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)

Connie N. Hess, Sunil V. Rao, David F. Kong, Laura H. Aberle, Kevin J. Anstrom, C. Michael Gibson, Ian Gilchrist, Alice K. Jacobs, Sanjit S. Jolly, Roxana Mehran, John C. Messenger, L. Kristin Newby, Ron Waksman, Mitchell W. Krucoff

Research output: Contribution to journalArticle

50 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalAmerican Heart Journal
Volume166
Issue number3
DOIs
StatePublished - Jan 1 2013

Fingerprint

Percutaneous Coronary Intervention
Registries
Randomized Controlled Trials
Thigh
Blood Vessels
Hemorrhage
Research
Safety
Radial Artery
Critical Pathways
National Institutes of Health (U.S.)
Spasm
United States Food and Drug Administration
Quality of Life
Radiation

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Hess, Connie N. ; Rao, Sunil V. ; Kong, David F. ; Aberle, Laura H. ; Anstrom, Kevin J. ; Gibson, C. Michael ; Gilchrist, Ian ; Jacobs, Alice K. ; Jolly, Sanjit S. ; Mehran, Roxana ; Messenger, John C. ; Newby, L. Kristin ; Waksman, Ron ; Krucoff, Mitchell W. / 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). In: American Heart Journal. 2013 ; Vol. 166, No. 3.
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abstract = "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.",
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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). / Hess, Connie N.; Rao, Sunil V.; Kong, David F.; Aberle, Laura H.; Anstrom, Kevin J.; Gibson, C. Michael; Gilchrist, Ian; Jacobs, Alice K.; Jolly, Sanjit S.; Mehran, Roxana; Messenger, John C.; Newby, L. Kristin; Waksman, Ron; Krucoff, Mitchell W.

In: American Heart Journal, Vol. 166, No. 3, 01.01.2013.

Research output: Contribution to journalArticle

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AU - Messenger, John C.

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AU - Waksman, Ron

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