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Platinum Chromium Stent Series PLATINUM Small Vessel (SV) Trial


The PLATINUM SV trial is a multicentre, prospective single-arm study, initiated in January 2009, evaluating the PROMUS Element stent in 94 patients for treatment of de novo lesions ≤28 mm long in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (visual estimate). The primary end-point of PLATINUM SV is the 12-month TLF rate, defined as any ischaemia-driven TLR, MI (Q-wave and non–Q-wave) related to the target vessel or cardiac death related to the target vessel. The comparator is a pre-defined performance goal based on historical TAXUS Express results in small vessels.


Technical and procedural success was 96.8 %. In the intent-to-treat group, there were three cardiac deaths, no MIs and no STs. These results support both the safety and efficacy of the PROMUS Element 2.25 mm stent.


The primary endpoint was met with a 12-month TLF rate of 2.4 % in the per-protocol group (89 patients receiving the PROMUS Element stent), which was significantly below the performance goal of 21.1 % (p<0.001).28


Table 6: PLATINUM WH – One-year Clinical Outcomes PROMUS


(Xience V) All-cause death, MI, TVR Cardiac death MI Q-wave MI Non–Q-wave MI


TVR, overall TLR, overall


Cardiac death or MI Target lesion failure Target vessel failure


ARC definite/probable ST


All-cause death or MI 22/732 (3.0) All death


9/732 (1.2) 5/732 (0.7) 13/732 (1.8) 5/732 (0.7) 9/732 (1.2) 21/732 (2.9) 14/732 (1.9) 18/732 (2.5) 23/727 (3.2) 29/727 (4.0) 3/725 (0.4)


PROMUS Element


(n=762) (n=768) 36/732 (4.9)


37/745 (5.0) 18/745 (2.4) 10/745 (1.3) 7/745 (0.9) 8/745 (1.1) 1/745 (0.1) 7/745 (0.9) 20/745 (2.7) 14/745 (1.9) 15/745 (2.0) 26/742 (3.5) 31/742 (4.2) 3/735 (0.4)


Note: one-year outcomes in the intention-to-treat population. Values are n/N (%).


ARC = Academic Research Consortium; MI = myocardial infarction; ST = stent thrombosis; TLR = target lesion revascularisation; TVR = target vessel revascularisation.


In total, the outcomes of the PLATINUM clinical trial programme suggest that the safety and efficacy observed with the everolimus and polymer combination in the PROMUS (Xience V) stent can be successfully transferred to the PtCr stent platform.


Summary


The thin-strut PtCr stent series has fulfilled the design goals of improved acute performance while maintaining excellent safety and efficacy in patients undergoing PCI. The PtCr stent is a highly deliverable, flexible and conformable thin-strut stent with excellent radiopacity, recoil and radial strength. Pre-clinical data with the PtCr stent demonstrated safety and vascular compatibility equivalent to the predicate devices. Clinical outcomes directly support the safety and efficacy of the PtCr stents in patients undergoing PCI. The


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OMEGA bare metal PtCr stent received CE Mark approval in March 2011. The drug-eluting stents which use the same PtCr alloy and stent platform, the everolimus-eluting PROMUS Element and the paclitaxel-eluting TAXUS Element (ION) stents, received Conformité Europeéne Mark approval in October 2009 and May 2010, respectively, while the TAXUS Element stent received FDA approval in April 2011 and is marketed in the US as the ION stent. The PROMUS Element stent is currently under review by the FDA.


Extensive investigation and analysis of the OMEGA, TAXUS Element (ION) and PROMUS Element stents has been undertaken, and additional corroborating data from ongoing clinical studies using all three PtCr stents will further define the potential of these new stent systems. n


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28. Meredith I, PLATINUM Small Vessel: 12-month outcomes. Presented at EuroPCR 2011, Paris, France, 2011.


p-value


0.97 0.49 0.85 0.58 0.25 0.12 0.59 0.83 0.96 0.56 0.72 0.85 1.0


INTERVENTIONAL CARDIOLOGY


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