Effect of bivalirudin on aortic valve intervention outcomes study: A two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty

Annapoorna Kini, Jennifer Yu, Mauricio G Cohen, Roxana Mehran, Usman Baber, Samantha Sartori, Georgios J. Vlachojannis, Jason C. Kovacic, Robert Pyo, Brian O'Neill, Vikas Singh, Evan Jacobs, Shyam Poludasu, Pedro Moreno, Michael C. Kim, Prakash Krishnan, Samin K. Sharma, George D. Dangas

Research output: Contribution to journalArticle

13 Citations (Scopus)

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 languageEnglish
Pages (from-to)312-319
Number of pages8
JournalEuroIntervention
Volume10
Issue number3
DOIs
StatePublished - Jan 1 2014

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Balloon Valvuloplasty
Aortic Valve
Registries
Heparin
Outcome Assessment (Health Care)
Hemorrhage
Blood Vessels
Aortic Valve Stenosis
bivalirudin
Multivariate Analysis
Stroke
Myocardial Infarction
Mortality

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 journalArticle

Kini, A, Yu, J, Cohen, MG, Mehran, R, Baber, U, Sartori, S, Vlachojannis, GJ, Kovacic, JC, Pyo, R, O'Neill, B, Singh, V, Jacobs, E, Poludasu, S, Moreno, P, Kim, MC, Krishnan, P, Sharma, SK & Dangas, GD 2014, 'Effect of bivalirudin on aortic valve intervention outcomes study: A two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty', EuroIntervention, vol. 10, no. 3, pp. 312-319. https://doi.org/10.4244/EIJV10I3A54
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. / Effect of bivalirudin on aortic valve intervention outcomes study : A two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty. In: EuroIntervention. 2014 ; Vol. 10, No. 3. pp. 312-319.
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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.",
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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.

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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

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