Clinical trial NCT00380809: Rotational Atherectomy Prior to Taxus Stent
Official title: Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complex Calcified Coronary Lesions
Lead sponsor: Segeberger Kliniken GmbH
Sponsor class: OTHER
First posted: 2006-09-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-stent late lumen loss
timeFrame: 9 months
Secondary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 9 months
measure: In-segment late lumen loss
timeFrame: 9 months
measure: In-segment binary restenosis
timeFrame: 9 months
measure: Primary angiographic success
timeFrame: Immediate
measure: Procedural duration and contrast dye amount
timeFrame: Immediate
measure: Strategy success
timeFrame: Immediate
Other outcomes:
Locations:
city: Bad Segeberg
country: Germany
facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Study officials:
affiliation: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
name: Gert Richardt, MD
role: STUDY_CHAIR
affiliation: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
name: Ahmed A. Khattab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
name: Mohamed Abdel-Wahab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.