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Published on: February 18, 2020
Drug-coated balloon: Long-term outcome from a real world three-center experience
Carlo Zivelonghi1, Matteo Ghione2, Giovanni Benfari1
1Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.
Insights
Drug-coated balloons (DCB) offer a viable treatment for in-stent restenosis and small vessel disease in coronary interventions. Long-term outcomes show acceptable cardiac event rates up to 48 months in an all-comers population.
Area of Science:
- Interventional Cardiology
- Vascular Medicine
- Biomedical Engineering
Background:
- In-stent restenosis (ISR) and small vessel disease remain challenges in percutaneous coronary interventions.
- New-generation drug-eluting stents (DES) have improved outcomes but do not fully address these subsets.
- Drug-coated balloons (DCB) represent an alternative revascularization strategy.
Purpose of the Study:
- To evaluate the long-term clinical outcomes of DCB treatment.
- To assess DCB efficacy in an all-comers population, including ISR and de novo small vessel lesions.
- To identify predictors of major adverse cardiac events (MACE) after DCB treatment.
Main Methods:
- Retrospective study of 143 consecutive patients treated with DCB from 2011-2014 across three Italian centers.
- Inclusion of both in-stent restenosis (75.4%) and de novo small vessel lesions (24.5%).
- Primary endpoints included cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and MACE.
Main Results:
- Procedural success was achieved in 94.6% of cases.
- At 48 months, survival free from MACE was 75.3%, with 3 cardiac deaths, 8 MIs, and 27 TLRs.
- No thrombotic events occurred; MACE rates were similar between ISR and de novo groups.
- Independent predictors of MACE included acute coronary syndromes, prior MI, prior surgical revascularization, peripheral arterial disease, and diabetes.
Conclusions:
- DCB is a valid revascularization strategy for patients with ISR and de novo small vessel coronary lesions.
- The treatment demonstrated acceptable long-term cardiac event rates up to 48 months.
- Further research may focus on optimizing DCB use in complex coronary subsets.
Objectives:
In-stent restenosis (ISR) and diffuse small vessel disease still represent challenging subsets for percutaneous coronary interventions, also in the new-generation DES era. We aim at reporting on the long-term clinical outcome of drug-coated balloons (DCB) in all-comers population.
Methods:
Consecutive patients treated with DCB between January 2011 and December 2014 were retrospectively studied in three centers of northern Italy. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TLR.
Results:
We included 143 patients. Of the 167 lesions treated, 41 (24.5%) were de novo lesions in small coronary vessels (<2.5 mm) and 126 (75.4%) were ISR. Among ISR lesions, 78.5% were DES-ISR, 32.5% were focal, 15.8% multifocal, 30.1% diffuse, 18.2% proliferative, and 3.1% were total occlusions. Procedural success was achieved in 94.6% of cases. Overall survival free from MACEs was 91.6% at 12 months, and 75.3% at 48 months, with a total of 3 cardiac deaths, 8 MI, and 27 TLR. No thrombotic event occurred in the treated segments. There were no differences in MACESs between the ISR and de novo lesions groups. At multivariate analysis, acute coronary syndromes, previous MI, previous surgical revascularization, peripheral arterial disease and diabetes were independent predictors of MACEs at long-term follow-up.
Conclusions:
DCB proved a valid revascularization strategy in an all-comers population of patients with ISR and de novo lesions in small vessels, with an acceptable rate of cardiac events up to 48 months follow-up.
