Achieved LDL-C Levels and Clinical Outcomes Following Percutaneous Coronary Intervention with Drug-Coated Balloons for De Novo Coronary Lesions

Q: What are the key findings of this study?

Achieved LDL-C ≥100 mg/dL at 6 months after drug-coated balloon PCI independently increased MACE risk compared with LDL-C <70 mg/dL (adjusted HR 2.39, 95% CI 1.33–4.31; P<0.01), driven by TLR.

Q: What is the clinical evidence from this study?

Study design: Observational. Population: De novo coronary artery disease treated with drug-coated balloon angioplasty (n=320). Intervention: Achieved LDL-C ≥100 mg/dL at 6 months post-PCI vs. Achieved LDL-C <70 mg/dL at 6 months post-PCI. Primary outcome: Major adverse cardiovascular events (MACE: composite of all-cause death, nonfatal myocardial infarction, and target lesion revascularization) (HR 2.39, 95% CI 1.33-4.31, p=<0.01).

Q: What does this research mean for the field?

Achieved LDL-C levels ≥100 mg/dL at 6 months after percutaneous coronary intervention with drug-coated balloons independently increase the risk of major adverse cardiac events compared with LDL-C levels <70 mg/dL, driven by target lesion revascularization. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To assess the association between achieved low-density lipoprotein cholesterol (LDL-C) levels and clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary lesions.

Takashi Nagasaka; S Ishio; 亮太 谷内; Shiro Amanai; Yohei Ishibashi; Noriaki Takama; Hideki Ishii

doi:10.5551/jat.66403

January 1, 2026Journal of Atherosclerosis and ThrombosisOpen Access

Achieved LDL-C Levels and Clinical Outcomes Following Percutaneous Coronary Intervention with Drug-Coated Balloons for De Novo Coronary Lesions

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Key result

Post-DCB LDL-C ≥100 mg/dL linked to ~2.4-fold higher MACE risk vs <70 mg/dL, driven by TLR.

HR 2.39
95% CI 1.33-4.31
P<0.01
n=320

Why the study?

The prognostic impact of achieved LDL-C levels after PCI with a drug-coated balloon for de novo coronary lesions remained unclear.

Does achieving lower LDL-C levels (<70 mg/dL vs. ≥100 mg/dL) at 6 months reduce major adverse cardiovascular events and target lesion revascularization in patients undergoing PCI with a drug-coated balloon for de novo coronary lesions?

Key Points

To assess the association between achieved low-density lipoprotein cholesterol (LDL-C) levels and clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) for de novo coronary lesions.
Retrospective study evaluating patients treated with paclitaxel-coated balloons using a DCB-only revascularization strategy guided by intravascular ultrasound or optical coherence tomography.
Achieved LDL-C levels were measured at 6 months post-PCI and categorized into three groups: <70 mg/dL, 70–<100 mg/dL, and ≥100 mg/dL.
Primary endpoint was major adverse cardiac events (MACE), defined as composite all-cause death, nonfatal myocardial infarction, and target lesion revascularization.
Procedural success was achieved in 304 of 320 patients (95.0%), with 15 patients exhibiting residual stenosis >30% and 1 patient experiencing final TIMI grade 2 flow with persistent flow-limiting dissection.
Lipid-lowering therapy included statins in 274 patients (85.6%), ezetimibe in 84 patients (26.3%), and PCSK9 inhibitors in 32 patients (10.0%), with statins and ezetimibe prescribed more frequently in patients achieving LDL-C <70 mg/dL.
Preprocedural lesion length was significantly longer in patients with higher LDL-C levels (P = 0.02), whereas postprocedural minimal lumen diameter and residual diameter stenosis did not differ among the groups.

Study Design

Type

Observational (n=320)

Multicenter

No

Structured PICO

Does achieving lower LDL-C levels (<70 mg/dL vs. ≥100 mg/dL) at 6 months reduce major adverse cardiovascular events and target lesion revascularization in patients undergoing PCI with a drug-coated balloon for de novo coronary lesions?

P

Population

320 consecutive patients (mean age 71.8 years, 23.7% female) undergoing drug-coated balloon PCI for de novo coronary lesions without bailout stenting, with available 6-month LDL-C data, followed for a mean of 890 days.

E

Exposure

Achieved LDL-C level ≥100 mg/dL (n=66) or 70–<100 mg/dL (n=101) at 6 months following intravascular imaging-guided (IVUS or OCT) paclitaxel-coated balloon angioplasty under ongoing lipid-lowering medical therapy (statins 85.6%, ezetimibe 26.3%, PCSK9 inhibitors 10.0%) and dual antiplatelet therapy

C

Comparator

Achieved LDL-C level <70 mg/dL (n=153) at 6 months following paclitaxel-coated balloon angioplasty under ongoing lipid-lowering medical therapy and dual antiplatelet therapy

O

Outcome

Major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, and target lesion revascularization (TLR), assessed using a 6-month landmark analysis over a mean follow-up of 890±260 dayscomposite

Main Result

Hazard Ratio: 2.39 (95% CI 1.33–4.31)

p-value: p=<0.01

In patients undergoing PCI with a drug-coated balloon for de novo coronary lesions, achieving an LDL-C level ≥100 mg/dL at 6 months is independently associated with a more than twofold increased risk of target lesion revascularization and major adverse cardiovascular events compared with achieving an LDL-C <70 mg/dL.

Limitations

Retrospective, single-center observational design with potential residual confounding and selection bias
Lack of detailed information regarding statin intensity, dosage, and timing of initiation
Exclusion of 28 patients without available 6-month LDL-C measurements
Absence of a concurrent drug-eluting stent comparator group
LDL-C levels were assessed at a single time point (6 months post-PCI) without longitudinal lipid profile evaluation
Detailed intravascular imaging plaque characterization (composition or burden) was not incorporated into the analyses
Retrospective, single-center design with potential residual confounding and selection bias
Detailed information on statin intensity, dosage, and timing of initiation was not consistently available
Absence of a concurrent drug-eluting stent (DES) comparator group
Detailed plaque characterization using IVUS or OCT was not incorporated into the analyses

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Implication

LDL-C ≥100 mg/dL at 6 months post-DCB PCI was associated with higher MACE; leaves open whether intensive lowering improves outcomes.

Abstract

Aim: Percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB) is a coronary revascularization strategy; however, the prognostic impact of achieved low-density lipoprotein cholesterol (LDL-C) levels after intervention remains unclear. In this study, we aimed to understand the association between LDL-C and the clinical outcomes in patients undergoing PCI with DCB.

Discussion

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Cite This Study

Nagasaka et al. (2026) conducted an observational in De novo coronary artery disease treated with drug-coated balloon angioplasty (n=320). Achieved LDL-C ≥100 mg/dL at 6 months post-PCI vs. Achieved LDL-C <70 mg/dL at 6 months post-PCI was evaluated on Major adverse cardiovascular events (MACE: composite of all-cause death, nonfatal myocardial infarction, and target lesion revascularization) (HR 2.39, 95% CI 1.33-4.31, p=<0.01). Achieved LDL-C ≥100 mg/dL at 6 months after drug-coated balloon PCI independently increased MACE risk compared with LDL-C <70 mg/dL (adjusted HR 2.39, 95% CI 1.33–4.31; P<0.01), driven by TLR.

synapsesocial.com/papers/6af0e999de503f3774140a67 https://doi.org/10.5551/jat.66403

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Achieved LDL-C Levels and Clinical Outcomes Following Percutaneous Coronary Intervention with Drug-Coated Balloons for De Novo Coronary Lesions

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Achieved LDL-C Levels and Clinical Outcomes Following Percutaneous Coronary Intervention with Drug-Coated Balloons for De Novo Coronary Lesions

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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