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Procedural advantages of a novel coronary stent design with ultra-thin struts and bioabsorbable abluminal polymer coating in an all-comers registry.

ABSTRACT: Introduction:The implications of novel drug-eluting stent (DES) design modifications including ultra-thin struts and new concepts of polymer coating for procedural efficacy are still unknown. Aim:To evaluate procedural efficacy and short-term safety of a novel DES design. Material and methods:In this all-comers registry, 407 consecutive patients were enrolled upon undergoing percutaneous coronary interventions (PCI) with the thin-strut bioabsorbable abluminal polymer-coated SYNERGY stent. These patients were then compared with the previous 407 patients undergoing PCI performed by the same interventionalists using currently established second-generation DES (Promus Element plus, Xience prime, Resolute Integrity). Several clinical and procedural data were compared, and the coronary artery complexity was assessed by the American College of Cardiology/American Heart Association classification and SYNTAX Score. Results:The study population consisted of 814 patients. A total of 859 Synergy stents were deployed in 480 target vessels in the Synergy group (n = 407), and 904 stents in 469 vessels in the second-generation DES group (n = 407). Coincidentally, target lesions in the Synergy group (A 2.7%, B1 13.8%, B2 38.6%, C 45.0%) were more complex (p < 0.01) than those in the second-generation DES group (A 4.9%, B1 18.7%, B2 42.3%, C 34.2%). In cases with severe lesions (B2/C), the median contrast agent amount and fluoroscopy time were significantly lower in the Synergy group, indicating improved deliverability (110 ml vs. 150 ml; p < 0.01 and 7.2 min vs. 9.1 min; p = 0.01). Rates of in-hospital major adverse cardiovascular events were comparable between the two groups. Conclusions:In an all-comers, real-world PCI population, novel stent design modifications including ultra-thin struts and abluminal bioabsorbable polymer coating are associated with improved procedural performance.

SUBMITTER: Abu Sharar H

PROVIDER: S-EPMC6173097 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Procedural advantages of a novel coronary stent design with ultra-thin struts and bioabsorbable abluminal polymer coating in an all-comers registry.

Abu Sharar Haitham H Gomes Bruna B Chorianopoulos Emmanuel E Kaya Ziya Z Gleissner Christian A CA Katus Hugo A HA Bekeredjian Raffi R

Postepy w kardiologii interwencyjnej = Advances in interventional cardiology 20180921 3

<h4>Introduction</h4>The implications of novel drug-eluting stent (DES) design modifications including ultra-thin struts and new concepts of polymer coating for procedural efficacy are still unknown.<h4>Aim</h4>To evaluate procedural efficacy and short-term safety of a novel DES design.<h4>Material and methods</h4>In this all-comers registry, 407 consecutive patients were enrolled upon undergoing percutaneous coronary interventions (PCI) with the thin-strut bioabsorbable abluminal polymer-coated ...[more]

PMID: 30302099

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Project description:Objectives Using quantitative coronary angiography (QCA), optical coherence tomography (OCT), histomorphometry, and pharmacokinetics, this study tried to evaluate the safety and efficacy of Biomagic rapamycin-eluting bioabsorbable scaffold (BVS) in non-atherosclerotic porcine coronary arteries. Background Biomagic BVS is a new generation of thin-strut bioabsorbable scaffold. We conducted comparative study detailing pathological response, safety and efficacy of Biomagic BVS and the Firebird2 rapamycin-eluting cobalt-based alloy stent (DES) in a porcine coronary artery model. The animals were followed up at 14 days, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after stent implantation. Methods A total of 143 devices (95 Biomagic and 48 Firebird2) were implanted in 2 or 3 main coronary arteries of 76 nonatherosclerotic swine and examined by QCA, OCT, light microscopy, and pharmacokinetics analyses at various time points. Results Vascular responses to Biomagic and Firebird2 were largely comparable at all time points, with struts being sequestered within the neointima. The degree of inflammation of both devices was mild to moderate, although the Biomagic score was higher at 14 days to 24 months. However, there was no statistical difference between the two groups except 14 days. At each follow-up time point, the percentage of area stenosis in the Biomagic group was greater than that in the Firebird 2 group, but there was no statistical difference between the two groups at 3 and 12 months. The extent of fibrin deposition was similar between Biomagic and Firebird2, which peaked at 1 month and decreased rapidly thereafter. Pharmacokinetic study showed that coronary tissue sirolimus concentration remained above 2 ng/mg of tissue at 28 day. Histomorphometry showed expansile remodeling of Biomagic-implanted arteries starting after 12 months, and lumen area was significantly greater in Biomagic than Firebird2 at 36 and 42 months. These changes correlated with dismantling of Biomagic seen after 12 months. OCT images confirmed that degradation of Biomagic was complete by 36 months. Conclusions Biomagic demonstrates comparable long-term safety to Firebird2 in porcine coronary arteries with mild to moderate inflammation. Although Biomagic was associated with greater percent stenosis relative to Firebird2 within 36 months, expansile remodeling was observed after 12 months in Biomagic with significantly greater lumen area at ≥36 months. Scaffold resorption is considered complete at 36 months.

Dataset Information

Procedural advantages of a novel coronary stent design with ultra-thin struts and bioabsorbable abluminal polymer coating in an all-comers registry.

Publications

Procedural advantages of a novel coronary stent design with ultra-thin struts and bioabsorbable abluminal polymer coating in an all-comers registry.

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