CLINICAL STUDY
Stenting in small coronary arteries (SISCA) trial
A randomized comparison between balloon angioplasty and the heparin-coated beStent
Rasmus Moer, MD*,*,
Yngvar Myreng, MD, PhD*,
Per Mølstad, MD, PhD*,
Per Albertsson, MD, PhD ,
P.ål Gunnes, MD, PhD ,
Bo Lindvall, MD ,
Rune Wiseth, MD, PhD||,
Kjetil Ytre-Arne, MD*,
John Kjekshus, MD, PhD¶ and
Svein Golf, MD, PhD*
* Department of Cardiology, The Feiring Heart Clinic, Feiring, Norway
Division of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
Department of Cardiology, Tromsø University Hospital, Tromsø, Norway
Department of Radiology/Cardiology, Huddinge University Hospital, Stockholm, Sweden
|| Division of Cardiology, University Hospital of Trondheim, Norwegian University of Science and Technology, Trondheim, Norway
¶ Department of Cardiology, National Hospital, Oslo, Norway
Manuscript received January 9, 2001;
revised manuscript received June 5, 2001,
accepted August 13, 2001.
* Reprint requests and correspondence: Dr. Rasmus Moer, Department of Cardiology, The Feiring Heart Clinic, N-2093 Feiring, Norway
moer{at}online.no
OBJECTIVES
The purpose of this study was to assess the clinical and angiographic benefits of elective stenting in coronary arteries with a reference diameter of 2.1 to 3.0 mm, as compared with traditional percutaneous transluminal coronary angioplasty (PTCA).
BACKGROUND
The problems related to small-vessel stenting might be overcome using modern stents designed for small vessels, combined with effective antiplatelet therapy.
METHODS
In five centers, 145 patients with stable or unstable angina were randomly assigned to elective stenting treatment with the heparin (Hepamed)-coated beStent or PTCA. Control angiography was performed after six months. The primary end point was the minimal lumen diameter (MLD) at follow-up. Secondary end points were the restenosis rate, event-free survival and angina status.
RESULTS
At follow-up, there was a trend toward a larger MLD in the stent group (1.69 ± 0.52 mm vs. 1.57 ± 0.44 mm, p = 0.096). Event-free survival at follow-up was significantly higher in the stent group: 90.5% vs. 76.1% (p = 0.016). The restenosis rate was low in both groups (9.7% and 18.8% in the stent and PTCA groups, respectively; p = 0.15). Analyzed as treated, both the MLD and restenosis rate were significantly improved in patients who had stents as compared with PTCA.
CONCLUSIONS
In small coronary arteries, both PTCA and elective stenting are associated with good clinical and angiographic outcomes after six months. Compared with PTCA, elective treatment with the heparin-coated beStent improves the clinical outcome; however, there was only a nonsignificant trend toward angiographic improvement.
|
Abbreviations and Acronyms
| | BA | = balloon/artery ratio | | DS | = diameter stenosis | | MACE | = major adverse cardiac event | | MLD | = minimal lumen diameter | | PTCA | = percutaneous transluminal coronary angioplasty | | QCA | = quantitative coronary angiography | | RD | = reference diameter | | SISCA | = Stenting In Small Coronary Arteries trial |
|
This article has been cited by other articles:
|
|
|
|
 
E. I. Levy, J. Mocco, R. M. Samuelson, R. D. Ecker, B. S. Jahromi, and L. N. Hopkins
Optimal treatment of carotid artery disease.
J. Am. Coll. Cardiol.,
March 11, 2008;
51(10):
979 - 985.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Cosottini, M. C. Michelassi, M. Puglioli, G. Lazzarotti, G. Orlandi, F. Marconi, G. Parenti, and C. Bartolozzi
Silent Cerebral Ischemia Detected With Diffusion-Weighted Imaging in Patients Treated With Protected and Unprotected Carotid Artery Stenting
Stroke,
November 1, 2005;
36(11):
2389 - 2393.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Pache, A. Dibra, J. Mehilli, J. Dirschinger, A. Schomig, and A. Kastrati
Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial
Eur. Heart J.,
July 1, 2005;
26(13):
1262 - 1268.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. Mauri, E. J. Orav, and R. E. Kuntz
Late Loss in Lumen Diameter and Binary Restenosis for Drug-Eluting Stent Comparison
Circulation,
June 28, 2005;
111(25):
3435 - 3442.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. Agostoni, G. G.L. Biondi-Zoccai, G. L. Gasparini, M. Anselmi, G. Morando, M. Turri, A. Abbate, E. P. McFadden, C. Vassanelli, P. Zardini, et al.
Is bare-metal stenting superior to balloon angioplasty for small vessel coronary artery disease? Evidence from a meta-analysis of randomized trials
Eur. Heart J.,
May 1, 2005;
26(9):
881 - 889.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. Ardissino, C. Cavallini, E. Bramucci, C. Indolfi, A. Marzocchi, A. Manari, G. Angeloni, G. Carosio, E. Bonizzoni, S. Colusso, et al.
Sirolimus-Eluting vs Uncoated Stents for Prevention of Restenosis in Small Coronary Arteries: A Randomized Trial
JAMA,
December 8, 2004;
292(22):
2727 - 2734.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. Moreno, C. Fernandez, F. Alfonso, R. Hernandez, M. J. Perez-Vizcayno, J. Escaned, M. Sabate, C. Banuelos, D. J. Angiolillo, L. Azcona, et al.
Coronary stenting versus balloon angioplasty in small vessels: A meta-analysis from 11 randomized studies
J. Am. Coll. Cardiol.,
June 2, 2004;
43(11):
1964 - 1972.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. H Chong and J. W. Cheng
Early Experiences and Clinical Implications of Restenosis and Drug-Eluting Stents: Part 2
Ann. Pharmacother.,
May 1, 2004;
38(5):
845 - 852.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. J Nordmann, P. Hengstler, B. M Leimenstoll, T. Harr, J. Young, and H. C Bucher
Clinical outcomes of stents versus balloon angioplasty in non-acute coronary artery disease: A meta-analysis of randomized controlled trials
Eur. Heart J.,
January 1, 2004;
25(1):
69 - 80.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
V Bhatia, R Bhatia, and M Dhindsa
Drug-eluting stents: new era and new concerns
Postgrad. Med. J.,
January 1, 2004;
80(939):
13 - 18.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. M. Brophy, P. Belisle, and L. Joseph
Evidence for Use of Coronary Stents: A Hierarchical Bayesian Meta-Analysis
Ann Intern Med,
May 20, 2003;
138(10):
777 - 786.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Haude, T. F.M. Konorza, U. Kalnins, A. Erglis, K. Saunamaki, H. D. Glogar, E. Grube, R. Gil, A. Serra, H. G. Richardt, et al.
Heparin-Coated Stent Placement for the Treatment of Stenoses in Small Coronary Arteries of Symptomatic Patients
Circulation,
March 11, 2003;
107(9):
1265 - 1270.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. N. Babapulle and M. J. Eisenberg
Coated Stents for the Prevention of Restenosis: Part II
Circulation,
November 26, 2002;
106(22):
2859 - 2866.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Kastrati, H. Schuhlen, and A. Schomig
Stenting for small coronary vessels: a contestable winner
J. Am. Coll. Cardiol.,
November 15, 2001;
38(6):
1604 - 1607.
[Full Text]
[PDF]
|
|
|
|
