Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions

N/AActive Not RecruitingNCT04561739

Xijing Hospital2,272 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

2,272

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Device-oriented Composite Endpoint (DoCE)

DoCE is a composite clinical endpoint of Cardiac cause death, Target vessel myocardial infarction (TV-MI), and Clinically and physiologically indicated target lesion revascularization (CI-TLR).

Time frame: 24 months

Secondary Outcomes

Device-oriented Composite Endpoint (DoCE)

Rates of the DoCE beside the time point of primary endpoint

Time frame: 1, 12, 36, and 60 months

Cardiac cause death

Rates of individual components of the DoCE

Time frame: 1, 12, 24, 36, and 60 months

Target vessel myocardial infarction (TV-MI)

Rates of individual components of the DoCE

Time frame: 1, 12, 24, 36, and 60 months

Clinically and physiologically indicated target lesion revascularization (CI-TLR)

Rates of individual components of the DoCE

Time frame: 1, 12, 24, 36, and 60 months

Patient-oriented composite endpoint (PoCE)

Patient-oriented composite endpoint (PoCE) defined as all-cause death, any stroke, any MI, and any clinically and indicated revascularisation)

Time frame: 1, 12, 24, 36, and 60 months

All-cause death

individual components of PoCE

Time frame: 1, 12, 24, 36, and 60 months

Any MI

individual components of PoCE

Time frame: 1, 12, 24, 36, and 60 months

Any stroke

individual components of PoCE

Time frame: 1, 12, 24, 36, and 60 months

Any revascularisation

individual components of PoCE

Time frame: 1, 12, 24, 36, and 60 months

Any clinically and physiologically indicated revascularisation

Time frame: 1, 12, 24, 36, and 60 months

Target vessel failure (TVF)

Target vessel failure, defined as cardiovascular death, TV MI and clinically-indicated target vessel revascularisation

Time frame: 1, 12, 24, 36, and 60 months

Clinical and physiologically indicated target vessel revascularization

Time frame: 1, 12, 24, 36, and 60 months

Net adverse clinical events (NACE)

Net adverse clinical events (NACE), define as POCE or BARC type 3 or 5 bleeding events

Time frame: 1, 12, 24, 36, and 60 months

BARC type 3 or 5 bleeding events

Time frame: 1, 12, 24, 36, and 60 months

BARC defined type 2, 3 or 5 bleeding events

Time frame: 1, 12, 24, 36, and 60 months

Definite/Probable Stent thrombosis rates

According to ARC-II classification

Time frame: 1, 12, 24, 36, and 60 months

Device success

Device success is defined by the following: DCB: 1.Successful delivery within 120 seconds (DCB in vessel) of the DCB device at the intended target lesion; 2.DCB is successfully dilated for at least 30 seconds and the device system is successfully withdrawn; 3.After DCB dilation, the target vessel has no flow limiting dissection (type D, E and F); and the final in-lesion residual stenosis is less than 30% by core laboratory QCA (preferred methodology) or visual assessment; 4.No bailout procedure by stent; DES: 1.1. Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion; 2.Successful withdrawal of the device delivery system; 3. 3. Attainment of a final in-stent residual stenosis of \<20% by core laboratory QCA (preferred methodology) or visual assessment;

Time frame: 0 day (during index PCI)

Procedure success during PCI

Device success + without the occurrence of DoCE + no stent thrombosis at discharge during the index procedure hospital stay (maximum of 7 days).

Time frame: 7 days

Clinically relevant ischemic or bleeding events

Time from randomization to the occurrence of first any ischemic or bleeding endpoints, including all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization and BARC-defined type 2 bleeding events

Time frame: 1, 12, 24, 36, and 60 months

Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes