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49th Annual Scientific Session of the American College of Cardiology, March 2000, Anaheim, California
- Angioplasty Versus Rotational Atherectomy for Treatment of Diffuse In-Stent Restenosis: Clinical and Angiographic Results From a Randomized Multicenter Trial (ARTIST Study).
- J. vom Dahl, U. Dietz, S. Silber, E. Niccoli, H. J. Büttner, F. Schiele, M. Thomas, F. Commeau, T. Ramsdale, E. Garcia, H. G. Klues
- J Am Coll Cardiol 35: 7A-8A (2000)
Background: Diffuse in-stent restenosis (ISR) with high recurrence rates remains a challenging problem for which the best mechanical treatment is not clear. The ARTIST study compared balloon angioplasty alone (PTCA) with rotational atherectomy followed by adjunctive low-pressure (</=6 atm) balloon angioplasty (ROTA) in patients with a first ISR of 10-50 mm length.
Methods and Results: 298 symptomatic patients (80.3% male, 61 ± 11 years) were randomized. Baseline demographic, clinical and angiographic parameters did not differ between the groups. Angiographic success (<30% diameter stenosis (DS)) with randomized device was 88% (PTCA) and 89% (ROTA) with crossovers in 0.7% and 5.9% resp. (p = 0.02). Stenting for suboptimal results was necessary in 8.9% vs. 7.2% (ns). In-hospital complications (myocardial infarction, reintervention, tamponade, puncture site) were slightly higher in the ROTA group (22/152 pts vs. 10/146, p = 0.04). There was no in-hospital CABG or death. The achieved angiographic results (minimal luminal diameter (MLD), luminal gain, DS) at the end of procedure were not different by quantitative analysis (QCA) between the two groups. Even free survival at 6 months was 91.1% (PTCA) and 79.6% (ROTA, p = 0.005). Angiographic follow-up is available in 259/269 eligible patients. By QCA, MLD (1.2 ± 0.6 mm vs. 1.0 ± 0.6 mm, p = 0.008), DS (56 ± 20% vs. 64 ± 22%, p = 0.005), restenosis (>50% DS) rate (51.2% vs. 64.8%, p = 0.04) as well as the need for target lesion reintervention (36.2% vs. 47.8%, p = 0.06) were in favor for the PTCA group.
Conclusions: In this angiographically controlled randomized study in patients with diffuse ISR balloon angioplasty had a better clinical and angiographic outcome as compared to rotational atherectomy followed by low-pressure balloon angioplasty. If rotational atherectomy followed by high-pressure balloon angioplasty will have more favorable results further needs further evaluation.
