Catheterization and Cardiovascular Interventions 85:380–381 (2015)
Editorial Comment Can Femoral Access Bleeding Outcomes Be Improved? William B. Hillegass,1,2* MD, MPH, and Brigitta C. Brott,2 MD 1 Heart South Cardiovascular Group, Alabaster, Alabama 2 University of Alabama at Birmingham, Birmingham, Alabama
In the absence of randomized trials, the role of vascular closure devices as a bleeding avoidance strategy compared to manual compression in STelevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention remains poorly defined. Vascular closure devices in a propensity adjusted observational analysis were associated with one less major bleed for every 32 STEMI patients closed [95% CI: 20, 77]. Adjuncts to technique coupled with vascular closure devices may have the potential to improve femoral access safety to the level of radial access.
Sanborn et al. analyzed vascular closure device (VCD) use versus manual compression (MC) in STelevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial . VCD use was associated with a major bleeding rate of 5.0% compared to 8.1% with MC (hazard ratio ¼ 0.61 [95% CI: 0.39, 0.94], p ¼ 0.02) in this propensity for VCD-treatment adjusted observational comparison. The lower rate of major bleeding associated with VCD use was independent of bivalirudin versus glycoprotein IIb/IIIa therapy. VCD use was associated with a similar reduction in bleeding compared to MC in an adjusted observational analysis of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial (odds ratio ¼ 0.78 [95% CI: 0.61,0.99], p ¼ 0.04). C 2015 Wiley Periodicals, Inc. V
Adequately powered randomized trials (RCTs) of VCD vs. MC in the PCI setting, particularly with current closure devices, are limited. Meta-analysis of the vascular closure vs. MC RCTs in PCI yield risk-ratios not proving incremental benefit of VCDs for bleeding, hematoma, and pseudo-aneurysm . In the setting of diagnostic only coronary angiography, the Comparison of Vascular Closure Devices vs. Manual Compression (ISAR-CLOSURE) randomized trial (n ¼ 4,524) yielded 4.8% hematoma rate with VCDs versus 6.8% with MC (p ¼ 0.006) but no overall significant effect on vascular complications with 6.9% with VCDs versus 7.9% with MC (p ¼ 0.23) . The main limitation of adjusted observational VCD versus MC comparisons has been residual confounding. This likely arises from the lack of elucidation and controlling for specific prognostically important factors leading to MC such as lack of anatomic suitability, burden of femoral disease, and operator/institutional factors. Femoral disease portending lack of VCD anatomic suitability is associated with a higher burden of cardiovascular disease and risk of events . However, in this propensity-adjusted analysis, unlike prior studies, there appears to be little residual confounding. An extensive set of baseline characteristics were well matched. Rates of major adverse cardiovascular events at one year (as a falsification hypothesis) were nearly identical (hazard ratio ¼ 1.07 [95% CI: 0.75, 1.51]) in the VCD versus MC cohorts. Hence, this study provides the most convincing observational evidence to date supporting VCDs as a bleeding avoidance strategy in STEMI patients undergoing PCI. The radial approach reduces access site bleeding and vascular complications compared to the femoral approach in meta-analysis of the RCTs. However, the majority of STEMI PCIs in the United States (93% in 2011) are performed from the femoral approach for Conflict of interest: Nothing to report. *Correspondence to: William Hillegass, Heart South Cardiovascular Group and the University of Alabama at Birmingham, Alabaster and Birmingham, AL. E-mail: [email protected]
Received 18 December 2014; Revision accepted 21 December 2014 DOI: 10.1002/ccd.25808 Published online 9 February 2015 in Wiley Online Library (wileyonlinelibrary.com)
Can Femoral Access Bleeding Outcomes Be Improved?
many reasons. In late 2012, 84% of all PCIs in the Natiional Cardiovascular Data Registry were performed femoral. In high-risk STEMI and complex PCI patients, the femoral approach will likely remain frequently utilized. Given this, can radial-like vascular access complication rates be achieved with the transfemoral approach? The authors note, albeit not randomized, that VCD and bivalirudin treated femoral patients had similar bleeding outcomes to the small radial cohort in HORIZONS. Investigating this hypothesis, the AngioSeal versus Radial approach (ARISE) randomized trial will prospectively compare radial vs. femoral access with vascular closure in non-STEMI acute coronary syndrome patients . Additional strategies that may improve the femoral approach are fluoroscopic landmarking (0.7% vs. 1.9%, any artery injury, p < 0.01), ultrasound guidance (1.4% vs. 3.4% vascular complications, p ¼ 0.04), femoral angiography prior to proceeding to intervention (odds ratio ¼ 28.7 [95% CI: 6.7,122.4] p < 0.0001, for vascular complication if access is outside the ideal anatomic range), and micropuncture vs. standard 18-gauge access needle in PCI (1.6% vs. 1.7% vascular complications, 2.1% vs. 4.1% bleeding, p ¼ 0.10). Largely evaluated in small randomized trials, these promising femoral access techniques should be coupled with VCDs in an adequately powered factorial design multi-center, multi-operator randomized trial. This large trial would
undoubtedly require registry-based data collection and follow-up. The optimal femoral access technique including the role of VCDs remains poorly defined. Despite the growth of the radial approach, optimizing femoral access outcomes should also remain a priority. REFERENCES 1. Sanborn TA, Tomey MI, Mehran R, Genereux P, Witzenbichler B, Brener SJ, Kirtane AJ, McAndrew TC, Kornowski8 R, Dudek D, Nikolsky E, Stone GW. Femoral vascular closure device use, bivalirudin anticoagulation and bleeding after primary angioplasty for STEMI: Results from the HORIZONS-AMI Trial. Cardiovasc Catheter Interv 2014;85:371–379. 2. Byrne RA, Cassese S, Linhart M, Kastrati A. Vascular access and closure in coronary angiography and percutaneous intervention. Nat Rev Cardiol 2013;10:27–40. 3. Schulz-Schupke S, Helde S, Gewalt S, et al. Comparison of Vascular Closure Devices vs. Manual Compression after femoral artery puncture: The ISAR-CLOSURE randomized clinical trial. JAMA 2014;312:1981–1987. 4. Davidsson L, Fagerberg B, Bergstrom G, Schmidt C. Ultrasoundassessed plaque occurrence in the carotid and femoral arteries are independent predictors of cardiovascular events in middle aged men during 10 years of follow-up. Atherosclerosis 2010;209: 469–473. 5. de Andrade PB, Piva e Mattos LA, Tebets MA, et al. Design and rationale of the AngioSeal versus the Radial approach In acute coronary Syndrome (ARISE) trial: A randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients. Trials 2013;14:435.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).