Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women).

MedStar author(s):
Citation: American Heart Journal. 166(3):421-8, 2013 Sep.PMID: 24016489Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov'tSubject headings: *Femoral Artery/su [Surgery] | *Percutaneous Coronary Intervention/mt [Methods] | *Postoperative Hemorrhage/pc [Prevention & Control] | *Radial Artery/su [Surgery] | Female | Humans | Percutaneous Coronary Intervention/ae [Adverse Effects] | Prospective Studies | Quality of Life | Registries | Treatment OutcomeYear: 2013Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0002-8703
Name of journal: American heart journalAbstract: Women are at higher risk than men for bleeding and vascular complications after percutaneous coronary intervention (PCI). Compared with femoral access, radial access reduces these complications but may be more challenging in women because of higher rates of radial artery spasm, tortuosity, and occlusion as well as lower rates of procedure success. Whether the safety advantages of radial versus femoral access in women undergoing PCI are outweighed by reduced effectiveness has not been studied. The Study of Access site For Enhancement of PCI for Women is a prospective, randomized clinical trial comparing radial with femoral arterial access in women undergoing PCI. In conjunction with the US Food and Drug Administration's Critical Path Cardiac Safety Research Consortium, this study embeds the randomized clinical trial into the existing infrastructure of the National Cardiovascular Data Registry CathPCI Registry through the National Institute of Health's National Cardiovascular Research Infrastructure. The primary efficacy end point is a composite of bleeding (Bleeding Academic Research Consortium types 2, 3, or 5) or vascular complication requiring intervention occurring at 72 hours after PCI or by hospital discharge. The primary feasibility end point is procedure success. Secondary end points include procedure duration, contrast volume, radiation dose, quality of life, and a composite of 30-day death, vascular complication, or unplanned revascularization. 2013.All authors: Aberle LH, Anstrom KJ, Gibson CM, Gilchrist IC, Hess CN, Jacobs AK, Jolly SS, Kong DF, Krucoff MW, Mehran R, Messenger JC, Newby LK, Rao SV, Waksman RFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2014-02-24
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 24016489 Available 24016489

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

Women are at higher risk than men for bleeding and vascular complications after percutaneous coronary intervention (PCI). Compared with femoral access, radial access reduces these complications but may be more challenging in women because of higher rates of radial artery spasm, tortuosity, and occlusion as well as lower rates of procedure success. Whether the safety advantages of radial versus femoral access in women undergoing PCI are outweighed by reduced effectiveness has not been studied. The Study of Access site For Enhancement of PCI for Women is a prospective, randomized clinical trial comparing radial with femoral arterial access in women undergoing PCI. In conjunction with the US Food and Drug Administration's Critical Path Cardiac Safety Research Consortium, this study embeds the randomized clinical trial into the existing infrastructure of the National Cardiovascular Data Registry CathPCI Registry through the National Institute of Health's National Cardiovascular Research Infrastructure. The primary efficacy end point is a composite of bleeding (Bleeding Academic Research Consortium types 2, 3, or 5) or vascular complication requiring intervention occurring at 72 hours after PCI or by hospital discharge. The primary feasibility end point is procedure success. Secondary end points include procedure duration, contrast volume, radiation dose, quality of life, and a composite of 30-day death, vascular complication, or unplanned revascularization. 2013.

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