Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis - ROSTER

Mar 07, 2004
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Date Published:
01/01/2004
Date Updated:
03/07/2004
Original Posted Date:
03/07/2004
References

Description:

The goal of the trial was to evaluate percutaneous rotational coronary atherectomy (PRCA) compared with balloon angioplasty (PTCA) among patients undergoing first-time percutaneous coronary intervention (PCI) for diffuse in-stent restenosis.

Hypothesis:

Target lesion revascularization (TLR) will occurr less frequently in the PRCA group compared with the PTCA group at 9 month follow-up.

Study Design

Study Design:

Patients Screened: 312
Patients Enrolled: 200
Mean Follow Up: 1 year
Mean Patient Age: mean age 64 years
Female: 29%
Mean Ejection Fraction: Mean baseline LVEF 55% in the PRCA arm and 53% in the PTCA arm (p=0.52).

Patient Populations:

First-time ISR with lesion length of >10 mm in a high-pressure deployed stent (3.0-3.5 mm in size) at least 8 weeks before current PCI.

Exclusions:

Underdeployed stents, defined as stent cross-section area <60% of average of proximal and distal vessel area; acute myocardial infarction (MI); inability to cross the lesion with the guidewire; possible or definite thrombus within the stent; unprotected left main coronary artery disease of >50% obviating the use of 8 Fr guiding catheter; or failure to obtain informed consent.

Primary Endpoints:

Target lesion revascularization (TLR) at 9 months

Secondary Endpoints:

MACE (death, MI, or repeat target lesion intervention) at 1 year and angiographic restenosis (defined as >50% diameter stenosis) in a substudy of the last 75 patients enrolled

Drug/Procedures Used:

Following baseline intravascular ultrasound (IVUS), patients were randomized to PRCA (n=100) or PTCA (n=100). Rotablation was performed using a burr-to-artery ratio >0.7 followed by low pressure adjunctive balloon dilatation (4–6 atm). High-pressure (12-16 atm) balloon dilatation was performed in the PTCA group. Use of a coronary stent at the discretion of the operator but was advised only in patients with >30% residual diameter stenosis or significant intimal dissections.

Concomitant Medications:

Aspirin 325 mg orally; intravenous heparin (70 units/kg bolus + additional boluses to maintain activated clotting time of 250-300 seconds during the procedure); glycoprotein IIb/IIIa inhibitors used only if clinically necessary due to procedural events; ticlopidine (250 mg twice daily for 4 weeks) if stent implanted.

Principal Findings:

Mean rotablator burr size in the PRCA arm was 2.21 mm, with burr size >=2.15 mm used in 88%. Mean total ablation time was 272 seconds. More balloons were used in the PTCA group vs PRCA (2.2 vs 1.4 in PRCA, p=0.07). Stents were used significantly less in the PRCA arm (10% vs 31%, p=0.0002). Acute luminal gain did not differ between treatment groups (1.37 mm with PRCA vs 1.32 mm with PTCA, p=0.26).

Repeat TLR at 9 months occurred less frequently in the PRCA group vs the PTCA group (32% vs 45%, 39% relative reduction, p=0.042). In a final "as-treated" analysis, TLR was 31% after PRCA alone (n=90), 45% after PTCA alone (n=69), and 44% after stenting (n=41), p=0.04. MACE at 1-year follow-up was lower in the PRCA group vs the PTCA group (38% vs 52%, p=0.04), but the difference was driven entirely by differences in TLR, with no difference in deaths (n=2 in each arm) or MI (n=3 in each arm).

There was no difference in total occlusion between the 2 groups in the angiographic substudy (4% with PRCA vs 7% with PTCA). However, the angiographic pattern of recurrent ISR was more frequently diffuse in the PTCA arm vs the PRCA arm (75% vs 38%, p=0.01).

Interpretation:

Among patients undergoing first-time PCI for diffuse in-stent restenosis, treatment with percutaneous rotational coronary atherectomy with low-pressure balloon dilatation was associated with a reduction in target lesion revascularization at 9 month follow-up compared with high-pressure balloon angioplasty. The reduction in TLR was observed despite similar angiographic acute gain after PRCA and PTCA. The positive results in the present trial differ from the negative results in the other larger PRCA trial, the ARTIST trial. In ARTIST, PRCA was associated with higher in-hospital complications, lower net gain in MLD, higher angiographic restenosis, and a trend toward higher TLR. One possible explanation for the differences in the results may be the single center design of ROSTER vs the multicenter design of ARTIST.

References:

Sharma SK, et al. Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER). Am Heart J 2004 Jan;147(1):16-22.

Keywords: Coronary Artery Disease, Follow-Up Studies, Atherectomy, Coronary, omega-Chloroacetophenone, Dilatation, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Stents


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