Direct implantation of rapamycin-eluting stents with bioresorbable drug carrier technology utilising the Svelte coronary stent-on-a-wire: the DIRECT II study

Verheye, Stefan; Khattab, Ahmed A.; Carrié, Didier; Stella, Pieter R.; Slagboom, Ton; Bartúnek, Jozef; Onuma, Yoshinobu; Serruys, Patrick W.

doi:10.4244/eijv12i5a101

Cited by 7 publications

(2 citation statements)

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“…Direct II was a small randomized study comparing Svelte (n=108) to Resolute Integrity (R-ZES; n=51) [105]. The primary endpoint of in stent late lumen loss at 6 months in the Svelte stent was noninferior to R-ZES (0.09 ± 0.31 mm vs 0.13 ± 0.27 mm, P noninferiority =0.001) (105).…”

Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%

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Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents

Akinapelli¹,

Chen

Roy

et al. 2017

CCR

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Drug-eluting stents (DES) have been shown to significantly reduce clinical and angiograph-ic restenosis compared to bare metal stents (BMS). The polymer coatings on DES elute antiproliferative drugs to inhibit intimal proliferation and prevent restenosis after stent implantation. Permanent poly-mers which do not degrade in vivo may increase the likelihood of stent-related delayed arterial healing or polymer hypersensitivity. In turn, these limitations may contribute to an increased risk of late clinical events. Intuitively, a polymer which degrades after completion of drug release, leaving an inert metal scaffold in place, may improve arterial healing by removing a chronic source of inflammation, neoath-erosclerosis, and/or late thrombosis. In this way, a biodegradable polymer may reduce late ischemic events. Additionally, improved healing after stent implantation could reduce the requirement for long-term dual antiplatelet therapy and the associated risk of bleeding and cost. This review will focus on bioabsorbable polymer-coated DES currently being evaluated in clinical trials.

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Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%

“…The primary endpoint of in stent late lumen loss at 6 months in the Svelte stent was noninferior to R-ZES (0.09 ± 0.31 mm vs 0.13 ± 0.27 mm, P noninferiority =0.001) (105). TVF at 1 year was 6.5% vs 9.8% ( P =0.52) [105]. …”

Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%