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DOI: 10.1055/s-2002-22046
Perkutane Revaskularisation der koronaren Mehrgefäßerkrankung nach Einführung von Stents
Eine multizentrische, prospektive StudiePercutaneous revascularization of multivessel coronary disease using stents - a multicenter, prospective studyPublication History
Manuskript-Eingang: 12. Oktober 2001
Annahme nach Revision: 17. Januar 2002
Publication Date:
14 March 2002 (online)

Hintergrund: Symptomatische Patienten mit koronarer Mehrgefäßerkrankung profitieren sowohl von der chirurgischen Revaskularisation als auch von der perkutanen Ballonangioplastie (PTCA). Die von 1986 - 1991 durchgeführte »German Angioplasty Bypass Investigation«(GABI-I)-Studie randomisierte Patienten in einen dieser Behandlungsarme. Zur Bewertung neu etablierter interventioneller Verfahren, insbesondere Stents, wurden in der vorliegenden GABI-II-Studie von 1996 - 1997 Patienten entsprechend den GABI-I-Kriterien prospektiv untersucht.
Patienten und Methodik: Konsekutiv wurden 136 Patienten mit Mehrgefäßerkrankung (108 Männer, 28 Frauen, mittleres Alter 63±12 Jahre) aufgenommen. Als Kontrollgruppe dienten die Patienten der GABI-I-Studie.
Ergebnisse: In GABI-II wurden durchschnittlich 2,1 ± 0,5 Gefäße pro Patient angioplastiert, Stents wurden in 63 % der Stenosen implantiert, 7 % der Patienten erhielten Abciximab. Bei Studienende nach 12 Monaten zeigte sich hinsichtlich des primären Endpunktes eine signifikante Verbesserung des Beschwerdebildes mit einem geringeren Prozentsatz von Patienten mit Angina der CCS-Klassen III oder IV (1,5 % gegenüber 8 % in der PTCA-Gruppe von GABI-I, p < 0,01). Im Rahmen der initialen Hospitalisierung erfolgte in keinem Fall eine Bypassoperation (vs. 9 % in GABI-I, p < 0,01). Im ersten Jahr war in 8 % eine chirurgische Revaskularisation erforderlich (21 % in GABI-I; p < 0,001), und in 20 % erfolgte eine erneute PTCA (vs. 23 % in GABI-I). Der Prozentsatz von Patienten ohne weitere Intervention war mit 72 % vs. 56 % höher in GABI-II als in der PTCA-Gruppe von GABI-I (p < 0,01), lag aber unter dem Wert der Bypasschirurgie-Gruppe von GABI-I (94 %, p < 0,001).
Folgerung: Bei koronarer Mehrgefäßerkrankung bleibt die PTCA mit einer höheren Reinterventionsrate verbunden als die chirurgische Revaskularisation. Im Vergleich zur perkutanen Revaskularisation 1986 - 1991 konnte diese Rate aber signifikant gesenkt werden, vor allem bedingt durch eine Reduktion der Bypassoperation. Dieser Effekt ist am ehesten auf den Einsatz koronarer Stents zurückzuführen.
Percutaneous revascularization of multivessel coronary disease using stents - a multicenter, prospective study
Background and objective: Symptomatic patients with multivessel coronary disease (MVD) benefit from both coronary artery bypass grafting (CABG) and percutaneous coronary angioplasty (PTCA). The »German Angioplasty Bypass Investigation« (GABI-I) trial randomized patients to one of these treatment strategies between 1986 and 1991. In order to evaluate the impact of current technology, in particular coronary stents, the GABI-II trial was initiated, which in 1996 and 1997 prospectively enrolled patients according to the initial GABI-I criteria.
Patients and methods: Into the study 136 consecutive patients (108 men, 28 women; 63 ± 12 years) were included. Patients from GABI-I served as controls.
Results: A mean of 2.1 ± 0.5 vessels were treated per patient (vs. 1.9 ± 0.5 vessels in the PTCA arm of GABI-I) and 63 % of the lesions were covered with stents. With respect to the primary endpoint less patients remained with a CCS class III or IV in GABI-II after 12 months (1,5 % vs. 8 % in the PTCA arm of GABI-I, p<0,01). No patient required emergency or urgent bypass operation in GABI-II (vs. 9 % in GABI-I, p < 0.01). After 12 months, 8 % of the patients were sent for bypass surgery (CABG) vs. 21 % in GABI-I (p < 0.001), and 20 % (vs. 23 % in GABI-I) of the patients underwent Re-PTCA. The percentage of patients without reinterventions was 72 % vs. 56 % in GABI-I (p < 0.01), but remained lower compared to patients randomized to CABG in GABI-I (94 %, p < 0.001).
Conclusion: PTCA in patients with MVD is still associated with a higher reintervention rate as compared with CABG. However, in contrast to angioplasty a decade ago, PTCA in conjunction with stents significantly lowered the need for subsequent revascularization, which was mainly driven by the reduced necessity for bypass surgery.
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Korrespondenz
Prof. Dr. C. W. Hamm
Kerckhoff Klinik, Abt. Kardiologie
61231 Bad Nauheim
Phone: 06032/9962202
Fax: 06032/9962298
Email: christian.hamm@kerckhoff.med.uni-giessen.de