Hitinder S. Gurm, MD; Carrie Hosman, PhD; David Share, MD; Mauro Moscucci, MD; Ben B. Hansen, PhD; for the Blue Cross Blue Shield of Michigan Cardiovascular Consortium
Note: Dr. Gurm had full access to all of the data in the study and takes responsibility for integrity of the data and accuracy of data analysis.
Acknowledgment: The authors thank all of the study coordinators, investigators, and patients who participated in BMC2.
Financial Support: By Blue Cross Blue Shield of Michigan. Dr. Hansen is supported in part by the National Science Foundation (grant SES-0753164).
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0899.
Reproducible Research Statement: Study protocol: Data dictionary available from Dr. Gurm (e-mail, firstname.lastname@example.org). Statistical code: Available from Dr. Hosman (e-mail, email@example.com). Data set: Not available.
Requests for Single Reprints: Hitinder S. Gurm, MD, Division of Cardiovascular Medicine, University of Michigan Cardiovascular Center, 2A394, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5853; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Gurm: Division of Cardiovascular Medicine, University of Michigan Cardiovascular Center, 2A394, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5853.
Drs. Hosman and Hansen: Statistics Department, University of Michigan, 439 West Hall, 1085 South University, Ann Arbor, MI 48109-1107.
Dr Share: 600 East Lafayette Boulevard, Mail Code 513P, Detroit, MI 48226-2998.
Dr Moscucci: University of Miami Miller School of Medicine, 1120 NW 14th Street, CRB Suite 1124, Miami, FL 33136.
Author Contributions: Conception and design: H.S. Gurm, M. Moscucci, B.B. Hansen.
Analysis and interpretation of the data: H.S. Gurm, C. Hosman, M. Moscucci, B.B. Hansen.
Drafting of the article: H.S. Gurm, C. Hosman.
Critical revision of the article for important intellectual content: H.S. Gurm, C. Hosman, D. Share, M. Moscucci, B.B. Hansen.
Final approval of the article: H.S. Gurm, C. Hosman, M. Moscucci, B.B. Hansen.
Statistical expertise: C. Hosman, B.B. Hansen.
Obtaining of funding: H.S. Gurm, D. Share, M. Moscucci.
Administrative, technical, or logistic support: H.S. Gurm.
Collection and assembly of data: H.S. Gurm.
The role of vascular closure devices (VCDs) in patients having percutaneous coronary intervention (PCI) is controversial, and recommendations for use vary.
To examine the use of and outcomes associated with VCDs in real-world practice.
Observational cohort study.
32 hospitals in Michigan that participate in a large multicenter quality improvement collaborative.
Consecutive patients having emergent and nonemergent PCI from 2007 to 2009.
Vascular complications and the need for transfusion.
Of the 85 048 PCIs performed during the study that met the inclusion criteria, 28 528 (37%) procedures used VCDs. In propensity score–matched analysis, VCDs were associated with reductions in vascular complications (odds ratio [OR], 0.78 [95% CI, 0.67 to 0.90]; P = 0.001) and postprocedure transfusions (OR, 0.85 [CI, 0.74 to 0.96]; P = 0.011). These findings were consistent across many prespecified subgroups except for patients with a body mass index (BMI) less than 25 kg/m2 and those treated with platelet glycoprotein (GP) IIb/IIIa inhibitors, in whom the benefit of VCDs over manual closure was attenuated. When the specific subtypes of vascular complications were evaluated, VCDs were associated with fewer hematomas (OR, 0.69 [CI, 0.58 to 0.83]; P < 0.001) or pseudoaneurysms (OR, 0.54 [CI, 0.38 to 0.76]; P < 0.001) but an increase in the odds of retroperitoneal bleeding (OR, 1.57 [CI, 1.12 to 2.20]; P = 0.009).
Unmeasured confounding cannot be excluded despite the study having measured and balanced many confounders.
Vascular closure devices were associated with a significant reduction in vascular complications and need for transfusion in this large cohort of patients having transfemoral PCI. This benefit was lost in patients receiving GP IIb/IIIa inhibitors and those with normal or lean BMI and was counterbalanced by a small increase in the more serious risk for retroperitoneal bleeding.
Blue Cross Blue Shield of Michigan and the National Science Foundation.
Gurm HS, Hosman C, Share D, et al, for the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Comparative Safety of Vascular Closure Devices and Manual Closure Among Patients Having Percutaneous Coronary Intervention. Ann Intern Med. 2013;159:660–666. doi: https://doi.org/10.7326/0003-4819-159-10-201311190-00004
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Published: Ann Intern Med. 2013;159(10):660-666.
Cardiology, Coronary Heart Disease, Percutaneous Coronary Intervention.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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