[The initial experience of the use of ReoPro in high-risk coronary angioplasty in Italy: the Italian Registry on the Conditions for the Use of ReoPro during Angioplasty (R.I.CO.R.D.A.)].
BACKGROUND
The R.I.CO.R.D.A. Registry was created with the aim of monitoring early Italian experience on the use of abciximab (ReoPro) in the setting of high-risk coronary angioplasty (PTCA). Indication for enrollment included abciximab administration either on an elective basis (i.e. preprocedural or planned) or as bailout for complicated PTCA (i.e. intraprocedural, as a rescue treatment).


METHODS
From June 1996 to January 1998, 359 patients undergoing PTCA on 443 lesions were enrolled in 24 Italian catheterization laboratories. In 91/359 patients (25%) abciximab was administered as bailout, and in the remaining cases on an elective basis as a pre-PTCA treatment.


RESULTS
The incidence of death, coronary artery bypass grafting, Q wave and large non-Q wave myocardial infarction, small non-Q wave myocardial infarction and recurrent ischemia in the elective group were 1.9, 1.9, 2.6, 6.7 and 3.4%, respectively. In the bailout group corresponding figures were 4.4 (p = NS), 3.3 (p = NS), 16.5 (p < 0.01), 16.5 (p < 0.01) and 12.1% (p < 0.01), respectively. The heparin dose during PTCA was quite variable, particularly in the very early stages. Overall, 46% of patients received a heparin dose of < or = 5000 IU, and the remaining a higher dose, more often 10,000 IU. The latter group showed a significantly higher incidence of bleeding complications (25 vs 10%, p < 0.01). The incidence of bleeding was almost double in patients treated with bailout abciximab as compared with the elective group (29 vs 15%, p < 0.01), according to the higher heparin dose administered (9253 +/- 3341 vs 6649 +/- 3156 IU, p < 0.01). Overall, the incidence of red blood cell transfusions was 5.8%.


CONCLUSIONS
The results of this Registry shed light on the actual use of abciximab in the setting of high-risk PTCA in Italy. The incidence of cardiac events and bleeding complications in the group of patients treated on an elective basis is comparable to that reported in the main large-scale international trials. The bailout abciximab group showed a higher incidence of both cardiac events and bleeding complications.
Simonetti
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I
Istituto di Clinica Medica Generale e Cardiologia, Università degli Studi, Firenze.
Gallopin
M
M
Klugmann
S
S
Gensini
G F
GF
D000077284:Abciximab; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods* / Q000706:statistics & numerical data; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000628:therapy; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012042:Registries; D012307:Risk Factors
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab