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Clinical Outcomes With a Biodegradable Polymer, Sirolimus-Eluting Stent
Study Questions:
What are the clinical outcomes with a targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population?
Methods:
The TARGET All Comers study investigators conducted a prospective, multicenter, open-label randomized noninferiority trial at 21 centers in 10 European countries. A total of 1,653 patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischemia who qualified for percutaneous coronary intervention were randomized 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomization was web-based, with random block allocation and stratification by center and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The control event rate for XIENCE was assumed to be 7%, the noninferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the noninferiority of the FIREHAWK compared with the XIENCE stent. Kaplan-Meier methods were used to calculate the time-to-event outcomes, and the log-rank test to compare between-group differences.
Results:
From December 17, 2015, to October 14, 2016, 1,653 patients were randomly assigned to implantation of the FIREHAWK (n = 823) or XIENCE (n = 830); 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6.1%) of 758 patients in the FIREHAWK group and in 45 (5.9%) of 764 patients in the XIENCE group (difference, 0.2%; 90% confidence interval [CI], −1.9 to 2.2; p for noninferiority = 0.004; 95% CI, −2.2 to 2.6; p for superiority = 0.88). There were no differences in ischemia-driven revascularization or stent thrombosis rates at 12 months. A total of 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0.17 mm (standard deviation, 0.48) in the FIREHAWK group and 0.11 mm (0.52) in the XIENCE group (p = 0.48), with an absolute difference of 0.05 mm (95% CI, −0.09 to 0.18; p for noninferiority = 0.024).
Conclusions:
The authors concluded that in a broad all-comers population of patients requiring stent implantation for myocardial ischemia, the FIREHAWK was noninferior to the XIENCE, as assessed with the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months.
Perspective:
This study reports that the FIREHAWK stent was noninferior to the XIENCE stent for the primary endpoint, target lesion failure at 12 months, and results were consistent across all tested subgroups. Furthermore, outcomes were not different between groups in any of the components of the primary endpoint or any secondary endpoint measures of safety or efficacy. Stent thrombosis rates were slightly higher than reported in other trials of more selective populations. However, it should be noted that that the deliverability of the FIREHAWK appeared to be worse than that of the XIENCE stent, and angiographic endpoints also tended to favor XIENCE. These nuances may limit clinical use of this stent at this time with many well performing new-generation drug-eluting stents available in the European and western market.
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and ACS, Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: Acute Coronary Syndrome, Coronary Angiography, Coronary Artery Disease, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Outcome Assessment, Health Care, Percutaneous Coronary Intervention, Polymers, Secondary Prevention, Sirolimus, Stents, Thrombosis
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