Six-month Coverage and Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography (OCTAMI)

• ClinicalTrials.gov Identifier: NCT00704561
• Recruitment Status: Completed
• First Posted: June 25, 2008
• Last Update Posted: February 10, 2010
• Sponsor: A.O. Ospedale Papa Giovanni XXIII
• Collaborators: Case Western Reserve University; Medtronic
• Information provided by: A.O. Ospedale Papa Giovanni XXIII

Tracking Information

• First Submitted Date: June 24, 2008
• First Posted Date: June 25, 2008
• Last Update Posted Date: February 10, 2010
• Study Start Date: April 2008
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 24, 2008): Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00704561 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 24, 2008)

• number of well apposed stent struts without neointima [ Time Frame: 6 months ]
• number of malapposed stent struts without neointima [ Time Frame: 6 months ]
• number of sections with > 30% uncovered struts/total struts [ Time Frame: 6 months ]
• Number of sections with incomplete strut apposition [ Time Frame: 6 months ]
• Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority) [ Time Frame: 6 months ]
• In segment OCT neontimal volume [ Time Frame: 6 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Six-month Coverage and Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography
• 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).
• Brief 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Myocardial Infarction

Intervention

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

Study Arms

• Active Comparator: DES
  Zotarolimus drug-eluting stent
  Interventions:

  • Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
  • Device: Coronary stent implantation
• Active Comparator: BMS
  bare metal stent
  Interventions:

  • Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
  • Device: Bare Metal Coronary Stent

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Guagliumi G, Sirbu V, Bezerra H, Biondi-Zoccai G, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa M. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. JACC Cardiovasc Interv. 2010 Jun;3(6):680-7. doi: 10.1016/j.jcin.2010.04.005.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2010): 44
• Original Estimated Enrollment (submitted: June 24, 2008): 40
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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])

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00704561
• Other Study ID Numbers: 457/2008
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Giulio Guagliumi, Ospedali Riuniti di Bergamo
• Study Sponsor: A.O. Ospedale Papa Giovanni XXIII

Collaborators

• Case Western Reserve University
• Medtronic

Investigators

• Principal Investigator: Giulio Guagliumi, MD; Cardiovascular Department Ospedali Riuniti di Bergamo

• PRS Account: A.O. Ospedale Papa Giovanni XXIII
• Verification Date: March 2009