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Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An
Neil J Wimmer1, Eric A Secemsky1, Laura Mauri1
1From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
Insights
Arterial closure devices (ACDs) modestly reduce bleeding complications after percutaneous coronary intervention (PCI). However, the number needed to treat with ACDs to prevent one major bleeding event remains high, indicating a limited clinical impact.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Bleeding complications after percutaneous coronary intervention (PCI) are linked to adverse patient outcomes.
- The efficacy of arterial closure devices (ACDs) in preventing bleeding during transfemoral PCI requires further investigation.
- Current clinical practice widely employs ACDs, yet their effectiveness remains uncertain.
Purpose of the Study:
- To evaluate the effectiveness of arterial closure devices (ACDs) in preventing vascular access site complications.
- To assess the impact of ACDs on bleeding reduction in patients undergoing transfemoral PCI.
- To utilize an instrumental variable approach to mitigate confounding factors.
Main Methods:
- Retrospective analysis of the CathPCI Registry (2009-2013) involving 1470 US sites.
- Employed a 2-stage instrumental variable analysis using physician operator ACD utilization rates.
- Vascular access site complications served as the primary outcome; non-access site bleeding acted as a falsification endpoint.
Main Results:
- Analysis included 2,056,585 PCIs with 1,053,155 ACD uses; vascular access site complication rate was 1.5%.
- Instrumental variable analysis indicated a 0.40% absolute risk reduction in vascular access site complications with ACD use (NNT=250).
- Negligible differences in non-access site bleeding supported the robustness of the analysis.
Conclusions:
- Arterial closure devices are associated with a modest decrease in major bleeding events post-PCI.
- A high number is needed to treat with ACDs to prevent a single major bleeding complication.
- The overall clinical benefit of ACDs for bleeding reduction requires careful consideration.
Background:
Bleeding is associated with poor outcomes after percutaneous coronary intervention (PCI). Although arterial closure devices (ACDs) are widely used in clinical practice, whether they are effective in reducing bleeding complications during transfemoral PCI is uncertain. The objective of this study was to evaluate the effectiveness of ACDs for the prevention of vascular access site complications in patients undergoing transfemoral PCI using an instrumental variable approach.
Methods And Results:
We performed a retrospective analysis of the CathPCI Registry from 2009 to 2013 at 1470 sites across the United States. Variation in the proportion of ACDs used by each individual physician operator was used as an instrumental variable to address potential confounding. A 2-stage instrumental variable analysis was used as the primary approach. The main outcome measure was vascular access site complications, and nonaccess site bleeding was used as a falsification end point (negative control) to evaluate for potential confounding. A total of 1 053 155 ACDs were used during 2 056 585 PCIs during the study period. The vascular access site complication rate was 1.5%. In the instrumental variable analysis, the use of ACDs was associated with a 0.40% absolute risk reduction in vascular access site complications (95% confidence interval, 0.31-0.42; number needed to treat=250). Absolute differences in nonaccess site bleeding were negligible (risk difference, 0.04%; 95% confidence interval, 0.01-0.07), suggesting acceptable control of confounding in the comparison.
Conclusions:
ACDs are associated with a modest reduction in major bleeding after PCI. The number needed to treat with ACDs to prevent 1 major bleeding event is high.
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