(Circulation. 1997;96:1482-1487.)
© 1997 American Heart Association, Inc.
Articles |
From Stiftsklinik Augustinum (R. von E., R.O., M.R., W.O.), München; Krankenhaus Siegburg (E.G.); Klinikum Bayreuth (W.M.); Klinikum Lippe-Detmold (U.T.); Universitätsklinikum Essen (R.E.); and Sandoz (J.B., G.W.), Nürnberg, Germany.
Correspondence to Rainer von Essen, MD, Klinik für Innere Medizin, Stiftsklinik Augustinum, Wolkerweg 16, 81375 München, Germany.
Background The VERAS study (VErringerung der Re- stenoserate nach Angioplastie durch ein Somatostatin-analogon [Prevention of Restenosis Following Angioplasty With a Somatostatin Analogue]) was a placebo-controlled trial to evaluate the effects of octreotide for the prevention of restenosis after coronary angioplasty. Octreotide is a somatostatin analogue with antiproliferative properties on smooth muscle cell growth in vitro that limits myointimal thickening of arteries in balloon injury models.
Methods and Results Patients received either octreotide or
placebo, starting 1 hour before angioplasty and continued for 3 weeks.
The minimal luminal diameters before and after angioplasty and at
6-month follow-up were analyzed with a digital quantitative
algorithm. Of the initial 274 patients recruited, 217 (108 in the
octreotide group and 109 in the placebo group) could be
analyzed after a complete 6-month evaluation: the minimal
luminal diameters were 1.67±0.57 mm in the
oc-treotide-treated group and 1.66±0.64 mm in the placebo
group (two-paired P=.70), and the relative losses were
0.16±0.22 and 0.13±0.21 (two-paired P=.27). The
restenosis rates were also identical in both treatment groups:
final diameter stenosis
50% (34.3% versus 33.9%,
two-paired P=1.0), loss of
50% of the initial gain
(34.3% versus 33.9%, two-paired P=1.0), and absolute
reduction of minimal luminal diameter >0.72 mm (29.6% versus
24.8%, two-paired P=.45). Likewise, there was no
difference with regard to the incidence of clinical events (death,
myocardial infarction, bypass operations, reintervention). Octreotide
was well tolerated, with the exception of gastrointestinal side
effects, which were three times more common than in the placebo
group.
Conclusions Octreotide did not reduce the angiographically determined restenosis rate or the incidence of major clinical events after coronary angioplasty.
Key Words: angioplasty restenosis octreotide
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