Abstract
Aims: We sought to assess if bivalirudin use during balloon aortic valvuloplasty (BAV) would affect clinical outcomes compared with heparin. Methods and results: We compared the outcomes of consecutive patients who underwent elective or urgent BAV with intraprocedural use of bivalirudin or heparin at two high-volume centres. All in-hospital events post BAV were adjudicated by an independent, blinded clinical events committee. Of 427 patients, 223 patients (52.2%) received bivalirudin and 204 (47.8%) received heparin. Compared with patients who received heparin, patients who received bivalirudin had significantly less major bleeding (4.9% vs. 13.2%, p=0.003). Net adverse clinical events (NACE, major bleeding or major adverse cardiovascular events [MACE]) were also reduced (11.2% vs. 20.1%, p=0.01). There was no significant difference in the rates of MACE (mortality, myocardial infarction or stroke, 6.7% vs. 11.3%, p=0.1), or vascular complications (major, 2.7% vs. 2.0%; minor, 4.5% vs. 4.9%; p=0.83). After multivariate analysis controlling for vascular preclosure, the use of bivalirudin remained independently associated with reduced major bleeding (OR 0.37; 95% CI: 0.16 to 0.84; p=0.02) while the association was attenuated in propensity-adjusted analysis (OR 0.44, 95% CI: 0.18 to 1.07, p=0.08). Conclusions: In this registry of patients with severe aortic stenosis, bivalirudin as compared to heparin resulted in improved in-hospital outcomes post BAV in terms of reduced major bleeding, similar MACE and reduced NACE. If verified in a randomised study and extended to the transcatheter aortic valve implantation (TAVI) population, these results might indicate a potential benefit for patients undergoing such procedures.
| Original language | English |
|---|---|
| Pages (from-to) | 312-319 |
| Number of pages | 8 |
| Journal | EuroIntervention |
| Volume | 10 |
| Issue number | 3 |
| DOIs | |
| State | Published - Jan 1 2014 |
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Keywords
- Anticoagulants
- Balloon aortic valvuloplasty
- Bivalirudin
- Bleeding
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
Effect of bivalirudin on aortic valve intervention outcomes study : A two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty. / Kini, Annapoorna; Yu, Jennifer; Cohen, Mauricio G; Mehran, Roxana; Baber, Usman; Sartori, Samantha; Vlachojannis, Georgios J.; Kovacic, Jason C.; Pyo, Robert; O'Neill, Brian; Singh, Vikas; Jacobs, Evan; Poludasu, Shyam; Moreno, Pedro; Kim, Michael C.; Krishnan, Prakash; Sharma, Samin K.; Dangas, George D.
In: EuroIntervention, Vol. 10, No. 3, 01.01.2014, p. 312-319.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Effect of bivalirudin on aortic valve intervention outcomes study
T2 - A two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty
AU - Kini, Annapoorna
AU - Yu, Jennifer
AU - Cohen, Mauricio G
AU - Mehran, Roxana
AU - Baber, Usman
AU - Sartori, Samantha
AU - Vlachojannis, Georgios J.
AU - Kovacic, Jason C.
AU - Pyo, Robert
AU - O'Neill, Brian
AU - Singh, Vikas
AU - Jacobs, Evan
AU - Poludasu, Shyam
AU - Moreno, Pedro
AU - Kim, Michael C.
AU - Krishnan, Prakash
AU - Sharma, Samin K.
AU - Dangas, George D.
PY - 2014/1/1
Y1 - 2014/1/1
N2 - Aims: We sought to assess if bivalirudin use during balloon aortic valvuloplasty (BAV) would affect clinical outcomes compared with heparin. Methods and results: We compared the outcomes of consecutive patients who underwent elective or urgent BAV with intraprocedural use of bivalirudin or heparin at two high-volume centres. All in-hospital events post BAV were adjudicated by an independent, blinded clinical events committee. Of 427 patients, 223 patients (52.2%) received bivalirudin and 204 (47.8%) received heparin. Compared with patients who received heparin, patients who received bivalirudin had significantly less major bleeding (4.9% vs. 13.2%, p=0.003). Net adverse clinical events (NACE, major bleeding or major adverse cardiovascular events [MACE]) were also reduced (11.2% vs. 20.1%, p=0.01). There was no significant difference in the rates of MACE (mortality, myocardial infarction or stroke, 6.7% vs. 11.3%, p=0.1), or vascular complications (major, 2.7% vs. 2.0%; minor, 4.5% vs. 4.9%; p=0.83). After multivariate analysis controlling for vascular preclosure, the use of bivalirudin remained independently associated with reduced major bleeding (OR 0.37; 95% CI: 0.16 to 0.84; p=0.02) while the association was attenuated in propensity-adjusted analysis (OR 0.44, 95% CI: 0.18 to 1.07, p=0.08). Conclusions: In this registry of patients with severe aortic stenosis, bivalirudin as compared to heparin resulted in improved in-hospital outcomes post BAV in terms of reduced major bleeding, similar MACE and reduced NACE. If verified in a randomised study and extended to the transcatheter aortic valve implantation (TAVI) population, these results might indicate a potential benefit for patients undergoing such procedures.
AB - Aims: We sought to assess if bivalirudin use during balloon aortic valvuloplasty (BAV) would affect clinical outcomes compared with heparin. Methods and results: We compared the outcomes of consecutive patients who underwent elective or urgent BAV with intraprocedural use of bivalirudin or heparin at two high-volume centres. All in-hospital events post BAV were adjudicated by an independent, blinded clinical events committee. Of 427 patients, 223 patients (52.2%) received bivalirudin and 204 (47.8%) received heparin. Compared with patients who received heparin, patients who received bivalirudin had significantly less major bleeding (4.9% vs. 13.2%, p=0.003). Net adverse clinical events (NACE, major bleeding or major adverse cardiovascular events [MACE]) were also reduced (11.2% vs. 20.1%, p=0.01). There was no significant difference in the rates of MACE (mortality, myocardial infarction or stroke, 6.7% vs. 11.3%, p=0.1), or vascular complications (major, 2.7% vs. 2.0%; minor, 4.5% vs. 4.9%; p=0.83). After multivariate analysis controlling for vascular preclosure, the use of bivalirudin remained independently associated with reduced major bleeding (OR 0.37; 95% CI: 0.16 to 0.84; p=0.02) while the association was attenuated in propensity-adjusted analysis (OR 0.44, 95% CI: 0.18 to 1.07, p=0.08). Conclusions: In this registry of patients with severe aortic stenosis, bivalirudin as compared to heparin resulted in improved in-hospital outcomes post BAV in terms of reduced major bleeding, similar MACE and reduced NACE. If verified in a randomised study and extended to the transcatheter aortic valve implantation (TAVI) population, these results might indicate a potential benefit for patients undergoing such procedures.
KW - Anticoagulants
KW - Balloon aortic valvuloplasty
KW - Bivalirudin
KW - Bleeding
UR - http://www.scopus.com/inward/record.url?scp=84905509615&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84905509615&partnerID=8YFLogxK
U2 - 10.4244/EIJV10I3A54
DO - 10.4244/EIJV10I3A54
M3 - Article
C2 - 24273237
AN - SCOPUS:84905509615
VL - 10
SP - 312
EP - 319
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 3
ER -