Coronary Stenosis, Drug-coated Balloon
Conditions
Keywords
Drug-coated balloon, Optical coherence tomography, De-novo coronary lesions, In-stent restenosis
Brief summary
In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. The aim of this study was to investigate the relationship between quantitative and qualitative OCT findings, angiographic and clinical outcomes after PCB for coronary lesions.
Detailed description
The paclitaxel drug-coated balloon (DCB) is an emerging device in percutaneous coronary intervention (PCI); it allows a rapid local release of an anti-restenotic drug without the use of a durable polymer or metal scaffold. The DCB has been proven to be effective with paclitaxel in preclinical trials and in clinical practice for the treatment of coronary lesions such as in-stent restenosis (ISR), de novo and bifurcation lesions. Optical coherence tomography (OCT) is an intravascular imaging modality that has higher resolution than intravascular ultrasound. Excellent contrast among lumen, vessel, and stent in OCT images allows accurate measurement of lumen and lesion. However, only a few studies have investigated the effect of DCB on the intimal lumen in the acute phase and during the follow-up using optical coherence tomography (OCT). In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. Demographic, angiographic, and procedural data were collected. Participants were followed up with coronary angiography and OCT for at least 6-9 months, combined with OCT to analyze qualitative analysis of changes in plaque characterization, and late lumen loss. The participants were followed up for long-term clinical events (including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization).
Interventions
PROCEDUREPercutaneous coronary intervention
All patients were treated with a loading dose of clopidogrel 300 or 600 mg before the procedure followed by maintenance clopidogrel 75 mg daily for 6 months. 100 U/ kg of unfractionated heparin was injected intravenously to maintain an activated clotting time ≥ 250 s during the procedure. For DCB treatment, the patient underwent predilation with an optimal-sized balloon (non-compliant balloon or cutting balloon) based on angiography (balloon-to-vessel ratio of 1.0), with the standard balloon shorter than the intended DCB size. The DCB was sized at 1:1 balloon-to-vessel ratio, delivered rapidly (median of 15 s) and inflated at nominal pressure for 60 s.
Sponsors
The First Affiliated Hospital of Dalian Medical University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Coronary angiography shows that at least one coronary artery has a diameter stenosis \>70% (left main stem diameter stenosis\>50%) * Stable or unstable angina * Availability for follow-up for up to 12 months
Exclusion criteria
* Acute myocardial infarction within 48 hours * Severe calcified lesions * Unable to tolerate dual antiplatelet treatment (DAPT) * Severe abnormal hematopoietic system, such as platelet count of \< 100×109/L or \> 700×109/L and white blood cell count of \< 3×109/L * Active bleeding or bleeding tendency * Severe coexisting conditions, such as severe renal insufficiency (GFR \< 60 ml/min•1.73m2), severe hepatic dysfunction \[elevated ALT (glutamicpyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation\], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc. * Life expectancy \< 12 months * Pregnancy or planning pregnancy * Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc. * Participation or planning to participate in another clinical trial during the same period * Refusal to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-segment late lumen loss | 6 months | Changes to lumen area assessed with the use of OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 6 months | The secondary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 6 months. |
Countries
China
Outcome results
None listed