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Multicenter Study
. 2016 Apr;9(4):e003464.
doi: 10.1161/CIRCINTERVENTIONS.115.003464.

Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An Instrumental Variable Analysis

Neil J Wimmer  1 , Eric A Secemsky  1 , Laura Mauri  1 , Matthew T Roe  1 , Paramita Saha-Chaudhuri  1 , David Dai  1 , James M McCabe  1 , Frederic S Resnic  1 , Hitinder S Gurm  1 , Robert W Yeh  2
Affiliations
Multicenter Study

Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An Instrumental Variable Analysis

Neil J Wimmer et al. Circ Cardiovasc Interv. 2016 Apr.

Abstract

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.

Keywords: bleeding; complications; femoral artery; percutaneous coronary intervention; vascular closure devices.

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Figures

Figure 1
Figure 1
Flow diagram of procedures considered for the simple IV analysis and the full instrumental variable analysis.
Figure 2
Figure 2
Utilization of arterial closure devices by physician
See this image and copyright information in PMC

References

    1. Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, Hamon M, Dangas GD, Lincoff AM, White HD, Moses JW, King SB, 3rd, Ohman EM, Stone GW. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol. 2007;49:1362–8. - PubMed
    1. Pinto DS, Stone GW, Shi C, Dunn ES, Reynolds MR, York M, Walczak J, Berezin RH, Mehran R, McLaurin BT, Cox DA, Ohman EM, Lincoff AM, Cohen DJ. Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes. J Am Coll Cardiol. 2008;52:1758–68. - PubMed
    1. Dauerman HL, Rao SV, Resnic FS, Applegate RJ. Bleeding avoidance strategies. Consensus and controversy. J Am Coll Cardiol. 2011;58:1–10. - PMC - PubMed
    1. Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011;377:1409–20. - PubMed
    1. Daugherty SL, Thompson LE, Kim S, Rao SV, Subherwal S, Tsai TT, Messenger JC, Masoudi FA. Patterns of use and comparative effectiveness of bleeding avoidance strategies in men and women following percutaneous coronary interventions: an observational study from the National Cardiovascular Data Registry. J Am Coll Cardiol. 2013;61:2070–8. - PMC - PubMed

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