Rotational Atherectomy Prior to Taxus Stent

Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial.

The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions.

Study Overview

• Status: Completed
• Conditions: Complex Calcified Coronary Lesions
• Intervention / Treatment: Procedure: Rotational Atherectomy + PES; Procedure: Standard Treatment (PES without Rotational Atherectomy)

Detailed Description

Calcification is an essential part of all atherosclerotic plaques. Its extent increases with the progression of atherosclerotic disease. Heavily calcified lesions form a particular threat to DES; both damage to the polymer coating during vigorous advancement and inadequate diffusion of the drug to the subintima through extensive calcium arcs could contribute to the ineffectiveness of DES when implanted into such lesions, or may lead to primary stent delivery or expansion failure. Rotational atherectomy can effectively ablate calcified plaques. In the DES era, data concerning rotational atherectomy are scarce. DES implantation following rotablation seems a rational combination, but is only poorly supported by controlled studies. In the present study, we are using the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions. This prospective, randomized, controlled study aims at evaluating the long term effects of both strategies in this complex cohort of patients.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Bad Segeberg, Germany, 23795
    • Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Angiographically proven coronary artery disease
• Angina II-IV° following the Canadian Cardiovascular Society Classification criteria and/or reproducible ischemia in the target area by ECG or scintigraphy
• The patient signing an informed written consent

From the following angiographic criteria, lesions must fulfil all first degree criteria and at least one second-degree criterion to be eligible for inclusion.

First degree criteria

• De-novo lesion in a native coronary artery
• Target reference vessel diameter between 2.5 and 4.0 mm by visual estimation
• Luminal diameter reduction of 70-99% by visual estimation
• Moderate to severe calcification of the target lesion (clearly defined)

Second degree criteria

• Ostial location
• Bifurcational lesions
• Long lesions (≥ 15mm)

Exclusion Criteria:

• Myocardial infarction within 4 weeks
• Left ventricular ejection fraction < 30%
• Limited long term prognosis due to other conditions

Angiographic exclusion criteria:

• Unprotected left main lesions
• Coronary artery bypass graft stenoses
• In-stent restenoses
• Chronic total occlusions
• Target vessel thrombus
• Target vessel dissection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rotational Atherectomy + PES; Elective lesion preparation with rotational atherectomy priot to stent implantation	Procedure: Rotational Atherectomy + PES
Active Comparator: Standard Treatment (PES without Rotational Atherectomy); Stenting without prior rotational atherectomy, usually preceeded with balloon dilatation	Procedure: Standard Treatment (PES without Rotational Atherectomy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-stent late lumen loss	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Major adverse cardiac events (MACE)	9 months
In-segment late lumen loss	9 months
In-segment binary restenosis	9 months
Primary angiographic success	Immediate
Procedural duration and contrast dye amount	Immediate
Strategy success	Immediate

Collaborators and Investigators

• Sponsor: Segeberger Kliniken GmbH
• Investigators: Study Chair: Gert Richardt, MD, Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH; Principal Investigator: Ahmed A. Khattab, MD, Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH; Principal Investigator: Mohamed Abdel-Wahab, MD, Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Publications and helpful links

General Publications

• Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
• Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
• Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.
• Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation. 2004 Apr 27;109(16):1942-7. doi: 10.1161/01.CIR.0000127110.49192.72. Epub 2004 Apr 12.
• Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 Oct 4;362(9390):1093-9. doi: 10.1016/S0140-6736(03)14462-5.
• Warth DC, Leon MB, O'Neill W, Zacca N, Polissar NL, Buchbinder M. Rotational atherectomy multicenter registry: acute results, complications and 6-month angiographic follow-up in 709 patients. J Am Coll Cardiol. 1994 Sep;24(3):641-8. doi: 10.1016/0735-1097(94)90009-4.
• Moussa I, Di Mario C, Moses J, Reimers B, Di Francesco L, Martini G, Tobis J, Colombo A. Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results. Circulation. 1997 Jul 1;96(1):128-36. doi: 10.1161/01.cir.96.1.128.
• Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013 Jan;6(1):10-9. doi: 10.1016/j.jcin.2012.07.017. Epub 2012 Dec 19.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 25, 2006
• First Submitted That Met QC Criteria: September 25, 2006
• First Posted (Estimate): September 26, 2006

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SK 106