A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction

THE GLOBAL USE OF STRATEGIES TO OPEN OCCLUDED CORONARY ARTERIES IN ACUTE CORONARY SYNDROMES (GUSTO IIb) ANGIOPLASTY SUBSTUDY INVESTIGATORS

doi:10.1056/NEJM199706053362301

A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction

THE GLOBAL USE OF STRATEGIES TO OPEN OCCLUDED CORONARY ARTERIES IN ACUTE CORONARY SYNDROMES (GUSTO IIb) ANGIOPLASTY SUBSTUDY INVESTIGATORS

Medicine

Coordinating Center
Duke University Medical Center
Intermediate Coordinating Center
Electrocardiographic Core Laboratory
Cleveland Clinic Foundation
Hospital Clínic
North Memorial Hospital
Maine Medical Center
Wilson Memorial Hospital
Mercy Hospital of Pittsburgh
Lahey Clinic
Presbyterian Hospital, Albuquerque
Lancaster General Hospital
St. Joseph's Hospital
St. Marys Hospital
Louisiana State University Medical Center
Robert W. Johnson Hospital
WellSpan Health - York Hospital
McLellan Memorial Veterans Affairs Hospital
University of Arkansas at Little Rock
Dartmouth-Hitchcock Medical Center
Cottonwood Hospital
West Florida Hospital
Emory University Midtown Hospital
St. Joseph's Hospital
Fairview-Southdale Hospital
Santa Rosa Memorial Hospital
Cedar Park Regional Medical Center
Penn State University-Hershey Medical Center
E. Alabama Medical Center
St. Mark's Hospital - Salt Lake City
Oakwood Hospital & Medical Center
Shadyside Hospital
Morton Plant Hospital
Memorial Mission Hospital
Good Samaritan Hospital Dayton
University Community Hospital Tampa
Proctor Hospital
St. Joseph's Medical Center
Rochester General Hospital
Roper Hospital
Hospital General Universitario Gregorio Marañón
Hospital Clínico Universitario de Valladolid
CHR de la Citadelle
Clinique Universitaires de Saint-Luc
Clinique St. Jean
CHU Sart-Tilman
Clinique Universitaire de Mont-Godinne
Ospedale Borgo Trento
Ospedale Maggiore
Ospedale di Circolo
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Krankenhaus am Urban
Freie Universität Berlin
Sahlgrenska University Hospital
University Hospital Basel
University Hospital Zürich
Geneva University Hospitals
Flinders Medical Centre
Royal North Shore Hospital
The Prince Charles Hospital
University of Ottawa

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

952 Citations (Scopus)

Abstract

Background: Among physicians who treat patients with acute myocardial infarction, there is controversy about the magnitude of the clinical benefit of primary (i.e., immediate) coronary angioplasty as compared with thrombolytic therapy. Methods: As part of the Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) trial, we randomly assigned 1138 patients from 57 hospitals who presented within 12 hours of acute myocardial infarction (with ST-segment elevation on the electrocardiogram) to primary angioplasty or accelerated thrombolytic therapy with recombinant tissue plasminogen activator (t-PA). We also randomly assigned 1012 patients to heparin or hirudin treatment in a factorial design. The primary study end point was a composite outcome of death, nonfatal reinfarction, and nonfatal disabling stroke at 30 days. Results: The incidence of the primary end point in the angioplasty end t-PA groups was 9.6 percent and 13.7 percent, respectively (odds ratio, 0.67; 95 percent confidence interval, 0.47 to 0.97; P = 0.033). Death occurred in 5.7 percent of the patients assigned to angioplasty and 7.0 percent of those assigned to t-PA (P=0.37), reinfarction in 4.5 percent and 6.5 percent (P=0.13), and disabling stroke in 0.2 percent and 0.9 percent (P = 0.11). At six months, there was no significant difference in the incidence of the composite outcome (14.1 percent vs. 16.1 percent, P not significant). The primary end point was observed in 10.6 percent of the patients in the angioplasty group assigned to heparin and 8.2 percent of those assigned to hirudin (P=0.37). Conclusions: This trial suggests that angioplasty provides a small-to-moderate, short-term clinical advantage over thrombolytic therapy with t-PA. Primary angioplasty, when it can be accomplished promptly at experienced centers, should be considered an excellent alternative method for myocardial reperfusion.

Original language	English
Pages (from-to)	1621-1628
Number of pages	8
Journal	New England Journal of Medicine
Volume	336
Issue number	23
DOIs	https://doi.org/10.1056/NEJM199706053362301
Publication status	Published - 1997

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10.1056/NEJM199706053362301

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@article{822e9112b7f64ed1b537c64562a1f909,

title = "A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction",

abstract = "Background: Among physicians who treat patients with acute myocardial infarction, there is controversy about the magnitude of the clinical benefit of primary (i.e., immediate) coronary angioplasty as compared with thrombolytic therapy. Methods: As part of the Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) trial, we randomly assigned 1138 patients from 57 hospitals who presented within 12 hours of acute myocardial infarction (with ST-segment elevation on the electrocardiogram) to primary angioplasty or accelerated thrombolytic therapy with recombinant tissue plasminogen activator (t-PA). We also randomly assigned 1012 patients to heparin or hirudin treatment in a factorial design. The primary study end point was a composite outcome of death, nonfatal reinfarction, and nonfatal disabling stroke at 30 days. Results: The incidence of the primary end point in the angioplasty end t-PA groups was 9.6 percent and 13.7 percent, respectively (odds ratio, 0.67; 95 percent confidence interval, 0.47 to 0.97; P = 0.033). Death occurred in 5.7 percent of the patients assigned to angioplasty and 7.0 percent of those assigned to t-PA (P=0.37), reinfarction in 4.5 percent and 6.5 percent (P=0.13), and disabling stroke in 0.2 percent and 0.9 percent (P = 0.11). At six months, there was no significant difference in the incidence of the composite outcome (14.1 percent vs. 16.1 percent, P not significant). The primary end point was observed in 10.6 percent of the patients in the angioplasty group assigned to heparin and 8.2 percent of those assigned to hirudin (P=0.37). Conclusions: This trial suggests that angioplasty provides a small-to-moderate, short-term clinical advantage over thrombolytic therapy with t-PA. Primary angioplasty, when it can be accomplished promptly at experienced centers, should be considered an excellent alternative method for myocardial reperfusion.",

author = "\{THE GLOBAL USE OF STRATEGIES TO OPEN OCCLUDED CORONARY ARTERIES IN ACUTE CORONARY SYNDROMES (GUSTO IIb) ANGIOPLASTY SUBSTUDY INVESTIGATORS\} and E. Topol and R. Califf and \{Van der Werf\}, F. and D. Ardissino and Armstrong, \{P. W.\} and E. Bates and K. Beatt and J. Cheseboro and V. Fuster and Gibler, \{W. B.\} and J. Gore and A. Guerci and J. Hochman and D. Holmes and N. Kleiman and K. Neuhaus and M. Ohman and J. Simes and M. Simoons and A. Vahanian and Weaver, \{W. D.\} and C. Granger and H. Phillips and J. Hochrein and B. Fraulo and I. Moffie and L. Paraschos and A. Stebbins and L. Woodlief and K. Lee and K. Pieper and Wagner, \{G. S.\} and K. Gates and S. Ellis and D. Debowey and R. Poliszczuk and H. Vilsack and A. Betriu and A. Luyten and L. Tobback and M. Kava and W. Sutherland and R. Frye and M. Cheitlin and D. DeMets and L. Fisher and J. Hirsh and P. Serruys and L. Walters and G. Hanovich and A. Antolick and M. Kellett and C. Berg and Jamal, \{N. M.\} and D. Whiting and V. Krishnaswami and A. Heyl and D. Gossman and M. Dorland and E. Berrios and H. White and R. Sexson and J. Ibarra and L. Frey and L. Lancaster and D. Lansman and F. Sheridan and R. McRae and S. Hejl and S. Palmeri and L. Casazza and W. Schrading and N. Sonin and D. Talley and J. Talley and S. Ashcraft and N. Niles and R. Edkins and L. Hollywood and G. Symkoviak and J. Pincock and D. Mishkel and J. Lehmann and D. Morris and R. Law-McKenzie and Gainey, \{P. C.\} and D. Baker and C. Sturm and R. Miller and S. Woods and D. Dageford and J. Hanrahan and I. Gilchrist and H. Zimmerman and M. Williams and G. Stegall and J. Perry and W. Schvaneveldt and A. Riba and C. Draus",

year = "1997",

doi = "10.1056/NEJM199706053362301",

language = "English",

volume = "336",

pages = "1621--1628",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "23",

}

THE GLOBAL USE OF STRATEGIES TO OPEN OCCLUDED CORONARY ARTERIES IN ACUTE CORONARY SYNDROMES (GUSTO IIb) ANGIOPLASTY SUBSTUDY INVESTIGATORS 1997, 'A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction', New England Journal of Medicine, vol. 336, no. 23, pp. 1621-1628. https://doi.org/10.1056/NEJM199706053362301

A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. / THE GLOBAL USE OF STRATEGIES TO OPEN OCCLUDED CORONARY ARTERIES IN ACUTE CORONARY SYNDROMES (GUSTO IIb) ANGIOPLASTY SUBSTUDY INVESTIGATORS.
In: New England Journal of Medicine, Vol. 336, No. 23, 1997, p. 1621-1628.

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

TY - JOUR

T1 - A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction

AU - THE GLOBAL USE OF STRATEGIES TO OPEN OCCLUDED CORONARY ARTERIES IN ACUTE CORONARY SYNDROMES (GUSTO IIb) ANGIOPLASTY SUBSTUDY INVESTIGATORS

AU - Topol, E.

AU - Califf, R.

AU - Van der Werf, F.

AU - Ardissino, D.

AU - Armstrong, P. W.

AU - Bates, E.

AU - Beatt, K.

AU - Cheseboro, J.

AU - Fuster, V.

AU - Gibler, W. B.

AU - Gore, J.

AU - Guerci, A.

AU - Hochman, J.

AU - Holmes, D.

AU - Kleiman, N.

AU - Neuhaus, K.

AU - Ohman, M.

AU - Simes, J.

AU - Simoons, M.

AU - Vahanian, A.

AU - Weaver, W. D.

AU - Granger, C.

AU - Phillips, H.

AU - Hochrein, J.

AU - Fraulo, B.

AU - Moffie, I.

AU - Paraschos, L.

AU - Stebbins, A.

AU - Woodlief, L.

AU - Lee, K.

AU - Pieper, K.

AU - Wagner, G. S.

AU - Gates, K.

AU - Ellis, S.

AU - Debowey, D.

AU - Poliszczuk, R.

AU - Vilsack, H.

AU - Betriu, A.

AU - Luyten, A.

AU - Tobback, L.

AU - Kava, M.

AU - Sutherland, W.

AU - Frye, R.

AU - Cheitlin, M.

AU - DeMets, D.

AU - Fisher, L.

AU - Hirsh, J.

AU - Serruys, P.

AU - Walters, L.

AU - Hanovich, G.

AU - Antolick, A.

AU - Kellett, M.

AU - Berg, C.

AU - Jamal, N. M.

AU - Whiting, D.

AU - Krishnaswami, V.

AU - Heyl, A.

AU - Gossman, D.

AU - Dorland, M.

AU - Berrios, E.

AU - White, H.

AU - Sexson, R.

AU - Ibarra, J.

AU - Frey, L.

AU - Lancaster, L.

AU - Lansman, D.

AU - Sheridan, F.

AU - McRae, R.

AU - Hejl, S.

AU - Palmeri, S.

AU - Casazza, L.

AU - Schrading, W.

AU - Sonin, N.

AU - Talley, D.

AU - Talley, J.

AU - Ashcraft, S.

AU - Niles, N.

AU - Edkins, R.

AU - Hollywood, L.

AU - Symkoviak, G.

AU - Pincock, J.

AU - Mishkel, D.

AU - Lehmann, J.

AU - Morris, D.

AU - Law-McKenzie, R.

AU - Gainey, P. C.

AU - Baker, D.

AU - Sturm, C.

AU - Miller, R.

AU - Woods, S.

AU - Dageford, D.

AU - Hanrahan, J.

AU - Gilchrist, I.

AU - Zimmerman, H.

AU - Williams, M.

AU - Stegall, G.

AU - Perry, J.

AU - Schvaneveldt, W.

AU - Riba, A.

AU - Draus, C.

PY - 1997

Y1 - 1997

N2 - Background: Among physicians who treat patients with acute myocardial infarction, there is controversy about the magnitude of the clinical benefit of primary (i.e., immediate) coronary angioplasty as compared with thrombolytic therapy. Methods: As part of the Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) trial, we randomly assigned 1138 patients from 57 hospitals who presented within 12 hours of acute myocardial infarction (with ST-segment elevation on the electrocardiogram) to primary angioplasty or accelerated thrombolytic therapy with recombinant tissue plasminogen activator (t-PA). We also randomly assigned 1012 patients to heparin or hirudin treatment in a factorial design. The primary study end point was a composite outcome of death, nonfatal reinfarction, and nonfatal disabling stroke at 30 days. Results: The incidence of the primary end point in the angioplasty end t-PA groups was 9.6 percent and 13.7 percent, respectively (odds ratio, 0.67; 95 percent confidence interval, 0.47 to 0.97; P = 0.033). Death occurred in 5.7 percent of the patients assigned to angioplasty and 7.0 percent of those assigned to t-PA (P=0.37), reinfarction in 4.5 percent and 6.5 percent (P=0.13), and disabling stroke in 0.2 percent and 0.9 percent (P = 0.11). At six months, there was no significant difference in the incidence of the composite outcome (14.1 percent vs. 16.1 percent, P not significant). The primary end point was observed in 10.6 percent of the patients in the angioplasty group assigned to heparin and 8.2 percent of those assigned to hirudin (P=0.37). Conclusions: This trial suggests that angioplasty provides a small-to-moderate, short-term clinical advantage over thrombolytic therapy with t-PA. Primary angioplasty, when it can be accomplished promptly at experienced centers, should be considered an excellent alternative method for myocardial reperfusion.

AB - Background: Among physicians who treat patients with acute myocardial infarction, there is controversy about the magnitude of the clinical benefit of primary (i.e., immediate) coronary angioplasty as compared with thrombolytic therapy. Methods: As part of the Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) trial, we randomly assigned 1138 patients from 57 hospitals who presented within 12 hours of acute myocardial infarction (with ST-segment elevation on the electrocardiogram) to primary angioplasty or accelerated thrombolytic therapy with recombinant tissue plasminogen activator (t-PA). We also randomly assigned 1012 patients to heparin or hirudin treatment in a factorial design. The primary study end point was a composite outcome of death, nonfatal reinfarction, and nonfatal disabling stroke at 30 days. Results: The incidence of the primary end point in the angioplasty end t-PA groups was 9.6 percent and 13.7 percent, respectively (odds ratio, 0.67; 95 percent confidence interval, 0.47 to 0.97; P = 0.033). Death occurred in 5.7 percent of the patients assigned to angioplasty and 7.0 percent of those assigned to t-PA (P=0.37), reinfarction in 4.5 percent and 6.5 percent (P=0.13), and disabling stroke in 0.2 percent and 0.9 percent (P = 0.11). At six months, there was no significant difference in the incidence of the composite outcome (14.1 percent vs. 16.1 percent, P not significant). The primary end point was observed in 10.6 percent of the patients in the angioplasty group assigned to heparin and 8.2 percent of those assigned to hirudin (P=0.37). Conclusions: This trial suggests that angioplasty provides a small-to-moderate, short-term clinical advantage over thrombolytic therapy with t-PA. Primary angioplasty, when it can be accomplished promptly at experienced centers, should be considered an excellent alternative method for myocardial reperfusion.

UR - https://www.scopus.com/pages/publications/0030908055

U2 - 10.1056/NEJM199706053362301

DO - 10.1056/NEJM199706053362301

M3 - Article

C2 - 9173270

AN - SCOPUS:0030908055

SN - 0028-4793

VL - 336

SP - 1621

EP - 1628

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 23

ER -

A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction

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