EFFECTS OF OCTREOTIDE TREATMENT ON RESTENOSIS AFTER CORONARY ANGIOPLASTY - RESULTS OF THE VERAS STUDY

Background The VERAS study (VErringerung der Restenoserate nach Angiop lastie durch ein Somatostatin-analogon [Prevention of Restenosis Follo wing Angioplasty With a Somatostatin Analogue]) was a placebo-controll ed trial to evaluate the effects of octreotide for the prevention of r estenosis after coronary angioplasty. Octreotide is a somatostatin ana logue with antiproliferative properties on smooth muscle cell growth i n vitro that limits myointimal thickening of arteries in balloon injur y models. Methods and Results Patients received either octreotide or p lacebo, starting 1 hour before angioplasty and continued for 3 weeks. The minimal luminal diameters before and after angioplasty and at 6-mo nth follow-up were analyzed with a digital quantitative algorithm. Of the initial 274 patients recruited, 217 (108 in the octreotide group a nd 109 in the placebo group) could be analyzed after a complete B-mont h evaluation: the minimal luminal diameters were 1.67+/-0.57 mm in the octreotide-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 bot h treatment groups: final diameter stenosis greater than or equal to 5 0% (34.3% versus 33.9%, two-paired P=1.0), loss of greater than or equ al to 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% ver sus 24.8%, two-paired P=.45). Likewise, there was no difference with r egard to the incidence of clinical events (death, myocardial infarctio n, 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 di d not reduce the angiographically determined restenosis rate or the in cidence of major clinical events after coronary angioplasty.