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Use of Bivalirudin for Chronic Total Occlusion Percutaneous Intervention: Insights From the PROGRESS-CTO Registry
Louis Verreault-Julien, Bahadir Simsek, Spyridon Kostantinis
1Emory University Hospital, 1364 Clifton Road NE, Suite F-607, Atlanta, GA 30322 USA. wissam.jaber@emory.edu.
Insights
Bivalirudin use in chronic total occlusion percutaneous coronary intervention (CTO-PCI) showed similar safety outcomes compared to unfractionated heparin. Further research is needed to confirm bivalirudin
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Medicine
Background:
- Limited data exist regarding bivalirudin use in chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
- Assessing the safety and efficacy of bivalirudin in CTO-PCI is crucial for clinical practice.
Purpose of the Study:
- To compare the outcomes of CTO-PCI using bivalirudin versus unfractionated heparin.
- To evaluate the primary endpoint of net adverse cardiac events (NACE) in patients undergoing CTO-PCI with either anticoagulant.
Main Methods:
- A comparison of CTO-PCIs performed with bivalirudin versus unfractionated heparin was conducted within the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO).
- The primary endpoint was NACE, defined as major adverse cardiac events (MACE) and vascular complications.
- Patient characteristics, procedural details, and clinical outcomes were analyzed.
Main Results:
- Bivalirudin was used in only 0.75% of CTO-PCI procedures (73 out of 9723).
- Procedural success rates, in-hospital NACE, MACE incidence, and vascular access complications were not significantly different between the bivalirudin and unfractionated heparin groups.
- Multivariable analysis indicated no increased risk of NACE associated with bivalirudin use (OR, 0.99; 95% CI, 0.13-7.27).
Conclusions:
- Bivalirudin is infrequently utilized in retrograde CTO-PCI procedures.
- The incidence of adverse events was comparable between bivalirudin and unfractionated heparin.
- Larger studies are warranted to definitively assess the safety profile of bivalirudin in CTO-PCI.
Background:
There are limited data on the use of bivalirudin for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Methods:
We compared CTO-PCIs performed using bivalirudin vs unfractionated heparin in the Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO; NCT02061436). The primary endpoint was net adverse cardiac events (NACE), defined as major adverse cardiac events (MACE) and vascular complications.
Results:
Between 2012 and 2022, a total of 73 of 9723 procedures (0.75%) were performed using bivalirudin. The J-CTO score (2.4 ± 1.2 vs 2.4 ± 1.3; P=.73) and the PROGRESS-CTO score (1.4 ± 0.9 vs 1.2 ± 1.0; P=.31) were similar in both groups, and the retrograde approach was used less often in the bivalirudin group (15% vs 30%; P<.01). Procedural success (89% vs 85%; P=.35), in-hospital NACE (1.4% vs 2.1%; P>.99), incidence of MACE (0% vs 0.76%; P=.64), and vascular access complications (1.4% vs 0.9%; P=.48) were not different between the 2 groups. On multivariable analysis, use of bivalirudin was not associated with an increased risk of NACE (odds ratio, 0.99; 95% confidence interval, 0.13-7.27).
Conclusion:
Bivalirudin is infrequently used during retrograde CTO-PCI. While the incidence of adverse events was similar with unfractionated heparin, larger studies are needed to assess the safety of bivalirudin.
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