Are drug-eluting stents indicated in large coronary arteries? Insights from a multi-centre percutaneous coronary intervention registry
Introduction
Vessel size is an important determinant of restenosis in patients undergoing percutaneous coronary intervention (PCI) with stent implantation. Restenosis rates are low (< 10%) in large coronary arteries after bare-metal stent (BMS) implantation [1], [2], [3], [4], [5]. Drug-eluting stents (DES) have been shown to be superior to BMS in reducing restenosis across a wide range of coronary lesions [6]. However, the absolute benefit from DES in patients at low risk of restenosis is reduced [7], [8]. Subgroup analyses of randomised trials have shown only modest differences in clinical outcomes between BMS and DES in large vessels [8], [9], [10], [11], [12]. Further, there is the small risk of late adverse events such as stent thrombosis (ST) and bleeding risk associated with the need for prolonged dual-antiplatelet therapy after DES implantation [13], [14], [15]. In the recent randomised BASKET trial comparing DES and BMS in an unselected population, there was an increased rate of late death or MI in patients who received DES in large coronary arteries ≥ 3 mm [8]. The aim of this study was to assess the clinical outcomes 1 year after deployment of BMS compared to DES in patients with large coronary vessels ≥ 3.5 mm.
Section snippets
Patient population and registry design
The study population consisted of 672 patients undergoing consecutive PCI with either a ≥ 3.5 mm stent or a ≥ 3.5 mm balloon for post-stent dilatation in 844 native coronary artery de-novo lesions from April 2004 to December 2005 from the Melbourne Interventional Group (MIG) registry. The study population was classified into 2 groups based on stent type deployed: (i) the DES group had utilisation of one or more DES (ii) the BMS group had utilisation of one or more BMS only.
The registry is a
Results
Of the 672 PCIs performed in 844 native coronary artery de-novo lesions, DES was implanted in 39.5% (n = 333) and BMS in 60.5% (n = 511) of lesions. Four patients received a combination of DES and BMS. Patients who received DES compared to BMS were older (65.5 ± 12.3 vs. 62.6 ± 12.3 years, p < 0.01), were more likely to be diabetic (26.5 vs. 14.1%, p < 0.01) or have left ventricular dysfunction, LVEF < 45% (10.9 vs. 6.0%, p = 0.02) (Table 1). Significantly less patients who presented with STEMI received DES
Discussion
In this study, PCI in large native coronary arteries (≥ 3.5 mm) was associated with a low incidence of adverse events irrespective of stent type used. There were no significant differences in 12-month mortality, TVR, MI, stent thrombosis, or MACE in patients who received ≥ 3.5 mm diameter DES vs. BMS. Most importantly TVR was less than 5% in large coronaries after deployment of either BMS or DES.
Our findings are consistent with results from randomised studies and other large registries which
Conclusions
In this study, DES implantation in large native coronary vessels ≥ 3.5 mm was associated with a low risk of MACE and repeat revascularization that was comparable to BMS. Before using DES in these patients one must weigh the risk of restenosis against the increased risk of stent thrombosis and the need for prolonged antiplatelet therapy. Further studies are warranted to establish if there is a subgroup of patients with large vessels that may gain long-term benefit from DES. Until such time, BMS
Acknowledgements
The Melbourne Interventional Group acknowledges funding from Pfizer, Servier, Schering-Plough, Boston Scientific, Johnson & Johnson, Sanofi-Aventis, Biotronik, Astra-Zeneca, Medtronic, and St Jude. These companies do not have access to the data, and do not have the right to review manuscripts before publication. Dr. Duffy's work is supported by a NHMRC Centre of Clinical Research Excellence grant to the Alfred and Baker Medical Unit.
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