Angioplasty Versus Rotational Atherectomy for Treatment of Diffuse In-Stent Restenosis Trial - ARTIST
Rotational atherectomy vs angioplasty to treat in-stent restenosis.
To determine the safety and efficacy of rotational atherectomy (RA) with balloon angioplasty (PTCA) compared to PTCA alone for the treatment of diffuse in-stent restenosis.
Patients Screened: Not reported
Patients Enrolled: 298
NYHA Class: Not reported
Mean Follow Up: 6 months
Mean Patient Age: Average 61 years
Mean Ejection Fraction: PTCA group: 61.7%, ROTA: 59.4%
1. angina and/or objective evidence of target vessel–related ischemia 2. documented ISR >70% by visual assessment within a stent ±5 mm of the stent edges 3. stent diameter 2.5 mm (balloon during implantation) 4. ISR as the only lesion for treatment 5. length of ISR of 10 to 50 mm by visual assessment 6. lesion accessible for rotablation.
(1) acute MI within the previous month 2) left ventricular ejection fraction <30% (3) evidence of intraluminal thrombus or dissection (4) unprotected ostial stenoses (5) missing visualization of the distal lumen after crossing with a guidewire (6) stents obviously not fully expanded (7) stents at or directly distal to a bend >45° (8) stents implanted within the previous 3 months, and (9) stents with a classic coil design that might impair QCA.
Minimal luminal diameter assessed by quantitative coronary angiography (QCA) at 6 months.
Event-free survival, restenosis at 6 months (>50% diameter reduction)
Rotational atherectomy with PTCA or PTCA alone. In PTCA group, PTCA was performed at the discretion of the local investigator. 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 performed in a substudy of 86 patients (45 PTCA, 41 ROTA).
Heparin bolus of 10,000 to 15,000 IU before the intervention with further doses if activated clotting time <250 seconds. All patients received aspirin and ticlopidine 500 mg/d for 2 weeks. Use of glycoprotein IIb/IIIa inhibitors was discouraged.
Initial procedural success rates (residual stenosis <30%) were similar in both groups (89% PTCA, 88% ROTA). At 6 month angiography, however, results in the PTCA group were superior with a mean net gain in minimal lumen diameter of 0.67 mm vs 0.45 mm for ROTA (p=0.0019). The mean gain in diameter stenosis was 25% and 17% (p=0.002), resulting in binary restenosis rates of 51% (PTCA) and 65% (ROTA) (p=0.039). Intravascular ultrasound demonstrated that the major difference between thr two modalities was the absence of stent over-expansion during PTCA after ROTA. Six-month event-free survival was also significantly higher after PTCA (91.3%) compared with ROTA (79.6%, p=0.0052).
For the treatment of diffuse in-stent restenosis, PTCA alone was associated better long-term outcomes than rotational atherectomy followed by adjunctive low-pressure PTCA.
Circulation 2002; 105: 583-8.
Keywords: Coronary Artery Disease, Atherectomy, Coronary, Disease-Free Survival, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Stents
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