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  • 1
    Online Resource
    Online Resource
    Impact of Symptomatic Peripheral Arterial Disease on 1-Year Mortality in Patients Undergoing Percutaneous Coronary Interventions
    SAGE Publications ; 2004
    In:  Journal of Endovascular Therapy Vol. 11, No. 1 ( 2004-02), p. 60-70
    Details
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 11, No. 1 ( 2004-02), p. 60-70
    Abstract: To determine the impact of symptomatic peripheral arterial disease (PAD) on clinical outcomes in patients treated with percutaneous coronary interventions (PCI). Methods and Results: Symptomatic PAD was identified in 1969 (18.9%) of 10440 consecutive patients undergoing PCI. Patients with PAD were older, more frequently female, and had smaller body surface area and more atherosclerotic risk factors, chronic renal insufficiency, and heart failure. Patients with PAD had lower rates of procedural success (94.2% versus 96.2%, p 〈 0.0001) and higher rates of in-hospital complications, including all-cause mortality (2.1% versus 1.1%, p=0.0002), cardiac death (1.5% versus 0.7%, p=0.0009), urgent coronary artery bypass grafting (1.9% versus 1.2%, p=0.01), recurrent ischemia (5.6% versus 2.8%, p 〈 0.0001), re-PCI to the target lesion (2.4% versus 1.1%, p 〈 0.0001), stroke (0.6% versus 0.3%, p=0.0344), transient ischemic attack (0.4% versus 0.1%, p=0.01), femoral hematoma (10.3% versus 8.5%, p=0.01), retroperitoneal hematoma (0.8% versus 0.3%, p=0.009), limb ischemia (3.0% versus 0.7%, p 〈 0.0001), gastrointestinal bleeding (1.9% versus 0.9%, p 〈 0.0001), and blood transfusion (10.1% versus 5.2%, p 〈 0.0001). At 1-year follow-up, patients with PAD had a higher mortality rate (13.6% versus 5.2%, p 〈 0.0001), a higher rate of myocardial infarction (8.3% versus 6.5%, p=0.008), and also more target lesion (21.2% versus 19.8%, p=0.02) or target vessel revascularization (24.6% versus 21.2%, p=0.002). By multivariate analysis, PAD was an independent predictor of 1-year mortality (odds ratio 1.71, 95% confidence interval 1.42 to 2.07, p 〈 0.0001). Conclusions: Nearly a fifth of patients undergoing PCI have symptomatic PAD. The presence of PAD is associated with lower rates of procedural success, higher rates of in-hospital and 1-year adverse events, and is independently associated with increased 1-year mortality.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    URL: Article
    DOI: 10.1177/152660280401100108
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2004
    detail.hit.zdb_id: 2049858-5
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  • 2
    Online Resource
    Online Resource
    Pharmacologic Therapy for Reducing Myocardial Infarct Size in Clinical Trials : Failed and Promising Approaches
    SAGE Publications ; 2015
    In:  Journal of Cardiovascular Pharmacology and Therapeutics Vol. 20, No. 1 ( 2015-01), p. 21-35
    Details
    In: Journal of Cardiovascular Pharmacology and Therapeutics, SAGE Publications, Vol. 20, No. 1 ( 2015-01), p. 21-35
    Abstract: In patients with acute ST-segment elevation myocardial infarction, early, successful, and durable reperfusion therapy optimizes the likelihood of favorable outcomes. Fibrinolysis and primary percutaneous coronary intervention improve survival compared to no reperfusion therapy in large part by reducing infarct size (IS) and preserving left ventricular ejection fraction. There is direct correlation between IS and clinical outcomes. In this article, we will review some of the more promising pharmacological agents geared toward reduction in IS, discuss the major pathways that can lead to this desirable outcome, and evaluate the results of clinical trials performed with these and other compounds.
    Type of Medium: Online Resource
    ISSN: 1074-2484 , 1940-4034
    URL: Article
    DOI: 10.1177/1074248414540799
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
    detail.hit.zdb_id: 2230155-0
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  • 3
    Online Resource
    Online Resource
    Percutaneous Coronary Intervention Followed by Minimally Invasive Mitral Valve Surgery in Ischemic Mitral Regurgitation
    SAGE Publications ; 2015
    In:  Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery Vol. 10, No. 6 ( 2015-11), p. 394-397
    Details
    In: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, SAGE Publications, Vol. 10, No. 6 ( 2015-11), p. 394-397
    Type of Medium: Online Resource
    ISSN: 1556-9845 , 1559-0879
    URL: Article
    DOI: 10.1177/155698451501000605
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
    detail.hit.zdb_id: 2223439-1
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  • 4
    Online Resource
    Online Resource
    Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
    SAGE Publications ; 2020
    In:  Clinical Trials Vol. 17, No. 6 ( 2020-12), p. 723-728
    Details
    In: Clinical Trials, SAGE Publications, Vol. 17, No. 6 ( 2020-12), p. 723-728
    Abstract: Non-inferiority trials are increasing in cardiovascular medicine, with approval of many drugs and devices on the basis of such studies. Surrogate markers as primary endpoints have been also more frequently used for efficient assessment of cardiovascular interventions. However, there is uncertainty about their concordance with clinical outcomes. Non-inferiority design using a surrogate marker as a primary endpoint may pose particular challenges in clinical interpretation. We sought to explore the publication trends, methodology, and reporting features of non-inferiority cardiovascular trials that used a primary surrogate marker as the primary endpoint. Methods We searched six high-impact journals ( The New England Journal of Medicine, The Journal of the American Medical Association, The Lancet, The Journal of the American College of Cardiology, Circulation, and European Heart Journal) from 1 January 1990 to 31 December 2018 and identified non-inferiority cardiovascular trials that used a surrogate marker as the primary endpoint. We assessed the non-inferiority margin reported in the manuscript and other publicly available platforms (e.g. protocol, clinicaltrials.gov). We also determined whether the included non-inferiority trials with surrogate markers as primary endpoints were followed by clinical outcome trials. Results We screened 15,553 publications and identified 247 cardiovascular trials that used a non-inferiority design. Of these, 37 had a surrogate marker as a primary endpoint (18 drug trials, 13 device trials, 6 others). All of these non-inferiority trials with surrogate outcomes were published after 2000, mostly in cardiology journals (13 in The Journal of the American College of Cardiology, 9 in European Heart Journal, 8 in Circulation, 6 in The Lancet, 1 in The New England Journal of Medicine), and their publication rate increased over time (p  〈  0.001 for linear trend). The median number of patients in the primary analysis was 300 (interquartile range: 202–465). The study protocol or a methods paper was publicly available for only 13 (35.1%) trials, of which the non-inferiority margin was not reported in 4 trials. In 16 studies (43.2%), the manuscript did not acknowledge the limitations of using a surrogate endpoint or the need for a definitive clinical outcome trial. Thirty-four trials (91.9%) concluded that the tested intervention met non-inferiority criteria. However, only five (13.5%) were followed by clinical outcomes trials the results of which did not always confirm non-inferiority. Conclusion Non-inferiority trials that use a surrogate marker as the primary endpoint are being increasingly performed. However, these trials pose particular challenges with design, reporting, and interpretation, which are not systematically and consistently addressed or reported.
    Type of Medium: Online Resource
    ISSN: 1740-7745 , 1740-7753
    URL: Article
    DOI: 10.1177/1740774520949157
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2159773-X
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  • 5
    Online Resource
    Online Resource
    Outcomes of a Combined Approach of Percutaneous Coronary Revascularization and Cardiac Valve Surgery
    SAGE Publications ; 2017
    In:  Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery Vol. 12, No. 1 ( 2017-01), p. 4-8
    Details
    In: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, SAGE Publications, Vol. 12, No. 1 ( 2017-01), p. 4-8
    Abstract: A subset of patients requiring coronary revascularization and valve surgery may benefit from a combined approach of percutaneous coronary intervention (PCI) and valve surgery, as opposed to the standard median sternotomy approach of combined coronary artery bypass and valve surgery. To evaluate its potential benefits and limitations, a literature search was performed using PubMed EMBASE, Ovid, and the Cochrane library, through March 2016 to identify all studies involving a combined approach of PCI and valve surgery in patients with coronary artery and valvular disease. There were five studies included in the study with a total of 324 patients, of which 75 (23.1%) had a history of previous cardiac surgery. The interval between PCI and surgery ranged from simultaneous intervention to a median of 38 days (interquartile range, 18–65 days). The surgical approach performed consisted of a minimally invasive one or median sternotomy. There were 275 single valve surgery (84.9%) and 49 double-valve surgery (15.1%) with a 30-day mortality ranging from 0% to 5.5%. The 1-year survival ranged from 78% to 96%, and the follow-up period ranged from 1.3 to 5 years. Herein, we present a review of the literature using this technique.
    Type of Medium: Online Resource
    ISSN: 1556-9845 , 1559-0879
    URL: Article
    DOI: 10.1097/imi.0000000000000342
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
    detail.hit.zdb_id: 2223439-1
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  • 6
    Online Resource
    Online Resource
    Outcomes of a Combined Approach of Percutaneous Coronary Revascularization and Cardiac Valve Surgery
    SAGE Publications ; 2017
    In:  Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery Vol. 12, No. 1 ( 2017-01), p. 4-8
    Details
    In: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, SAGE Publications, Vol. 12, No. 1 ( 2017-01), p. 4-8
    Type of Medium: Online Resource
    ISSN: 1556-9845 , 1559-0879
    URL: Article
    DOI: 10.1177/155698451701200102
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
    detail.hit.zdb_id: 2223439-1
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  • 7
    Online Resource
    Online Resource
    Percutaneous Coronary Intervention Followed by Minimally Invasive Mitral Valve Surgery in Ischemic Mitral Regurgitation
    SAGE Publications ; 2015
    In:  Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery Vol. 10, No. 6 ( 2015-11), p. 394-397
    Details
    In: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery, SAGE Publications, Vol. 10, No. 6 ( 2015-11), p. 394-397
    Abstract: The optimal treatment strategy in patients with coronary artery disease and ischemic mitral regurgitation (IMR) remains controversial. A staged approach of percutaneous coronary intervention (PCI) followed by minimally invasive valve surgery, rather than combined median sternotomy coronary artery bypass and valve surgery, may be a viable alternative. Methods We retrospectively evaluated 31 consecutive patients with coronary artery disease and severe IMR who underwent a staged procedure at our institution between February 2009 and April 2014. Results The mean ± SD age, preoperative left ventricular ejection fraction, and mitral regurgitation grade were 72 ± 7 years, 35% ± 11%, and 3.6 ± 0.6, respectively. The mean ± SD Society of Thoracic Surgeons-predicted mortality score was 5.1% ± 4.2%. Percutaneous coronary intervention was performed for 1- and 2-vessel disease in 22 patients (71%) and 9 patients (29%), respectively, with 23 patients (74%) having drug-eluting stents placed. Minimally invasive valve surgery was performed within a median of 36 days after PCI, with 61% of the patients being on dual antiplatelet therapy. Post-operatively, there was 1 case of acute kidney injury, 1 case of reoperation for bleeding, and no cerebrovascular accidents. The 30-day mortality was 3%. The median total hospital length of stay was 8 days (interquartile range, 7–10). At a mean ± SD follow-up of 2.4 ± 1.6 years, 2 patients required PCI for target-vessel revascularization. Actuarial survival at 1 and 5 years was 84% and 80%, respectively. Conclusions A staged approach in patients with coronary artery disease and IMR can be performed with a low perioperative morbidity and good midterm survival.
    Type of Medium: Online Resource
    ISSN: 1556-9845 , 1559-0879
    URL: Article
    DOI: 10.1097/imi.0000000000000218
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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  • 8
    Online Resource
    Online Resource
    The Promise of Meaningful Eligibility Determination : Functional Intervention-Based Multifactored Preschool Evaluation
    SAGE Publications ; 1999
    In:  The Journal of Special Education Vol. 33, No. 2 ( 1999-07), p. 112-124
    Details
    In: The Journal of Special Education, SAGE Publications, Vol. 33, No. 2 ( 1999-07), p. 112-124
    Abstract: Despite considerable controversy, standardized norm-referenced assessment procedures are widely used to determine eligibility for special education services. Under Public Law 105-17, children ages 3 through 9 may receive special services under the broad category of child with a disability—rather than traditional diagnostic labels—based on a delay in one or more developmental domains. Due to the limitations of traditional ability and developmental norm-referenced measures, the determination of developmental delays may be highly error prone and unrelated to intervention decisions. As an alternative, we describe minimal requirements for functional intervention-based assessment and suggest strategies for using these methods to analyze developmental delays and make special service eligibility decisions for preschool children (intervention-based multifactored evaluation or IBMFE). The IBMFE model provides a basis for deriving logical, natural, and meaningful discrepancies in behavior or performance through the contextual analysis of child-related, environmental, and instructional variables.
    Type of Medium: Online Resource
    ISSN: 0022-4669 , 1538-4764
    URL: Article
    DOI: 10.1177/002246699903300205
    Language: English
    Publisher: SAGE Publications
    Publication Date: 1999
    detail.hit.zdb_id: 2066654-8
    SSG: 5,3
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