doi: 10.1161/hc0502.103347
(Circulation. 2002;105:583.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Rotational Atherectomy Does Not Reduce Recurrent In-Stent Restenosis
Results of the Angioplasty Versus Rotational Atherectomy for Treatment of Diffuse In-Stent Restenosis Trial (ARTIST)
From the Medizinische Klinik I (J.v.D., P.K.H., R.H., H.G.K.), Universitätsklinikum, Rheinisch-Westfaelische Technische Hochschule Aachen, Germany; Johann Gutenberg Universität (U.D.), Mainz, Germany; Klinik Dr Müller (S.S.), Munich, Germany; Spedali Civil (L.N.), Brescia, Italy; Herzzentrum Bad Krozingen (H.J.B.), Germany; University Hospital Jean-Minoz (F.S.), Besancon, France; King’s College Hospital (M.T.), London, UK; Centre Hospitalier Privé St Martin (P.C.), Caen, France; Cardiothoracic Centre (D.R.R.), Liverpool, UK; Hospital Gregorio Maranon (E.G.), Madrid, Spain; Universitätsklinikum Eppendorf (C.W.H.), Hamburg, Germany; and Institut für Statistik und Biometrie (T.R.), Universität zu Köln, Köln, Germany.
Correspondence to Jürgen vom Dahl, MD, FESC, Medizinische Klinik II, Kliniken MariaHilf GmbH, Viersener Str 450, D-41063 Moenchengladbach, Germany. E-mail jvomdahl{at}post.klinikum.rwth-aachen.de
Background— Aim of this trial was to compare rotational atherectomy followed by balloon angioplasty (rotablation [ROTA] group) with balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA] group) alone in patients with diffuse in-stent restenosis.
Methods and Results— The ARTIST study is a multicenter, randomized, prospective European trial with 298 patients with in-stent restenosis>70% (mean lesion length, 14±8 mm) in stents, implanted in coronary arteries for 
3 months. In the PTCA group, angioplasty was performed at the discretion of the local investigator, and rotablation was performed by using a stepped-burr approach followed by adjunctive PTCA with low (
6 atm) inflation pressure. Intravascular ultrasound during the intervention and at follow-up was used in a substudy in 86 patients (45 PTCA, 41 ROTA). Angiography demonstrated no difference regarding the short-term outcome, with equivalent procedural success rates defined as remaining stenosis <30% (89% PTCA, 88% ROTA). However, the results showed that, in the long term, PTCA was a significantly better strategy than ROTA. Mean net gain in minimal lumen diameter was 0.67 mm and 0.45 mm for PTCA and ROTA, respectively (P=0.0019). Mean gain in diameter stenosis was 25% and 17% (P=0.002), resulting in restenosis (50%) rates of 51% (PTCA) and 65% (ROTA) (P=0.039). By intravascular ultrasound, the major difference was the missing stent over-expansion during PTCA after ROTA. Six-month event-free survival was significantly higher after PTCA (91.3%) compared with ROTA (79.6%, P=0.0052).
Conclusions— In terms of the primary objective of the study, PTCA produced a significantly better long-term outcome than ROTA followed by adjunctive low-pressure PTCA.
Key Words: angioplasty • stents • restenosis • rotational atherectomy • ultrasonics
This article has been cited by other articles:
 |
|
 |
|
  V. J. Dzau, E. M. Antman, H. R. Black, D. L. Hayes, J. E. Manson, J. Plutzky, J. J. Popma, and W. Stevenson The Cardiovascular Disease Continuum Validated: Clinical Evidence of Improved Patient Outcomes: Part I: Pathophysiology and Clinical Trial Evidence (Risk Factors Through Stable Coronary Artery Disease) Circulation, December 19, 2006; 114(25): 2850 - 2870. [Full Text] [PDF]
|
|
|
|
 |
|
 B. Scheller, C. Hehrlein, W. Bocksch, W. Rutsch, D. Haghi, U. Dietz, M. Bohm, and U. Speck Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter N. Engl. J. Med., November 16, 2006; 355(20): 2113 - 2124. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 F. Alfonso, M.-J. Perez-Vizcayno, R. Hernandez, A. Bethencourt, V. Marti, J. R. Lopez-Minguez, J. Angel, R. Mantilla, C. Moris, A. Cequier, et al. A Randomized Comparison of Sirolimus-Eluting Stent With Balloon Angioplasty in Patients With In-Stent Restenosis: Results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) Trial J. Am. Coll. Cardiol., June 6, 2006; 47(11): 2152 - 2160. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
H. L. Dauerman Treatment of Stent Restenosis: Moving Beyond Momentum J. Am. Coll. Cardiol., June 6, 2006; 47(11): 2161 - 2163. [Full Text] [PDF]
|
|
|
|
 |
|
 G. W. Stone, S. G. Ellis, C. D. O'Shaughnessy, S. L. Martin, L. Satler, T. McGarry, M. A. Turco, D. J. Kereiakes, L. Kelley, J. J. Popma, et al. Paclitaxel-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents: The TAXUS V ISR Randomized Trial JAMA, March 15, 2006; 295(11): 1253 - 1263. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Mukherjee and D. J. Moliterno Brachytherapy for In-Stent Restenosis: A Distant Second Choice to Drug-Eluting Stent Placement JAMA, March 15, 2006; 295(11): 1307 - 1309. [Full Text] [PDF]
|
|
|
|
 |
|
 E Iofina, P W Radke, P Skurzewski, P K Haager, R Blindt, K-C Koch, P Hanrath, J vom Dahl, and R Hoffmann Superiority of sirolimus eluting stent compared with intracoronary {beta} radiation for treatment of in-stent restenosis: a matched comparison Heart, December 1, 2005; 91(12): 1584 - 1589. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Alfonso, J. M. Auge, J. Zueco, A. Bethencourt, J. R. Lopez-Minguez, J. M. Hernandez, J. A. Bullones, I. Calvo, E. Esplugas, M. J. Perez-Vizcayno, et al. Long-Term Results (Three to Five Years) of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Stenting (RIBS) Randomized Study J. Am. Coll. Cardiol., September 6, 2005; 46(5): 756 - 760. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Alfonso Drug-Eluting Stents and In-Stent Restenosis JAMA, April 20, 2005; 293(15): 1855 - 1855. [Full Text] [PDF]
|
|
|
|
 |
|
 Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al. Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology Eur. Heart J., April 2, 2005; 26(8): 804 - 847. [Full Text] [PDF]
|
|
|
|
|
|
F. Alfonso Should we use the cutting balloon in patients with in-stent restenosis? J. Am. Coll. Cardiol., December 21, 2004; 44(12): 2416 - 2416. [Full Text] [PDF]
|
|
|
|
|
|
F Saia, P A Lemos, C A Arampatzis, A Hoye, M Degertekin, K Tanabe, G Sianos, P C Smits, W J van der Giessen, P J de Feyter, et al. Routine sirolimus eluting stent implantation for unselected in-stent restenosis: insights from the rapamycin eluting stent evaluated at Rotterdam cardiology hospital (RESEARCH) registry Heart, October 1, 2004; 90(10): 1183 - 1188. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 F. S. Resnic, K. H. Zou, D. V. Do, G. Apostolakis, and L. Ohno-Machado Exploration of a Bayesian Updating Methodology to Monitor the Safety of Interventional Cardiovascular Procedures Med Decis Making, August 1, 2004; 24(4): 399 - 407. [Abstract] [PDF]
|
|
|
|
|
|
J. A. Bittl, D. P. Chew, E. J. Topol, D. F. Kong, and R. M. Califf Meta-Analysis of randomized trials of percutaneous transluminal coronary angioplasty versus atherectomy, cutting balloon atherotomy, or laser angioplasty J. Am. Coll. Cardiol., March 17, 2004; 43(6): 936 - 942. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Albiero, S. Silber, C. Di Mario, C. Cernigliaro, S. Battaglia, B. Reimers, A. Frasheri, V. Klauss, J. M. Auge, P. Rubartelli, et al. Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: Results of the restenosis cutting balloon evaluation trial (RESCUT) J. Am. Coll. Cardiol., March 17, 2004; 43(6): 943 - 949. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Alfonso, J. Zueco, A. Cequier, R. Mantilla, A. Bethencourt, J. R. Lopez-Minguez, J. Angel, J. M. Auge, M. Gomez-Recio, C. Moris, et al. A randomized comparison ofrepeat stenting with balloon angioplasty in patients with in-stent restenosis J. Am. Coll. Cardiol., September 3, 2003; 42(5): 796 - 805. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. Bhargava, G. Karthikeyan, A. S Abizaid, and R. Mehran New approaches to preventing restenosis BMJ, July 31, 2003; 327(7409): 274 - 279. [Full Text] [PDF]
|
|
|
|
|
|
C. O. Costantini, A. J. Lansky, G. S. Mintz, K. Shirai, G. Dangas, R. Mehran, M. Fahy, S. Slack, M. Coral, P. S. Teirstein, et al. Intravascular brachytherapy for native coronary ostial in-stent restenotic lesions J. Am. Coll. Cardiol., May 21, 2003; 41(10): 1725 - 1731. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. J. Popma, M. Suntharalingam, A. J. Lansky, R. R. Heuser, B. Speiser, P. S. Teirstein, V. Massullo, T. Bass, R. Henderson, S. Silber, et al. Randomized Trial of 90Sr/90Y {beta}-Radiation Versus Placebo Control for Treatment of In-Stent Restenosis Circulation, August 27, 2002; 106(9): 1090 - 1096. [Abstract] [Full Text] [PDF]
|
|