http://www.theheart.org/web_slides/1232965.do Five-year clinical trial on PLATINUM to assess the PROMUS Clement stent system for treatment of de novo coronary artery lesions

1. PLATINUM

2. PLATINUM
G Stone (Columbia University Medical Center, NY)
American College of Cardiology 2011 Scientific Sessions
• Five-year clinical trial to assess the PROMUS Clement stent system for
treatment of de novo coronary artery lesions:
Promus Element contains the same drug (everolimus) and polymer as
Xience V, with platinum scaffolding instead of cobalt to make the stent easier
to use—more flexible, less chance of recoil, more radiopaque (easier to see)
• Population and treatment:
1530 patients undergoing PCI in one or two coronary arteries
Randomized to the new platinum stent or the cobalt stent
• Primary outcome:
12-month rate of TLF: a composite of target-vessel-related cardiac death,
target-vessel-related MI, or ischemia-driven TLR, in the per-protocol
population
TLF: target lesion failure
TLR: target lesion revascularization

3. PLATINUM: Results
• The new platinum stent was noninferior to the control stent
• Primary end point:
3.4% and 2.9% for the platinum and control stents, respectively (p for
noninferiority=0.001; p for superiority=0.60)
• No significant differences seen between the two in other safety/efficacy measures:
Stent thrombosis: 0.4% in each group
TLR: 1.9% in each group
• Only 3.3% of the study population had adverse events

4. PLATINUM: Commentary*
"The bar is set very high now."
- Dr Charles J Davidson
"When it comes to deciding which stent is better than another, it will come down to
nuanced aspects, and these don't come to light until you are using these devices in
lots and lots of people, not in these small trials designed for regulatory approval."
- Dr Edward J McNulty
"It's going to be difficult to distinguish these devices as being meaningfully
different."
- Dr Martin Leon
*All comments from Everolimus-eluting stent performs well in PLATINUM
(http://www.theheart.org/article/1207155.do)

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