0
Clinical Investigations: SURGERY |

Thromboembolic and Bleeding Complications Following St. Jude Medical Valve Replacement*: Results of the German Experience With Low-Intensity Anticoagulation Study

Detlef Hering, MD; Cornelia Piper, MD; Rito Bergemann, MD; Carina Hillenbach, PhD; Manfred Dahm, MD; Christof Huth, MD; Dieter Horstkotte, MD
Author and Funding Information

*From the Department of Cardiology (Drs. Hering, Piper, and Horstkotte), Heart Center North-Rhine Westphalia, Bad Oeynhausen; Institute for Medical Outcome Research (Drs. Bergemann and Hillenbach), Loerrach; Department of Cardiothoracic and Vascular Surgery (Dr. Dahm), University Hospital Mainz, Mainz; and Department of Cardiothoracic Surgery (Dr. Huth), Otto-von-Guericke-University, Magdeburg, Germany.

Correspondence to: Dieter Horstkotte, MD, Department of Cardiology, Heart Center North-Rhine Westphalia, Ruhr University, Bad Oeynhausen, Georgstrasse 11, 32545 Bad Oeynhausen, Germany; e-mail: akohlstaedt@hdz-nrw.de



Chest. 2005;127(1):53-59. doi:10.1378/chest.127.1.53
Text Size: A A A
Published online

Study objectives: Due to their inherent thrombogenicity, mechanical cardiac valves necessitate lifelong oral anticoagulation. Less intensive oral anticoagulation than recommended earlier might result in a lower incidence of bleeding complications without increasing the embolic hazard significantly.

Design: Comparison of three different intensities of oral anticoagulation in a prospective, randomized multicenter design. Three months after valve replacement, patients were randomly assigned to stratum A, international normalized ratio (INR) 3.0 to 4.5; stratum B, INR 2.5 to 4.0; or stratum C, INR 2.0 to 3.5.

Patients: Data from 2,735 patients following aortic valve replacement (AVR; n = 2,024), mitral valve replacement (MVR; n = 553), and combined AVR and MVR (n = 158) with the St. Jude Medical (SJM) valve (St. Jude Medical; St. Paul, MN) between July 1993 and May 1999 were analyzed, covering a total follow-up period of 6,801 patient-years. All complications were registered prospectively.

Measurements and results: Fifty-one thromboembolic events (TEs) were documented, resulting in a linearized incidence of 0.75 TEs per 100 patient-years, 22 of which were minor (0.32% per patient-year), 10 were moderate (0.15% per patient-year), and 19 were severe (0.28% per patient-year). Thromboembolism following AVR was significantly lower than after MVR (0.53% per patient-year vs 1.64% per patient-year). Patients reported 1,687 bleeding complications (24.8% per patient-year). The vast majority of bleeding complications (n = 1,509; 22.2% per patient-year) were classified as minor, 140 were classified as moderate (2.06% per patient-year), and 38 were classified as severe (0.56% per patient-year). The clinically relevant incidences of moderate and severe TEs and bleeding complications were not significantly different between the three prespecified INR strata.

Conclusions: The intention-to-treat analysis of the results of the German Experience With Low Intensity Anticoagulation study leads to the unexpected result that despite a sophisticated reporting system, the incidence of moderate and severe TE and bleeding complications was comparably low in all INR strata and more or less within the so-called background incidence reported for an age-related “normal” population. This study supports reexamination of the intensity of anticoagulation in patients with the SJM valve.


Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
Pharmacology and Management of the Vitamin K Antagonists*: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
PubMed Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543