanding the optional stent types for short DAPT regimens.

ZEUS

2018

DES-ineligible patients (52% HBR, n = 1,606)

Zotarolimus-eluting DES + individualized short DAPT (median 1 month) vs. BMS + short DAPT

12-month MACCE

Short DAPT combined with new-generation DES yields better long-term ischemic outcomes than BMS in HBR patients without incremental bleeding risk.

SENIOR

2019

Elderly PCI patients (≥ 75 years, HBR-enriched, n = 1,200)

Biodegradable polymer DES + 1-month (stable CAD)/6-month (ACS) DAPT vs. BMS

1-year all-cause death/MI/stroke/target lesion revascularization

Short-duration DAPT combined with BP-DES significantly reduces ischemic adverse events in elderly HBR patients, superior to traditional BMS strategy.

EVOLVE Short DAPT

2021

HBR PCI patients (n = 2,005)

Synergy BP-DES + 3-month DAPT

1-year stent thrombosis and target vessel myocardial infarction

3-month abbreviated DAPT is safe for HBR patients treated with biodegradable polymer DES, providing an intermediate short-duration DAPT option.