Results of the study to determine rotablator and transluminal angioplasty strategy (STRATAS)

doi:10.1016/S0002-9149(00)01486-7

The American Journal of Cardiology

Volume 87, Issue 6, 15 March 2001, Pages 699-705

https://doi.org/10.1016/S0002-9149(00)01486-7 Get rights and content

Abstract

Rotational atherectomy is used to debulk calcified or complex coronary stenoses. Whether aggressive burr sizing with minimal balloon dilation (<1 atm) to limit deep wall arterial injury improves results is unknown. Patients being considered for elective rotational atherectomy were randomized to either an “aggressive” strategy (n = 249) (maximum burr/artery >0.70 alone, or with adjunctive balloon inflation ≤1 atm), or a “routine” strategy (n = 248) (maximum burr/artery ≤0.70 and routine balloon inflation ≥4 atm). Patient age was 62 ± 11 years. Fifty-nine percent routine and 60% aggressive strategy patients had class III to IV angina. Fifteen percent routine and 16% aggressive strategy patients had a restenotic lesion treated; lesion length was 13.6 versus 13.7 mm. Reference vessel diameter was 2.64 mm. Maximum burr size (1.8 vs 2.1 mm), burr/artery ratio (0.71 vs 0.82), and number of burrs used (1.9 vs 2.7) were greater for the aggressive strategy, p <0.0001. Final minimum lumen diameter and residual stenosis were 1.97 mm and 26% for the routine strategy versus 1.95 mm and 27% for the aggressive strategy. Clinical success was 93.5% for the routine strategy and 93.9% for the aggressive strategy. Creatine kinase-myocardial band (CK-MB) was >5 times normal in 7% of the routine versus 11% of the aggressive group. CK-MB elevation was associated with a decrease in rpm of >5,000 from baseline for a cumulative time >5 seconds, p = 0.002. At 6 months, 22% of the routine patients versus 31% of the aggressive strategy patients had target lesion revascularization. Angiographic follow-up (77%) showed minimum lumen diameter to be 1.26 mm in the routine group versus 1.16 mm in the aggressive group, and the loss index 0.54 versus 0.62. Dichotomous restenosis was 52% for the routine strategy versus 58% for the aggressive strategy. Multivariable analysis indicated that left anterior descending location (odds ratio 1.67, p = 0.02) and operator-reported excessive speed decrease >5,000 rpm (odds ratio 1.74, p = 0.01) were significantly associated with restenosis. Thus, the aggressive rotational atherectomy strategy offers no advantage over more routine burr sizing plus routine angioplasty. Operator technique reflected by an rpm decrease of >5,000 from baseline is associated with CK-MB elevation and restenosis.

Section snippets

Methods

The clinical protocol and study end points were developed by an independent steering committee, data and angiographic core labs (see Appendix). None of those involved had a conflict of interest with the study sponsor, Boston Scientific Northwest Technology Center (formerly Heart Technology, Inc.), Redmond, Washington.

To be considered as an operator for the trial, each physician had to have performed ≥100 successful rotational atherectomy procedures and be certified by both the angiographic and

Baseline data

Seventeen clinical sites recruited and randomized 500 patients for the study. Individual sites contributed between 2 and 83 patients (Table 1). Three patients were withdrawn from the study after initial randomization. One patient had right coronary artery dissection during diagnostic angiography and was sent for bypass surgery without attempting percutaneous intervention. A second patient developed complications during treatment of a nonstudy lesion in another vessel before treatment of the

Discussion

Rotational atherectomy is frequently performed in complex lesion subsets, as it was in the Excimer laser, Rotational atherectomy, and Balloon Angioplasty Comparison (ERBAC)8 trial, and now in STRATAS. Prospective data collection and review by a core laboratory confirmed a favorable acute outcome in ERBAC, and this finding was documented in this study. ERBAC was criticized because of the high target vessel revascularization rate seen after rotational atherectomy, and it was speculated that a

Acknowledgements

We wish to thank David Auth, PhD, for his enthusiastic support of this study. We thank Boston Scientific Northwest Technology Center for funding the study. We also thank Kathryn Brock, Cynthia Kepp, Chris Clark, and Heidi Raynor for their assistance in preparing the manuscript.

References (26)

P.M van der Zwet et al.
A new approach for the quantification of complex lesion morphologythe gradient field transform; basic principles and validation results
J Am Coll Cardiol
(1994)
D.C Warth et al.
Rotational atherectomy multicenter registryacute results, complications and 6-month angiographic follow-up in 709 patients
J Am Coll Cardiol
(1994)
A.I MacIsaac et al.
High speed rotational atherectomyoutcome in calcified and noncalcified coronary artery lesions
J Am Coll Cardiol
(1995)
R.E Kuntz et al.
A generalized model of restenosis after conventional balloon angioplasty, stenting, and directional atherectomy
J Am Coll Cardiol
(1993)
A Kastrati et al.
Influence of lesion length on restenosis after coronary stent placement
Am J Cardiol
(1999)
M Moscucci et al.
Effect of prior coronary restenosis on the risk of subsequent restenosis after stent placement or directional atherectomy
Am J Cardiol
(1994)
A.E Villa et al.
Rotational coronary atherectomy
P.L Whitlow
Rotational atherectomy
Coletti RH, Haik BJ, Wiederman JG. Marked reduction in slow-reflow after rotational atherectomy through use of a novel...
SAS Institute I. The LOGISTIC Procedure. SAS/STAT User’s Guide. 4 ed. vol. 2. Cary, NC: SAS Institute, Inc.,...

T.J Ryan et al.

Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty)

Circulation

(1988)

S.G Ellis et al.

Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection

Circulation

(1990)

N Reifart et al.

Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study

Circulation

(1997)

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^☆: This study was supported by an unrestricted grant from Boston Scientific Northwest Technology Center (formerly Heart Technology, Inc.), Redmond, Washington.

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Results of the study to determine rotablator and transluminal angioplasty strategy (STRATAS)☆

Abstract

Section snippets

Methods

Baseline data

Discussion

Acknowledgements

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

Am J Cardiol

Rotational coronary atherectomy

Rotational atherectomy

Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty)

Circulation

Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection

Circulation

Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study

Circulation