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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