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Previous Volume 356:1009-1019 March 8, 2007 Number 10 Next

Abstract Full Text PDF PDA Full Text PowerPoint Slide Set Perspective by Maisel, W. H. Perspective by Farb, A. Editorial by Curfman, G. D. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article by Maisel, W. H. Related Article by Farb, A. PubMed Citation

Abstract Italiano

	TRANSLATED TITLE: Confronto tra esiti a lungo termine con stent a rilascio di farmaco e stent metallici semplici in Svezia

Premessa Recenti segnalazioni hanno evidenziato la possibilità di un aumentato rischio di trombosi tardiva dello stent con gli stent a rilascio di farmaco rispetto agli stent metallici semplici.

Metodi Abbiamo valutato 6.033 pazienti trattati con stent a rilascio di farmaco e 13.738 pazienti trattati con stent metallici semplici nel 2003 e nel 2004, utilizzando dati provenienti dal Coronary Angiography and Angioplasty Registry svedese. L'analisi degli esiti, che copriva un periodo di durata fino a 3 anni, era basata su 1.424 casi di exitus e 2.463 infarti miocardici, ed è stata aggiustata per differenze nelle caratteristiche al basale.

Risultati Non si sono registrate differenze significative tra i due gruppi dello studio per quanto riguarda l'end point composito costituito da exitus e infarto miocardico nei 3 anni di follow-up. A 6 mesi, è stata osservata una tendenza verso un minore tasso non aggiustato di eventi nei pazienti con stent a rilascio di farmaco rispetto a quelli con stent metallici semplici, con 13,4 di tali eventi in meno ogni 1000 pazienti. Dopo i 6 mesi, tuttavia, i pazienti con stent a rilascio di farmaco facevano osservare un tasso di eventi significativamente più elevato, con 12,7 eventi in più ogni 1000 pazienti per anno (rischio relativo aggiustato: 1,20; intervallo di confidenza al 95% [IC 95%]: 1,05-1,37). A 3 anni, la mortalità risultava significativamente superiore nei pazienti con stent a rilascio di farmaco (rischio relativo aggiustato: 1,18; IC 95%: 1,04-1,35) e, dai 6 mesi ai 3 anni, il rischio relativo aggiustato per exitus in questo gruppo era pari a 1,32 (IC 95%: 1,11-1,57).

Conclusioni Gli stent a rilascio di farmaco sono risultati associati ad un aumentato tasso di exitus rispetto agli stent metallici semplici. Questa tendenza è apparsa dopo i 6 mesi, quando il rischio di exitus risultava superiore di 0,5 punti percentuali ed un end point composito costituito da exitus ed infarto miocardico risultava superiore di 0,5-1,0 punti percentuali per anno. Appare necessario determinare la sicurezza a lungo termine degli stent a rilascio di farmaco in studi clinici randomizzati di grandi dimensioni.

Source Information

From the Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala (B.L., S.K.J., J.L., T.N., L.W.); and Linköping University Hospital, Linköping (U.S.) — both in Sweden.

This article (10.1056/NEJMoa067722) was published at www.nejm.org on February 12, 2007.

Address reprint requests to Dr. Lagerqvist at the Uppsala Clinical Research Center, Uppsala University Hospital, 751 85 Uppsala, Sweden, or at bo.lagerqvist{at}ucr.uu.se.

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