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Coronary Artery Disease: HELP
Articles by Robert C. Stoler
Based on 3 articles published since 2010
(Why 3 articles?)
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Between 2010 and 2020, Robert Stoler wrote the following 3 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
1 Clinical Trial 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. 2017

Cutlip, Donald E / Garratt, Kirk N / Novack, Victor / Barakat, Mark / Meraj, Perwaiz / Maillard, Luc / Erglis, Andrejs / Jauhar, Rajiv / Popma, Jeffrey J / Stoler, Robert / Silber, Sigmund / Anonymous16860893. ·Cardiology Division, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts. Electronic address: dcutlip@bidmc.harvard.edu. · Christiana Health Care System, Newark, Delaware. · Clinical Research Center, Soroka University Medical Center, Beersheba, Israel. · North Shore University Hospital, Manhasset, New York. · GCS ES Axium Rambot, Aix-en-Provence, France. · University of Latvia, Riga, Latvia. · Baylor Heart and Vascular Hospital at Baylor University Medical Center, Dallas, Texas. · Cardiology Division, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts. · Department of Cardiology, Heart Center at the Isar, Munich, Germany. · CeloNova BioSciences, San Antonio, Texas. ·JACC Cardiovasc Interv · Pubmed #28104210.

ABSTRACT: OBJECTIVES: The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. BACKGROUND: Polyzene-F-coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. METHODS: Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. RESULTS: Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. CONCLUSIONS: 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.

2 Article Analysis of stroke occurring in the SYNTAX trial comparing coronary artery bypass surgery and percutaneous coronary intervention in the treatment of complex coronary artery disease. 2013

Mack, Michael J / Head, Stuart J / Holmes, David R / Ståhle, Elisabeth / Feldman, Ted E / Colombo, Antonio / Morice, Marie-Claude / Unger, Felix / Erglis, Andrejs / Stoler, Robert / Dawkins, Keith D / Serruys, Patrick W / Mohr, Friedrich W / Kappetein, A Pieter. ·Division of Cardiothoracic Surgery, Baylor Healthcare System, The Heart Hospital, Plano, Texas 75075, USA. michaema@baylorhealth.edu ·JACC Cardiovasc Interv · Pubmed #23523456.

ABSTRACT: OBJECTIVES: This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial's randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease. BACKGROUND: The SYNTAX trial compared PCI to CABG in patients with de novo 3-vessel and/or left main coronary disease. METHODS: The SYNTAX randomized trial was conducted at 85 U.S. and European sites (n = 1,800). All strokes (up to 4 years) were independently adjudicated by a clinical events committee that included a neurologist. An additional 1,077 (of which 644 were followed for 5 years) and 198 patients were included in the CABG and PCI registries, respectively. RESULTS: In the randomized cohort, 31 CABG and 19 PCI patients experienced 33 and 20 strokes post-randomization at 4-year follow-up, respectively (p = 0.062). Three strokes occurred pre-procedurally but following randomization in CABG-treated patients. After CABG, a large proportion of strokes occurred acutely (0 to 30 days: 9 of 33), whereas in the PCI arm, most strokes occurred >30 days after the procedure (18 of 20). Stroke resulted in death in 3 patients in both the PCI and CABG groups. Of the patients who developed stroke, 68% (21 of 31) in the CABG group had residual deficits at discharge; in the PCI group, 47% (9 of 19) had residual deficits. In a multivariate analysis, treatment with CABG was not significantly associated with increased stroke rates (odds ratio: 1.67, 95% confidence interval: 0.93 to 3.01, p = 0.089). The incidence and outcomes of stroke were similar in the randomized trial and registries. CONCLUSIONS: There is a higher risk of periprocedural stroke in patients undergoing CABG versus PCI; however, the risk converges over the first 4 years of follow-up. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972).

3 Article The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. 2013

Kirtane, Ajay J / Leon, Martin B / Ball, Michael W / Bajwa, Harpaul S / Sketch, Michael H / Coleman, Patrick S / Stoler, Robert C / Papadakos, Stylianos / Cutlip, Donald E / Mauri, Laura / Kandzari, David E / Anonymous5500753. ·Columbia University Medical Center/New York Presbyterian Hospital, New York, New York 10032, USA. akirtane@columbia.edu ·JACC Cardiovasc Interv · Pubmed #23523453.

ABSTRACT: OBJECTIVES: This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions. BACKGROUND: Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices. METHODS: Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety. RESULTS: At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES. CONCLUSIONS: These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).