Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction

Gregg W. Stone, Jack L. Martin, Menko Jan De Boer, Massimo Margheri, Ezio Bramucci, James C. Blankenship, Christopher Metzger, Raymond J Gibbons, Barbara S. Lindsay, Bonnie H. Weiner, Alexandra J. Lansky, Mitchell W. Krucoff, Martin Fahy, W. John Boscardin

Research output: Contribution to journalArticle

62 Citations (Scopus)

Abstract

Background: Myocardial salvage is often suboptimal after percutaneous coronary intervention in ST-segment elevation myocardial infarction. Posthoc subgroup analysis from a previous trial (AMIHOT I) suggested that intracoronary delivery of supersaturated oxygen (SSO2) may reduce infarct size in patients with large ST-segment elevation myocardial infarction treated early. Methods and Results: A prospective, multicenter trial was performed in which 301 patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset were randomized to a 90-minute intracoronary SSO2 infusion in the left anterior descending artery infarct territory (n=222) or control (n=79). The primary efficacy measure was infarct size in the intention-to-treat population (powered for superiority), and the primary safety measure was composite major adverse cardiovascular events at 30 days in the intention-to-treat and per-protocol populations (powered for noninferiority), with Bayesian hierarchical modeling used to allow partial pooling of evidence from AMIHOT I. Among 281 randomized patients with tc-99m-sestamibi single-photon emission computed tomography data in AMIHOT II, median (interquartile range) infarct size was 26.5% (8.5%, 44%) with control compared with 20% (6%, 37%) after SSO 2. The pooled adjusted infarct size was 25% (7%, 42%) with control compared with 18.5% (3.5%, 34.5%) after SSO2 (PWilcoxon=0. 02; Bayesian posterior probability of superiority, 96.9%). The Bayesian pooled 30-day mean (±SE) rates of major adverse cardiovascular events were 5.0± 1.4% for control and 5.9± 1.4% for SSO2 by intention-to-treat, and 5.1 ± 1.5% for control and 4.7± 1.5% for SSO2 by per-protocol analysis (posterior probability of noninferiority, 99.5% and 99.9%, respectively). Conclusions: Among patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset, infusion of SSO 2 into the left anterior descending artery infarct territory results in a significant reduction in infarct size with noninferior rates of major adverse cardiovascular events at 30 days. Clinical Trial Registration: Clinicaltrials.gov Identifier: NCT00175058 (Circ Cardiovasc Intervent. 2009;2:366-375.)

Original languageEnglish (US)
Pages (from-to)366-375
Number of pages10
JournalCirculation: Cardiovascular Interventions
Volume2
Issue number5
DOIs
StatePublished - Oct 2009

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Percutaneous Coronary Intervention
Myocardial Infarction
Oxygen
Arteries
Single-Photon Emission-Computed Tomography
Population
Multicenter Studies
Clinical Trials
Safety
ST Elevation Myocardial Infarction

Keywords

  • Angioplasty
  • Infarct size
  • Myocardial infarction
  • Reperfusion

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. / Stone, Gregg W.; Martin, Jack L.; De Boer, Menko Jan; Margheri, Massimo; Bramucci, Ezio; Blankenship, James C.; Metzger, Christopher; Gibbons, Raymond J; Lindsay, Barbara S.; Weiner, Bonnie H.; Lansky, Alexandra J.; Krucoff, Mitchell W.; Fahy, Martin; Boscardin, W. John.

In: Circulation: Cardiovascular Interventions, Vol. 2, No. 5, 10.2009, p. 366-375.

Research output: Contribution to journalArticle

Stone, GW, Martin, JL, De Boer, MJ, Margheri, M, Bramucci, E, Blankenship, JC, Metzger, C, Gibbons, RJ, Lindsay, BS, Weiner, BH, Lansky, AJ, Krucoff, MW, Fahy, M & Boscardin, WJ 2009, 'Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction', Circulation: Cardiovascular Interventions, vol. 2, no. 5, pp. 366-375. https://doi.org/10.1161/CIRCINTERVENTIONS.108.840066
Stone, Gregg W. ; Martin, Jack L. ; De Boer, Menko Jan ; Margheri, Massimo ; Bramucci, Ezio ; Blankenship, James C. ; Metzger, Christopher ; Gibbons, Raymond J ; Lindsay, Barbara S. ; Weiner, Bonnie H. ; Lansky, Alexandra J. ; Krucoff, Mitchell W. ; Fahy, Martin ; Boscardin, W. John. / Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. In: Circulation: Cardiovascular Interventions. 2009 ; Vol. 2, No. 5. pp. 366-375.
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abstract = "Background: Myocardial salvage is often suboptimal after percutaneous coronary intervention in ST-segment elevation myocardial infarction. Posthoc subgroup analysis from a previous trial (AMIHOT I) suggested that intracoronary delivery of supersaturated oxygen (SSO2) may reduce infarct size in patients with large ST-segment elevation myocardial infarction treated early. Methods and Results: A prospective, multicenter trial was performed in which 301 patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset were randomized to a 90-minute intracoronary SSO2 infusion in the left anterior descending artery infarct territory (n=222) or control (n=79). The primary efficacy measure was infarct size in the intention-to-treat population (powered for superiority), and the primary safety measure was composite major adverse cardiovascular events at 30 days in the intention-to-treat and per-protocol populations (powered for noninferiority), with Bayesian hierarchical modeling used to allow partial pooling of evidence from AMIHOT I. Among 281 randomized patients with tc-99m-sestamibi single-photon emission computed tomography data in AMIHOT II, median (interquartile range) infarct size was 26.5{\%} (8.5{\%}, 44{\%}) with control compared with 20{\%} (6{\%}, 37{\%}) after SSO 2. The pooled adjusted infarct size was 25{\%} (7{\%}, 42{\%}) with control compared with 18.5{\%} (3.5{\%}, 34.5{\%}) after SSO2 (PWilcoxon=0. 02; Bayesian posterior probability of superiority, 96.9{\%}). The Bayesian pooled 30-day mean (±SE) rates of major adverse cardiovascular events were 5.0± 1.4{\%} for control and 5.9± 1.4{\%} for SSO2 by intention-to-treat, and 5.1 ± 1.5{\%} for control and 4.7± 1.5{\%} for SSO2 by per-protocol analysis (posterior probability of noninferiority, 99.5{\%} and 99.9{\%}, respectively). Conclusions: Among patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset, infusion of SSO 2 into the left anterior descending artery infarct territory results in a significant reduction in infarct size with noninferior rates of major adverse cardiovascular events at 30 days. Clinical Trial Registration: Clinicaltrials.gov Identifier: NCT00175058 (Circ Cardiovasc Intervent. 2009;2:366-375.)",
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T1 - Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction

AU - Stone, Gregg W.

AU - Martin, Jack L.

AU - De Boer, Menko Jan

AU - Margheri, Massimo

AU - Bramucci, Ezio

AU - Blankenship, James C.

AU - Metzger, Christopher

AU - Gibbons, Raymond J

AU - Lindsay, Barbara S.

AU - Weiner, Bonnie H.

AU - Lansky, Alexandra J.

AU - Krucoff, Mitchell W.

AU - Fahy, Martin

AU - Boscardin, W. John

PY - 2009/10

Y1 - 2009/10

N2 - Background: Myocardial salvage is often suboptimal after percutaneous coronary intervention in ST-segment elevation myocardial infarction. Posthoc subgroup analysis from a previous trial (AMIHOT I) suggested that intracoronary delivery of supersaturated oxygen (SSO2) may reduce infarct size in patients with large ST-segment elevation myocardial infarction treated early. Methods and Results: A prospective, multicenter trial was performed in which 301 patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset were randomized to a 90-minute intracoronary SSO2 infusion in the left anterior descending artery infarct territory (n=222) or control (n=79). The primary efficacy measure was infarct size in the intention-to-treat population (powered for superiority), and the primary safety measure was composite major adverse cardiovascular events at 30 days in the intention-to-treat and per-protocol populations (powered for noninferiority), with Bayesian hierarchical modeling used to allow partial pooling of evidence from AMIHOT I. Among 281 randomized patients with tc-99m-sestamibi single-photon emission computed tomography data in AMIHOT II, median (interquartile range) infarct size was 26.5% (8.5%, 44%) with control compared with 20% (6%, 37%) after SSO 2. The pooled adjusted infarct size was 25% (7%, 42%) with control compared with 18.5% (3.5%, 34.5%) after SSO2 (PWilcoxon=0. 02; Bayesian posterior probability of superiority, 96.9%). The Bayesian pooled 30-day mean (±SE) rates of major adverse cardiovascular events were 5.0± 1.4% for control and 5.9± 1.4% for SSO2 by intention-to-treat, and 5.1 ± 1.5% for control and 4.7± 1.5% for SSO2 by per-protocol analysis (posterior probability of noninferiority, 99.5% and 99.9%, respectively). Conclusions: Among patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset, infusion of SSO 2 into the left anterior descending artery infarct territory results in a significant reduction in infarct size with noninferior rates of major adverse cardiovascular events at 30 days. Clinical Trial Registration: Clinicaltrials.gov Identifier: NCT00175058 (Circ Cardiovasc Intervent. 2009;2:366-375.)

AB - Background: Myocardial salvage is often suboptimal after percutaneous coronary intervention in ST-segment elevation myocardial infarction. Posthoc subgroup analysis from a previous trial (AMIHOT I) suggested that intracoronary delivery of supersaturated oxygen (SSO2) may reduce infarct size in patients with large ST-segment elevation myocardial infarction treated early. Methods and Results: A prospective, multicenter trial was performed in which 301 patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset were randomized to a 90-minute intracoronary SSO2 infusion in the left anterior descending artery infarct territory (n=222) or control (n=79). The primary efficacy measure was infarct size in the intention-to-treat population (powered for superiority), and the primary safety measure was composite major adverse cardiovascular events at 30 days in the intention-to-treat and per-protocol populations (powered for noninferiority), with Bayesian hierarchical modeling used to allow partial pooling of evidence from AMIHOT I. Among 281 randomized patients with tc-99m-sestamibi single-photon emission computed tomography data in AMIHOT II, median (interquartile range) infarct size was 26.5% (8.5%, 44%) with control compared with 20% (6%, 37%) after SSO 2. The pooled adjusted infarct size was 25% (7%, 42%) with control compared with 18.5% (3.5%, 34.5%) after SSO2 (PWilcoxon=0. 02; Bayesian posterior probability of superiority, 96.9%). The Bayesian pooled 30-day mean (±SE) rates of major adverse cardiovascular events were 5.0± 1.4% for control and 5.9± 1.4% for SSO2 by intention-to-treat, and 5.1 ± 1.5% for control and 4.7± 1.5% for SSO2 by per-protocol analysis (posterior probability of noninferiority, 99.5% and 99.9%, respectively). Conclusions: Among patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset, infusion of SSO 2 into the left anterior descending artery infarct territory results in a significant reduction in infarct size with noninferior rates of major adverse cardiovascular events at 30 days. Clinical Trial Registration: Clinicaltrials.gov Identifier: NCT00175058 (Circ Cardiovasc Intervent. 2009;2:366-375.)

KW - Angioplasty

KW - Infarct size

KW - Myocardial infarction

KW - Reperfusion

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