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Primary percutaneous transluminal coronary angioplasty for Acute Myocardial Infarction in patients not included in randomized studies

Identifieur interne : 001682 ( Istex/Corpus ); précédent : 001681; suivant : 001683

Primary percutaneous transluminal coronary angioplasty for Acute Myocardial Infarction in patients not included in randomized studies

Auteurs : Ralf Zahn ; Rudolf Schiele ; Karlheinz Seidl ; Caroline Bergmeier ; Karl K. Haase ; Hans G. Glunz ; Karl E. Hauptmann ; Thomas Voigtl Nder ; Martin Gottwik ; Jochen Senges

Source :

RBID : ISTEX:31C5AEB55C30C90D1D479283AF857DBA5D53E4DA

Abstract

Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of >12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates.

Url:
DOI: 10.1016/S0002-9149(99)00092-2

Links to Exploration step

ISTEX:31C5AEB55C30C90D1D479283AF857DBA5D53E4DA

Le document en format XML

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<div type="abstract" xml:lang="en">Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of >12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates.</div>
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<abstract>Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of >12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates.</abstract>
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<json:item>
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<note>This study was supported in part by Zeneca, Bristol Myers-Squibb, Ministerium für Gesundheit, Arbeit, Soziales des Landes Rheinland-Pfalz, and Lanesversicherungsanstalt Rheinland-Pfalz, Barmer und Betriebskrankenkassen Rheinland-Pfalz, Mainz, Germany. Manuscript received October 7, 1998; revised manuscript received and accepted December 30, 1998.</note>
<note type="content">Section title: Coronary Artery Disease</note>
<note type="content">Figure 1: Selection of patients from the MITRA trial.</note>
<note type="content">Table I: Baseline Characteristics of Patients Included Versus Not Included in Randomized Trials legend legend</note>
<note type="content">Table II: Clinical Events During Hospitalization in Patients Included Versus Not Included in Randomized Trials legend legend</note>
<note type="content">Table III: Baseline Characteristics of Subgroups of Patients Not Included in Randomized Trials legend legend</note>
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<p>Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of >12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates.</p>
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<ce:note-para>This study was supported in part by Zeneca, Bristol Myers-Squibb, Ministerium für Gesundheit, Arbeit, Soziales des Landes Rheinland-Pfalz, and Lanesversicherungsanstalt Rheinland-Pfalz, Barmer und Betriebskrankenkassen Rheinland-Pfalz, Mainz, Germany. Manuscript received October 7, 1998; revised manuscript received and accepted December 30, 1998.</ce:note-para>
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<namePart type="termsOfAddress">MD</namePart>
<affiliation>Herzzentrum Ludwigshafen, Ludwigshafen, the Westpfalz-Klinikum, Kaiserslautern, the Krankenhaus der Barmherzigen Brüder Trier, the Johannes Gutenberg Universität Mainz, and the Klinikum, Nürnberg, Germany</affiliation>
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<dateIssued encoding="w3cdtf">1999</dateIssued>
<copyrightDate encoding="w3cdtf">1999</copyrightDate>
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<languageTerm type="code" authority="iso639-2b">eng</languageTerm>
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<abstract lang="en">Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of >12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates.</abstract>
<note>This study was supported in part by Zeneca, Bristol Myers-Squibb, Ministerium für Gesundheit, Arbeit, Soziales des Landes Rheinland-Pfalz, and Lanesversicherungsanstalt Rheinland-Pfalz, Barmer und Betriebskrankenkassen Rheinland-Pfalz, Mainz, Germany. Manuscript received October 7, 1998; revised manuscript received and accepted December 30, 1998.</note>
<note type="content">Section title: Coronary Artery Disease</note>
<note type="content">Figure 1: Selection of patients from the MITRA trial.</note>
<note type="content">Table I: Baseline Characteristics of Patients Included Versus Not Included in Randomized Trials legend legend</note>
<note type="content">Table II: Clinical Events During Hospitalization in Patients Included Versus Not Included in Randomized Trials legend legend</note>
<note type="content">Table III: Baseline Characteristics of Subgroups of Patients Not Included in Randomized Trials legend legend</note>
<note type="content">Table IV: Clinical Events During Hospitalization in Subgroups of Patients Not Included in Randomized Trials legend legend</note>
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<title>The American Journal of Cardiology</title>
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<title>AJC</title>
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<genre type="journal">journal</genre>
<originInfo>
<dateIssued encoding="w3cdtf">19990501</dateIssued>
</originInfo>
<identifier type="ISSN">0002-9149</identifier>
<identifier type="PII">S0002-9149(00)X0116-6</identifier>
<part>
<date>19990501</date>
<detail type="volume">
<number>83</number>
<caption>vol.</caption>
</detail>
<detail type="issue">
<number>9</number>
<caption>no.</caption>
</detail>
<extent unit="issue pages">
<start>1303</start>
<end>1422</end>
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<extent unit="pages">
<start>1314</start>
<end>1319</end>
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<identifier type="istex">31C5AEB55C30C90D1D479283AF857DBA5D53E4DA</identifier>
<identifier type="DOI">10.1016/S0002-9149(99)00092-2</identifier>
<identifier type="PII">S0002-9149(99)00092-2</identifier>
<identifier type="ArticleID">7025</identifier>
<accessCondition type="use and reproduction" contentType="copyright">©1999 Excerpta Medica Inc.</accessCondition>
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