Targeted Therapy with a Localized abluminal Groove Low-Dose Sirolimus-Eluting Bioabsorbable Polymer Coronary Stent in Chronic Total Occlusions: The TARGET CTO Non-Inferiority Randomized Trial.
Geng Wang, Ruiyan Zhang, Shao-Liang Chen, Jian'an Wang, Yi Li, Ming Zheng, Ruifen Cao, Yitong Ma, Zhiqi Sun, Xueqi Li, Xi Su, Wen Lu, Yawei Xu, Xue Li, Yang Li, Fucheng Sun, Yaling Han
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引用次数: 0
Abstract
Background: Our objective was to compare the efficacy and safety of a drug-eluting stent featuring an abluminal bioabsorbable sirolimus-containing polymer coating (BP-SES) with an everolimus-eluting stent with a durable polymer (DP-EES) in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs).
Methods: TARGET CTO is a multi-center, open-label, non-inferiority trial that randomized patients to either BP-SES or DP-EES in a 1:1 fashion following successful CTO re-canalization. The primary endpoint that was powered for non-inferiority assessment is in-stent late lumen loss (LLL) at 12 months.
Results: A total of 206 subjects underwent randomization, with 103 assigned to the BP-SES group and 103 to the DP-EES group. Baseline clinical and angiographic characteristics were comparable. The primary endpoint demonstrated non-inferiority for the BP-SES group compared to the DP-EES group (0.21±0.43 mm vs. 0.21±0.33 mm; p=0.934, 2-sided; difference 0.01mm [BP-SES minus DP-EES]; 95% CI: -0.13 to 0.12 mm; p non-inferiority <0.001,1-sided). No significant differences were observed in secondary angiographic or clinical endpoints. The rates of 12-month in-stent and in-segment binary restenosis in the BP-SES group and the DP-EES group were similar (6.8% vs. 7.5%, p=0.86; and 8.1% vs. 8.8%; p=0.89, respectively). Although there was a trend favoring the BP-SES group, the difference between the BP-SES group and DP-EES group at 12 months in target lesion failure (2.1% vs. 8.0%, p=0.054) and target lesion revascularization (2.1% vs. 7.1%, p=0.089) did not reach statistical significance. No definite or probable stent thromboses were reported in either group.
Conclusions: Compared to DP-EES, PCI of CTOs with BP-SES showed similar results in terms of late loss and binary restenosis at the 12-month follow-up.
Clinical trial: ClinictalTrial.gov, number NCT03040934.
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The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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