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N-of-1 Trial of Angina Verification Before Percutaneous Coronary Intervention.
Rajkumar, Christopher A; Foley, Michael J; Ahmed-Jushuf, Fiyyaz; Simader, Florentina A; Mohsin, Muhammad; Ganesananthan, Sashiananthan; Nowbar, Alexandra N; Chotai, Shayna; Sen, Sayan; Petraco, Ricardo; Nijjer, Sukhjinder S; Sehmi, Joban; Ruparelia, Neil; Dungu, Jason N; Kabir, Alamgir; Tang, Kare; Gamma, Reto; Davies, John R; Kotecha, Tushar; Cole, Graham D; Howard, James P; Keeble, Thomas R; Clesham, Gerald; O'Kane, Peter D; Harrell, Frank E; Francis, Darrel P; Shun-Shin, Matthew J; Al-Lamee, Rasha K.
Afiliación
  • Rajkumar CA; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom. Electronic address: https://twitter.com/rajkumar_chris.
  • Foley MJ; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Ahmed-Jushuf F; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Simader FA; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Mohsin M; National Heart and Lung Institute, Imperial College London, London, United Kingdom.
  • Ganesananthan S; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Nowbar AN; Barking Havering and Redbridge University Hospitals NHS Trust, London, United Kingdom.
  • Chotai S; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Sen S; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Petraco R; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Nijjer SS; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Sehmi J; West Hertfordshire Hospitals NHS Trust, Watford, United Kingdom.
  • Ruparelia N; Imperial College Healthcare NHS Trust, London, United Kingdom; Royal Berkshire NHS Foundation Trust, Reading, United Kingdom.
  • Dungu JN; Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom; Anglia Ruskin University, Chelmsford, United Kingdom.
  • Kabir A; Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom.
  • Tang K; Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom.
  • Gamma R; Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom.
  • Davies JR; Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom; Anglia Ruskin University, Chelmsford, United Kingdom.
  • Kotecha T; Royal Free London NHS Foundation Trust, London, United Kingdom.
  • Cole GD; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Howard JP; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Keeble TR; Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom; Anglia Ruskin University, Chelmsford, United Kingdom.
  • Clesham G; Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom; Anglia Ruskin University, Chelmsford, United Kingdom.
  • O'Kane PD; University Hospitals Dorset NHS Foundation Trust, Bournemouth, United Kingdom.
  • Harrell FE; Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
  • Francis DP; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Shun-Shin MJ; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom.
  • Al-Lamee RK; National Heart and Lung Institute, Imperial College London, London, United Kingdom; Imperial College Healthcare NHS Trust, London, United Kingdom. Electronic address: r.al-lamee13@imperial.ac.uk.
J Am Coll Cardiol ; 84(1): 1-12, 2024 Jul 02.
Article en En | MEDLINE | ID: mdl-38752902
ABSTRACT

BACKGROUND:

In stable coronary artery disease, 30% to 60% of patients remain symptomatic despite successful revascularization. Perhaps not all symptoms reported by a patient with myocardial ischemia are, in fact, angina.

OBJECTIVES:

This study sought to determine whether independent symptom verification using a placebo-controlled ischemic stimulus could distinguish which patients achieve greatest symptom relief from percutaneous coronary intervention (PCI).

METHODS:

ORBITA-STAR was a multicenter, n-of-1, placebo-controlled study in patients undergoing single-vessel PCI for stable symptoms. Participants underwent 4 episodes (60 seconds each) of low-pressure balloon occlusion across their coronary stenosis, randomly paired with 4 episodes of placebo inflation. Following each episode, patients reported the similarity of the induced symptom in comparison with their usual symptom. The similarity score ranged from -10 (placebo replicated the symptom more than balloon occlusion) to +10 (balloon occlusion exactly replicated the symptom). The primary endpoint was the ability of the similarity score to predict symptom relief with PCI.

RESULTS:

Fifty-one patients were recruited, aged 62.9 ± 8.6 years. The median fractional flow reserve was 0.68 (Q1-Q3 0.57-0.79), and the instantaneous wave-free ratio was 0.80 (Q1-Q3 0.48-0.89). The median similarity score was 3 (Q1-Q3 0.875-5.25). The similarity score was a strong predictor of symptom improvement following PCI a patient with an upper quartile similarity score of 5.25 was significantly more likely to have lower angina frequency at follow-up (OR 8.01; 95% credible interval 2.39-15.86) than a patient with a lower quartile similarity score of 0.875 (OR 1.31; 95% credible interval 0.71-1.99), Pr(difference) >99.9%.

CONCLUSIONS:

Similarity score powerfully predicted symptom improvement from PCI. These data lay the foundation for independent symptom mapping to target PCI to those patients most likely to benefit. (Systematic Trial of Angina Assessment Before Revascularization [ORBITA-STAR]; NCT04280575).
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Intervención Coronaria Percutánea / Angina de Pecho Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Am Coll Cardiol Año: 2024 Tipo del documento: Article

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Intervención Coronaria Percutánea / Angina de Pecho Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Am Coll Cardiol Año: 2024 Tipo del documento: Article