Clinical trial NCT05209412: Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions
Official title: Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions: an Open-label, Multicenter, Randomized, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: De Novo Stenosis
Coronary Artery Disease
Percutaneous Coronary Intervention
Keywords: Drug-coated balloons
Fractional flow reserve
Percutaneous coronary intervention
De novo lesions
Drug-eluting stent
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronary restenosis has been one of the main reasons affecting the prognosis of patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). With drug-eluting stents (DES), which elutes an antiproliferative drug to the vessel wall and reduces the restenosis rate; however, the incidence of restenosis is still about 10%. The 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).

DCB angioplasty has the following advantages compared with DES implantation: Firstly, the drug in DCB is uniformly distributed and released; whereas the drug release of DES via stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, the physiological function of coronary arteries would be maintained.

Studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease. The application of DCB in large vessels with de novo lesions is still to be investigated. The DEBUT study showed that in high bleeding risk patients aimed using only 1-month DAPT, DCB was superior to BMS in terms of MACE \[MACE (cardiovascular mortality, nonfatal myocardial infarction or revascularization of ischemia-reperfusion target lesions)\] at 9-month follow-up.

However, there is still a lack of evidence comparing the DCB versus DES in large vessels with de novo lesions. The current study aims to investigate if in patients undergoing PCI for de novo stenoses in large vessels, DCB is non-inferior to DES.


Eligibility criteria: Inclusion Criteria:

1. 18y ≤ age ≤ 80y;
2. De-novo coronary artery lesions with an indication for PCI;
3. Target lesion diameter stenosis ≥ 70% (visual) or ≥ 50% (visual) with evidence of ischemia;
4. Target lesion reference vessel diameter (2.5mm-4.0 mm), Length of a single target lesion ≤ 35mm; Total treated lesion length ≤ 60 mm;
5. Vessels treated ≤ 2; only one DCB/DES is allowed for each target vessel;
6. ≤ 2 non-target lesions (non-TL) are allowed, and can not be in the same vessel as the target lesion (randomization should be implemented only after the successful treatment of all non-TL);
7. Patients who are able to complete the follow-up and compliant to the prescribed medication.

Exclusion Criteria:

1. Myocardial infarction (\< 7 days);
2. Heavy thrombotic burden in target vessel;
3. eGFR \< 30ml/min or hemodialysis patients;
4. Other cardiovascular and cerebrovascular procedures planned within 12 months after index PCI;
5. Patients with contraindications to antiplatelet agents and anticoagulants or bleeding tendency, history of active peptic ulcer, and stroke within 6 months;
6. Life expectancy of less than 1 years;
7. Patient is a woman who is pregnant or nursing;
8. Known allergic to medications such as Aspirin, Heparin, antiplatelet drugs, paclitaxel, or contrast; patients with systemic lupus erythematosus or other systemic immune diseases;
9. Chronic total occlusion lesion;
10. Unprotected left main disease;
11. Bifurcation lesion requiring 2 stents;
12. Ostial lesions, distance from left main ≤ 2mm;
13. Severe calcification or distortion;
14. Arterial, venous or prosthetic grafts;
15. In-stent stenosis requiring revascularization (defined as stenosis≥50% by visual or positive functional assessments in any vessel);
16. Myocardial bridging located at target lesions;
17. Currently participating in another trial and not yet at its primary endpoint;
18. Participants deemed unsuitable to be enrolled by investigators for unable to comply with protocol or other reasons.

Primary outcomes:
measure: Coronary fraction flow reserve (FFR) value
timeFrame: 12 months
Secondary outcomes:
measure: In segment Late lumen loss (LLL)
timeFrame: 12 months
Other outcomes:
measure: Procedural success rate
timeFrame: 7 days
measure: Percentage of lesion segments diameter stenosis (DS%)
timeFrame: 12 months
measure: Binary restenosis (DS% ≥ 50%)
timeFrame: 12 months
measure: Target lesion failure (TLF)
timeFrame: 1, 6, 12 months
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 1, 6, 12 months
measure: Definite/Probable Stent thrombosis rates
timeFrame: 1, 6, 12 months
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: Xijing Hospital
name: Chao Gao, M.D, Ph.D
role: STUDY_CHAIR
References: