CLINICAL

Rethink DAPT

A single stent procedure shouldn’t take a year.

Current treatment options offer a stenting procedure that force many patients and their families to become responsible for a long-term dual antiplatelet therapy (DAPT) regimen.

While DAPT is known to prevent heart attacks and stent thrombosis, prolonged DAPT substantially increases the risk of bleeding and mortality.

Now European physicians are studying a new option to treat high bleed risk patients without having to compromise between possible bleeding or stent thrombosis.

Click here to predict stent thrombosis vs. bleeding risk using the DAPT Score calculator.

* Patients who are unable or unwilling to take blood thinning medications.

DAPT Duration and Bleeding Events

THE DAPT study demonstrated in patients receiving DES:

  • 30 month vs. 12 month DAPT showed 71% reduction in risk of stent thrombosis
  • 29% reduction in risk of MACCE
  • Increased bleeding by 61%
  • Due to increased bleeding, increased mortality by 36%1

The High Bleed Trade-off of 1 Less Stent Thrombosis

In another meta-analysis of 32,000 patients, for every one less stent thrombosis, there were two more bleeding events.2

Bleeding Impact on Mortality

Complications from bleeding after PCI occur more frequently than myocardial infarctions and have a greater impact on mortality.

The ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) Study demonstrated that post discharge bleeding was strongly associated with 5 times higher crude rate mortality at 2 years.3

Given the increased risk of mortality, physicians are now changing the way they think about DAPT, especially for patients at higher risk of bleeding.

Be COBRA Confident

CeloNova BioSciences is investing in cutting-edge clinical trials in Europe to provide physicians with new treatment options for their patients without having to choose between stent thrombosis and bleeding. Learn more about the next-generation stenting solution with an excellent safety profile.

About Cobra PzF Stent

1. Mauri et al. NEJM 2014; 371:2155-2166.

2. Giustino et al. JACC 2015; 65:1298-310.

3. Genereux, et al. Incidence, Predictors and Impact of Post-Discharge Bleeding after PCI. JACC 2015;66:1036-45.

CeloNova Clinical Trials

Our Safety & Quality Commitment

CeloNova BioSciences is dedicated to developing ongoing clinical trials that evaluate and support patient safety and product performance levels.

Our clinical trial results are publicly available through peer-reviewed publications and located at ClinicalTrials.gov.

Clinical Program Overview

889 patients from the 1st generation PzF coated stent and 3,043 patients from the 2nd generation are being studied.

Clinical Outcomes

CeloNova clinical program highlights include:

  • Target lesion revascularization range of 3.6%-6.5%
  • Stent thrombosis rate of 0%

The COBRA PzF stent is currently being studied in three important clinical trials:

The PzF SHIELD Trial

This is a prospective, multi-center, non-randomized, single arm clinical trial that was conducted 35 sites in the United States and Outside United States (OUS). This study is an FDA regulated IDE trial for the COBRA PzF nanocoated stent. CeloNova plans on announcing the primary endpoint results at TCT 2016.

TCT 2016 Symposium

COBRA REDUCE Trial

About one in five patients are at high risk of bleeding after stenting. Complications from bleeding after PCI occur more frequently than myocardial infarctions and have a greater impact on mortality.4 This randomized controlled trial will evaluate if the COBRA PzF stent, with its novel Polyzene-F nanocoating and advanced thin-strut design, can help reduce bleeding as compared to drug eluting stents (DES), by shortening the duration of dual antiplatelet therapy (DAPT) to 14 days in patients treated with oral anticoagulation and undergoing PCI.

For additional trial information, please visit clinicaltrials.gov.

e-COBRA Registry

A prospective, consecutively enrolled, observational, multi-center study in France to evaluate the safety and effectiveness of COBRA PzF Coronary Stent System in patients undergoing PCI in a real world setting.  The study will include all comers patients including ACS and high risk of bleeding, and will assess MACE, stent thrombosis (ARC definition), TLR and DAPT duration.

4. Genereux, et al. JACC 2015;66:1036-45.

Case Studies

We are proud of our results. Learn more about the clinical impact of CeloNova BioScience’s first and second generation coronary stents in our case studies below.

COBRA PzF NanoCoated Stent System
A 72-year-old male underwent bypass surgery in 1995 with LIMA and vein grafts to LAD and PDA. Tortuous anatomy provided an extremely challenging setting for the stenting procedure. The following case study reviews the successful crossing of the acute proximal angle of the vein graft, attributed to the novel COBRA PzF stent design.

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Polyzene-F COBRA PzF Coronary Stent System: Addressing an unmet clinical need 
A 72-year-old female with a history of significant comorbidities was diagnosed with a 75% stenotic mid-LAD lesion, placing her at high risk of bleeding. The following case study reviews a successful experience with the new, Polyzene-F COBRA PzF Coronary Stent System, designed to achieve shorter dual antiplatelet therapy duration while reducing restenosis.

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Publications

CeloNova BioScience’s first and second generation coronary stents with novel Polyzene-F nanocoating have been studied in numerous peer reviewed journals. Learn more in the publications below:

Tamburino C, La Manna A, Di Salvo ME, et al.  First-in-man 1-year clinical outcomes of the CATANIA Coronary Stent System with Nanothin Polyzene-F in De Novo Native Coronary Artery Lesions: The ATLANTA (Assessment of The Latest Non-Thrombogenic Angioplasty stent) Trial. JACC Cardiovascular Interventions. 2009; 2:197-204.
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Tamburino C, Capodanno D, Di Salvo ME, et al.  Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry. EuroIntervention. 2012; 7:1062-1068.
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La Manna A, Capodanno D, Cera M, Di Salvo ME, et al. Optical Coherence Tomographic Results at Six-Month Follow-Up Evaluation of the CATANIA Coronary Stent System with NanoThin Polyzene-F Surface Modification (from the Assessment of the Latest Non-Thrombogenic Angioplasty Stent [ATLANTA] Trial). American Journal of Cardiology. 2009; 103:1551-1555.
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Tamburino C, Giacoppo D, Capodanno D. The Rapid Evaluation of Vessel Healing after Angioplasty (REVEAL) trial. Interventional Cardiology. 2011; 3:451-460.
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Sakakura K, Pacheco E, Nakano M, et al. Improved arterial healing in response to a novel polyphosphazene surface-modified stent in swine. EuroIntervention. May 22, 2013.
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Wade CWR, Gourlay S, Rice R, Hegyeli A, et al. Biocompatibility of Eight Poly(Organophosphazenes). US Army Medical Bioengineering Research & Development Laboratory and Army Material and Mechanics Research Center.

Richter GM, Stampfl U, Stampfl S, Rehnitz C, et al.  A New Polymer Concept for Coating of Vascular Stents Using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to Reduce Thrombogenicity and Late In-Stent Stenosis. Investigative Radiology. 2005; 40:210-8.
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Satzl S, Henn C, Christoph P, et al.  The Efficacy of Nanoscale Poly[bis(triflouroethoxy)phosphazene] (PTFEP) Coatings in Reducing Thrombogenicity and Late In-Stent Stenosis in a Porcine Coronary Artery Model. Investigative Radiology. 2007; 42:303-11.
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Radeleff B, Thierjung H, Stampfl U, et al. Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model. CardioVascular and Interventional Radiology. 2008; 31:971-80.
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Stampfl U, Sommer C, Thierjung H, et al. Reduction of Late In-Stent Stenosis in a Porcine Coronary Artery Model by Cobalt Chromium Stents with a Nanocoat of Polyphosphazene (Polyzene-F ). CardioVascular and Interventional Radiology. 2008; August 15.
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Henn C, Satzl S, Christoph P, et al. Efficacy of a Plyphosphazene Nanocoat in reducing Thrombogenicity, In-Stent Stenosis, and Inflammatory Response in Porcine Renal and Iliac Artery Stents. Journal of Vascular and Interventional Radiology. 2008;19:427-37.
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Welle A, Grunze M, Tur D. Plasma Protein Adsorption and Platelet Adhesion on Poly[bis(trifluoroethoxy)phosphazene] and reference material surfaces. Journal of Colloid and Interface Science. 1998; 197:263-274.
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Reichert WM, Filisko FE, Barenberg SA. Polyphosphazenes: Effect of molecular motions on thrombogenesis. Journal of Biomedical Materials Research. 1982; 16:301-312.
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Huang Y, Liu X, Wang L, et al. Long-term biocompatibility evaluation of a novel polymer-coated stent in a porcine coronary stent model. Coronary Artery Disease. 2003; 14:401-408.
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Welle A, Grunze M, Tur D. Blood Compatibility of Poly[bis(trifluoroethoxy)phosphazene]. Journal of Applied Medical Polymers. 2000; 4:6-10.
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Mrowietz C, Franke RP, Seyfert UT, et al. Haemocompatibility of polymer-coated stainless steel stents as compared to uncoated stents. Clinical Hemorheology and Microcirculation. 2005; 32(2):89-103.
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