Details

Autor(en) / Beteiligte

• Alderman, Edwin L.
• Levy, Jerrold H.
• Rich, Jeffrey B.
• Nili, Moshe
• Vidne, Bernardo
• Schaff, Hartzell
• Uretzky, Gideon
• Pettersson, Gosta
• Thiis, Jens J.
• Hantler, Charles B.
• Chaitman, Bernard
• Nadel, Andrea

Titel

Analyses of coronary graft patency after aprotinin use: Results from the international multicenter aprotinin graft patency experience (IMAGE) trial

Ist Teil von

• The Journal of thoracic and cardiovascular surgery, 1998-11, Vol.116 (5), p.716-730

Ort / Verlag

United States: Mosby, Inc

Erscheinungsjahr

1998

Quelle

MEDLINE

Beschreibungen/Notizen

• Objective: We examined the effects of aprotinin on graft patency, prevalence of myocardial infarction, and blood loss in patients undergoing primary coronary surgery with cardiopulmonary bypass. Methods: Patients from 13 international sites were randomized to receive intraoperative aprotinin (n = 436) or placebo (n = 434). Graft angiography was obtained a mean of 10.8 days after the operation. Electrocardiograms, cardiac enzymes, and blood loss and replacement were evaluated. Results: In 796 assessable patients, aprotinin reduced thoracic drainage volume by 43% ( P < .0001) and requirement for red blood cell administration by 49% ( P < .0001). Among 703 patients with assessable saphenous vein grafts, occlusions occurred in 15.4% of aprotinin-treated patients and 10.9% of patients receiving placebo ( P = .03). After we had adjusted for risk factors associated with vein graft occlusion, the aprotinin versus placebo risk ratio decreased from 1.7 to 1.05 (90% confidence interval, 0.6 to 1.8). These factors included female gender, lack of prior aspirin therapy, small and poor distal vessel quality, and possibly use of aprotinin-treated blood as excised vein perfusate. At United States sites, patients had characteristics more favorable for graft patency, and occlusions occurred in 9.4% of the aprotinin group and 9.5% of the placebo group ( P = .72). At Danish and Israeli sites, where patients had more adverse characteristics, occlusions occurred in 23.0% of aprotinin- and 12.4% of placebo-treated patients ( P = .01). Aprotinin did not affect the occurrence of myocardial infarction (aprotinin: 2.9%; placebo: 3.8%) or mortality (aprotinin: 1.4%; placebo: 1.6%). Conclusions: In this study, the probability of early vein graft occlusion was increased by aprotinin, but this outcome was promoted by multiple risk factors for graft occlusion. (J Thorac Cardiovasc Surg 1998;116:716-30)