Treatment of drug-eluting stent restenosis with a paclitaxel-eluting balloon resulted in a significantly lower 1-year MACE rate compared to an everolimus-eluting stent (8.6% vs 27.5%; P=0.046).
Observational (n=86)
Does a paclitaxel-eluting balloon improve survival free of major adverse cardiac events at 1 year compared to an everolimus-eluting stent in patients with drug-eluting stent restenosis?
In patients with drug-eluting stent restenosis, treatment with a paclitaxel-eluting balloon was associated with significantly lower rates of MACE and target lesion revascularization at 1 year compared to an everolimus-eluting stent.
Absolute Event Rate: 8.6% vs 27.5%
p-value: p=0.046
OBJECTIVE: Drug-eluting stent (DES) implantation is a very effective treatment of bare-metal stent-in-stent restenosis (BMS-ISR). Therapeutic options for drug-eluting stent-in-stent restenosis (DES-ISR) are less well defined, as there are only few data on safety and effectiveness of interventional modalities. This study compared the 1-year clinical outcome after the use of drug-eluting balloon (DEB) to second-generation everolimus-eluting stent (EES) for treatment of DES-ISR. METHODS: This observational study included 86 patients with 86 DES-ISR. Forty patients were treated by repeat percutaneous coronary intervention (PCI) using an EES. Forty-six patients were treated by repeat PCI using a DEB. Follow-up periods were 22 ± 11 and 25 ± 19 months, respectively. The primary endpoint of the study was survival free of major adverse cardiac events (MACEs) at 1 year. Secondary endpoints were needed for target lesion revascularization (TLR), definite stent thrombosis (ST) at 1 year, and MACE rate during total follow-up period. RESULTS: Baseline clinical and angiographic parameters were comparable between the two groups. EES were associated with a higher MACE rate at 1 year compared to DEB (27.5 vs. 8.6%, respectively; P = 0.046). TLR rates for EES and DEB were 22.5% versus 4.3%, respectively, P = 0.029, while rates of definite ST at 1 year follow-up were comparable (2.5% vs. 0%, respectively; P = 0.945). There were no differences in myocardial infarction rates between the two groups (5% vs. 2%, respectively; P = 0.595) and in mortality. Considering the complete follow-up periods, DEB were associated with significantly less MACE compared to EES (log-rank test, P = 0.045). Furthermore, comparison of TLR rates showed a strong trend in favor of DEB compared to EES (P = 0.074). CONCLUSIONS: Treatment of DES-ISR using a DEB is associated with favorable rates of MACE and TLR at 1-year follow-up compared to the implantation of an EES.
Almalla et al. (Fri,) conducted a observational in Drug-eluting stent-in-stent restenosis (DES-ISR) (n=86). Paclitaxel-eluting balloon (DEB) vs. Everolimus-eluting stent (EES) was evaluated on Major adverse cardiac events (MACEs) at 1 year (p=0.046). Treatment of drug-eluting stent restenosis with a paclitaxel-eluting balloon resulted in a significantly lower 1-year MACE rate compared to an everolimus-eluting stent (8.6% vs 27.5%; P=0.046).