Rotational Atherectomy Does Not Reduce Recurrent In-Stent Restenosis

Abstract

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.