Clinical trial NCT04561739: Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions
Official title: Paclitaxel-coated Balloon for the Treatment of De-novo Non-complex Coronary Artery Lesions: an Open-label, Multicentre, Randomised, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: De Novo Stenosis
Coronary Artery Disease
Keywords: drug-coated balloons
percutaneous coronary intervention
de novo stenosis
drug-eluting stent
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 2272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The introduction of Bare-metal stents (BMS) since 1986 has alleviated the limitations of plain old balloon angioplasty (POBA) related elastic recoil and flow-limiting dissections. Later on, higher restenosis rates due to exaggerated neointimal growth in BMS has led to the development of drug-eluting stents (DES), which elutes an antiproliferative drug to the vessel wall and reduce the restenosis rate. However, late stent thrombosis and restenosis, with a hazard of nearly 2% per year after implantation, remained a concern and motivated the development of drug-coated balloons (DCB).

The advantages of DCB are that leaving no metal in the blood vessel and respect the vessel anatomy.

Recently, studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease. In the BASKET-SMALL 2 trial, which compared SeQuent Please DCB with EES or Taxus DES in the vessels that have reference diameter\<3mm, showed that at 12-month follow-up, DCB was non-inferior to DES (MACE \[cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation\] rates: 8% vs. 9%).

Although some small-scale RCT using surrogate endpoints have reported that no significant difference in MLD or late lumen loss between the two groups in large vessels, up to now, there is no large-scale RCT comparing the clinical outcomes of DCB versus DES in large vessels with de novo lesions.

Therefore, the investigators hypothesized that in patients undergoing non-complex percutaneous coronary intervention (PCI) for de-novo stenoses, drug-coated balloon (DCB) is non-inferior to drug-eluting stents (DES).


Eligibility criteria: Inclusion Criteria:

1. Patients with an indication for PCI due to acute or chronic coronary syndrome
2. Patients with de-novo, non-complex lesion\* and underwent successful pre-dilation\*\*
3. Patients who are able to complete the follow-up and compliant to the prescribed medication

   * Non-complex PCI is defined as

1. Vessels treated\<3; stents implanted\<3; lesions treated\<3 or Total stent length\<60 mm 2. Bifurcation does not require 2 stents 3. Non left main lesion 4. Non venous or arterial graft lesion 5. Non chronic total occlusion lesion 6. Do not require the use of atherectomy device

\*\*Successful pre-dilation is defined as fulfilling all the following criteria

1. Thrombolysis In Myocardial Infarction \[TIMI\] flow =3
2. Without dissections type D, E, and F
3. Residual stenoses \<30% after balloon pre-dilation (visual).
4. Without serious complication requiring the termination of PCI

Exclusion Criteria:

1. Under the age of 18
2. Unable to give informed consent
3. The patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
4. Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
5. Currently participating in another trial and not yet at its primary endpoint
6. The concurrent medical condition with a life expectancy of less than 2 years
7. Previous intracranial hemorrhage
8. In-stent stenosis requiring revascularization (defined as stenosis≥50% by visual or positive functional assessments in any vessel)
9. Atrial fibrillation
10. Prior CABG
11. Cardiogenic shock

Primary outcomes:
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 24 months
Secondary outcomes:
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 1, 12, 36, and 60 months
measure: Cardiac cause death
timeFrame: 1, 12, 24, 36, and 60 months
measure: Target vessel myocardial infarction (TV-MI)
timeFrame: 1, 12, 24, 36, and 60 months
measure: Clinically and physiologically indicated target lesion revascularization (CI-TLR)
timeFrame: 1, 12, 24, 36, and 60 months
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 1, 12, 24, 36, and 60 months
measure: All-cause death
timeFrame: 1, 12, 24, 36, and 60 months
measure: Any MI
timeFrame: 1, 12, 24, 36, and 60 months
measure: Any stroke
timeFrame: 1, 12, 24, 36, and 60 months
measure: Any revascularisation
timeFrame: 1, 12, 24, 36, and 60 months
measure: Any clinically and physiologically indicated revascularisation
timeFrame: 1, 12, 24, 36, and 60 months
measure: Target vessel failure (TVF)
timeFrame: 1, 12, 24, 36, and 60 months
measure: Clinical and physiologically indicated target vessel revascularization
timeFrame: 1, 12, 24, 36, and 60 months
measure: Net adverse clinical events (NACE)
timeFrame: 1, 12, 24, 36, and 60 months
measure: BARC type 3 or 5 bleeding events
timeFrame: 1, 12, 24, 36, and 60 months
measure: BARC defined type 2, 3 or 5 bleeding events
timeFrame: 1, 12, 24, 36, and 60 months
measure: Definite/Probable Stent thrombosis rates
timeFrame: 1, 12, 24, 36, and 60 months
measure: Device success
timeFrame: 0 day (during index PCI)
measure: Procedure success during PCI
timeFrame: 7 days
measure: Clinically relevant ischemic or bleeding events
timeFrame: 1, 12, 24, 36, and 60 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: National University of Ireland, Galway
name: Patrick Serruys, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: National University of Ireland, Galway
name: Yoshinobu Onuma, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Chao Gao, M.D., Ph.D.
role: STUDY_CHAIR
References: