The SPIRIT V Study

Grube, Eberhard; Chevalier, Bernard; Smits, Peter; Džavík, Vladimir; Patel, Tejas; Mullasari, Ajit; Wöhrle, Jochen; Stuteville, Marrianne; Dorange, Cécile; Kaul, Upendra; Investigators, Spirit V

doi:10.1016/j.jcin.2010.11.006

Cited by 55 publications

(11 citation statements)

References 13 publications

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“…Additional studies will be required to address the unique protein adsorption behavior of PVDF-HFP and how that relates to the clinical observation of satisfactory fluoropolymer performance. 30,[50][51][52] In fact, fluoropolymers have long been a preferred group of materials for blood contact applications. [53][54][55] Furthermore, PVDF-HFP has favorable mechanical properties to perform as a durable coating for substrates that are subject to deformation (as are stents).…”

Section: Discussionmentioning

confidence: 99%

“…[53][54][55] Furthermore, PVDF-HFP has favorable mechanical properties to perform as a durable coating for substrates that are subject to deformation (as are stents). 56 In large clinical studies, PVDF-HFP coated stents have demonstrated lower levels of acute and late state thrombosis 30 compared to other stents, although release of antiproliferative agents, variability in stent design, and coating processing technologies used complicate simple conclusions about the contribution of the biomaterials themselves.…”

Section: Discussionmentioning

confidence: 99%

“…27,28 However, it is clear that measurement of many relevant parameters will more meaningfully profile the blood interactions of a particular bloodcontacting material. 29 Since poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP) polymer-coated XIENCE V V R DES (Abbott Vascular) have demonstrated low thrombogenicity in large scale clinical studies, 30 assessment parameters can be compared to clinical stent performance to develop hypotheses to advance our understanding of blood compatibility.…”

Section: Introductionmentioning

confidence: 99%

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Blood compatibility assessment of polymers used in drug eluting stent coatings

et al. 2016

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Differences in thrombosis rates have been observed clinically between different drug eluting stents. Such differences have been attributed to numerous factors, including stent design, injury created by the catheter delivery system, coating application technologies, and the degree of thrombogenicity of the polymer. The relative contributions of these factors are generally unknown. This work focuses on understanding the thrombogenicity of the polymer by examining mechanistic interactions with proteins, human platelets, and human monocytes of a number of polymers used in drug eluting stent coatings, in vitro. The importance for blood interactions of adsorbed albumin and the retention of albumin was suggested by the data. Microscopic imaging and immunostaining enhanced the interpretation of results from the lactate dehydrogenase cell counting assay and provided insight into platelet interactions, total quantification, and morphometry. In particular, highly spread platelets may be surface-passivating, possibly inhibiting ongoing thrombotic events. In many of the assays used here, poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP) showed a differentiated protein deposition pattern that may contribute to the explanation of the consistently thromboresistant blood-materials interaction for fluororpolymers cited in literature. These results are supportive of one of several possible factors contributing to the good thromboresistant clinical safety performance of PVDF-HFP coated drug eluting stents.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Blood compatibility assessment of polymers used in drug eluting stent coatings

et al. 2016

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“…These studies include the SPIRIT V study, XIENCE V USA, and XIENCE V India. In the SPIRIT V study, the 1-year rates of MACE, stent thrombosis, and target lesion revascularization in complex patients were similar to those observed in the simple patient populations included in the SPIRIT II and III trials 31. Through 2 years, the rate of definite or probable stent thrombosis was low (0.79%) 32.…”

Section: Clinical Studiesmentioning

confidence: 53%

Everolimus-eluting stents: update on current clinical studies

Allocco

Joshi²,

Dawkins³

2011

MDER

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“…There are an ample number of studies available for the DP-coated EES. 14 , 17 , 18 , 19 The MACE rates at 12 months were 5.1% according to the SPIRIT V study, 17 one of the benchmark studies for the Xience V EES. The results are comparable with those of the present study, where 12-month MACE rates were 4.9% in the DP-EES group and 4.2% in the BDP-EES group.…”

Section: Discussionmentioning

confidence: 99%

Twelve-month comparative analysis of clinical outcomes using biodegradable polymer–coated everolimus-eluting stents versus durable polymer–coated everolimus-eluting stents in all-comer patients

Abhyankar¹,

Sandhu

Polavarapu³

2019

Indian Heart Journal

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Aim The purpose of the present study was to examine whether clinical differences exist between the biodegradable polymer (BDP)–coated Tetrilimus everolimus-eluting stent (EES) and the durable polymer (DP)–coated Xience EES by comparing the major adverse cardiac event (MACE) rate at 12 months in all-comer patients. Methods This study was designed as a multicentre, observational, retrospective, investigator-initiated study between January 2016 and October 2016. Two hundred thirteen patients who underwent percutaneous coronary intervention (PCI) with the BDP-EES were compared with 204 patients who underwent PCI with the DP-EES, irrespective of lesion complexity, comorbidities and acute presentation. The primary end point was MACE defined as a composite of cardiac death, myocardial infarction and target lesion revascularization. Results Baseline clinical and lesion characteristics of both the groups were similar, although the BDP-EES group had a significantly higher number of patients with diabetes mellitus (39.9% vs. 30.4%; p = 0.042) and type C lesion (67.4% vs. 48.1%; p < 0.001) than the DP-EES group. The 12-month MACE rate was 4.2% for the BDP-EES group versus 4.9% for the DP-EES group ( p = 0.740). Mortality was lower in the BDP-EES group than in the DP-EES group (0.9% vs. 2.0%; p = 0.441). Conclusion The present comparative analysis shows that the BDP-coated Tetrilimus EES was as safe and effective as the DP-coated Xience EES during the 12-month follow-up period despite complex lesion characteristics.

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The SPIRIT V Study

Cited by 55 publications

References 13 publications

Blood compatibility assessment of polymers used in drug eluting stent coatings

Blood compatibility assessment of polymers used in drug eluting stent coatings

Everolimus-eluting stents: update on current clinical studies

Twelve-month comparative analysis of clinical outcomes using biodegradable polymer–coated everolimus-eluting stents versus durable polymer–coated everolimus-eluting stents in all-comer patients

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