Are drug-eluting stents indicated in large coronary arteries? Insights from a multi-centre percutaneous coronary intervention registry

doi:10.1016/j.ijcard.2008.06.046

International Journal of Cardiology

Volume 130, Issue 3, 28 November 2008, Pages 374-379

https://doi.org/10.1016/j.ijcard.2008.06.046 Get rights and content

Abstract

Background

Restenosis rates are low in large coronary vessels ≥ 3.5 mm after bare-metal stent (BMS) implantation. The benefit of drug-eluting stents (DES) in large vessels is not established.

Objective

We aim to assess clinical outcomes after deployment of BMS compared to DES in patients with large coronary vessels ≥ 3.5 mm.

Methods

We analysed 672 consecutive patients undergoing percutaneous coronary interventions with ≥ 3.5 mm stent implantation in native coronary artery de-novo lesions from the Melbourne Interventional Group (MIG) registry. Baseline characteristics, 30-day and 12-month outcomes of patients receiving BMS were compared to DES. Multivariate analysis was performed to identify predictors of major adverse cardiac events [MACE, consisting of death, myocardial infarction (MI) and target vessel revascularisation (TVR)].

Results

Of the 672 PCIs performed in 844 lesions, DES was implanted in 39.5% (n = 333) and BMS in 60.5% (n = 511) of lesions. Patients who received DES compared to BMS were older, more likely to be diabetic, had left ventricular dysfunction < 45% or complex lesions. Significantly fewer patients who presented with ST-elevation MI received DES compared to BMS. There were no significant differences in 12-month mortality (0.5 vs. 2.9%, p = 0.07), TVR (3.6 vs. 4.8%, p = 0.54), MI (6.3 vs. 3.4%, p = 0.15), stent thrombosis (0.9 vs. 1.0%, p = 0.88), or MACE (9.4 vs. 9.4%, p = 0.90) in patients who received DES vs. BMS. Stent length ≥ 20 mm was the only independent predictor of 12-month MACE (Odds Ratio 2.07, 95% CI 1.14–3.76, p = 0.02).

Conclusion

In this registry, BMS implantation in large native coronary vessels ≥ 3.5 mm was associated with a low risk of MACE and repeat revascularization at 12 months that was comparable to DES.

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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Citation Excerpt :
In this registry, similar results between the two groups were noted with a low risk of MACE (9.4% vs. 9.4%, respectively; p = 0.90) and repeat revascularization (4.0% vs. 2.3%, respectively; p = 0.35) at 12-month follow-up. Stent length ≥ 20 mm was the only independent predictor of MACE (Odds Ratio 2.07, 95% CI 1.14–3.76, p = 0.02) [51]. Another analysis of 240 patients aimed to compare the clinical outcome of different DESs (44.9% of SES; 43.9% of PES; 11.2% of ZES) and BMSs deployed in large coronary arteries (≥ 3.5 mm) [52].
Compared to bare metal stent (BMS) implantation, drug-eluting stents (DES) is significantly better in attenuating intimal hyperplasia and reducing the rate of revascularization. However, the requirement of prolonged dual antiplatelet therapy (DAPT) and the economic cost have been the major disadvantages of DES. Studies have shown that the use of DES in small vessels decrease revascularization rate, but the results in large vessels vary. Previous studies have shown that the extent of late loss is unrelated to vessel diameter, and that late loss is easily accommodated in large vessels, thus resulting in decreased clinical benefit of DES in this setting. No definite cut-off point value of the vessel size has yet been demonstrated. Series studies aimed at evaluating the clinical outcomes of DES versus BMS in large vessels, but their results have been controversial. In this review, we evaluate the latest studies on clinical outcomes for different vessel sizes and clinical conditions. Nonetheless, further large clinical trials are warranted to address the clinical results of newer stents in different size vessels, especially in large vessels.
Long-term outcomes of drug-eluting stents versus bare-metal stents in large coronary arteries
2013, International Journal of Cardiology
Citation Excerpt :
It has been demonstrated that drug-eluting stents (DES) are more effective than bare-metal stents (BMS) in patients with lesions in small coronary arteries (< 3.0 mm) [4,5]. However, previous studies have shown that the clinical outcomes of DES did not significantly differ from those of BMS in large coronary arteries [6–12]. The definitions of large coronary artery diameters varied widely in previous studies.
Long-term (> 3 years) outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in large coronary arteries were not conclusive. In addition, large coronary vessels were defined using a wide size range (≥ 3.0 mm) in previous studies. The aim of this study was to assess the long-term efficacy of DES versus BMS in subgroups of different vessel sizes.
A total of 1096 patients (1342 lesions) who underwent either DES or BMS implantation in large coronary vessels was followed for a mean duration of 4.5 years. Patients were divided into 4 subgroups by the reference vessel diameters (Q1: 3.0–3.25 mm, Q2: 3.26–3.50 mm, Q3: 3.51–3.75 mm, and Q4: 3.76–4.50 mm). The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. The propensity score-adjusted Cox regression method was applied.
In the 3 subgroups with smaller vessel sizes, the adjusted risk of MACE in DES recipients was reduced by 82% in Q1 (hazard ratio [HR]: 0.18, 95% confidence interval [CI]: 0.09–0.38), 49% in Q2 (HR: 0.51, 95% CI: 0.26–0.98), and 67% in Q3 (HR: 0.33, 95% CI: 0.15–0.73). However, in the largest vessel subgroup (> 3.75 mm), all clinical outcomes were not significantly different irrespective of the stent type used.
The incidence of MACE in 3.0–3.75 mm vessels was significantly reduced by the use of DES than by the use of BMS during a long-term follow-up. However, DES lost its benefit in > 3.75 mm vessels.
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Clinical trials and registries have generally compared DES with BMS in all patients with coronary heart disease without specifically addressing DES use based on the patient's perceived risk of TVR [2,3,5]. Low TVR rates have been reported following BMS deployment in patient subsets with certain clinical and/or lesion characteristics such as non-diabetics, and shorter lesions in large diameter arteries [6,7] though randomised trials have not specifically evaluated their use in such circumstances [8]. Identification of specific patient subsets with low TVR rates post-BMS deployment, may minimise concerns about the risk of late stent thrombosis and the need for compliance with dual antiplatelet therapy with aspirin and clopidogrel for one year, and may have a favourable economic impact [9].
Drug-eluting stent (DES) deployment during percutaneous coronary intervention (PCI) has reduced target-vessel revascularisation rates (TVR). The selective use of DES in patients at highest risk of restenosis may allay concerns about universal compliance of dual antiplatelet therapy for one year, and potentially reduce costs. If this strategy achieved acceptably low TVR rates, such an approach could be attractive.
Late clinical outcomes were examined in 2115 consecutive patients (mean age 63 ± 12 years, 75% male, 22% diabetics) who underwent PCI in the first three years from October 2003, after commencing the following selective criteria for DES use: left main stenosis; ostial lesions of major epicardial arteries; proximal LAD lesions; lesions ≥ 20 mm in length with vessel diameter ≤ 3.0 mm; lesions in vessels ≤ 2.5 mm; diabetics with vessel(s) ≤ 3.0 mm; and in-stent restenosis. Among patients undergoing PCI, 2075 (98%) patients received stents (29% ≥ 1 DES and 71% bare metal stent [BMS]), and among those who received DES, there was a 92% compliance with these criteria. There were no differences in clinical outcomes between the two stent groups except for definite stent thrombosis, which occurred in 2% after DES, and 0.6% after BMS at one year (p = 0.002). With BMS, large coronary arteries (≥3.5 mm), intermediate (3–3.49 mm) and small arteries (<3 mm) in diameter had a TVR rate at one year of 3.6%, 7.2% and 8.2% respectively (p = 0.005).
It is possible to use selective criteria for DES while maintaining low TVR rates. The TVR rate with BMS was low in those with stent diameters ≥ 3.5 mm. The higher DES stent thrombosis rate reflects first generation DES use, though whether routine second generation DES use reduces these rates needs confirmation.
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View full text

Are drug-eluting stents indicated in large coronary arteries? Insights from a multi-centre percutaneous coronary intervention registry

Abstract

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Patient population and registry design

Results

Discussion

Conclusions

Acknowledgements

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

Am J Cardiol

Lancet

Lancet

Heart Lung Circ

J Am Coll Cardiol

Am Heart J

Cardiovasc Revasc Med

Am J Cardiol

J Am Coll Cardiol

Vessel size and long-term outcome after coronary stent placement

Circulation

Influence of coronary vessel size on renarrowing process and late angiographic outcome after successful balloon angioplasty

Circulation

Real-world bare metal stenting: identification of patients at low or very low risk of 9-month coronary revascularization

Catheter Cardiovasc Interv

A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease

N Engl J Med

Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial

JAMA

Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial

Circulation