Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation

Jorn Brouwer; Vincent J. Nijenhuis; Ronak Delewi; Renicus S. Hermanides; Wouter Holvoet; Christophe L. F. Dubois; Peter Frambach; Bernard De Bruyne; Gert K. van Houwelingen; Jan A. S. Van der Heyden; Petr Tousek; Frank van der Kley; Ian Buysschaert; Carl E. Schotborgh; Bert Ferdinande; Pim van der Harst; John Roosen; Joyce Peper; Frederick W. F. Thielen; Leo Veenstra; Dean R. P. P. Chan Pin Yin; Martin J. Swaans; Benno J. W. M. Rensing; Arnoud W. J. van 't Hof; Leo Timmers; Johannes C. Kelder; Pieter R. Stella; Jan Baan; Jurrien M. ten Berg

doi:10.1056/nejmoa2017815

Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation

Jorn Brouwer^*, Vincent J. Nijenhuis, Ronak Delewi, Renicus S. Hermanides, Wouter Holvoet, Christophe L. F. Dubois, Peter Frambach, Bernard De Bruyne, Gert K. van Houwelingen, Jan A. S. Van der Heyden, Petr Tousek, Frank van der Kley, Ian Buysschaert, Carl E. Schotborgh, Bert Ferdinande, Pim van der Harst, John Roosen, Joyce Peper, Frederick W. F. Thielen, Leo VeenstraDean R. P. P. Chan Pin Yin, Martin J. Swaans, Benno J. W. M. Rensing, Arnoud W. J. van 't Hof, Leo Timmers, Johannes C. Kelder, Pieter R. Stella, Jan Baan, Jurrien M. ten Berg

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

123 Citations (Web of Science)

Abstract

BACKGROUND

The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.

METHODS

In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.

RESULTS

A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P=0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P=0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P

CONCLUSIONS

Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months.

Original language	English
Pages (from-to)	1447-1457
Number of pages	11
Journal	New England Journal of Medicine
Volume	383
Issue number	15
DOIs	https://doi.org/10.1056/nejmoa2017815
Publication status	Published - 8 Oct 2020

Keywords

DUAL ANTIPLATELET THERAPY
REPLACEMENT
RISK
DEFINITIONS
TAVI
METAANALYSIS
OUTCOMES
DISEASE
ESC

Access to Document

10.1056/nejmoa2017815

Cite this

Brouwer, J., Nijenhuis, V. J., Delewi, R., Hermanides, R. S., Holvoet, W., Dubois, C. L. F., Frambach, P., De Bruyne, B., van Houwelingen, G. K., Van der Heyden, J. A. S., Tousek, P., van der Kley, F., Buysschaert, I., Schotborgh, C. E., Ferdinande, B., van der Harst, P., Roosen, J., Peper, J., Thielen, F. W. F., ... ten Berg, J. M. (2020). Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. New England Journal of Medicine, 383(15), 1447-1457. https://doi.org/10.1056/nejmoa2017815

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title = "Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation",

abstract = "BACKGROUNDThe effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.METHODSIn a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.RESULTSA total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P=0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P=0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; PCONCLUSIONSAmong patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months.",

keywords = "DUAL ANTIPLATELET THERAPY, REPLACEMENT, RISK, DEFINITIONS, TAVI, METAANALYSIS, OUTCOMES, DISEASE, ESC",

author = "Jorn Brouwer and Nijenhuis, {Vincent J.} and Ronak Delewi and Hermanides, {Renicus S.} and Wouter Holvoet and Dubois, {Christophe L. F.} and Peter Frambach and {De Bruyne}, Bernard and {van Houwelingen}, {Gert K.} and {Van der Heyden}, {Jan A. S.} and Petr Tousek and {van der Kley}, Frank and Ian Buysschaert and Schotborgh, {Carl E.} and Bert Ferdinande and {van der Harst}, Pim and John Roosen and Joyce Peper and Thielen, {Frederick W. F.} and Leo Veenstra and Yin, {Dean R. P. P. Chan Pin} and Swaans, {Martin J.} and Rensing, {Benno J. W. M.} and {van 't Hof}, {Arnoud W. J.} and Leo Timmers and Kelder, {Johannes C.} and Stella, {Pieter R.} and Jan Baan and {ten Berg}, {Jurrien M.}",

year = "2020",

month = oct,

day = "8",

doi = "10.1056/nejmoa2017815",

language = "English",

volume = "383",

pages = "1447--1457",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOCIETY",

number = "15",

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Brouwer, J , Nijenhuis, VJ, Delewi, R, Hermanides, RS, Holvoet, W, Dubois, CLF, Frambach, P, De Bruyne, B, van Houwelingen, GK, Van der Heyden, JAS, Tousek, P, van der Kley, F, Buysschaert, I, Schotborgh, CE, Ferdinande, B, van der Harst, P, Roosen, J, Peper, J, Thielen, FWF, Veenstra, L, Yin, DRPPCP, Swaans, MJ, Rensing, BJWM, van 't Hof, AWJ, Timmers, L, Kelder, JC, Stella, PR, Baan, J & ten Berg, JM 2020, 'Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation', New England Journal of Medicine, vol. 383, no. 15, pp. 1447-1457. https://doi.org/10.1056/nejmoa2017815

TY - JOUR

T1 - Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation

AU - Brouwer, Jorn

AU - Nijenhuis, Vincent J.

AU - Delewi, Ronak

AU - Hermanides, Renicus S.

AU - Holvoet, Wouter

AU - Dubois, Christophe L. F.

AU - Frambach, Peter

AU - De Bruyne, Bernard

AU - van Houwelingen, Gert K.

AU - Van der Heyden, Jan A. S.

AU - Tousek, Petr

AU - van der Kley, Frank

AU - Buysschaert, Ian

AU - Schotborgh, Carl E.

AU - Ferdinande, Bert

AU - van der Harst, Pim

AU - Roosen, John

AU - Peper, Joyce

AU - Thielen, Frederick W. F.

AU - Veenstra, Leo

AU - Yin, Dean R. P. P. Chan Pin

AU - Swaans, Martin J.

AU - Rensing, Benno J. W. M.

AU - van 't Hof, Arnoud W. J.

AU - Timmers, Leo

AU - Kelder, Johannes C.

AU - Stella, Pieter R.

AU - Baan, Jan

AU - ten Berg, Jurrien M.

PY - 2020/10/8

Y1 - 2020/10/8

N2 - BACKGROUNDThe effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.METHODSIn a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.RESULTSA total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P=0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P=0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; PCONCLUSIONSAmong patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months.

AB - BACKGROUNDThe effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.METHODSIn a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.RESULTSA total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P=0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P=0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; PCONCLUSIONSAmong patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months.

KW - DUAL ANTIPLATELET THERAPY

KW - REPLACEMENT

KW - RISK

KW - DEFINITIONS

KW - TAVI

KW - METAANALYSIS

KW - OUTCOMES

KW - DISEASE

KW - ESC

U2 - 10.1056/nejmoa2017815

DO - 10.1056/nejmoa2017815

M3 - Article

C2 - 32865376

VL - 383

SP - 1447

EP - 1457

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 15

ER -