A randomized comparison of paclitaxel-eluting stents versus bare-metal stents for treatment of unprotected left main coronary artery stenosis.
OBJECTIVE
To optimize percutaneous coronary intervention (PCI) strategy for unprotected left main (LM) disease, we performed a randomized study: intravascular ultrasound (IVUS)-guided bare-metal stent (BMS) or paclitaxel-eluting stent (PES) implantation after lesion pre-treatment with cutting balloon (CB) for unprotected LM lesions.


BACKGROUND
Recent studies have shown promising results in terms of safety and feasibility for patients with LM disease who underwent PCI with stent implantation. However, comparison of BMS and PES for LM lesions has not yet been evaluated.


METHODS
One hundred three patients were randomly assigned to receive BMS (n = 50) or PES (n = 53) implantation. All interventions were IVUS guided, and CB pre-treatment before stenting was performed in all patients. All patients were scheduled for 6-month follow-up.


RESULTS
Baseline clinical characteristics were comparable in both cohorts. Stent implantation was successful in all lesions. Follow-up analysis showed binary restenosis in 11 (22%) BMS and in 3 (6%) PES patients (p = 0.021). By IVUS, percentage of neointimal volume obstruction at 6 months was reduced from 25.20 +/- 22.02% with BMS to 16.60 +/- 17.25% with PES (p = 0.02). At 6 months, the major adverse cardiac event-free survival rate was 70% in BMS and 87% in PES patients (p = 0.036).


CONCLUSIONS
This study demonstrates that PCI of LM with IVUS guidance and CB pre-treatment is safe and effective. No serious procedure-related complications were observed, and clinical outcomes appeared to be good. Finally, the findings demonstrate that implantation of PES may be superior to BMS in the large-diameter LM vessel at 6 months, warranting the performance of a large-scale randomized trial.
Erglis
Andrejs
A
Latvian Center of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia. a.a.erglis@stradini.lv
Narbute
Inga
I
Kumsars
Indulis
I
Jegere
Sanda
S
Mintale
Iveta
I
Zakke
Ilja
I
Strazdins
Uldis
U
Saltups
Andris
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D003328:Coronary Thrombosis / Q000517:prevention & control; D003331:Coronary Vessels / Q000473:pathology; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel