Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography

Acute Myocardial Infarction Clinical Trial

— OCTAMI  

Official title:

Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704561
• Other study ID #: 457/2008
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: October 2009

Study information

• Verified date: May 2022
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.

Description:

Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute Myocardial MI with ST segment Elevation, within 12 hours from symptoms onset

• Native coronary artery disease with >70% diameter stenosis (no prior stent implant, no prior brachytherapy)

• Vessel size in between 2.5 and 3.75 mm

• Signed patient informed consent

Exclusion Criteria:

• Lesions in coronary artery bypass grafts

• Significant left main disease

• Killip class IV

• Reecent major bleeding (6 months)

• Renal failure with creatinine value > 2.5 mg/dl

• Allergy to aspirin and or clopidogrel/ticlopidine

• Patient in anticoagulant therapy

• IMA due to a stent thrombosis

• No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [= 3.75 mm in diameter])

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction
• DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
DRIVER bare metal stent implanted in acute myocardial infarction
• Coronary stent implantation
Comparison of Drug Eluting versus Bare Metal Stent
• Bare Metal Coronary Stent
Comaprison between Drug Eluting and Bare Metal Coronary Stents

Locations

Country	Name	City	State
Italy	Ospedali Riuniti di Bergamo	Bergamo

Sponsors (3)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII	Case Western Reserve University, Medtronic

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Jüni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. — View Citation

Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Münzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. Epub 2006 Aug 14. — View Citation

Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. Epub 2006 May 5. — View Citation

Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvänne M, Suttorp MJ, Violini R, Schömig A. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007 Nov;28(22):2706-13. Epub 2007 Sep 27. Review. — View Citation

Kindermann M, Adam O, Werner N, Böhm M. Clinical Trial Updates and Hotline Sessions presented at the European Society of Cardiology Congress 2007: (FINESSE, CARESS, OASIS 5, PRAGUE-8, OPTIMIST, GRACE, STEEPLE, SCAAR, STRATEGY, DANAMI-2, ExTRACT-TIMI-25, ISAR-REACT 2, ACUITY, ALOFT, 3CPO, PROSPECT, EVEREST, COACH, BENEFiT, MERLIN-TIMI 36, SEARCH-MI, ADVANCE, WENBIT, EUROASPIRE I-III, ARISE, getABI, RIO). Clin Res Cardiol. 2007 Nov;96(11):767-86. Epub 2007 Oct 25. — View Citation

Lüscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation. 2007 Feb 27;115(8):1051-8. Review. — View Citation

Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. Epub 2006 Nov 29. — View Citation

Nakazawa G, Finn AV, John MC, Kolodgie FD, Virmani R. The significance of preclinical evaluation of sirolimus-, paclitaxel-, and zotarolimus-eluting stents. Am J Cardiol. 2007 Oct 22;100(8B):36M-44M. Review. — View Citation

Pinto Slottow TL, Waksman R. Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel meeting on the endeavor zotarolimus-eluting coronary stent. Circulation. 2008 Mar 25;117(12):1603-8. doi: 10.1161/CIRCULATIONAHA.107.752261. — View Citation

Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent	Non inferiority	6 months
Secondary	number of well apposed stent struts without neointima	number of well apposed stent struts without neointima	6 months
Secondary	number of malapposed stent struts without neointima	number of malapposed stent struts without neointima	6 months
Secondary	number of sections with > 30% uncovered struts/total struts	number of sections with > 30% uncovered struts/total struts	6 months
Secondary	Number of sections with incomplete strut apposition	Number of sections with incomplete strut apposition	6 months
Secondary	Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)	Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)	6 months
Secondary	In segment OCT neontimal volume	In segment OCT neontimal volume	6 months