Stepwise dual antiplatelet therapy de-escalation versus standard therapy for 12 months in patients with bifurcation lesions undergoing drug-coated balloon angioplasty: Insights from the REC-CAGEFREE II trial

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Acute coronary syndrome with bifurcation lesions (n=1948). Intervention: Stepwise dual antiplatelet therapy (DAPT) de-escalation vs. Standard DAPT (12-month aspirin plus ticagrelor). Primary outcome: 12-month net adverse clinical events (NACE), defined as a composite of all-cause death, stroke, myocardial infarction, or revascularization, and BARC type 3 or 5 bleeding (HR 1.15, 95% CI 0.75-1.77, p=0.509).

Q: What does this research mean for the field?

Stepwise dual antiplatelet therapy de-escalation results in similar 12-month net adverse clinical events compared to standard therapy while reducing major bleeding in acute coronary syndrome patients with bifurcation lesions undergoing drug-coated balloon angioplasty. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Yongmeng Yan; Qiong Wang; Yi Liu; Feng Yang; Yumin Qiu; Prof. Yanqing Wu; Jing Zhou; Mingxing Wu; Ping Xie; Lijun Liu; Hua Wang; Yanjin Wei; Zhihui Zhang; Min Fan; Wangwei Yang; Fangjun Mou; Jianzheng Liu; Guotao Fu; Bin Zhu; Zhiwei Jiang; Scot Garg; Yoshinobu Onuma; Duolao Wang; Patrick W.J.C. Serruys; Xingqiang He; Ling Tao; Chao Gao

doi:10.1016/j.ijcard.2026.134961

Key result

Stepwise DAPT de-escalation shows no benefit over standard DAPT for NACE in bifurcation ACS.

HR 1.15
95% CI 0.75-1.77
P=0.509
n=1,948

Why the study?

The optimal antiplatelet strategy for ACS patients with bifurcation lesions undergoing drug-coated balloon angioplasty remains unclear.

Does stepwise DAPT de-escalation reduce net adverse clinical events in ACS patients with bifurcation lesions undergoing DCB-only angioplasty compared to standard 12-month DAPT?

Key Points

To assess the safety and efficacy of stepwise dual antiplatelet therapy de-escalation compared with standard 12-month therapy in acute coronary syndrome patients with bifurcation lesions treated with drug-coated balloons.
Conducted a prespecified subgroup analysis of the REC-CAGEFREE II randomized trial involving 884 patients with bifurcation lesions out of 1,948 acute coronary syndrome patients undergoing drug-coated balloon-only angioplasty.
Participants received either stepwise dual antiplatelet therapy (DAPT) de-escalation (1 month aspirin plus ticagrelor, 5 months ticagrelor monotherapy, 6 months aspirin monotherapy) or standard DAPT (12 months aspirin plus ticagrelor), with inverse probability of treatment weighting applied.
The primary endpoint was 12-month net adverse clinical events (NACE), combining a patient-oriented composite endpoint (all-cause death, stroke, myocardial infarction, or revascularization) and BARC type 3 or 5 bleeding.
The 12-month NACE incidence was 11.5% (51/447) with stepwise de-escalation versus 9.4% (41/437) with standard DAPT (HR IPTW: 1.15, 95% CI: 0.75–1.77, P = 0.509; P for interaction = 0.221).
Patient-oriented composite endpoints showed no statistically significant difference between stepwise de-escalation and standard DAPT groups (11.0% vs. 8.0%, HR IPTW: 1.39, 95% CI: 0.89–2.16, P = 0.153).
Stepwise DAPT de-escalation significantly decreased BARC type 3 or 5 major bleeding compared with standard therapy (0.5% vs. 1.8%, HR IPTW: 0.15, 95% CI: 0.03–0.72, P = 0.048).

Study Design

Type

RCT (n=1,948)

Structured PICO

Does stepwise DAPT de-escalation reduce net adverse clinical events in ACS patients with bifurcation lesions undergoing DCB-only angioplasty compared to standard 12-month DAPT?

P

Population

1,948 patients with acute coronary syndrome undergoing drug-coated balloon-only angioplasty, of whom 884 had bifurcation lesions, followed for 12 months.

I

Intervention

Stepwise dual antiplatelet therapy (DAPT) de-escalation (1-month aspirin plus ticagrelor, followed by 5-month ticagrelor monotherapy, followed by 6-month aspirin monotherapy).

C

Comparator

Standard DAPT (12-month aspirin plus ticagrelor).

O

Outcome

12-month net adverse clinical events (NACE), defined as a composite of patient-oriented composite endpoint (PoCE: all-cause death, stroke, myocardial infarction, or revascularization) and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding.composite

Main Result

Hazard Ratio: 1.15 (95% CI 0.75–1.77)

Absolute Event Rate: 11.5% vs 9.4%

p-value: p=0.509

Stepwise DAPT de-escalation yields similar ischemic outcomes but significantly reduces major bleeding compared to standard 12-month DAPT in ACS patients treated with DCB-only angioplasty for bifurcation lesions.

Implication

Similar NACE with less major bleeding in subgroup; hypothesis-generating and should not yet change practice in ACS bifurcation lesions.

Abstract

BACKGROUND The optimal antiplatelet strategy for patients with acute coronary syndrome (ACS) and bifurcation lesions undergoing drug-coated balloon (DCB) angioplasty remains unclear. METHODS This was a prespecified subgroup analysis of the REC-CAGEFREE II trial, which randomized 1948 ACS patients undergoing DCB-only angioplasty to stepwise dual antiplatelet therapy (DAPT) de-escalation (1-month aspirin plus ticagrelor, 5-month ticagrelor monotherapy, 6-month aspirin monotherapy) or standard DAPT (12-month aspirin plus ticagrelor). Participants were stratified into bifurcation and non-bifurcation subgroups based on whether any target lesion involved a bifurcation, with inverse probability of treatment weighting (IPTW) applied to adjust for imbalances. The primary endpoint was 12-month net adverse clinical events (NACE), defined as a composite of the patient-oriented composite endpoint (PoCE: all-cause death, stroke, myocardial infarction, or revascularization) and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. RESULTS Among 1948 patients, 884 (45.4%) were in the bifurcation subgroup. At 12 months, no significant interaction was observed between bifurcation/non-bifurcation and treatment strategy for NACE (Pinteraction = 0.221). In the bifurcation subgroup, NACE occurred in 51/447 (11.5%) patients receiving stepwise DAPT de-escalation and in 41/437 (9.4%) patients receiving standard DAPT (HRIPTW:1.15, 95%CI:0.75-1.77, P = 0.509). PoCE did not differ significantly between stepwise DAPT de-escalation and standard DAPT groups (11.0% versus 8.0%, HRIPTW:1.39, 95%CI:0.89-2.16, P = 0.153), whereas stepwise DAPT de-escalation was associated with a lower incidence of BARC type 3 or 5 bleeding (0.5% versus 1.8%, HRIPTW,0.15, 95%CI:0.03-0.72, P = 0.048). CONCLUSIONS Stepwise DAPT de-escalation may be a safe and effective strategy for ACS patients with bifurcation lesions undergoing DCB-only angioplasty.

Discussion

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Cite This Study

Yan et al. (2026) conducted an RCT in Acute coronary syndrome with bifurcation lesions (n=1,948). Stepwise dual antiplatelet therapy (DAPT) de-escalation vs. Standard DAPT (12-month aspirin plus ticagrelor) was evaluated on 12-month net adverse clinical events (NACE), defined as a composite of all-cause death, stroke, myocardial infarction, or revascularization, and BARC type 3 or 5 bleeding (HR 1.15, 95% CI 0.75-1.77, p=0.509). Stepwise DAPT de-escalation yielded similar 12-month NACE compared to standard DAPT in ACS patients with bifurcation lesions (11.5% vs 9.4%; HR 1.15, 95% CI 0.75-1.77, P=0.509).

synapsesocial.com/papers/6ac5ae4b9e451472f9bc955e https://doi.org/10.1016/j.ijcard.2026.134961

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Stepwise dual antiplatelet therapy de-escalation versus standard therapy for 12 months in patients with bifurcation lesions undergoing drug-coated balloon angioplasty: Insights from the REC-CAGEFREE II trial

Key Points

Study Design

Structured PICO

Main Result

Implication

Abstract

Discussion

Cite This Study

Stepwise dual antiplatelet therapy de-escalation versus standard therapy for 12 months in patients with bifurcation lesions undergoing drug-coated balloon angioplasty: Insights from the REC-CAGEFREE II trial

Key Points

Study Design

Structured PICO

Main Result

Implication

Abstract

Discussion

Cite This Study

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