Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome

Matthew T. Roe, Derek D. Cyr, Debra Eckart, Phillip Schulte, Michael A. Morse, Kimberly L. Blackwell, Neal E. Ready, S. Yousuf Zafar, Anne W. Beaven, John H. Strickler, Jane E. Onken, Kenneth J. Winters, Lisa Houterloot, Dmitry Zamoryakhin, Stephen D. Wiviott, Harvey D. White, Dorairaj Prabhakaran, Keith A A Fox, Paul W. Armstrong, E. Magnus Ohman

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Aims Studies have suggested increased cancer incidence associated with long-term dual antiplatelet therapy (DAPT) for acute coronary syndrome (ACS). We evaluated cancer incidence and treatment-related differences in an analysis of DAPT for ACS. Methods and results The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial enrolled 9326 participants with ACS, who received aspirin plus clopidogrel or prasugrel. Median treatment exposure was 15 months. Cancer history and screening procedures were collected. Suspected non-benign neoplasm events were reported and adjudicated. The primary outcome was detection of new, non-benign neoplasm. Factors associated with neoplasm events, the relationship of these events to cardiovascular and bleeding endpoints, and treatment-related differences in neoplasm detection were studied. Among 9240 participants who received ≥1 dose of study drug, 1.8% had a confirmed neoplasm event. The efficacy composite of cardiovascular death, myocardial infarction, or stroke occurred more frequently among those with a neoplasm event vs. those without (18.2 vs. 13.5%) as did Global Use of Strategies to Open Occluded Coronary Arteries severe/moderate bleeding (11.2 vs. 1.5%). Screening rates were substantially higher in North America and Western Europe/Scandinavia vs. other regions. Factors most strongly associated with detection of neoplasm events were older age, region, male sex, and current/recent smoking. Among the pre-specified population without a history of neoplasm or previous curative treatment for neoplasm (n = 9105), the incidence of neoplasm events was similar with prasugrel vs. clopidogrel (1.8 vs. 1.7%; HR = 1.04; 95% CI 0.77-1.42; P = 0.79). Conclusions Neoplasm events were infrequent during long-term DAPT after ACS, were associated with differential cancer-screening practices across regions, and the frequency of neoplasm detection was similar with prasugrel vs. clopidogrel.

Original languageEnglish (US)
Pages (from-to)412-422
Number of pages11
JournalEuropean Heart Journal
Volume37
Issue number4
DOIs
StatePublished - Jan 21 2016
Externally publishedYes

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clopidogrel
Acute Coronary Syndrome
Neoplasms
Therapeutics
Early Detection of Cancer
Prasugrel Hydrochloride
Incidence
Hemorrhage

Keywords

  • Acute coronary syndrome
  • Adjudication
  • Antiplatelet drugs
  • Clinical trial
  • Clopidogrel
  • Neoplasm
  • Prasugrel
  • Surveillance

ASJC Scopus subject areas

  • Medicine(all)
  • Cardiology and Cardiovascular Medicine

Cite this

Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. / Roe, Matthew T.; Cyr, Derek D.; Eckart, Debra; Schulte, Phillip; Morse, Michael A.; Blackwell, Kimberly L.; Ready, Neal E.; Zafar, S. Yousuf; Beaven, Anne W.; Strickler, John H.; Onken, Jane E.; Winters, Kenneth J.; Houterloot, Lisa; Zamoryakhin, Dmitry; Wiviott, Stephen D.; White, Harvey D.; Prabhakaran, Dorairaj; Fox, Keith A A; Armstrong, Paul W.; Ohman, E. Magnus.

In: European Heart Journal, Vol. 37, No. 4, 21.01.2016, p. 412-422.

Research output: Contribution to journalArticle

Roe, MT, Cyr, DD, Eckart, D, Schulte, P, Morse, MA, Blackwell, KL, Ready, NE, Zafar, SY, Beaven, AW, Strickler, JH, Onken, JE, Winters, KJ, Houterloot, L, Zamoryakhin, D, Wiviott, SD, White, HD, Prabhakaran, D, Fox, KAA, Armstrong, PW & Ohman, EM 2016, 'Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome', European Heart Journal, vol. 37, no. 4, pp. 412-422. https://doi.org/10.1093/eurheartj/ehv611
Roe, Matthew T. ; Cyr, Derek D. ; Eckart, Debra ; Schulte, Phillip ; Morse, Michael A. ; Blackwell, Kimberly L. ; Ready, Neal E. ; Zafar, S. Yousuf ; Beaven, Anne W. ; Strickler, John H. ; Onken, Jane E. ; Winters, Kenneth J. ; Houterloot, Lisa ; Zamoryakhin, Dmitry ; Wiviott, Stephen D. ; White, Harvey D. ; Prabhakaran, Dorairaj ; Fox, Keith A A ; Armstrong, Paul W. ; Ohman, E. Magnus. / Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. In: European Heart Journal. 2016 ; Vol. 37, No. 4. pp. 412-422.
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abstract = "Aims Studies have suggested increased cancer incidence associated with long-term dual antiplatelet therapy (DAPT) for acute coronary syndrome (ACS). We evaluated cancer incidence and treatment-related differences in an analysis of DAPT for ACS. Methods and results The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial enrolled 9326 participants with ACS, who received aspirin plus clopidogrel or prasugrel. Median treatment exposure was 15 months. Cancer history and screening procedures were collected. Suspected non-benign neoplasm events were reported and adjudicated. The primary outcome was detection of new, non-benign neoplasm. Factors associated with neoplasm events, the relationship of these events to cardiovascular and bleeding endpoints, and treatment-related differences in neoplasm detection were studied. Among 9240 participants who received ≥1 dose of study drug, 1.8{\%} had a confirmed neoplasm event. The efficacy composite of cardiovascular death, myocardial infarction, or stroke occurred more frequently among those with a neoplasm event vs. those without (18.2 vs. 13.5{\%}) as did Global Use of Strategies to Open Occluded Coronary Arteries severe/moderate bleeding (11.2 vs. 1.5{\%}). Screening rates were substantially higher in North America and Western Europe/Scandinavia vs. other regions. Factors most strongly associated with detection of neoplasm events were older age, region, male sex, and current/recent smoking. Among the pre-specified population without a history of neoplasm or previous curative treatment for neoplasm (n = 9105), the incidence of neoplasm events was similar with prasugrel vs. clopidogrel (1.8 vs. 1.7{\%}; HR = 1.04; 95{\%} CI 0.77-1.42; P = 0.79). Conclusions Neoplasm events were infrequent during long-term DAPT after ACS, were associated with differential cancer-screening practices across regions, and the frequency of neoplasm detection was similar with prasugrel vs. clopidogrel.",
keywords = "Acute coronary syndrome, Adjudication, Antiplatelet drugs, Clinical trial, Clopidogrel, Neoplasm, Prasugrel, Surveillance",
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T1 - Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome

AU - Roe, Matthew T.

AU - Cyr, Derek D.

AU - Eckart, Debra

AU - Schulte, Phillip

AU - Morse, Michael A.

AU - Blackwell, Kimberly L.

AU - Ready, Neal E.

AU - Zafar, S. Yousuf

AU - Beaven, Anne W.

AU - Strickler, John H.

AU - Onken, Jane E.

AU - Winters, Kenneth J.

AU - Houterloot, Lisa

AU - Zamoryakhin, Dmitry

AU - Wiviott, Stephen D.

AU - White, Harvey D.

AU - Prabhakaran, Dorairaj

AU - Fox, Keith A A

AU - Armstrong, Paul W.

AU - Ohman, E. Magnus

PY - 2016/1/21

Y1 - 2016/1/21

N2 - Aims Studies have suggested increased cancer incidence associated with long-term dual antiplatelet therapy (DAPT) for acute coronary syndrome (ACS). We evaluated cancer incidence and treatment-related differences in an analysis of DAPT for ACS. Methods and results The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial enrolled 9326 participants with ACS, who received aspirin plus clopidogrel or prasugrel. Median treatment exposure was 15 months. Cancer history and screening procedures were collected. Suspected non-benign neoplasm events were reported and adjudicated. The primary outcome was detection of new, non-benign neoplasm. Factors associated with neoplasm events, the relationship of these events to cardiovascular and bleeding endpoints, and treatment-related differences in neoplasm detection were studied. Among 9240 participants who received ≥1 dose of study drug, 1.8% had a confirmed neoplasm event. The efficacy composite of cardiovascular death, myocardial infarction, or stroke occurred more frequently among those with a neoplasm event vs. those without (18.2 vs. 13.5%) as did Global Use of Strategies to Open Occluded Coronary Arteries severe/moderate bleeding (11.2 vs. 1.5%). Screening rates were substantially higher in North America and Western Europe/Scandinavia vs. other regions. Factors most strongly associated with detection of neoplasm events were older age, region, male sex, and current/recent smoking. Among the pre-specified population without a history of neoplasm or previous curative treatment for neoplasm (n = 9105), the incidence of neoplasm events was similar with prasugrel vs. clopidogrel (1.8 vs. 1.7%; HR = 1.04; 95% CI 0.77-1.42; P = 0.79). Conclusions Neoplasm events were infrequent during long-term DAPT after ACS, were associated with differential cancer-screening practices across regions, and the frequency of neoplasm detection was similar with prasugrel vs. clopidogrel.

AB - Aims Studies have suggested increased cancer incidence associated with long-term dual antiplatelet therapy (DAPT) for acute coronary syndrome (ACS). We evaluated cancer incidence and treatment-related differences in an analysis of DAPT for ACS. Methods and results The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial enrolled 9326 participants with ACS, who received aspirin plus clopidogrel or prasugrel. Median treatment exposure was 15 months. Cancer history and screening procedures were collected. Suspected non-benign neoplasm events were reported and adjudicated. The primary outcome was detection of new, non-benign neoplasm. Factors associated with neoplasm events, the relationship of these events to cardiovascular and bleeding endpoints, and treatment-related differences in neoplasm detection were studied. Among 9240 participants who received ≥1 dose of study drug, 1.8% had a confirmed neoplasm event. The efficacy composite of cardiovascular death, myocardial infarction, or stroke occurred more frequently among those with a neoplasm event vs. those without (18.2 vs. 13.5%) as did Global Use of Strategies to Open Occluded Coronary Arteries severe/moderate bleeding (11.2 vs. 1.5%). Screening rates were substantially higher in North America and Western Europe/Scandinavia vs. other regions. Factors most strongly associated with detection of neoplasm events were older age, region, male sex, and current/recent smoking. Among the pre-specified population without a history of neoplasm or previous curative treatment for neoplasm (n = 9105), the incidence of neoplasm events was similar with prasugrel vs. clopidogrel (1.8 vs. 1.7%; HR = 1.04; 95% CI 0.77-1.42; P = 0.79). Conclusions Neoplasm events were infrequent during long-term DAPT after ACS, were associated with differential cancer-screening practices across regions, and the frequency of neoplasm detection was similar with prasugrel vs. clopidogrel.

KW - Acute coronary syndrome

KW - Adjudication

KW - Antiplatelet drugs

KW - Clinical trial

KW - Clopidogrel

KW - Neoplasm

KW - Prasugrel

KW - Surveillance

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