Zotarolimus-Eluting Coronary Stent System Research Articles

462 Accidental detection of an anomalous origin of the coronary arteries in a patient with STEMI: a case report

Abstract Coronary artery anomalies and variants are relatively uncommon congenital disorders of the coronary artery anatomy and constitute the second most common cause of sudden cardiac death in young competitive athletes. Normally there are two main coronary arteries, which stem from the sinuses of Valsalva and descend towards the cardiac apex. The most frequent anomalous origin of the coronary arteries associated with sudden cardiac death is the anomalous origin of a coronary artery from the contralateral sinus, particularly if the anomalous coronary artery has a course between the aorta and the pulmonary artery. The diagnosis of a coronary artery anomaly is insidious since patients are usually asymptomatic. Indeed, in most of the cases, coronary anomalies are discovered incidentally during coronary angiography or on autopsy following sudden cardiac death. However, in some cases, symptoms like angina, syncope, heart failure, and myocardial infarction may occur. We want to describe the case of a 54 years old man who went to another hospital of our district with chest pain. The EKG showed an infero-lateral STEMI. The patient underwent systemic thrombolysis complicated by arrhythmic storm, treated with effective DC shock, then he was urgently transferred to our Hospital to perform a PCI rescue. The coronary angiography showed a critical stenosis of the right coronary artery, treated with the implantation of a zotarolimus-eluting coronary stent system. Surprisingly, an abnormal origin of the anterior interventricular artery and circumflex artery from seperated hosts in the right coronary sinus was detected. A computed tomography showed the separated origin of the right coronary artery and the left main from the right coronary sinus; moreover, the left main presented a retroaortic course between the bulb and the left atrium; the left anterior intraventricular artery run anterior to the aortic root. During hospitalization, a diagnosis of diabetes was made with consequent setting of adequate hypoglycemic therapy. Serial echocardiograms showed an improval in the ejection fraction (from 35–40% to 50%). The patient was discharged in well clinical conditions and 1 month later at the follow-up, during an outpatient visit, he was fully asymptomatic. The dynamic EKG according to Holter showed rare isolated ventricular beats; laboratory tests were normal. The anomalous origin of a coronary ostium from the contralateral sinus is the most frequently anomaly which is associated with sudden cardiac death, in particular when the left coronary artery origins from the right sinus. The rapid advancement of the imaging techniques, including CT, CMR, intravascular ultrasound, and optical coherence tomography, have provided us with a wealth of new information on this subject. Coronary artery CT offers the best performance in terms of spatial resolution, acquisition time, and image contrast but the use is limited due the dose of ionizing radiation and the use of contrast agents, in particular taking into account that most patients are young. CMR is capable of visualizing the origin of the coronary arteries non-invasively, without use of ionizing radiation and contrast agents. Currently however, due to spatial resolution, the capability of CMR to visualize smaller coronary branches is still a limiting factor preventing full assessment of coronary arteries using this modality. Developments and more widespread access to advanced cardiac imaging will undoubtedly lead to earlier diagnoses. The taxonomies of the anomalous origin of coronary arteries are inconsistent and complex and so we want to make our contribution to the register of cases of abnormal origin of coronary arteries for the risk of sudden cardiac death and ischaemic events related to.

TCT-410 Assessing Suitability for Short-Term DAPT: Thromboresistance, Albumin Retention, and Endothelial Function in the Resolute Onyx Zotarolimus Versus BioFreedom Biolimus-Eluting Coronary Stent Systems

Thromboresistance and endothelial function have never been compared between current best-in-generation Resolute Onyx Zotarolimus-Eluting Coronary Stent System (RO-DES) and the BioFreedom polymer-free drug-coated stent (BF-DCS). In an ex vivo carotid to pig arteriovenous shunt model,

TCT-460 Multi-Center, Randomized Evaluation of the Elixir DESyne® Novolimus Eluting Coronary Stent System with Biodegradable Polymer Compared to a Zotarolimus-Eluting Coronary Stent System: Final 5-Year Results from the EXCELLA BD Study

A non-inferiority study evaluating the long-term safety and effectiveness of the Elixir DESyne® BD Novolimus Eluting Coronary Stent System (NECSS), a Co-Cr stent with a biodegradable polymer compared to the control Endeavor Zotarolimus Eluting Coronary Stent System (ZECSS) (Medtronic, Santa Rosa,

TCT-586 Multi-Center, Prospective, Randomized, Single-Blind, Consecutive Enrollment Evaluation of the Elixir DESyne® Novolimus Eluting Coronary Stent System with Biodegradable Polymer Compared to a Zotarolimus-Eluting Coronary Stent System: 3-Year Results from the EXCELLA BD Study

Evaluate the long-term safety and effectiveness of the Elixir DESyne® BD Novolimus Eluting Coronary Stent System (NECSS), a Co-Cr stent with a biodegradable polymer compared to the control Endeavor Zotarolimus Eluting Coronary Stent System (ZECSS) (Medtronic, Santa Rosa, CA). 149 patients were

TCT-593 Multi-Center, Prospective, Randomized, Single-Blind, Consecutive Enrollment Evaluation of the Elixir DESyne® Novolimus-Eluting Coronary Stent System with Durable Polymer Compared to the Endeavor Zotarolimus-Eluting Coronary Stent System: Final Results from the EXCELLA II Study

TCT-593 Multi-Center, Prospective, Randomized, Single-Blind, Consecutive Enrollment Evaluation of the Elixir DESyne® Novolimus-Eluting Coronary Stent System with Durable Polymer Compared to the Endeavor Zotarolimus-Eluting Coronary Stent System: Final Results from the EXCELLA II Study

TCT-200 Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation a Novolimus-Eluting Coronary Stent System with Bioabsorbable Polymer Compared to a Zotarolimus-Eluting Coronary Stent System: Long Term (24- Month) Clinical Follow Up from the EXCELLA BD Study

Long term safety and efficacy of the Elixir DESyne(r) BD Novolimus Eluting Coronary Stent System (NECSS), a Co-Cr stent with a bioabsorbable polymer compared to the control Endeavor Zotarolimus Eluting Coronary Stent System is not known 149 patients were randomized 3:1, either to the Elixir DESyne

Multi center, prospective, randomized, single blind, consecutive enrollment evaluation of the elixir desynetm novolimus-eluting coronary stent system with durable polymer compared to the endeavor zota

Aims: To evaluate the long term safety and efficacy of the Elixir DESyneTM Novolimus-Eluting Coronary Stent System (CSS) compared to the Endeavor Zotarolimus-Eluting CSS through assessment of clinical, angiographic, and IVUS endpoints through 3 years. Method and results: 210 patients were randomized 2:1 either to the DESyne CSS loaded with 5mcg per mm of stent length of Novolimus, a sirolimus metabolite, eluted via a durable methacrylate polymer, or to the Endeavor CSS loaded with 10mcg per mm of stent length of Zotarolimus eluted via a durable phosphoryl choline polymer. All patients were analyzed for the primary endpoint of late lumen loss (LLL) assessed by QCA at 9 months. All patients also underwent evaluation for secondary endpoints which included a Device-orientated Composite Endpoint (DoCE) defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR); clinically-indicated Target Vessel Revascularization (TVR); and stent thrombosis all evaluated at 1, 6, 9, and 12 months and annually through 5 years. View this table: Table 1: 9-month Angiographic, IVUS and Conclusion: The study met the non-inferiority endpoint and also demonstrated superiority of the DESyne CSS as compared to control (Endeavor). Long term clinical results through 3 years and a review of angiographic and IVUS results will be presented.

CRT-63 Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation A Novolimus-eluting Coronary Stent System With Bioabsorbable Polymer Compared To a Zotarolimus-eluting Coronary Stent System: 12- Month Clinical And 6-month Angiographic and IVUS Results: The Excella BD Study

To evaluate the safety and effectiveness of the Elixir DESyneTM BD Novolimus Eluting Coronary Stent System (CSS) with a bioabsorbable polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System through the assessment of clinical, angiographic, and IVUS endpoints. 149 patients were

Abstract 18720: Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation a Novolimus-Eluting Coronary Stent System with Bioabsorbable Polymer Compared to a Zotarolimus-Eluting Coronary Stent System: 12- Month Clinical and 6-Month Angiographic and IVUS Results: the EXCELLA BD Study

Aims: To evaluate the safety and effectiveness of the Elixir DESyne TM BD Novolimus Eluting Coronary Stent System (CSS) with a bioabsorbable polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System through the assessment of clinical, angiographic, and IVUS endpoints. Method and Results: 149 patients were randomized 3:1, either to the Elixir DESyne BD Novolimus Eluting CSS loaded with 5mcg per mm of stent length of Novolimus, a sirolimus metabolite, eluted via a bioabsorbable polylactide-based polymer, or to the Endeavor Zotarolimus-eluting CSS loaded with 10mcg per mm of stent length of Zotarolimus eluted via a durable phosphoryl choline polymer. All patients were analyzed for the primary endpoint of in-stent late lumen loss (LLL) assessed by QCA at 6 months. Moreover, all patients underwent evaluation for the secondary endpoints including the Device-orientated Composite Endpoint (DoCE) defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization; clinically-indicated Target Vessel Revascularization (TVR), and stent thrombosis at 1, 6, 9, and 12 months and annually through 5 years. Lesions were also evaluated for angiographic endpoints at 6 months including: in-segment LLL, percent diameter stenosis, minimal lumen diameter post-procedure and at 6 months, and angiographic binary restenosis (ABR) (≥50%). A subset of patients underwent intravascular ultrasound (IVUS) evaluation including percent (%) neointimal obstruction at 6 months. The study met the primary endpoint demonstrating both non-inferiority and superiority of the DESyne BD compared to the control (0.12±0.15 vs 0.67±0.47, p<0.001), additionally, in-stent ABR was significantly lower for DESyne BD (0% vs 7.9%, p=0.003). Excellent clinical results at 6 months were demonstrated for both devices. Clinical results through 12 months and additional angiographic and IVUS results will be presented. Conclusion: Clinical results through 12 months and complete angiographic and IVUS results will be presented.

TCT-583 Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation a Novolimus-Eluting Coronary Stent System with Bioabsorbable Polymer Compared to a Zotarolimus-Eluting Coronary Stent System: 12- Month Clinical and 6-Month Angiographic and IVUS Results: the EXCELLA BD Study

To evaluate the safety and effectiveness of the Elixir DESyneTM BD Novolimus Eluting Coronary Stent System (CSS) with a bioabsorbable polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System through the assessment of clinical, angiographic, and IVUS endpoints. A total of 149

Clinical Evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries: The RESOLUTE US Clinical Trial

The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population. The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety. The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores. Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = -2.8%, upper 1-sided 95% confidence interval: -1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%. The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453).

Rationale and design of the clinical evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the treatment of de novo lesions in native coronary arteries (the RESOLUTE US clinical trial)

Drug-eluting stents (DES) are commonly used to treat obstructive coronary disease and avoid restenosis. Newer DES have been developed to improve effectiveness and safety. We describe a clinical trial to evaluate a DES with a novel polymer that may improve the antirestenosis effectiveness while maintaining the safety standards of currently Food and Drug Administration-approved DES. The RESOLUTE US Trial is a multicenter, nonrandomized trial prospectively designed to compare the Resolute zotarolimus-eluting stent (R-ZES) to the Food and Drug Administration-approved Endeavor ZES using patient-level historical control data, adjusting for baseline covariates through propensity score. The stents differ primarily in the polymer, which, in the R-ZES, is designed to elute zotarolimus over a longer period. The study will enroll up to 1,574 patients with ischemic heart disease due to de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. The primary end point is target lesion failure at 12 months postprocedure, defined as the composite of cardiac death, target-vessel myocardial infarction (MI), and clinically driven target lesion revascularization by percutaneous or surgical methods. Secondary end points include device, lesion and procedural success, death, MI, cardiac death and MI, composites of these clinical events, and stent thrombosis at each follow-up assessment up to 5 years postprocedure. The RESOLUTE US Trial (ClinicalTrials.gov #NCT00726453) is a prospective, multicenter, observational study with a patient-level historical control designed to assess the safety and efficacy of the R-ZES for the treatment of de novo lesions in native coronary arteries.

A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zotarolimus- Versus Paclitaxel-Eluting Stents in De Novo Occlusive Lesions in Coronary Arteries: The ZoMaxx I Trial

A novel zotarolimus-eluting coronary stent system (ZoMaxx, Abbott Laboratories, Abbott Park, Illinois) was compared with a paclitaxel-eluting coronary stent (Taxus Express2) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. The primary end point was defined as noninferiority of in-segment late lumen loss after 9 months. The ZoMaxx stent system elutes 10 microg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum. Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent. After 9 months, late lumen loss was significantly greater in the ZoMaxx group (in-stent 0.67 +/- 0.57 mm vs. 0.45 +/- 0.48 mm; p < 0.001; in-segment 0.43 +/- 0.60 mm vs. 0.25 +/- 0. 45 mm; p = 0.003), resulting in significantly higher rates of >50% angiographic restenosis (in-stent 12.9% vs. 5.7%; p = 0.03; in-segment 16.5% vs. 6.9%; p = 0.007). The upper bound of the 95% confidence interval on the difference in in-segment late lumen loss between the 2 treatment groups (0.27 mm) exceeded the 0.25 mm value pre-specified for noninferiority. There were no significant differences between ZoMaxx and Taxus-treated groups with respect to target lesion revascularization (8.0% vs. 4.1%; p = 0.14), major adverse cardiac events (12.6% vs. 9.6%; p = 0.43), or stent thrombosis (0.5% in both groups). After 9 months, the ZoMaxx stent showed less neointimal inhibition than the Taxus stent, as shown by higher in-stent late loss and restenosis by qualitative coronary angiography.

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …