Study Design

Study Design:

Patients Screened: Not reported
Patients Enrolled: 298
NYHA Class: Not reported
Mean Follow Up: 6 months
Mean Patient Age: Average 61 years
Female: 20%
Mean Ejection Fraction: PTCA group: 61.7%, ROTA: 59.4%

Patient Populations:

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.

Exclusions:

(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.

Primary Endpoints:

Minimal luminal diameter assessed by quantitative coronary angiography (QCA) at 6 months.

Secondary Endpoints:

Event-free survival, restenosis at 6 months (>50% diameter reduction)

Drug/Procedures Used:

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).

Concomitant Medications:

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.