CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY
Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial
Ferdinand Kiemeneij, MD*,
Patrick W. Serruys, MD, FACC ,
Carlos Macaya, MD ,
Wolfgang Rutsch, MD ,
Guy Heyndrickx, MD, FACC||,
Per Albertsson, MD¶,
Jean Fajadet, MD#,
Victor Legrand, MD**,
Pierre Materne, MD,
Jorge Belardi, MD,
Ulrich Sigwart, MD, FACC,
Antonio Colombo, MD, FACC||||,
Jean-Jacques Goy, MD¶¶,
Clemens M. C. Disco, MSc##,
Marie-Angèle Morel, BSc## on behalf of the Benestent I Study Group
* Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
Erasmus University, Rotterdam, Netherlands
Hospital Clinico San Carlos, Madrid, Spain
Universitätsklinikum Charité, Berlin, Germany
|| Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
¶ Sahlgrenska University Hospital, Göteborg, Sweden
# Clinique Pasteur, Toulouse, France
** CHU Sart Tilman, Liège, Belgium
CHR Hôpital de la Citadelle, Liège, Belgium
Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina
Royal Brompton & National Heart Hospital, London, United Kingdom
|||| Centro Cuore Columbus, Milan, Italy
¶¶ Centre Hospitalier Universitaire, Lausanne, Switzerland
## Cardialysis, Rotterdam, Netherlands
Manuscript received June 12, 2000;
revised manuscript received January 9, 2001,
accepted January 24, 2001.
Reprint requests and correspondence: Dr. Patrick W. Serruys, Department of Interventional Cardiology, Thoraxcenter Bd 418, University Hospital Dijkzigt, Rotterdam, the Netherlands
serruys{at}card.azr.nl
OBJECTIVES
This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years.
BACKGROUND
The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation.
METHODS
Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle.
RESULTS
No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance.
CONCLUSIONS
The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.
|
Abbreviations and Acronyms
| | CABG | = coronary artery bypass grafting | | CI | = confidence interval | | CVA | = cerebrovascular accident | | MI | = myocardial infarction | | PTCA | = percutaneous transluminal coronary angioplasty | | RR | = relative risk | | STRESS | = Stent Restenosis trial | | TLR | = target lesion revascularization |
|
This article has been cited by other articles:
|
|
|
|
 
S. Yokoyama, M. Takano, M. Yamamoto, S. Inami, S. Sakai, K. Okamatsu, S. Okuni, K. Seimiya, D. Murakami, T. Ohba, et al.
Extended Follow-Up by Serial Angioscopic Observation for Bare-Metal Stents in Native Coronary Arteries: From Healing Response to Atherosclerotic Transformation of Neointima
Circ Cardiovasc Interv,
June 1, 2009;
2(3):
205 - 212.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. Ricciardi, B. A. Virnig, J. W. Ogilvie Jr, P. S. Dahlberg, H. P. Selker, and N. N. Baxter
Volume-Outcome Relationship for Coronary Artery Bypass Grafting in an Era of Decreasing Volume
Arch Surg,
April 1, 2008;
143(4):
338 - 344.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. Martuscelli, F. Clementi, M. M. Gallagher, A. D'Eliseo, G. Chiricolo, A. Nigri, B. Marino, F. Romeo, and on behalf of CABRI trialists
Revascularization strategy in patients with multivessel disease and a major vessel chronically occluded; data from the CABRI trial
Eur. J. Cardiothorac. Surg.,
January 1, 2008;
33(1):
4 - 8.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. M. Wilson and J. T. Willerson
Myocardial Revascularization with Percutaneous Devices
Card. Surg. Adult,
January 1, 2008;
3(2008):
573 - 598.
[Full Text]
|
|
|
|
|
|
|
D. O. Williams and J. D. Abbott
Et Tu, Bare Metal Stent?
Circulation,
November 20, 2007;
116(21):
2363 - 2365.
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. M. Das, A. A. El-Menyar, A. M. Salam, R. Singh, W. A. K. Dabdoob, H. A. Albinali, and J. Al Suwaidi
Contrast-enhanced 64-Section Coronary Multidetector CT Angiography versus Conventional Coronary Angiography for Stent Assessment
Radiology,
November 1, 2007;
245(2):
424 - 432.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. Meier
(Active) stents are no panacea, a deja-vu
Eur. Heart J.,
March 2, 2007;
28(6):
653 - 654.
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. Pugliese, F. Cademartiri, C. van Mieghem, W. B. Meijboom, P. Malagutti, N. R. A. Mollet, C. Martinoli, P. J. de Feyter, and G. P. Krestin
Multidetector CT for visualization of coronary stents.
RadioGraphics,
May 1, 2006;
26(3):
887 - 904.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A Bagust, A D Grayson, N D Palmer, R A Perry, and T Walley
Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study
Heart,
January 1, 2006;
92(1):
68 - 74.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
W. M. Klein, Y. v. d. Graaf, J. Seegers, J. H. Spithoven, E. Buskens, J. G. v. Baal, J. Buth, F. L. Moll, T. T. C. Overtoom, M. R. H. M. v. Sambeek, et al.
Dutch Iliac Stent Trial: Long-term Results in Patients Randomized for Primary or Selective Stent Placement
Radiology,
December 21, 2005;
(2005)
2382041053.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
G Sianos, A Hoye, F Saia, W van der Giessen, P Lemos, P J de Feyter, P C Levendag, R van Domburg, and P W Serruys
Long term outcome after intracoronary {beta} radiation therapy
Heart,
July 1, 2005;
91(7):
942 - 947.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
W. K. Laskey
Late Follow-Up From RAVEL: Transition From Intention to Observation
Circulation,
March 1, 2005;
111(8):
958 - 960.
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. E. Cutlip, A. G. Chhabra, D. S. Baim, M. S. Chauhan, S. Marulkar, J. Massaro, A. Bakhai, D. J. Cohen, R. E. Kuntz, and K. K.L. Ho
Beyond Restenosis: Five-Year Clinical Outcomes From Second-Generation Coronary Stent Trials
Circulation,
September 7, 2004;
110(10):
1226 - 1230.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. J. Cohen, A. Bakhai, C. Shi, L. Githiora, T. Lavelle, R. H. Berezin, M. B. Leon, J. W. Moses, J. P. Carrozza Jr, J. P. Zidar, et al.
Cost-Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex Coronary Stenoses: Results From the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) Trial
Circulation,
August 3, 2004;
110(5):
508 - 514.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. G. Raja, F. Eefting, H. Nathoe, P. Stella, C. Borst, S. Ernst, P. de Jaegere, D. van Dijk, J. Diephuis, E. Jansen, et al.
Stents May Be Better After One Year, But One Year Is Not Lifelong * Response
Circulation,
June 8, 2004;
109(22):
e312 - e313.
[Full Text]
[PDF]
|
|
|
|
|
|
|
F Versaci, A Gaspardone, F Tomai, I Proietti, A S Ghini, L Altamura, G Ando, F Crea, P A Gioffre, and L Chiariello
A comparison of coronary artery stenting with angioplasty for isolated stenosis of the proximal left anterior descending coronary artery: five year clinical follow up
Heart,
June 1, 2004;
90(6):
672 - 675.
[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]
|
|
|
|
|
|
|
M. P. Kelley, B. D. Klugherz, S. M. Hashemi, N. F. Meneveau, J. M. Johnston, W. H. Matthai Jr, V. S. Banka, H. C. Herrmann, J. W. Hirshfeld Jr, S. E. Kimmel, et al.
One-year clinical outcomes of protected and unprotected left main coronary artery stenting
Eur. Heart J.,
September 1, 2003;
24(17):
1554 - 1559.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. Rubartelli, E. Verna, L. Niccoli, C. Giachero, M. Zimarino, G. Bernardi, C. Vassanelli, L. Campolo, E. Martuscelli, and Gruppo Italiano di Studio sullo Stent nelle Occlus
Coronary stent implantation is superior to balloon angioplasty for chronic coronary occlusions: Six-year clinical follow-up of the GISSOC trial
J. Am. Coll. Cardiol.,
May 7, 2003;
41(9):
1488 - 1492.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. E. Sousa, M. A. Costa, A. G.M.R. Sousa, A. C. Abizaid, A. C. Seixas, A. S. Abizaid, F. Feres, L. A. Mattos, R. Falotico, J. Jaeger, et al.
Two-Year Angiographic and Intravascular Ultrasound Follow-Up After Implantation of Sirolimus-Eluting Stents in Human Coronary Arteries
Circulation,
January 28, 2003;
107(3):
381 - 383.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
W O Myers
A standard from the classical period
Heart,
December 1, 2002;
88(5):
449 - 450.
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. Regar, K. Kozuma, G. Sianos, V.L.M.A. Coen, W.J. van der Giessen, D. Foley, P. de Feyter, B. Rensing, P. Smits, J. Vos, et al.
Routine intracoronary beta-irradiation. Acute and one year outcome in patients at high risk for recurrence of stenosis
Eur. Heart J.,
July 1, 2002;
23(13):
1038 - 1044.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. Kimura, K. Abe, S. Shizuta, K. Odashiro, Y. Yoshida, K. Sakai, K. Kaitani, K. Inoue, Y. Nakagawa, H. Yokoi, et al.
Long-Term Clinical and Angiographic Follow-Up After Coronary Stent Placement in Native Coronary Arteries
Circulation,
June 25, 2002;
105(25):
2986 - 2991.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
