CLINICAL RESEARCH: CLINICAL TRIAL
A Randomized Comparison of Paclitaxel-Eluting Stents Versus Bare-Metal Stents for Treatment of Unprotected Left Main Coronary Artery Stenosis
Andrejs Erglis, MD, PhD, FESC, FACC*,*,
Inga Narbute, MD*,
Indulis Kumsars, MD*,
Sanda Jegere, MD*,
Iveta Mintale, MD*,
Ilja Zakke, MD, FESC*,
Uldis Strazdins, MD* and
Andris Saltups, MD, FACC, FRACP, MRACP
* Latvian Center of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia
Cabrini Medical Centre and Monash Medical Centre, Melbourne, Australia.
Manuscript received September 6, 2006;
revised manuscript received March 5, 2007,
accepted March 6, 2007.
* Reprint requests and correspondence: Dr. Andrejs Erglis, Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Pilsonu 13, Riga, Latvia, LV 1002. (Email: a.a.erglis{at}stradini.lv).
Objectives: 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.
|
Abbreviations and Acronyms
| | BMS = bare-metal stent(s) | | CABG = coronary artery bypass grafting | | CB = cutting balloon | | IVUS = intravascular ultrasound | | LAD = left anterior descending | | LCX = left circumflex | | LM = left main | | MLA = minimum lumen area | | MLD = minimal lumen diameter | | PCI = percutaneous coronary intervention | | PES = paclitaxel-eluting stent(s) | | QCA = quantitative coronary analysis | | TLR = target lesion revascularization |
|
Related Article
-
Left Main Drug-Eluting Stents: Natural Progression or a Bridge Too Far?
- Gregg W. Stone, Jeffrey W. Moses, and Martin B. Leon
J. Am. Coll. Cardiol. 2007 50: 498-500.
[Full Text]
[PDF]
This article has been cited by other articles:
|
|
|
|
 
D. E. Kandzari, A. Colombo, S.-J. Park, C. L. Tommaso, S. G. Ellis, L. A. Guzman, P. S. Teirstein, C. Tamburino, J. Ormiston, G. W. Stone, et al.
Revascularization for unprotected left main disease: evolution of the evidence basis to redefine treatment standards.
J. Am. Coll. Cardiol.,
October 20, 2009;
54(17):
1576 - 1588.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Montalescot, D. Brieger, K. A. Eagle, F. A. Anderson Jr, G. FitzGerald, M. S. Lee, Ph. G. Steg, A. Avezum, S. G. Goodman, J. M. Gore, et al.
Unprotected left main revascularization in patients with acute coronary syndromes
Eur. Heart J.,
October 1, 2009;
30(19):
2308 - 2317.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. Alfonso
Left main coronary artery stenting crossing the rubicon.
J. Am. Coll. Cardiol.,
May 12, 2009;
53(19):
1769 - 1772.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Mehilli, A. Kastrati, R. A. Byrne, O. Bruskina, R. Iijima, S. Schulz, J. Pache, M. Seyfarth, S. Massberg, K.-L. Laugwitz, et al.
Paclitaxel- Versus Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Disease
J. Am. Coll. Cardiol.,
May 12, 2009;
53(19):
1760 - 1768.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. Vaquerizo, T. Lefevre, O. Darremont, M. Silvestri, Y. Louvard, J. L. Leymarie, P. Garot, H. Routledge, F. de Marco, T. Unterseeh, et al.
Unprotected Left Main Stenting in the Real World: Two-Year Outcomes of the French Left Main Taxus Registry
Circulation,
May 5, 2009;
119(17):
2349 - 2356.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Carlsson, S. K. James, J. Lindback, F. Schersten, T. Nilsson, U. Stenestrand, B. Lagerqvist, and for the SCAAR (Swedish Coronary Angiography and An
Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria
J. Am. Coll. Cardiol.,
April 21, 2009;
53(16):
1389 - 1398.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. S. Teirstein
Percutaneous Revascularization Is the Preferred Strategy for Patients With Significant Left Main Coronary Stenosis
Circulation,
February 24, 2009;
119(7):
1021 - 1033.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S.-J. Park and D.-W. Park
Percutaneous Coronary Intervention With Stent Implantation Versus Coronary Artery Bypass Surgery for Treatment of Left Main Coronary Artery Disease: Is It Time to Change Guidelines?
Circ Cardiovasc Interv,
February 1, 2009;
2(1):
59 - 68.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. Yau, P. Molnar, M. C. Moon, S. Buhay, J. P. Werner, K. Molnar, L. Saward, D. Del Rizzo, and P. Zahradka
meta-Iodobenzylguanidine, an Inhibitor of Arginine-Dependent Mono(ADP-ribosyl)ation, Prevents Neointimal Hyperplasia
J. Pharmacol. Exp. Ther.,
September 1, 2008;
326(3):
717 - 724.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The year in interventional cardiology.
J. Am. Coll. Cardiol.,
June 17, 2008;
51(24):
2355 - 2369.
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. G. Malvindi, J. Dunning, and N. Vitale
For which patients with left main stem disease is percutaneous intervention rather than coronary artery bypass grafting the better option?
Interactive CardioVascular and Thoracic Surgery,
April 1, 2008;
7(2):
306 - 314.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Brinker
The left main facts: faced, spun, but alas too few.
J. Am. Coll. Cardiol.,
March 4, 2008;
51(9):
893 - 898.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. S. Teirstein
Unprotected left main intervention patient selection, operator technique, and clinical outcomes.
J. Am. Coll. Cardiol. Intv.,
February 1, 2008;
1(1):
5 - 13.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. N. DeMaria, J. J. Bax, O. Ben-Yehuda, P. Clopton, G. K. Feld, G. S. Ginsburg, B. H. Greenberg, J. D. Knoke, W. Y.W. Lew, J. A.C. Lima, et al.
Highlights of the year in JACC 2007.
J. Am. Coll. Cardiol.,
January 29, 2008;
51(4):
490 - 512.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A Randomized Comparison of Drug-Eluting and Bare-Metal Stents in Left Main Lesions
Journal Watch Cardiology,
August 29, 2007;
2007(829):
3 - 3.
[Full Text]
|
|
|
|
|
|
|
G. W. Stone, J. W. Moses, and M. B. Leon
Left Main Drug-Eluting Stents: Natural Progression or a Bridge Too Far?
J. Am. Coll. Cardiol.,
August 7, 2007;
50(6):
498 - 500.
[Full Text]
[PDF]
|
|
|
|
