A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease

Figures & data

Figure 1 Design structure of the Promus Element stent.

Figure 2 Key differences between the Promus Element and Synergy stent. In the thinner-strut Synergy stent, the drug and bioabsorbable poly-DL-lactide-co-glycolide (PLGA) polymer are applied to the abluminal stent surface only (A). The Synergy stent has different strut thickness, connector angle, and peak radius diameters, resulting in an enhanced stent platform (B). Panel (C) shows similar radiopacity between the stents despite reduced strut thickness in the Synergy stent.

Figure 3 Kinetics of drug release and polymer absorption with the Synergy stent.

Note: The Synergy Stent shows drug release over 90–120 days, concurrent with polymer absorption.
Abbreviation: PLGA, poly-DL-lactide-co-glycolide.

Table 1 PLATINUM and EVOLVE Clinical Trial Programs

Study	Design	Lesion type	Lesion length	Baseline RVD	Control	1° Endpoint	Patients N°
PLATINUM QCA	Prospective multicenter single-arm	De novo	≤34 mm	≥2.25 to ≤4.25 mm	Historical results Taxus Express	30-day TLF 9-month in-stent LLL	100
PLATINUM RCT	Prospective multicenter single-blind randomized	De novo (≤2 lesions)	≤24 mm	≥2.5 to ≤4.25 mm	CoCr-EES (Xiencev or Promus)	12-month TLF	1,530
PLATINUM SV	Prospective multicenter single-arm	De novo	≤28 mm	≥2.25 to <2.50 mm	Historical results Taxus Express	12-month TLF	94
PLATINUM LL	Prospective multicenter single-arm	De novo	24–34mm	≥2.50 to ≤4.25 mm	Historical results Taxus Express	12-month TLF	102
PLATINUM PK	Prospective multicenter single-arm	De novo	≤24 mm	≥2.5 to ≤4.25 mm	N/A	Observational	20
EVOLVE FHU	Prospective multicenter single-blind randomized	De novo	≤28 mm	≥2.25 to ≤3.5 mm	PtCr-EES (Promus Element)	30-day rate of TLF 6-month in-stent LLL	291
EVOLVE II RCT	Prospective multicenter single-blind randomized	De novo (≤3 lesions; ≤2 vessels)	≤34 mm	≥2.25 to ≤4.0 mm	PtCr-EES (Promus Element plus)	12-month TLF	1,684
EVOLVE II PK	Prospective multicenter single-arm	De novo (≤3 lesions; ≤2 vessels)	≤34 mm	≥2.25 to ≤4.0 mm	N/A	Observational	20–30
EVOLVE II DM	Prospective multicenter single-arm	De novo (≤3 lesions; ≤2 vessels)	≤34 mm	≥2.25 to ≤4.0 mm	N/A	12-month TLF	250–292
EVOLVE QCA	Prospective multicenter	De novo	≤34 mm	≥2.25 to ≤4.0 mm	N/A	9-month in-stent LL	100

Abbreviations: RVD, reference vessel diameter; QCA, quantitative coronary angiography; TLF, target lesion failure (defined as the composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularization); RCT, randomized control trial; SV, small vessel; LL, long lesion; PK, pharmacokinetic; FHU, first human use; DM, diabetes mellitus; LLL, late luminal loss; CoCr-EES, cobalt chromium everolimus-eluting stent; PtCr-EES, platinum chromium everolimus-eluting stent; N/A, not available.

Figure 4 Coronary angiography and optical coherence tomography (OCT) 9 months after Promus Element implantation. A diffusely diseased right coronary artery (A) was treated with three slightly overlapping Promus Element stents. Panel (B) confirms excellent radiopacity of the Platinum Chromium Element stent platform. Follow-up angiography at 9 months shows prolonged vessel patency (C). A representative OCT image confirms favorable healing: all struts (white arrows) are covered with a thin homogeneous layer of neointimal tissue (arrowhead) with a well-preserved lumen area (D).