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(WFRF:(Steg Philippe Gabriel)) srt2:(2015-2019) srt2:(2019) pers:(Bhatt Deepak L)
 

Sökning: (WFRF:(Steg Philippe Gabriel)) srt2:(2015-2019) srt2:(2019) pers:(Bhatt Deepak L) > Ticagrelor in patie...

  • Bhatt, Deepak L.Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA;Harvard Med Sch, Boston, MA 02115 USA (författare)

Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI) : a phase 3, placebo-controlled, randomised trial

  • Artikel/kapitelEngelska2019

Förlag, utgivningsår, omfång ...

  • 2019
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-396662
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-396662URI
  • https://doi.org/10.1016/S0140-6736(19)31887-2DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

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Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Background Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor.Methods The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria:a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population).Findings Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3.3 years (IQR 2.8-3.8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7.3%] of 5558 vs 480 [8.6%] of 5596; HR 0.85 [95% CI 0.74-0.97], p=0.013). The same effect was not observed in patients without PCI (p=0.76, p(interaction)=0.16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3.1%] with ticagrelor vs 183 (3.3%) with placebo; HR 0.96 [95% CI 0.78-1.18], p=0.68), as well as all-cause death (282 [5.1%] vs 323 [5.8%]; 0.88 [0.75-1.03], p=0.11). TIMI major bleeding occurred in 111 (2.0%) of 5536 patients receiving ticagrelor and 62 (1.1%) of 5564 patients receiving placebo (HR 2.03 [95% CI 1.48-2.76], p<0.0001), and fatal bleeding in 6 (0.1%) of 5536 patients with ticagrelor and 6 (0.1%) of 5564 with placebo (1.13 [0.36-3.50], p=0.83). Intracranial haemorrhage occurred in 33 (0.6%) and 31 (0.6%) patients (1.21 [0.74-1.97], p=0.45). Ticagrelor improved net clinical benefit:519/5558 (9.3%) versus 617/5596 (11.0%), HR=0.85, 95% CI 0.75-0.95, p=0.005, in contrast to patients without PCI where it did not, p(interaction)=0.012. Benefit was present irrespective of time from most recent PCI.Interpretation In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Steg, Philippe GabrielUniv Paris, Hop Bichat, AP HP,INSERM,U1148, French Alliance Cardiovasc Trials,Dept Hosp Univ, Paris, France;Royal Brompton Hosp, Natl Heart & Lung Inst, London, England (författare)
  • Mehta, Shamir R.Hamilton Hlth Sci, Populat Hlth Res Inst, Hamilton, ON, Canada;McMaster Univ, Hamilton, ON, Canada (författare)
  • Leiter, Lawrence A.Univ Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Toronto, ON, Canada (författare)
  • Simon, TabassomeSorbonne Univ, Hop St Antoine, AP HP, Dept Clin Pharmacol,Clin Res Platform URCEST CRB, Paris, France (författare)
  • Fox, KimRoyal Brompton Hosp, Natl Heart & Lung Inst, London, England (författare)
  • Held, Claes,1956-Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi(Swepub:uu)clahe947 (författare)
  • Andersson, MarielleAstraZeneca BioPharmaceut Res & Dev, Late Stage Dev, Cardiovasc Renal & Metab, Molndal, Sweden (författare)
  • Himmelmann, AndersAstraZeneca BioPharmaceut Res & Dev, Late Stage Dev, Cardiovasc Renal & Metab, Molndal, Sweden (författare)
  • Ridderstrale, WilhelmAstraZeneca BioPharmaceut Res & Dev, Late Stage Dev, Cardiovasc Renal & Metab, Molndal, Sweden (författare)
  • Chen, JerseyAstraZeneca BioPharmaceut Res & Dev, Late Stage Dev, Cardiovasc Renal & Metab, Gaithersburg, MD USA (författare)
  • Song, YangBaim Inst Clin Res, Boston, MA USA (författare)
  • Diaz, RafaelEstudios Clin Latino Amer, Dept Med, Rosario, Santa Fe, Argentina (författare)
  • Goto, ShinyaTokai Univ, Sch Med, Dept Med Cardiol, Isehara, Kanagawa, Japan (författare)
  • James, Stefan K,1964-Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)stjam367 (författare)
  • Ray, Kausik K.Imperial Coll London, Dept Primary Care & Publ Hlth, Imperial Ctr Cardiovasc Dis Prevent, London, England (författare)
  • Parkhomenko, Alexander N.Inst Cardiol, Emergency Cardiol Dept, Kiev, Ukraine (författare)
  • Kosiborod, Mikhail N.Univ Missouri Kansas City, St Lukes Mid Amer Heart Inst, Kansas City, MO USA;Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia (författare)
  • McGuire, Darren K.Univ Texas Southwestern Med Ctr Dallas, Dallas, TX 75390 USA (författare)
  • Harrington, Robert A.Stanford Univ, Dept Med, Stanford, CA 94305 USA (författare)
  • Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA;Harvard Med Sch, Boston, MA 02115 USAUniv Paris, Hop Bichat, AP HP,INSERM,U1148, French Alliance Cardiovasc Trials,Dept Hosp Univ, Paris, France;Royal Brompton Hosp, Natl Heart & Lung Inst, London, England (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:The Lancet394:10204, s. 1169-11800140-67361474-547X

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