Comparison of sirolimus-eluting and bare metal stent for treatment of patients with total coronary occlusions: results of the GISSOC II-GISE multicentre randomized trial.
OBJECTIVE
Percutaneous coronary intervention with bare metal stent (BMS) in chronic total coronary occlusions (CTOs) is associated with a higher rate of angiographic restenosis and reocclusion than that observed in subtotal stenoses. Preliminary reports have suggested a better performance of drug-eluting stents in CTO. In this multicentre, randomized trial, we compared the mid-term angiographic and clinical outcome of sirolimus-eluting stent (SES) or BMS implantation after successful recanalization of CTO.


RESULTS
Patients with CTO older than 1 month, after successful recanalization, were randomized to implantation of SES (78 patients) or BMS (74 patients) in 13 Italian centres. Clopidogrel therapy was prescribed for 6 months. The primary endpoint was in-segment minimal luminal diameter (MLD) at 8-month follow-up. Secondary clinical endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR) at 24 months. Patients treated with SES showed, at in-segment analysis, a larger MLD (1.98 +/- 0.57 vs. 0.98 +/- 0.80 mm, P < 0.001), a lower late luminal loss (-0.06 +/- 0.49 vs. 1.11 +/- 0.79 mm, P < 0.001), and lower restenosis (9.8 vs. 67.7%, P < 0.001) and reocclusion (0 vs. 17%, P = 0.001) rates. At 24-month follow-up, patients in the SES group experienced fewer major adverse cardiac events (50.0 vs. 17.6%, P < 0.001) mainly due to a lower rate of both TLR (44.9 vs. 8.1%, P < 0.001) and TVR (44.9 vs. 14.9%, P < 0.001).


CONCLUSIONS
In CTO, SES is markedly superior to BMS in terms of restenosis and reocclusion rate, and incidence of repeat revascularization at 24 months. Clinicaltrials.gov identifier: NCT00220558.
Rubartelli
Paolo
P
Dipartimento di Cardiologia, Ospedale Villa Scassi, Corso Scassi 1, 16149 Genova, Italy. paolo.rubartelli@villascassi.it
Petronio
Anna Sonia
AS
Guiducci
Vincenzo
V
Sganzerla
Paolo
P
Bolognese
Leonardo
L
Galli
Mario
M
Sheiban
Imad
I
Chirillo
Fabio
F
Ramondo
Angelo
A
Bellotti
Sandro
S
D017023:Coronary Angiography; D054059:Coronary Occlusion / Q000000981:diagnostic imaging / Q000188:drug therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007558:Italy; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus