Left Main Stenting With Paclitaxel-Eluting Stents Versus Bare-Metal Stents - Left Main Stenting With Paclitaxel-Eluting Stents Versus Bare-Metal Stents
The goal of the trial was to evaluate percutaneous coronary intervention (PCI) of unprotected left main (LM) using paclitaxel-eluting stents (PES) compared with bare-metal stents (BMS) in patients with well preserved left ventricular function with an expected good long-term prognosis.
Patients Enrolled: 103
Mean Follow Up: 6 months
Mean Patient Age: Mean age, 62 years
Clinically symptomatic LM disease with angiographic evidence of >50% diameter stenosis but suitable for stent implantation and a well-preserved left ventricular function in patients in whom a good long-term prognosis could be expected
Patients at a single hospital were randomized to LM stenting using PES (n = 53) or BMS (n = 50). Lesions were treated with a cutting balloon prior to intravascular ultrasound (IVUS)-guided stenting. Repeat angiography was performed at 6 months.
Pre-PCI: aspirin (100 mg) and clopidogrel (300 mg)
Post-PCI: clopidogrel (75 mg/day for 6 months)
Indication for PCI was predominantly stable angina (82%). Prior PCI had been performed in 39% of patients. The LM lesion was in the distal portion (bifurcation) in 68% of the BMS group and 81% of the PES group. Glycoprotein IIb/IIIa inhibitors were used in 77% of patients. Mean pre-PCI stenosis was 63%. One patient had perforation after the cutting balloon intervention. Post-dilation with a larger or noncompliant balloon was used in 60% of patients.
At 6-month angiographic follow-up, binary restenosis was present in 6% of the PES group and 22% of the BMS group (p = 0.021). Mean percent stenosis was 15.8% and 21.8%, respectively (p = 0.037). On IVUS, late lumen loss averaged 0.22 mm in the PES group vs. 0.60 mm in the BMS group (p < 0.001). Neointimal volume was smaller in the PES group than in the BMS group (17.22 vs. 25.98 mm3, p = 0.014), as was percent neointimal volume obstruction (16.6% vs. 25.2%, p = 0.023).
By 6 months, there was one death in each group and myocardial infarction (MI) had occurred in 9% of the PES group and 14% of the BMS group (p = 0.55). Target lesion revascularization had been performed in 2% of the PES group and 16% of the BMS group (p = 0.014). There were no cases of stent thrombosis in the 6-month follow-up period.
Among patients with unprotected LM disease undergoing PCI, use of PES was associated with less stenosis on 6-month angiographic follow-up compared with BMS, but clinical use of these results is questionable given the clear indication for coronary artery bypass surgery (CABG) in this population. In addition, the study has several other flaws, including the short-term follow-up of patients of only 6 months, the small sample size, and the use of stenosis on protocol-driven angiography as a surrogate endpoint, enrollment of patients at only one hospital, and the open-label, nonblinded design.
Additionally, the overall rates of MI were relatively high (12% by 6 months) as was need for repeat PCI of the LM. The short follow-up of only 6 months is not adequate to comment on the risk of stent thrombosis, which is known to increase over time with drug-eluting stents.
The SYNTAX trial is currently evaluating the use of PCI compared with CABG for LM disease or triple-vessel disease, although the relatively short-term endpoint selected for the trial, a composite of death, stroke, MI, or repeat revascularization at 12 months, may not answer the question of optimal therapy given the established long-term mortality benefit of CABG over PCI shown in trials such as SoS.
Erglis A, Narbute I, Kumsars I, et al. A Randomized Comparison of Paclitaxel-Eluting Stents Versus Bare-Metal Stents for Treatment of Unprotected Left Main Coronary Artery Stenosis. J Am Coll Cardiol 2007;50:491-7.
Keywords: Stroke, Myocardial Infarction, Follow-Up Studies, Ventricular Function, Left, Angina, Stable, Coronary Restenosis, Drug-Eluting Stents, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Paclitaxel, Biological Markers, Thrombosis, Coronary Artery Bypass
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