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Titolo:
RANDOMIZED COMPARISON OF IMPLANTATION OF HEPARIN-COATED STENTS WITH BALLOON ANGIOPLASTY IN SELECTED PATIENTS WITH CORONARY-ARTERY DISEASE (BENESTENT-II)
Autore:
SERRUYS PW; VANHOUT B; BONNIER H; LEGRAND V; GARCIA E; MACAYA C; SOUSA E; VANDERGIESSEN W; COLOMBO A; SEABRAGOMES R; KIEMENEIJ F; RUYGROK P; ORMISTON J; EMANUELSSON H; FAJADET J; HAUDE M; KLUGMANN S; MOREL MA;
Indirizzi:
ERASMUS UNIV,INTERUNIV CARDIOL INST NETHERLANDS,HEARTCTR,DEPT INTERVENT CARDIOL NL-3015 GD ROTTERDAM NETHERLANDS UNIV ROTTERDAM HOSP,CTR THORAX ROTTERDAM NETHERLANDS ERASMUS UNIV,INST MED TECHNOL NL-3015 GD ROTTERDAM NETHERLANDS CATHARINA HOSP EINDHOVEN NETHERLANDS CHU LIEGE BELGIUM GREGORIO MARANON MADRID SPAIN UNIV HOSP SAN CARLOS MADRID SPAIN INST DANTE PAZZANESE SAO PAULO BRAZIL CTR CUORE COLUMBUS MILAN ITALY HOSP SANTA CRUZ LINDA A VELHA PORTUGAL ONZE LIEVE VROUW HOSP AMSTERDAM NETHERLANDS GREEN LANE HOSP AUCKLAND 3 NEW ZEALAND SAHLGRENS UNIV HOSP GOTHENBURG SWEDEN CLIN PASTEUR TOULOUSE FRANCE UNIV ESSEN GESAMTHSCH ESSEN GERMANY OSPED MAGGIORE TRIESTE TRIESTE ITALY
Titolo Testata:
Lancet
fascicolo: 9129, volume: 352, anno: 1998,
pagine: 673 - 681
SICI:
0140-6736(1998)352:9129<673:RCOIOH>2.0.ZU;2-G
Fonte:
ISI
Lingua:
ENG
Soggetto:
PALMAZ-SCHATZ STENTS; FOLLOW-UP; PLACEMENT; RESTENOSIS; THERAPY; ANGINA; PTCA;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
31
Recensione:
Indirizzi per estratti:
Citazione:
P.W. Serruys et al., "RANDOMIZED COMPARISON OF IMPLANTATION OF HEPARIN-COATED STENTS WITH BALLOON ANGIOPLASTY IN SELECTED PATIENTS WITH CORONARY-ARTERY DISEASE (BENESTENT-II)", Lancet, 352(9129), 1998, pp. 673-681

Abstract

Background The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty inselected patients with stable or stabilised unstable angina, with oneor more de-novo lesions, less than 18 mm long, in vessels of diameter3 mm or more. Methods 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. Findings Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameterwas greater in the stent group than in the balloon-angioplasty group,(1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis greater than or equal to 50%) of 16%and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. InterpretationOver 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 03/04/20 alle ore 11:16:44