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Paclitaxel-eluting balloons reduce late lumen loss in coronary in-stent restenosis
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In the prospective, randomized Treatment of In-Stent Restenosis study, use of paclitaxel-eluting balloons to treat bare metal stent restenosis yielded lower rates of late lumen loss at 12 months compared with use of second-generation everolimus-eluting stents.
The study included 136 adults with BMS in-stent restenosis (≥ 50% diameter stenosis) who underwent treatment at the University Hospital Ostrava in the Czech Republic between 2012 and 2014. Participants were randomly allocated at a 1:1 ratio to receive a paclitaxel-eluting balloon (PEB; Sequent Please, B. Braun Melsungen AG) or an everolimus-eluting stent (EES; Promus Element, Boston Scientific). There were 74 in-stent restenosis lesions in each group.
Patients were seen for clinical follow-up at 6 and 12 months after the procedure and angiographic follow-up occurred at 12 months, unless required earlier. The primary endpoint was defined as in-segment late lumen loss at 12 months as assessed by quantitative control angiography. The following secondary endpoints were identified: incidence of binary in-stent restenosis (≥ 50% diameter stenosis) and overall incidence of MACE at 1 year. MACE was defined as CV death, nonfatal acute IM or target vessel revascularization.
The researchers found a variation in late lumen loss between PEB and EES stent groups. PEB was both noninferior and superior to EES; the 2-sided 95% CI between PEB and EES was 0.149 to 0.558, which was greater than the noninferiority margin of 0.12, according to the findings.
At 12 months, the PEB group showed significantly less late lumen loss vs. the EES group (mean, 0.09 ± 0.44 mm; median, 0.02 mm vs. mean, 0.44 ± 0.73 mm; median, 0.19 mm; P = .0004). However, the difference in the incidence of repeated binary restenosis between the groups was not significantly different (8.7% vs. 19.12%; P = .078). Moreover, clinical follow-up did not reveal significant differences in 12-month MACE (P = .213) or TVR (P = .11).
An equal number of acute MI and deaths occurred in both groups. The PEB group had an average event-free survival of 13.67 months (95% CI, 13.39-13.94) vs. 14.22 months in the EES group (95% CI, 13.4-15.05). A log-rank test revealed no difference between the two groups in event-free survival (time to MACE, P = .098).
According to analysis of the highest-risk subgroups, PEB-treated patients with in-stent restenosis length greater than 10 mm had less late lumen loss at 12 months compared with EES-treated patients with comparable in-stent restenosis length (0.05 vs. 0.26 mm; P = .0002). Similarly, PEB-treated patients with vessel diameter less than 3 mm had less 12-month late lumen loss vs. EES-treated patients with the same diameter (0.05 vs. 0.16 mm; P = .003). No significant difference was observed between the groups among patients with diabetes. The findings demonstrated a significantly higher chance of repeated binary restenosis in the EES group (OR = 3.192; 95% CI, 1.058-9.269) with adjustment for diabetes, renal insufficiency, type of original lesion, artery diameter less than 3 mm and in-stent restenosis length greater than 10 mm (unadjusted OR = 2.482; 95% CI, 0.884-6.971).
“Our results suggest that the treatment of [BMS] in-stent restenosis using a [PEB] reduces 12-month late lumen loss significantly compared with the implantation of second-generation [EES],” the researchers wrote. “The significantly better early postprocedural angiographic results in the EES group, mainly because of a lower early elastic recoil after the second stent implantation, were not long-lasting, and the subsequent 12-month parameters did not differ between the two groups.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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