海豹翼紫杉醇洗脱球囊导管治疗裸金属支架再狭窄的疗效
Efficacy of a seal-wing paclitaxel-eluting balloon catheters in the treatment of bare metal stent restenosis.
作者信息
Pleva Leos, Kukla Pavel, Zapletalova Jana, Hlinomaz Ota
机构信息
Department of Cardiovascular Diseases, University Hospital Ostrava, tr. 17. listopadu 1790, 708 52, Ostrava, Czech Republic.
Department of Medical Biophysics, Palacky University, Hněvotínská 3, 775 15, Olomouc, Czech Republic.
出版信息
BMC Cardiovasc Disord. 2017 Jun 26;17(1):168. doi: 10.1186/s12872-017-0602-6.
BACKGROUND
Our study aimed to compare the efficacy of seal-wing paclitaxel-eluting balloon catheters (PEB) with iopromide-coated PEB and everolimus-eluting stents (EES) for treating bare metal stent restenosis (BMS-ISR).
METHODS
We enrolled 64 patients with 69 BMS-ISR. The control group comprised patients from the iopromide-PEB and EES arms of a previous TIS study. The primary end-point was 12-month in-segment late lumen loss (LLL). Secondary end-points included incidence of binary in-stent restenosis and 12-month major adverse cardiac events (MACE).
RESULTS
Compared to iopromide-coated PEB, seal-wing PEB was associated with significantly higher 12-month LLL (0.30 vs. 0.02 mm; p < 0.0001), repeated binary restenosis (28.12% vs. 8.7%; p = 0.012), 12-month MACE (26.98% vs. 10.29%; p = 0.003), and target vessel revascularization (TVR; 20.63% vs. 7.35%; p = 0.009). Compared to EES, no significant differences were found in the 12-month LLL (0.30 vs. 0.19 mm; p = 1.000), repeated binary restenosis (28.12% vs. 19.12%; p = 0.666), 12-month MACE (26.98% vs. 19.12%; p = 0.102) or TVR (20.63% vs. 16.18%; p = 0.360).
CONCLUSION
BMS-ISR treatment using seal-wing PEB led to significantly higher 12-month LLL, repeated binary restenosis, MACE, and TVR compared to iopromide-coated PEB. However, no significant differences were found in comparison with EES.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT01735825.
背景
我们的研究旨在比较密封翼紫杉醇洗脱球囊导管（PEB）与碘普罗胺涂层PEB和依维莫司洗脱支架（EES）治疗裸金属支架再狭窄（BMS-ISR）的疗效。
方法
我们纳入了64例患有69处BMS-ISR的患者。对照组包括来自先前一项TIS研究中碘普罗胺-PEB和EES组的患者。主要终点是12个月时节段内晚期管腔丢失（LLL）。次要终点包括支架内再狭窄二元发生率和12个月时主要不良心脏事件（MACE）。
结果
与碘普罗胺涂层PEB相比，密封翼PEB的12个月LLL显著更高（0.30对0.02毫米；p<0.0001），重复支架内再狭窄二元发生率更高（28.12%对8.7%；p=0.012），12个月MACE发生率更高（26.98%对10.29%；p=0.003），以及靶血管血运重建（TVR；20.63%对7.35%；p=0.009）。与EES相比，12个月LLL（0.30对0.19毫米；p=1.000）、重复支架内再狭窄二元发生率（28.12%对19.12%；p=0.666）、12个月MACE发生率（26.98%对19.12%；p=0.102）或TVR（20.63%对16.18%；p=0.360）均未发现显著差异。
结论
与碘普罗胺涂层PEB相比，使用密封翼PEB治疗BMS-ISR导致12个月LLL、重复支架内再狭窄二元发生率、MACE和TVR显著更高。然而，与EES相比未发现显著差异。
试验注册
ClinicalTrials.gov；NCT01735825。
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