This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB).
Background
To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR.
Methods
Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group).
Results
Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p < 0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR.
Conclusions
The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.
Key Words
drug-coated balloon
drug-eluting stent
in-stent restenosis
Abbreviations and Acronyms
BMS
bare-metal stent(s)
CI
confidence interval
DAPT
dual antiplatelet therapy
DCB
drug-coated balloon
DES
drug-eluting stent(s)
HR
hazard ratio
ISR
in-stent restenosis
IVUS
intravascular ultrasound
MACE
major adverse cardiac event(s)
PCI
percutaneous coronary intervention
ST
stent thrombosis
TLR
target lesion revascularization
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Dr. Latib is on a Medtronic Advisory Board. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
