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).
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.


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.
vom Dahl
Juergen
J
Medizinische Klinik I, Universitätsklinikum, Rheinisch-Westfaelische Technische Hochschule Aachen, Germany. jvomdahl@post.klinikum.rwth-aachen.de
Dietz
Ulrich
U
Haager
Philipp K
PK
Silber
Sigmund
S
Niccoli
Luigi
L
Buettner
Hans Juergen
HJ
Schiele
Francois
F
Thomas
Martyn
M
Commeau
Philippe
P
Ramsdale
David R
DR
Garcia
Eulogio
E
Hamm
Christian W
CW
Hoffmann
Rainer
R
Reineke
Thorsten
T
Klues
Heinrich G
HG
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D017225:Atherectomy, Coronary / Q000009:adverse effects; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000601:surgery*; D018592:Cross-Over Studies; D018572:Disease-Free Survival; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000517:prevention & control / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D012086:Reoperation; D055502:Secondary Prevention; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014654:Vascular Patency