The Clinical Efficacy and Safety of Drug-coated Balloon

The Clinical Efficacy and Safety of Drug-coated Balloon in Coronary Lesions: a Real-World, All-Comers ,Single-center, Prospective Study

Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. Treating in-stent restenosis (ISR) 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 (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.

Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES.

Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion.

Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis<30% post-DCB, maintaining TIMI flow=3, DCB dilation time<60s, and appropriate balloon to vessel ratio> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice.

This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Angioplasty, Balloon

• Study Type: Observational
• Enrollment (Actual): 2487

Contacts and Locations

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • Ling Tao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who received PCI with one or more drug-coated balloons (DCB) in the Xijing hospital of the Air Force Medical University from December 1, 2015 to December 1, 2019.

Description

Inclusion Criteria:

1. Patients who received PCI with one or more drug-coated balloons (DCB)
2. Patients who did not received drug-eluting stent implantation

Exclusion Criteria:

1. Currently participating in another trial or participants unable to comply to follow-up

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-oriented Composite Endpoint (DoCE)	DoCE is a composite clinical endpoint of cardiac death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-oriented Composite Endpoint (DoCE)	DoCE is a composite clinical endpoint of cardiac death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)	1 month, 1, 2, 3, 5, 7, 10 years
POCE	POCE is a composite clinical endpoint of all-cause death, any stroke, non-fatal myocardial infarction (MI), any revascularization	1 month, 1, 2, 3, 5, 7, 10 years
All-cause death	Rates of individual components of PoCE	1 month, 1, 2, 3, 5, 7, 10 years
Non-fatal myocardial infarction (MI)	Rates of individual components of PoCE	1 month, 1, 2, 3, 5, 7, 10 years
Any stroke	Rates of individual components of PoCE	1 month, 1, 2, 3, 5, 7, 10 years
Any revascularization	Rates of individual components of PoCE	1 month, 1, 2, 3, 5, 7, 10 years
Cardiac death	Rates of individual components of DoCE	1 month, 1, 2, 3, 5, 7, 10 years
Target vessel myocardial infraction (TV-MI)	Rates of individual components of DoCE	1 month, 1, 2, 3, 5, 7, 10 years
Clinically individual target lesion revascularization (CI-TLR)	Rates of individual components of DoCE	1 month, 1, 2, 3, 5, 7, 10 years
Target vessel failure (TVF)	Target vessel failure is defined as cardiovascular death, target vessel myocardial infraction (TV-MI), and clinically-indicated target vessel revascularization	1 month, 1, 2, 3, 5, 7, 10 years
Clinically-indicated target vessel revascularization	Rates of individual components of TVF	1 month, 1, 2, 3, 5, 7, 10 years
BARC type 3 or 5 bleeding events	Bleeding events type 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria	1 month, 1, 2, 3, 5, 7, 10 years
Net adverse clinical events (NACE)	NACE is a composite clinical endpoint of all-cause death, any stroke, any any non-fatal myocardial infarction ( MI) any revascularization and BARC type 3 or 5 bleeding events	1 month, 1, 2, 3, 5, 7, 10 years
Vessel-oriented Composite Endpoint (VOCE)	VOCE is a composite clinical endpoint of Vessel-related cardiovascular Death, Target-vessel related MI, Clinically-oriented Target vessel revascularization	1 month, 1, 2, 3, 5, 7, 10 years
Vessel-related cardiovascular Death	Rates of individual components of VOCE	1 month, 1, 2, 3, 5, 7, 10 years

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Ling Tao, MD, Ph.D., Xijing Hospital; Study Chair: Chao Gao, MD, Ph.D., Xijing Hospital

Publications and helpful links

General Publications

• He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Drug-coated balloons; De-novo; All-comers; In-stent stenosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CAGE-FREE registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No