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'Bleeding Avoidance Strategies' and PCI
Abstract & Commentary
By Andrew J. Boyle, MD, Assistant Professor of Medicine, Interventional Cardiology, University of California, San Francisco. Dr. Boyle reports no financial relationships relevant to this field of study.
Source: Marso SP et al. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA. 2010;303:2156-2164.
Access-site bleeding is one of the major complications of percutaneous coronary intervention (PCI). It is associated with the need for blood transfusions, increased length of stay, and increased healthcare expenditure. Strategies to reduce access-site bleeding may have the ability to improve these outcomes. Bivalirudin is a direct thrombin inhibitor that has been shown to be at least as effective as unfractionated heparin (UFH) in preventing thrombotic complications of PCI, but with lower rates of bleeding. Vascular closure devices (VCD), such as Angioseal and Perclose, have not been proven to reduce access site-bleeding complications in clinical trials, but are anecdotally believed to do so in real-world practice.
Marso and colleagues examined the National Cardiovascular Data Registry (NCDR) CathPCI Registry for the use of bivalirudin, the use of VCD, and the use of both in patients undergoing PCI. They report the associated access site-bleeding complication rates and compare them to patients receiving manual compression for hemostasis and a non-bivalirudin antithrombin regimen, such as heparin. After excluding patients who did not have femoral artery access, those with more than one PCI procedure during the hospitalization, those with cardiogenic shock, or who died during the procedure, and those with missing data, more than 1.5 million patients were included between 2004 and 2008. Their definition of bleeding complication was peri-procedural bleeding that required a blood transfusion, increased the length of hospital stay, or was associated with a drop in hemoglobin of > 3 g/dL. Using propensity-score matching to try to reduce the variability between groups, they describe the rate of bleeding complications based on the use of bivalirudin, the use of VCD, or both, compared to manual compression.
Results: Overall, bleeding occurred in 30,429 patients (2%). Manual compression was used in 35% of patients, vascular closure devices in 24%, bivalirudin in 23%, and vascular closure devices plus bivalirudin in 18%. Bleeding events were reported in 2.8% of patients who received manual compression, compared with 2.1% receiving VCDs, 1.6% receiving bivalirudin, and 0.9% receiving both strategies (p < 0.001). After propensity matching, the use of vascular closure devices, bivalirudin, or both were associated with reductions in bleeding complications compared to manual compression in patients undergoing PCI (OR 0.77, 0.67, and 0.38, respectively). The authors describe a "risk-treatment paradox" where patients at higher risk for bleeding were less likely to receive bivalirudin and/or VCDs.
Marso et al have used the NCDR database to examine the use of "bleeding reduction strategies" in patients undergoing PCI. A strength of the study is the large number of patients included. Several important caveats need to be addressed before interpreting these findings. Firstly, several key factors that predispose to bleeding are not included in this analysis. Glycoprotein IIb/IIIa inhibitor use is not reported, thienopyridine use is not reported, procedural-activated clotting time is not reported, and platelet count, hemoglobin, international normalized ratio (INR), and sheath size are not reported. Much of these data are available in the NCDR dataset, and so it is not clear why it is not included. Secondly, the major obstacles to using VCDs are anatomical, such as small-caliber femoral artery (VCDs are contra-indicated in vessels < 4 mm diameter), severe calcification, and arteriotomy at branch points or in branch vessels rather than the common femoral artery. These data are not captured in the NCDR dataset and are, thus, not reported here. Much of the "risk-treatment paradox" that the authors describe is probably related to anatomical factors preventing the use of VCDs, or to the use of more aggressive anti-platelet therapy in higher-risk patients (which is backed by solid clinical trial data). Thirdly, this study was performed largely before much of the current data regarding bivalirudin had been published and added to the PCI guidelines. Thus, this study, although attracting a lot of attention in the press, can only be considered hypothesis-generating, and should not change current standard of care in clinical practice. The implication that there is a missed opportunity to improve the safety of PCI must be tested in prospective, randomized, controlled trials.