A Prospective, Randomized Evaluation of a Novel Everolimus-Eluting Coronary Stent: The PLATINUM (A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of up to Two De Novo Coronary Artery Lesions) Trial

Study Questions:

What are the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI)?

Methods:

A total of 1,530 patients undergoing PCI of one or two de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. The Kaplan-Meier product-limit method was used to estimate event rates for time-to-event outcomes; data were compared with the log-rank test.

Results:

The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%; 95% confidence interval: -1.3% to 2.3%, pnoninferiority = 0.001, psuperiority = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr- EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death, or MI (2.5% vs. 2.0%, p = 0.56); TLR (1.9% vs. 1.9%, p = 0.96); or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00).

Conclusions:

The authors concluded that in this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF.

Perspective:

The current study evaluated a novel stent, based on a new metal alloy, the PtCr-EES with a modified scaffold designed to provide improved deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. The new stent demonstrated an excellent safety profile, with nonsignificantly different 12-month rates of cardiac death, MI, and stent thrombosis compared to the CoCr-EES currently in use, and was noninferior for TLF. Thus, along with stainless steel and cobalt chromium, platinum chromium may now be considered an acceptable metal alloy for use in drug-eluting stents. Additional multicenter studies are indicated in patients with complex coronary anatomy to further assess stent deliverability and other ease-of-use characteristics.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Stainless Steel, Cobalt, Drug-Eluting Stents, Platinum, Chromium, Coronary Vessels, Stents, Percutaneous Coronary Intervention


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