Browsing by Subject "Stents"
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Item Open Access Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.(PLoS One, 2008-05-07) Weinfurt, Kevin P; Seils, Damon M; Tzeng, Janice P; Lin, Li; Schulman, Kevin A; Califf, Robert MBACKGROUND: Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006. METHODOLOGY/PRINCIPAL FINDINGS: We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote. CONCLUSIONS/SIGNIFICANCE: In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.Item Open Access Contemporary percutaneous treatment of infrapopliteal arterial disease: a practical approach.(Journal of interventional cardiology, 2007-06) Golzar, Jaafer A; Belur, Akhila; Carter, Luther I; Choksi, Nishit; Safian, Robert D; O'Neill, William WItem Open Access Exosome-eluting stents for vascular healing after ischaemic injury.(Nature biomedical engineering, 2021-10) Hu, Shiqi; Li, Zhenhua; Shen, Deliang; Zhu, Dashuai; Huang, Ke; Su, Teng; Dinh, Phuong-Uyen; Cores, Jhon; Cheng, KeDrug-eluting stents implanted after ischaemic injury reduce the proliferation of endothelial cells and vascular smooth muscle cells and thus neointimal hyperplasia. However, the eluted drug also slows down the re-endothelialization process, delays arterial healing and can increase the risk of late restenosis. Here we show that stents releasing exosomes derived from mesenchymal stem cells in the presence of reactive oxygen species enhance vascular healing in rats with renal ischaemia-reperfusion injury, promoting endothelial cell tube formation and proliferation, and impairing the migration of smooth muscle cells. Compared with drug-eluting stents and bare-metal stents, the exosome-coated stents accelerated re-endothelialization and decreased in-stent restenosis 28 days after implantation. We also show that exosome-eluting stents implanted in the abdominal aorta of rats with unilateral hindlimb ischaemia regulated macrophage polarization, reduced local vascular and systemic inflammation, and promoted muscle tissue repair.Item Open Access Geographic variation in carotid revascularization among Medicare beneficiaries, 2003-2006.(Archives of internal medicine, 2010-07) Patel, MR; Greiner, MA; DiMartino, LD; Schulman, KA; Duncan, PW; Matchar, DB; Curtis, LHBackground
Little is known about patterns in the use of carotid revascularization since a 2004 Medicare national coverage decision supporting carotid artery stenting. We examined geographic variation in and predictors of carotid endarterectomy and carotid stenting.Methods
Analysis of claims from the Centers for Medicare & Medicaid Services from January 1, 2003, through December 31, 2006. Patients were 65 years or older and had undergone carotid endarterectomy or carotid stenting. The main outcome measures were annual age-adjusted rates of carotid endarterectomy and carotid stenting, factors associated with the use of carotid revascularization, and mortality rate at 30 days and 1 year.Results
The rate of endarterectomy decreased from 3.2 per 1000 person-years in 2003 to 2.6 per 1000 person-years in 2006. After adjustment for demographic and clinical characteristics, there was significant geographic variation in the odds of carotid revascularization, with the East North Central region having the greatest odds of endarterectomy (odds ratio, 1.60; 95% confidence interval, 1.55-1.65) and stenting (1.61; 1.46-1.78) compared with New England. Prior endarterectomy (odds ratio, 3.06; 95% confidence interval, 2.65-3.53) and coronary artery disease (2.12; 2.03-2.21) were strong predictors of carotid stenting. In 2005, mortality was 1.2% at 30 days and 6.8% at 1 year for endarterectomy and 2.3% at 30 days and 10.3% at 1 year for stenting.Conclusions
Significant geographic variation exists for carotid endarterectomy and carotid stenting. Prior endarterectomy and coronary disease were associated with greater odds of carotid stenting.Item Open Access More Versus Better: Learning From the Medtronic Valiant Navion Recall.(Circulation. Cardiovascular interventions, 2022-07) Weissler, E Hope; Roe, Matthew; Hammill, Bradley G; Hughes, G ChadItem Open Access Outcomes of metallic stents for malignant ureteral obstruction.(J Urol, 2012-09) Goldsmith, Zachariah G; Wang, Agnes J; Bañez, Lionel L; Lipkin, Michael E; Ferrandino, Michael N; Preminger, Glenn M; Inman, Brant APURPOSE: Malignant ureteral obstruction often necessitates chronic urinary diversion and is associated with high rates of failure with traditional ureteral stents. We evaluated the outcomes of a metallic stent placed for malignant ureteral obstruction and determined the impact of risk factors previously associated with increased failure rates of traditional stents. MATERIALS AND METHODS: Patients undergoing placement of the metallic Resonance® stent for malignant ureteral obstruction at an academic referral center were identified retrospectively. Stent failure was defined as unplanned stent exchange or nephrostomy tube placement for signs or symptoms of recurrent ureteral obstruction (recurrent hydroureteronephrosis or increasing creatinine). Predictors of time to stent failure were assessed using Cox regression. RESULTS: A total of 37 stents were placed in 25 patients with malignant ureteral obstruction. Of these stents 12 (35%) were identified to fail. Progressive hydroureteronephrosis and increasing creatinine were the most common signs of stent failure. Three failed stents had migrated distally and no stents required removal for recurrent infection. Patients with evidence of prostate cancer invading the bladder at stent placement were found to have a significantly increased risk of failure (HR 6.50, 95% CI 1.45-29.20, p = 0.015). Notably symptomatic subcapsular hematomas were identified in 3 patients after metallic stent placement. CONCLUSIONS: Failure rates with a metallic stent are similar to those historically observed with traditional polyurethane based stents in malignant ureteral obstruction. The invasion of prostate cancer in the bladder significantly increases the risk of failure. Patients should be counseled and observed for subcapsular hematoma formation with this device.Item Open Access Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy.(Circulation, 2017-01-24) Gibson, C Michael; Pinto, Duane S; Chi, Gerald; Arbetter, Douglas; Yee, Megan; Mehran, Roxana; Bode, Christoph; Halperin, Jonathan; Verheugt, Freek WA; Wildgoose, Peter; Burton, Paul; van Eickels, Martin; Korjian, Serge; Daaboul, Yazan; Jain, Purva; Lip, Gregory YH; Cohen, Marc; Peterson, Eric D; Fox, Keith AABACKGROUND: Patients with atrial fibrillation who undergo intracoronary stenting traditionally are treated with a vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT), yet this treatment leads to high risks of bleeding. We hypothesized that a regimen of rivaroxaban plus a P2Y12 inhibitor monotherapy or rivaroxaban plus DAPT could reduce bleeding and thereby have a favorable impact on all-cause mortality and the need for rehospitalization. METHODS: Stented subjects with nonvalvular atrial fibrillation (n=2124) were randomized 1:1:1 to administration of reduced-dose rivaroxaban 15 mg daily plus a P2Y12 inhibitor for 12 months (group 1); rivaroxaban 2.5 mg twice daily with stratification to a prespecified duration of DAPT of 1, 6, or 12 months (group 2); or the reference arm of dose-adjusted VKA daily with a similar DAPT stratification (group 3). The present post hoc analysis assessed the end point of all-cause mortality or recurrent hospitalization for an adverse event, which was further classified as the result of bleeding, a cardiovascular cause, or another cause blinded to treatment assignment. RESULTS: The risk of all-cause mortality or recurrent hospitalization was 34.9% in group 1 (hazard ratio=0.79; 95% confidence interval, 0.66-0.94; P=0.008 versus group 3; number needed to treat=15), 31.9% in group 2 (hazard ratio=0.75; 95% confidence interval, 0.62-0.90; P=0.002 versus group 3; number needed to treat=10), and 41.9% in group 3 (VKA+DAPT). Both all-cause death plus hospitalization potentially resulting from bleeding (group 1=8.6% [P=0.032 versus group 3], group 2=8.0% [P=0.012 versus group 3], and group 3=12.4%) and all-cause death plus rehospitalization potentially resulting from a cardiovascular cause (group 1=21.4% [P=0.001 versus group 3], group 2=21.7% [P=0.011 versus group 3], and group 3=29.3%) were reduced in the rivaroxaban arms compared with the VKA arm, but other forms of rehospitalization were not. CONCLUSIONS: Among patients with atrial fibrillation undergoing intracoronary stenting, administration of either rivaroxaban 15 mg daily plus P2Y12 inhibitor monotherapy or 2.5 mg rivaroxaban twice daily plus DAPT was associated with a reduced risk of all-cause mortality or recurrent hospitalization for adverse events compared with standard-of-care VKA plus DAPT. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01830543.Item Open Access Relationship Between Cancer and Cardiovascular Outcomes Following Percutaneous Coronary Intervention.(J Am Heart Assoc, 2015-07-06) Hess, Connie N; Roe, Matthew T; Clare, Robert M; Chiswell, Karen; Kelly, Joseph; Tcheng, James E; Hagstrom, Emil; James, Stefan K; Khouri, Michel G; Hirsch, Bradford R; Kong, David F; Abernethy, Amy P; Krucoff, Mitchell WBACKGROUND: Cardiovascular disease and cancer increasingly coexist, yet relationships between cancer and long-term cardiovascular outcomes post-percutaneous coronary intervention (PCI) are not well studied. METHODS AND RESULTS: We examined stented PCI patients at Duke (1996-2010) using linked data from the Duke Information Systems for Cardiovascular Care and the Duke Tumor Registry (a cancer treatment registry). Our primary outcome was cardiovascular mortality. Secondary outcomes included composite cardiovascular mortality, myocardial infarction, or repeat revascularization and all-cause mortality. We used adjusted cause-specific hazard models to examine outcomes among cancer patients (cancer treatment pre-PCI) versus controls (no cancer treatment pre-PCI). Cardiovascular mortality was explored in a cancer subgroup with recent (within 1 year pre-PCI) cancer and in post-PCI cancer patients using post-PCI cancer as a time-dependent variable. Among 15 008 patients, 3.3% (n=496) were cancer patients. Observed rates of 14-year cardiovascular mortality (31.4% versus 27.7%, P=0.31) and composite cardiovascular death, myocardial infarction, or revascularization (51.1% versus 55.8%, P=0.37) were similar for cancer versus control groups; all-cause mortality rates were higher (79.7% versus 49.3%, P<0.01). Adjusted risk of cardiovascular mortality was similar for cancer patients versus controls (hazard ratio 0.95; 95% CI 0.76 to 1.20) and for patients with versus without recent cancer (hazard ratio 1.46; 95% CI 0.92 to 2.33). Post-PCI cancer, present in 4.3% (n=647) of patients, was associated with cardiovascular mortality (adjusted hazard ratio 1.51; 95% CI 1.11 to 2.03). CONCLUSIONS: Cancer history was present in a minority of PCI patients but was not associated with worse long-term cardiovascular outcomes. Further investigation into PCI outcomes in this population is warranted.Item Open Access Ticagrelor versus clopidogrel in patients with symptomatic peripheral artery disease and prior coronary artery disease: Insights from the EUCLID trial.(Vascular medicine (London, England), 2018-12) Berger, Jeffrey S; Abramson, Beth L; Lopes, Renato D; Heizer, Gretchen; Rockhold, Frank W; Baumgartner, Iris; Fowkes, F Gerry R; Held, Peter; Katona, Brian G; Norgren, Lars; Jones, W Schuyler; Millegård, Marcus; Blomster, Juuso; Reist, Craig; Hiatt, William R; Patel, Manesh R; Mahaffey, Kenneth WPatients with peripheral artery disease (PAD) are at heightened risk of cardiovascular morbidity and mortality. We sought to evaluate the risk of concomitant coronary artery disease (CAD) in patients with symptomatic PAD versus PAD without diagnosed CAD, and whether ticagrelor was superior to clopidogrel in reducing that risk. The EUCLID trial randomized 13,885 patients with PAD to antithrombotic monotherapy with ticagrelor or clopidogrel. CAD was defined as prior myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) surgery. Median follow-up was 30 months. Among 4032 (29%) patients with PAD and CAD, 63% had prior MI, 54% prior PCI, and 38% prior CABG. After adjustment for baseline characteristics, patients with PAD and CAD had significantly higher rates of the primary endpoint (cardiovascular death/MI/stroke, 15.3% vs 8.9%, hazard ratio (HR) 1.50, 95% CI: 1.13-1.99; p=0.005), but no statistically significant increase in acute limb ischemia (HR 1.28, 95% CI: 0.57-2.85; p=0.55) or major bleeding (HR 1.10, 95% CI: 0.49-2.48; p=0.81) versus PAD without CAD. Among patients with PAD and CAD, there was no differential treatment effect between ticagrelor versus clopidogrel for the primary efficacy endpoint (HR 1.02, 95% CI: 0.87-1.19; p=0.84), acute limb ischemia (HR 1.03, 95% CI: 0.63-1.69; p=0.89), or major bleeding (HR 1.06, 95% CI: 0.66-1.69; p=0.81). There was a statistically significant interaction between prior coronary stent placement and study treatment ( p=0.03) with a numerical reduction in the primary efficacy endpoint with ticagrelor versus clopidogrel (13.8% vs 16.8%, HR 0.82, 95% CI: 0.65-1.03; p=0.09). Patients with PAD and prior CAD had higher composite rates of cardiovascular death, MI, and ischemic stroke versus PAD without diagnosed CAD. There were no significant differences between ticagrelor and clopidogrel in cardiovascular events or major bleeding. ClinicalTrials.gov Identifier: NCT01732822.