TWO-YEAR RESULTS OF THE PLATINUM RANDOMIZED TRIAL COMPARING PLATINUM CHROMIUM PROMUS ELEMENT AND COBALT CHROMIUM PROMUS/XIENCE V EVEROLIMUS-ELUTING STENTS IN DE NOVO CORONARY ARTERY LESIONS

  • Stone G
  • Teirstein P
  • Meredith I
  • et al.
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Abstract

Background: In the multinational, prospective, randomized PLATINUM trial, the platinum chromium PROMUS Element Everolimus Eluting Stent (PtCr‐EES) was non‐inferior to the predicate cobalt chromium PROMUS/XIENCE V EES (CoCr‐EES) for 12‐month target lesion failure (TLF). However, longer‐term outcomes have not yet been reported. Methods: Patients (N=1530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter >2.50 mm to <4.25 mm and length <24 mm) were randomized 1:1 to PtCr‐EES versus CoCr‐EES. Exclusion criteria included acute or recent myocardial infarction (MI), left ventricular ejection fraction <30%, left main or ostial location, major bifurcation disease, chronic total occlusion, and target vessel thrombus. Routine angiographic follow‐up was not performed. Results: Technical success (98.8% CoCr‐EES, 99.4% PtCr‐EES; P=0.14) and clinical procedural success (98.2% CoCr‐EES, 98.3% PtCr‐EES; P=0.83) were high and not significantly different between groups. At 12 months, PtCr‐EES was non‐inferior to the CoCr‐EES for TLF (cardiac death or MI related to the target vessel or ischemia‐driven target lesion revascularization [TLR]), with rates of 2.9% (CoCr‐EES) versus 3.4% (PtCr‐EES) in the perprotocol population (P[noninferiority]=0.001, P[superiority]=0.60). There were no significant differences in death (1.2% CoCr‐EES, 1.3% PtCr‐EES; P=0.85), myocardial infarction (1.8% CoCr‐EES, 1.1% PtCr‐EES; P=0.25), TLR (1.9% CoCr‐EES, 1.9% PtCr‐EES; P=0.96), or definite/probable stent thrombosis (0.4% CoCr‐EES, 0.4% PtCr‐EES; P>0.99) in the intent‐to‐treat analysis. Two‐year clinical follow‐up is underway. Conclusions: Long‐term evaluation of novel drug‐eluting stents is critical to assess safety and efficacy. The two‐year results from the PLATINUM trial will be available for presentation for the first time at the ACC in March 2012.

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Stone, G. W., Teirstein, P., Meredith, I., Bouchard, A., Carri&eacute;, D., M&ouml;llmann, H., … Dawkins, K. (2012). TWO-YEAR RESULTS OF THE PLATINUM RANDOMIZED TRIAL COMPARING PLATINUM CHROMIUM PROMUS ELEMENT AND COBALT CHROMIUM PROMUS/XIENCE V EVEROLIMUS-ELUTING STENTS IN DE NOVO CORONARY ARTERY LESIONS. Journal of the American College of Cardiology, 59(13), E323. https://doi.org/10.1016/s0735-1097(12)60324-6

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