Key result
The platinum-chromium everolimus-eluting stent was non-inferior to the cobalt-chromium stent for target vessel failure at 12 months (4.6% vs 3.2%; P=0.012 for non-inferiority).
Why the study?
Does the platinum-chromium everolimus-eluting stent provide non-inferior safety and efficacy compared to the cobalt-chromium everolimus-eluting stent in patients with stable or unstable coronary artery disease?
RCT (n=2,980)
Single-blind
2:1
Yes
Does the platinum-chromium everolimus-eluting stent provide non-inferior safety and efficacy compared to the cobalt-chromium everolimus-eluting stent in patients with stable or unstable coronary artery disease?
Hazard Ratio: 1.44 (95% CI 0.96–2.16)
Absolute Event Rate: 4.6% vs 3.2%
p-value: p=0.012 for non-inferiority
The platinum-chromium everolimus-eluting stent met non-inferiority criteria for 12-month target vessel failure compared to the cobalt-chromium everolimus-eluting stent in an all-comers population, although per-protocol analysis favored the cobalt-chromium platform.
Supports non-inferiority of platinum-chromium stents in this cohort; leaves open randomized confirmation before practice change.
AIMS: The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES. METHODS AND RESULTS: We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44). CONCLUSIONS: At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.
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Fajadet et al. (2017) conducted an RCT in stable or unstable coronary artery disease (n=2,980). Platinum-chromium everolimus-eluting stent vs. Cobalt-chromium everolimus-eluting stent was evaluated on Target vessel failure (TVF) at 12 months (composite of target vessel-related cardiac death, MI, and ischaemia-driven TVR) (HR 1.44, 95% CI 0.96-2.16, p=0.012 for non-inferiority). The platinum-chromium everolimus-eluting stent was non-inferior to the cobalt-chromium stent for target vessel failure at 12 months (4.6% vs 3.2%; P=0.012 for non-inferiority).
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