Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry

Manel Sabaté, Salvatore Brugaletta, Alexandre Abizaid, Adrian Banning, Antonio Bartorelli, Vladimír Džavík, Stephen Ellis, David Holmes, Runlin Gao, Myung Ho Jeong, Victor Legrand, Franz Josef Neumann, Maria Nyakern, Christian Spaulding, Hans Peter Stoll, Stephen Worthley, Philip Urban

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. Methods A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months. Results The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 ± 9.9 vs.62.9 ± 10.7, P < 0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. The NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P < 0.04and P < 0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p = 0.4). Conclusions Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB.

Original languageEnglish (US)
Pages (from-to)2522-2527
Number of pages6
JournalInternational Journal of Cardiology
Volume168
Issue number3
DOIs
StatePublished - Oct 3 2013

Fingerprint

Drug-Eluting Stents
Vitamin K
Registries
Stents
Sirolimus
Therapeutics
Hemorrhage
Thrombosis
Pulmonary Embolism
Venous Thrombosis
Atrial Fibrillation
Cause of Death
Myocardial Infarction

Keywords

  • Anticoagulation
  • Antivitamin K therapy
  • Coronary stent
  • Drug-eluting stent
  • Hemorrhagic event
  • Sirolimus-eluting stent
  • Stent thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry. / Sabaté, Manel; Brugaletta, Salvatore; Abizaid, Alexandre; Banning, Adrian; Bartorelli, Antonio; Džavík, Vladimír; Ellis, Stephen; Holmes, David; Gao, Runlin; Jeong, Myung Ho; Legrand, Victor; Neumann, Franz Josef; Nyakern, Maria; Spaulding, Christian; Stoll, Hans Peter; Worthley, Stephen; Urban, Philip.

In: International Journal of Cardiology, Vol. 168, No. 3, 03.10.2013, p. 2522-2527.

Research output: Contribution to journalArticle

Sabaté, M, Brugaletta, S, Abizaid, A, Banning, A, Bartorelli, A, Džavík, V, Ellis, S, Holmes, D, Gao, R, Jeong, MH, Legrand, V, Neumann, FJ, Nyakern, M, Spaulding, C, Stoll, HP, Worthley, S & Urban, P 2013, 'Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry', International Journal of Cardiology, vol. 168, no. 3, pp. 2522-2527. https://doi.org/10.1016/j.ijcard.2013.03.064
Sabaté, Manel ; Brugaletta, Salvatore ; Abizaid, Alexandre ; Banning, Adrian ; Bartorelli, Antonio ; Džavík, Vladimír ; Ellis, Stephen ; Holmes, David ; Gao, Runlin ; Jeong, Myung Ho ; Legrand, Victor ; Neumann, Franz Josef ; Nyakern, Maria ; Spaulding, Christian ; Stoll, Hans Peter ; Worthley, Stephen ; Urban, Philip. / Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry. In: International Journal of Cardiology. 2013 ; Vol. 168, No. 3. pp. 2522-2527.
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abstract = "Background Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. Methods A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months. Results The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 ± 9.9 vs.62.9 ± 10.7, P < 0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8{\%}), presence of a prosthetic valve in 21 (7.1{\%}), embolization of cardiac origin in 17 (5.7{\%}), pulmonary embolism or deep vein thrombosis in 17 (5.7{\%}), and miscellaneous diagnoses in 64 (21.6{\%}) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. The NON-VKA group (8.3{\%} and 3{\%} vs. 5.3{\%} and 1.2{\%}, P < 0.04and P < 0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38{\%} vs. 1.1{\%}, p = 0.4). Conclusions Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB.",
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T1 - Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry

AU - Sabaté, Manel

AU - Brugaletta, Salvatore

AU - Abizaid, Alexandre

AU - Banning, Adrian

AU - Bartorelli, Antonio

AU - Džavík, Vladimír

AU - Ellis, Stephen

AU - Holmes, David

AU - Gao, Runlin

AU - Jeong, Myung Ho

AU - Legrand, Victor

AU - Neumann, Franz Josef

AU - Nyakern, Maria

AU - Spaulding, Christian

AU - Stoll, Hans Peter

AU - Worthley, Stephen

AU - Urban, Philip

PY - 2013/10/3

Y1 - 2013/10/3

N2 - Background Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. Methods A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months. Results The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 ± 9.9 vs.62.9 ± 10.7, P < 0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. The NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P < 0.04and P < 0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p = 0.4). Conclusions Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB.

AB - Background Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. Methods A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months. Results The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 ± 9.9 vs.62.9 ± 10.7, P < 0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. The NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P < 0.04and P < 0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p = 0.4). Conclusions Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB.

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KW - Antivitamin K therapy

KW - Coronary stent

KW - Drug-eluting stent

KW - Hemorrhagic event

KW - Sirolimus-eluting stent

KW - Stent thrombosis

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