Key result
Drug-eluting balloons showed no significant difference in major adverse cardiac events compared to second-generation drug-eluting stents for bifurcation in-stent restenosis (p=0.585).
Why the study?
Does a drug-eluting balloon compared to a second-generation drug-eluting stent improve major adverse cardiac events in patients with in-stent restenosis involving a coronary bifurcation lesion?
Cohort (n=158)
Does a drug-eluting balloon compared to a second-generation drug-eluting stent improve major adverse cardiac events in patients with in-stent restenosis involving a coronary bifurcation lesion?
p-value: p=0.585
Drug-eluting balloons offer an acceptable alternative to second-generation drug-eluting stents for treating bifurcation in-stent restenosis, with comparable MACE rates at nearly 2 years.
No MACE difference seen with DEB versus DES in bifurcation ISR; hypothesis-generating and requires RCTs before practice change.
AIMS: To report clinical outcomes in patients treated with drug-eluting balloon (DEB) versus second-generation drug-eluting stent (DES) for in-stent restenosis (ISR) involving a bifurcation lesion. METHODS AND RESULTS: Between February 2007 and November 2012, 167 bifurcation restenoses in 158 patients were treated with either DEB (n=73) or second-generation DES (n=85). The EuroSCORE was significantly higher in the DEB group (4.2±3.8 vs. 2.8±2.1, p=0.004). Regarding restenosed stent type, second-generation DES was more frequently seen in the DEB group (26.9% vs. 6.7%, p<0.001). In this group, there was also a trend towards more frequent stenting for a previous ISR (stent-in-stent) as compared with the DES group (25.6% vs. 15.6%, p=0.074). Over a median follow-up period of 701 days, there was no significant difference in major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction including periprocedural myocardial infarction, target vessel revascularisation, between the two groups (p=0.585). Independent predictors of MACE on multivariate Cox regression analysis included stent-in-stent (HR: 2.16; 95% CI: 1.11 to 4.20; p=0.023) and true bifurcation lesions (HR: 2.98; 95% CI: 1.45 to 6.14; p=0.001). CONCLUSIONS: DEB for bifurcation restenosis may be an acceptable treatment option, especially in cases where repeat stenting has not already been performed for the treatment of a previous restenosis.
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Naganuma et al. (2016) conducted a cohort in In-stent restenosis involving a bifurcation lesion (n=158). Drug-eluting balloon (DEB) vs. Second-generation drug-eluting stent (DES) was evaluated on Major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction including periprocedural myocardial infarction, target vessel revascularisation (p=0.585). Drug-eluting balloons showed no significant difference in major adverse cardiac events compared to second-generation drug-eluting stents for bifurcation in-stent restenosis (p=0.585).
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