1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon

Summary

Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated to the balloon. Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.

Bleeding after PCI remains a substantial clinical problem. Bleeding post-PCI increases the risk of adverse outcomes such as death, non-fatal myocardial infarction, and prolongs hospital stay. Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 5.7-fold. The antiplatelet medications are the major cause of bleeding events post-PCI.

Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome. Compared with the DES, because of the absence of metal inside the coronary artery, the use of DCB might theoretically allow shorter duration antiplatelet therapy. However, the optimal course of DAPT for the DCB treated patients remains controversial.

In 2013, the consensus from the German group suggested that for the acute coronary syndrome, DAPT should be used for 12 months. The consensus of DAPT developed by the European Society of Cardiology (ESC) in 2017 stated that "in patients treated with DCB, dedicated clinical trials investigating the optimal duration of DAPT are lacking." So far, there are no randomized data showing the optimal DAPT duration for the DCB treated patients.

In the current study, we use Aspirin + Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month, afterward, Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm, to compare with the Reference arm, which is Aspirin + Ticagrelor for 12-month in a non-inferiority statistical assumption, aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment.

Conditions

• Antiplatelet Drug
• Acute Coronary Syndrome
• Angioplasty, Balloon

Interventions

DRUG

Aspirin 100mg for 1-month (immediately after PCI)

Aspirin for 1-month immediately after PCI to be a part of medication treatment in the Experimental arm

DRUG

Ticagrelor 90mg for 6-month (immediately after PCI)

Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm

DRUG

Aspirin 100mg for 6-month (6-month post PCI)

Aspirin for 6-month at 6 months post-PCI (after the discontinuation of the 6-month Ticagrelor treatment) to be a part of medication treatment in the Experimental arm

DRUG

Aspirin 100mg for 12-month (immediately after PCI)

Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm

DRUG

Ticagrelor 90mg for 12-month (immediately after PCI)

Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm

Sponsors & Collaborators

• Xijing Hospital

  lead OTHER

Principal Investigators

• Ling Tao, MD,PHD · Xijing Hospital

• Patrick Serruys, MD,PHD · National University of Ireland, Galway

• Yoshinobu Onuma, MD,PHD · National University of Ireland, Galway

• Chao Gao, MD,PHD · Xijing Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2024-03-01

Completion

2026-12-01

Countries

• China

Study Locations