Urgent surgery in patients with a recently implanted coronary drug-eluting stent

A phase II study of 'bridging' antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel

S. Savonitto, M. D'Urbano, M. Caracciolo, F. Barlocco, G. Mariani, M. Nichelatti, S. Klugmann, S. De Servi

Research output: Contribution to journalArticle

145 Citations (Scopus)

Abstract

BackgroundPatients with a recently implanted coronary drug-eluting stent (DES) who need urgent surgery are at increased risk of surgical bleeding unless clopidogrel is discontinued beforehand, but clopidogrel discontinuation has been associated with a high rate of adverse events due to stent thrombosis. This pilot study tested the hypothesis that the i.v. perioperative administration of the short-acting antiplatelet agent tirofiban allows the safe withdrawal of clopidogrel without increasing the rate of surgical bleeding.MethodsPhase II study with a Simon two-stage design.ResultsThirty patients with a recently implanted DES [median (range) 4 (1-12) months] and high-risk characteristics for stent thrombosis underwent urgent major surgery or eye surgery. Clopidogrel was to be withdrawn 5 days before surgery, and tirofiban started 24 h later, continued until 4 h before surgery, and resumed 2 h after surgery until oral clopidogrel was resumed. The use of aspirin was decided by the surgeon. There were no cases of death, myocardial infarction, stent thrombosis, or surgical re-exploration due to bleeding during the index admission, with a risk estimate of 0-11.6% (one-tail 97.5% CI). There was one case of thrombolysis in myocardial infarction (TIMI) major and one of TIMI minor bleeding in the postoperative phase; another four patients were transfused without meeting the TIMI criteria for major or minor bleeding.ConclusionsIn patients with a recently implanted DES and high-risk characteristics for stent thrombosis needing urgent surgery, a 'bridging strategy' using i.v. tirofiban may allow temporary withdrawal of oral clopidogrel without increasing the risk of bleeding.

Original languageEnglish
Pages (from-to)285-291
Number of pages7
JournalBritish Journal of Anaesthesia
Volume104
Issue number3
DOIs
Publication statusPublished - Mar 2010

Fingerprint

tirofiban
clopidogrel
Drug-Eluting Stents
Hemorrhage
Stents
Thrombosis
Myocardial Infarction
Therapeutics
Oral Surgery
Platelet Aggregation Inhibitors
Ambulatory Surgical Procedures
Aspirin

Keywords

  • Blood
  • Coagulation
  • Coronary occlusion
  • Heart
  • Preoperative period
  • Surgery

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

Cite this

Urgent surgery in patients with a recently implanted coronary drug-eluting stent : A phase II study of 'bridging' antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel. / Savonitto, S.; D'Urbano, M.; Caracciolo, M.; Barlocco, F.; Mariani, G.; Nichelatti, M.; Klugmann, S.; De Servi, S.

In: British Journal of Anaesthesia, Vol. 104, No. 3, 03.2010, p. 285-291.

Research output: Contribution to journalArticle

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title = "Urgent surgery in patients with a recently implanted coronary drug-eluting stent: A phase II study of 'bridging' antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel",
abstract = "BackgroundPatients with a recently implanted coronary drug-eluting stent (DES) who need urgent surgery are at increased risk of surgical bleeding unless clopidogrel is discontinued beforehand, but clopidogrel discontinuation has been associated with a high rate of adverse events due to stent thrombosis. This pilot study tested the hypothesis that the i.v. perioperative administration of the short-acting antiplatelet agent tirofiban allows the safe withdrawal of clopidogrel without increasing the rate of surgical bleeding.MethodsPhase II study with a Simon two-stage design.ResultsThirty patients with a recently implanted DES [median (range) 4 (1-12) months] and high-risk characteristics for stent thrombosis underwent urgent major surgery or eye surgery. Clopidogrel was to be withdrawn 5 days before surgery, and tirofiban started 24 h later, continued until 4 h before surgery, and resumed 2 h after surgery until oral clopidogrel was resumed. The use of aspirin was decided by the surgeon. There were no cases of death, myocardial infarction, stent thrombosis, or surgical re-exploration due to bleeding during the index admission, with a risk estimate of 0-11.6{\%} (one-tail 97.5{\%} CI). There was one case of thrombolysis in myocardial infarction (TIMI) major and one of TIMI minor bleeding in the postoperative phase; another four patients were transfused without meeting the TIMI criteria for major or minor bleeding.ConclusionsIn patients with a recently implanted DES and high-risk characteristics for stent thrombosis needing urgent surgery, a 'bridging strategy' using i.v. tirofiban may allow temporary withdrawal of oral clopidogrel without increasing the risk of bleeding.",
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T2 - A phase II study of 'bridging' antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel

AU - Savonitto, S.

AU - D'Urbano, M.

AU - Caracciolo, M.

AU - Barlocco, F.

AU - Mariani, G.

AU - Nichelatti, M.

AU - Klugmann, S.

AU - De Servi, S.

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N2 - BackgroundPatients with a recently implanted coronary drug-eluting stent (DES) who need urgent surgery are at increased risk of surgical bleeding unless clopidogrel is discontinued beforehand, but clopidogrel discontinuation has been associated with a high rate of adverse events due to stent thrombosis. This pilot study tested the hypothesis that the i.v. perioperative administration of the short-acting antiplatelet agent tirofiban allows the safe withdrawal of clopidogrel without increasing the rate of surgical bleeding.MethodsPhase II study with a Simon two-stage design.ResultsThirty patients with a recently implanted DES [median (range) 4 (1-12) months] and high-risk characteristics for stent thrombosis underwent urgent major surgery or eye surgery. Clopidogrel was to be withdrawn 5 days before surgery, and tirofiban started 24 h later, continued until 4 h before surgery, and resumed 2 h after surgery until oral clopidogrel was resumed. The use of aspirin was decided by the surgeon. There were no cases of death, myocardial infarction, stent thrombosis, or surgical re-exploration due to bleeding during the index admission, with a risk estimate of 0-11.6% (one-tail 97.5% CI). There was one case of thrombolysis in myocardial infarction (TIMI) major and one of TIMI minor bleeding in the postoperative phase; another four patients were transfused without meeting the TIMI criteria for major or minor bleeding.ConclusionsIn patients with a recently implanted DES and high-risk characteristics for stent thrombosis needing urgent surgery, a 'bridging strategy' using i.v. tirofiban may allow temporary withdrawal of oral clopidogrel without increasing the risk of bleeding.

AB - BackgroundPatients with a recently implanted coronary drug-eluting stent (DES) who need urgent surgery are at increased risk of surgical bleeding unless clopidogrel is discontinued beforehand, but clopidogrel discontinuation has been associated with a high rate of adverse events due to stent thrombosis. This pilot study tested the hypothesis that the i.v. perioperative administration of the short-acting antiplatelet agent tirofiban allows the safe withdrawal of clopidogrel without increasing the rate of surgical bleeding.MethodsPhase II study with a Simon two-stage design.ResultsThirty patients with a recently implanted DES [median (range) 4 (1-12) months] and high-risk characteristics for stent thrombosis underwent urgent major surgery or eye surgery. Clopidogrel was to be withdrawn 5 days before surgery, and tirofiban started 24 h later, continued until 4 h before surgery, and resumed 2 h after surgery until oral clopidogrel was resumed. The use of aspirin was decided by the surgeon. There were no cases of death, myocardial infarction, stent thrombosis, or surgical re-exploration due to bleeding during the index admission, with a risk estimate of 0-11.6% (one-tail 97.5% CI). There was one case of thrombolysis in myocardial infarction (TIMI) major and one of TIMI minor bleeding in the postoperative phase; another four patients were transfused without meeting the TIMI criteria for major or minor bleeding.ConclusionsIn patients with a recently implanted DES and high-risk characteristics for stent thrombosis needing urgent surgery, a 'bridging strategy' using i.v. tirofiban may allow temporary withdrawal of oral clopidogrel without increasing the risk of bleeding.

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KW - Coagulation

KW - Coronary occlusion

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KW - Preoperative period

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