A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
21 Dec 2023
21 Dec 2023
Historique:
medline:
22
12
2023
pubmed:
28
11
2023
entrez:
28
11
2023
Statut:
ppublish
Résumé
Percutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown. We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina. A total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group. Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.).
Sections du résumé
BACKGROUND
BACKGROUND
Percutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown.
METHODS
METHODS
We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina.
RESULTS
RESULTS
A total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group.
CONCLUSIONS
CONCLUSIONS
Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.).
Identifiants
pubmed: 38015442
doi: 10.1056/NEJMoa2310610
pmc: PMC7615400
mid: EMS190971
doi:
Substances chimiques
Cardiovascular Agents
0
Banques de données
ClinicalTrials.gov
['NCT03742050']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2319-2330Subventions
Organisme : Medical Research Council
ID : MR/V001620/1
Pays : United Kingdom
Organisme : British Heart Foundation
ID : FS/ICRF/22/26039
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/S021108/1
Pays : United Kingdom
Organisme : British Heart Foundation
ID : FS/17/16/32560
Pays : United Kingdom
Organisme : British Heart Foundation
ID : FS/ICRF/22/26051
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/W000520/1
Pays : United Kingdom
Investigateurs
Christopher Rajkumar
(C)
Michael Foley
(M)
Fiyyaz Ahmed-Jushuf
(F)
Florentina Simader
(F)
Sashiananthan Ganesananthan
(S)
Danqi Wang
(D)
Muhammad Mohsin
(M)
Rachel Pathimagaraj
(R)
Krzysztof Macierzanka
(K)
Ricardo Petraco
(R)
Ramzi Khamis
(R)
Graham Cole
(G)
James Howard
(J)
Jamil Mayet
(J)
Darrel Francis
(D)
Rasha Al-Lamee
(R)
Arif Kokhar
(A)
Aisha Gohar
(A)
Ioannis Lampadakis
(I)
Henry Seligman
(H)
Amit Kaura
(A)
Sukhjinder Njjer
(S)
Sayan Sen
(S)
Punit Ramrakha
(P)
Raffi Kaprielian
(R)
Iqbal Malik
(I)
Masood Khan
(M)
Amarjit Sethi
(A)
Rodney Foale
(R)
Thomas Keeble
(T)
Kare Tang
(K)
John Davies
(J)
Reto Gamma
(R)
Gerald Clesham
(G)
Jason Dungu
(J)
Alamgir Kabir
(A)
Shah Mohd Nazri
(S)
Peter O'Kane
(P)
Jonathan Hinton
(J)
Jehangir Din
(J)
Alexandra Nowbar
(A)
Tushar Kotecha
(T)
Peter Haworth
(P)
James Spratt
(J)
Rupert Williams
(R)
Claudia Cosgrove
(C)
Pitt Lim
(P)
Helen Routledge
(H)
Lal Mughal
(L)
Jasper Trevelyan
(J)
Manas Sinha
(M)
Nick Curzen
(N)
James Wilkinson
(J)
Rohit Sirohi
(R)
Alison Calver
(A)
John Rawlins
(J)
Richard Jabbour
(R)
Neil Ruparelia
(N)
Joban Sehmi
(J)
Tim Kinnaird
(T)
Fairoz Abdul
(F)
Vasileios Panoulas
(V)
David Collier
(D)
George Thornton
(G)
Afzal Sohaib
(A)
Patrick McVeigh
(P)
Neil Chapman
(N)
Vikas Kapil
(V)
Jaymin Shah
(J)
Frank E Harrell
(FE)
Matthew Shun-Shin
(M)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.
Références
Control Clin Trials. 2004 Apr;25(2):143-56
pubmed: 15020033
Circ Cardiovasc Qual Outcomes. 2020 Feb;13(2):e006363
pubmed: 32063040
Trends Cardiovasc Med. 2015 Feb;25(2):116-8
pubmed: 25467244
Eur Heart J Digit Health. 2022 Apr 11;3(2):276-283
pubmed: 36713021
BMJ. 1995 Aug 26;311(7004):551-3
pubmed: 7663213
J Am Coll Cardiol. 2018 Jan 2;71(1):95-97
pubmed: 29301633
N Engl J Med. 2020 Apr 9;382(15):1395-1407
pubmed: 32227755
N Engl J Med. 2007 Apr 12;356(15):1503-16
pubmed: 17387127
Lancet. 2018 Jan 6;391(10115):31-40
pubmed: 29103656
Clin Cardiol. 2016 Dec;39(12):721-727
pubmed: 28026916
Eur Heart J Suppl. 2022 Nov 11;24(Suppl H):H32-H42
pubmed: 36382002
N Engl J Med. 2012 Sep 13;367(11):991-1001
pubmed: 22924638
J Am Heart Assoc. 2021 Feb 2;10(3):e017381
pubmed: 33496201
N Engl J Med. 2020 Apr 9;382(15):1408-1419
pubmed: 32227753
J Am Coll Cardiol. 2017 May 2;69(17):2212-2241
pubmed: 28291663
J Am Coll Cardiol. 2004 Apr 21;43(8):1375-82
pubmed: 15093870
Lancet. 2020 May 2;395(10234):1444-1451
pubmed: 32234534
Br J Surg. 2020 Aug;107(9):1114-1122
pubmed: 32187680
Lancet. 2020 Mar 7;395(10226):828-838
pubmed: 32145797
Circulation. 2019 Dec 10;140(24):1971-1980
pubmed: 31707827
Eur Heart J. 2020 Jan 14;41(3):407-477
pubmed: 31504439
EuroIntervention. 2022 Apr 22;17(18):1490-1497
pubmed: 35156616
Stat Med. 2017 Nov 30;36(27):4316-4335
pubmed: 28872693
Circulation. 2003 Feb 18;107(6):817-23
pubmed: 12591750
Circulation. 2023 Aug 29;148(9):e9-e119
pubmed: 37471501
N Engl J Med. 1992 Jan 2;326(1):10-6
pubmed: 1345754
JAMA. 2015 Nov 17;314(19):2045-53
pubmed: 26551163