Study to Determine Rotablator and Transluminal Angioplasty Strategy - STRATAS

Description:

Aggressive vs. conventional rotational atherectomy strategy in native vessels.

Hypothesis:

To compare the long-term angiographic and clinical outcome of an aggressive rotablator strategy vs. conventional rotablator strategy in native coronary arteries.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 500
Mean Follow Up: 6 months

Patient Populations:

Native coronary arteries
Lesion length < 20mm
Vessel size < 3.25mm

Primary Endpoints:

Major cardiac adverse events at 6 months

Secondary Endpoints:

MLD at 6 months

Drug/Procedures Used:

Aggressive rotablator strategy (Burr:artery ratio 0.7-0.9) with no or low pressure (1 atm) adjunctive balloon inflation versus conventional rotablator strategy (Burr:artery ratio 0.6-0.8) with adjunctive balloon dilatation (Balloon:artery ratio 1.1-1.3).

Principal Findings:

Patient and target lesion characteristics including vessel diameter and target lesion stenosis severity were no different comparing both groups. The aggressive group used more burrs, larger final burrs, with a greater burr/artery ratio and had longer ablation time.

Elevation of CK-MB occurs frequently after rotational atherectomy. CPK, CK-MB (CKMBR < ratio of normal) and ECGs were prospectively collected and adjudicated by a blinded core laboratory. In a multivariate model of CK elevation, only the presence of no reflow, transient abrupt closure, sidebranch occlusion, larger final MLD and moderate to heavy calcium were independent predictors. More aggressive rotational atherectomy, age, gender, diabetes and HTN were not predictors.
Preliminary 6-month results after 482 patients had completed follow-up (238 patients assigned to aggressive strategy and 244 patients assigned to conventional strategy) showed no significant difference in death (2.5% aggressive vs 5.1% conservative), myocardial infarction (2.5% aggressive vs. 1% conservative), or target lesion revascularization (34.5% aggressive, 27.4% conservative).

Follow-up MLD was 1.22 ± 0.72 mm for the aggressive group and 1.31 ± 0.69 for the conventional group at 6 months.

Interpretation:

An aggressive rotational atherectomy strategy with low or no adjunctive PTCA does not decrease restenosis or adverse clinical events when compared to conventional rotablator strategies for native coronary lesions. Intraprocedural complications are not significantly different comparing both techniques, despite increased resource utilization involved with the aggressive strategy. MI occurs frequently after rotational atherectomy and is predicted by angiographic complications, vessel calcification and a larger final MLD. There is no association of MI and late mortality or TVR.

References:

1. J Am Coll Cardiol 1988;31(Abstr Suppl):455A. Preliminary results
2. J Am Coll Cardiol 1988;31(Abstr Suppl):378A. Preliminary results

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Atherectomy, Coronary, Creatine Kinase, MB Form, Dilatation, Diabetes Mellitus, Calcium


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