9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

Novack, Victor; Barakat, Mark; Meraj, Perwaiz; Maillard, Luc; Ērglis, Andrejs; Jauhar, Rajiv; Popma, Jeffrey J.; Stoler, Robert C.; Silber, Sigmund; Cutlip, Donald E.; Allaqaband, Suhail; Caputo, Ronald P.; Beohar, Nirat; Brown, David F.M.; Garratt, Kirk N.; George, Jon C.; Varghese, Vincent; Huth, Mark; Larrain, Germán; Lee, Tommy; Malik, Amir; Martin, Scott; McGarry, Thomas; Phillips, Charles M.; Shah, Alpesh; Ball, Michael; Price, Rosemary J. G.; Rossi, Joseph S.; Taylor, Charles A.; Tolleson, Thaddeus R.; Nicholson, William J.; Srinivas, K.; Shoukfeh, Mohammad; Finn, Aloke V.; Devireddy, C.; Shoultz, Charles A.; Robbins, Mark; Kiesz, R. Stefan; Menon, Pramod; Weilenmann, Daniel; Sievert, Horst; Stanković, Goran; Berland, Jacques; Delarche, Nicolas; Hirsch, Jean Lou; Shayne, J.; Serra, Antonio; Fernández‐Ortíz, Antonio; Monassier, J. P.

doi:10.1016/j.jcin.2016.10.037

Cited by 39 publications

(31 citation statements)

References 22 publications

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“…Other anti-thrombogenic stent coatings (e.g. of the COBRA coronary stent, coated with polyzene-F) have anti-thrombogenic properties, but only shorten the period during which DAPT is required [ 35 ]. This may reduce the haemorrhagic risk of “responders”, but the management of “non-responders” and patients with acute haemorrhagic stroke is not facilitated by these coating concepts.…”

Section: Discussionmentioning

confidence: 99%

Hydrophilic Stent Coating Inhibits Platelet Adhesion on Stent Surfaces: Initial Results In Vitro

Lenz-Habijan

Bhogal

Peters

et al. 2018

Cardiovasc Intervent Radiol

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BackgroundEndovascular stents and flow diverter stents (FDS) have revolutionized the treatment of intradural aneurysms; however, the need for dual anti-platelet treatment (DAPT) limits their use and can cause additional issues. Therefore, there is a need to develop stent coatings that negate the need for DAPT.MethodsTwo different hydrophilic polymer coatings (HPC-I and HPC-II) were used to coat small nickel titanium plates to initially test the hydrophilic properties of these coatings when applied to nickel titanium. The plates were subsequently incubated with non-medicated whole blood from healthy volunteers for 10 min and stained with a CD61 immunofluorescent antibody that allows detection of adherent platelets. The coatings were applied to FDS wires and were again incubated with non-medicated whole blood from the same volunteers. Scanning electron microscopy was used to detect adherent platelets on the wire surface.ResultsThe HPC-II coating (1.12 ± 0.4%) showed a significantly lower CD61 +ve cell count (p ≤ 0.001) compared to both uncoated NiTi plates (48.61 ± 7.3%) and those with the HPC-I coating (mean 40.19 ± 8.9%). Minimal adherent platelets were seen on the FDS nickel titanium wires coated with the HPC-II compared to uncoated FDS under electron microscopy.ConclusionThere is a significant decrease in the number of adherent CD61 +ve platelets on nickel titanium surfaces coated with the HPC-II coating compared to uncoated surfaces. The coating can be successfully applied to the wires of flow diverters. The results of this study are promising with regard to the development of new anti-thrombogenic endovascular devices.

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Section: Discussionmentioning

confidence: 99%

Hydrophilic Stent Coating Inhibits Platelet Adhesion on Stent Surfaces: Initial Results In Vitro

Lenz-Habijan

Bhogal

Peters

et al. 2018

Cardiovasc Intervent Radiol

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“…Third generation DESs seem to have abrupt closure risks below 1% but often with the tradeoff of higher need for TLR, 3.5% in the polymer free DES study, or 5-6% in high-risk bleeding populations [48]. The Cobra PzF seems to have significantly narrowed the gap between DES and BMS with an intermediate solution that has an Ball comers^TLR of 4.3% in a 940 patient registry and a TLR of 4.6% in the well-controlled US/OUS trial leading to FDA approval [44,49].…”

Section: Discussionmentioning

confidence: 99%

“…The COBRA PzF Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization, and Avoiding Long-Term Dual Anti-Platelet Therapy (PzF SHIELD) (ClinicalTrials.gov Identifier: NCT01925794) study led to the approval of COBRA PzF in the USA. The PzF SHIELD Study was a non-randomized, multi-center, prospective, single arm, controlled clinical study conducted at 35 sites in the US and Europe [44]. Between August 2013 and February 2015, 296 patients were enrolled and treated with COBRA PzF stent.…”

Section: Clinical Findingsmentioning

confidence: 99%

Translational Research and Early Favorable Clinical Results of a Novel Polyphosphazene (Polyzene-F) Nanocoating

Bates

Yousaf

Lee³

et al. 2019

Regen. Eng. Transl. Med.

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This manuscript is a review of the preclinical and early clinical findings related to a unique fluorinated polyphosphazene nanolayer device surface modification. Polyzene-F (PzF) is a novel, high-molecular weight, highly pure polyphosphazene that was designed to enhance the biologic interface between a medical device surface and human tissue or blood. The polymer also has unique mechanical properties that for the first time allow implants to be paved with a coating that has a nanoscale thickness of < 50 nm. The coating has inherent thrombus resistant properties and takes on biomimetic properties soon after implant due to favorable protein adhesion. Over the last 1.5 decades, PzF has undergone extensive preclinical testing including benchtop endothelial cell migration and platelet adhesion studies followed by increasingly sophisticated evaluation in 16 different animal models. The coating consistently has shown reduced platelet adhesion, decreased clotting, reduced inflammation, and accelerated healing compared with different surfaces as well as uncoated controls. These preclinical findings have translated into early compelling clinical evidence that suggest enhanced healing and reduced thrombosis can be achieved with a PzF-coated implant. There are now two PzF nanocoated products approved by the US Food and Drug Association (FDA), embolic spheres, and a coronary stent. This is the first detailed overview of the history, preclinical findings, and current clinical results attributed to the PzF coating with emphasis on the coronary stent Cobra-PzF. Lay Summary Over the last few decades, we have seen remarkable advances in medical technology including the development of less invasive surgical alternatives for the treatment of heart and vascular disease. One of the key advances in treating or preventing heart attack, stroke, and limb loss has been the development of stents. Stents are small, metallic, mesh-like devices that can be expanded within blocked vessels via small catheters placed through the groin or wrist. These stents provide structural support while the vessel heals. One of the challenges with stents and other permanent device implants is related to how our bodies react to foreign

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“…As in the original trial, the polymer free biolimus stent was superior to BMS with reduced risk of TVR (3.9 vs 9.0%, P = 0.009), less definite or probable ST (9.3 vs 18.5%, P = 0.001), MI (6.9 vs 13.8%, P = 0.005), and cardiac mortality (3.4 vs 6.9%, P = 0.049). Similarly, the 296 patient SHIELD Trial prospectively analyzed the COBRA Polyzene‐F NanoCoated Coronary Stent System for the treatment of de novo coronary artery lesions . All patients were required to continue dual anti‐platelet agents for 30 days after stent placement; 52% continued DAPT for 9 months.…”

Section: Ultrashort Dapt With Newer Stentsmentioning

confidence: 99%

“…Similarly, the 296 patient SHIELD Trial prospectively analyzed the COBRA Polyzene-F NanoCoated Coronary Stent System for the treatment of de novo coronary artery lesions. 19 in the setting of similar DAPT use between groups. 23 Additionally, although adverse outcomes were associated with reference vessel diameter (RVD) <2.25 mm before 1 year, 90% of scaffold thrombosis occurred in appropriately sized vessels between 1 and 3 years.…”

Section: Ultrashort Dapt With Newer Stentsmentioning

confidence: 99%

Percutaneous coronary intervention: 2017 in review

Rao

Sheth

Grines

2018

J Interven Cardiology

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In an effort to keep the interventional community up-to-date with the abundant amount of new data, we have selected what we believe to be the most important publications in percutaneous coronary intervention from January 1, 2017 to 2 The overall rate of complete revascularization (CR) was 61.7%.In those patients with CR, there was no difference between CABG or PCI regarding death from any cause as well as composite of death, MI, and stroke at 5 year follow up, even at higher SYNTAX scores.However, compared to CABG with CR, PCI with incomplete revascularization put patients at a significant higher risk for similar endpoints. These studies suggest that the ability to achieve CR should be strongly considered when deciding between CABG and PCI in MVD.As we have learned from contemporary data on revascularization, certain subsets of patients have fared better with one revascularization strategy over another. An observational cohort study of multiple Swedish registries found that in patients with Type 1 diabetes and MVD, first multi-vessel revascularization with PCI was associated with higher risk of cardiac death, MI, and repeat revascularization although with similar all-cause mortality when compared to CABG. 3 This study indicates that CABG may be the preferred strategy in patients with Type 1 diabetes in need of multi-vessel revascularization, and is in agreement with earlier trials showing most of the benefit in patients treated with insulin, but not oral agents.In patients with low or intermediate SYNTAX score, PCI of unprotected left main with everolimus-eluting stents (EES) was shown to be noninferior to CABG with respect to a composite endpoint of death, stroke, and MI at 3 years in the EXCEL trial. 4 Of the 1905 patients randomized during the trial, 1788 patients were also followed for quality of life assessment to fully understand patient's perspective.

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9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

Abstract: The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.

Cited by 39 publications

References 22 publications

Hydrophilic Stent Coating Inhibits Platelet Adhesion on Stent Surfaces: Initial Results In Vitro

Hydrophilic Stent Coating Inhibits Platelet Adhesion on Stent Surfaces: Initial Results In Vitro

Translational Research and Early Favorable Clinical Results of a Novel Polyphosphazene (Polyzene-F) Nanocoating

Percutaneous coronary intervention: 2017 in review

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