Rotational Atherectomy Does Not Reduce Recurrent In-Stent Restenosis

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 (/= 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.