Bivalirudin Is Associated With Improved In-Hospital Outcomes Compared With Heparin in Percutaneous Vascular Interventions

Abstract

Background— Peripheral vascular interventions are increasingly preferred for the treatment of patients with symptomatic peripheral arterial disease because they are associated with similar clinical outcomes and lower morbidity than open surgical procedures. The objective of this study was to assess the comparative effectiveness of procedural anticoagulation with bivalirudin compared with unfractionated heparin in patients undergoing peripheral vascular interventions. Methods and Results— This was a retrospective, observational study using the Premier Hospital administrative database. We examined 23 934 consecutive patients undergoing lower extremity peripheral vascular interventions between January 2008 and December 2012 who were treated with either bivalirudin or unfractionated heparin. In-hospital end points included death, myocardial infarction, transfusion, stroke, amputation, and the composite end points of major adverse cardiovascular events, and net adverse clinical events. Propensity score matching was performed to control for baseline imbalances and yielded 3649 matched pairs. After propensity score matching, patients treated with bivalirudin had lower in-hospital event rates with significantly lower mortality (odds ratio, 0.40; P =0.017), need for blood product transfusion (odds ratio, 0.74; P =0.009), major adverse cardiovascular events (odds ratio, 0.64; P =0.003), and net adverse clinical events (odds ratio, 0.72; P <0.001). These associations were observed consistently across clinically relevant subgroups. Conclusions— In patients undergoing peripheral vascular interventions, procedural anticoagulation with bivalirudin may result in more favorable in-hospital outcomes compared with unfractionated heparin, the current standard of care. These observations will require prospective confirmation in a randomized, controlled trial.

Bivalirudin versus heparin for peripheral vascular intervention: You get what you pay for…

“…We showed that bivalirudin‐treated patients experienced lower in‐hospital mortality, need for blood product transfusion, major adverse cardiac events, and net adverse clinical events. These associations were consistent both in the overall unadjusted study population and the 3,649 PSM pairs, and remained consistent in all clinically relevant subgroups .…”

Research update for articles published in EJCI in 2015

“…These findings suggested that bleeding complications may contribute to suboptimal results of PCI in stable CAD. Since its publication, additional evidence has gathered that occurrence of periprocedural bleeding in patients with CAD is associated with increased risk of subsequent mortality [73][74][75][76][77]. Two recent studies that included 8582 and 5018 patients undergoing PCI showed that bleeding was associated with increased risk of 2-year mortality with the highest risk observed within the first 30 days after PCI [73,74].…”

“…Two recent studies that included 8582 and 5018 patients undergoing PCI showed that bleeding was associated with increased risk of 2-year mortality with the highest risk observed within the first 30 days after PCI [73,74]. Other studies have shown that the survival benefit associated with bleeding avoidance strategies such as the use of radial artery for vascular access or bivalirudin is at least partially explainable by reduced bleeding risk [75][76][77].…”

Will Bivalirudin Have an Impact in Peripheral Vascular Interventions?

“…In this issue of Circulation: Cardiovascular Interventions, Kimmelstiel et al 7 compare the clinical outcomes of patients undergoing PVI with bivalirudin or UFH alone in a retrospective, propensity-matched assessment. The investigators included patient outcomes from the Premier hospital database, which provides patient-level data from >600 hospitals in the United States.…”

“…Armed with information from cost-effectiveness analysis, as well as prospective bleeding risk assessment as with the HAS-BLED (a composite score that predicts bleeding in patients with atrial fibrillation on oral anticoagulation with the following risk factors: hypertension, abnormal renal/ liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly [>65 years], drugs/ alcohol concomitantly) or the dual antiplatelet therapy score calculators, future anticoagulant and antiplatelet strategies may one day be tailored to each individual patient undergoing PVI. 14,15 Although many questions remain about optimal strategies for patients undergoing PVI, the study by Kimmelstiel et al 7 provides new insight and motivation for further investigation into the role of bivalirudin in PVI, particularly in patients with high risk of bleeding.…”