Activity of Platelets After Inhibition and Cardiovascular Events Optical Coherence Tomography Study

Acute Coronary Syndrome Clinical Trial

— APICE-OCT  

Official title:

Activity of Platelets After Inhibition and Cardiovascular Events: Drug Eluting Stent Implantation in Patients With Acute Coronary Syndrome: Optical Coherence Tomography Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239654
• Other study ID #: APICE OCT Study (Project 4)
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2010
• Last updated: May 22, 2012
• Start date: September 2010
• Est. completion date: August 2011

Study information

• Verified date: May 2012
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthItaly: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

It is an exploratory study evaluating a biological effect (stent strut coverage) using a novel technology such as OCT without any clinical implication.

Description:

The question of whether DES are safe, has become an area of considerable interest and controversy with the publication of a relatively small randomized trial (BASKET-LATE), an observational study and a meta-analysis reporting increased rates of ST, MI, and death with DES compared to BMS. The motivating factor was the presentation of a meta-analysis at the European Society of Cardiology meeting in Barcelona in September 2006, which suggested an increase in the risk of death and MI following implantation of sirolimus-eluting stents.

The major issue in these meta-analyses is that they were limited either by small sample sizes, duration of follow-ups, lack of access to source data, or by using landmark analyses that excluded events in first 6 months.

Moreover, the largest meta-analysis of DES vs. BMS and SES vs. PES published recently in The Lancet by Settler et al performed a network analyses with a mixed-treatment comparison of 38 randomized trials (18023 patients) with a follow-up of up to 4 years. This analysis again confirmed that DES and BMS were associated with similar rates of overall and cardiac mortality Regarding "real world" population, two observational registries recently published, i.e. the Western Denmark Heart Registry and the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) confirmed no difference in the hard endpoints between DES and BMS. However, it must be remembered that these studies are observational and at best are hypothesis-generating.

Some autoptic studies have observed an incomplete healing following first generation DES implantation as compared to BMS; in these series late ST was associated with more delayed healing compared with patent DES. Among all the unsettled or not fully tested indications for usage of DES, ACS is most probably the one where implantation of BMS remains the most used approach because of the uncertainty regarding the thrombotic risk of DES in a thrombus rich milieu and the low risk for restenosis following BMS implantation in patients with acute MI. Despite encouraging results from currently published data with DES, well designed and appropriately powered clinical trials are warranted in order to establish long term safety and efficacy (incremental advantage over BMS) of DES in this setting. Moreover, recently it was reported that exposed struts were more frequent with first generation DES, and percent neointimal hyperplasia(NIH) area was smaller in ACS lesions than in non-ACS lesions.

For this specific purpose, we will evaluate, using OCT, complete neointimal coverage of Everolimus- vs. Zotarolimus Eluting Stent implanted in the novo lesions on native coronary arteries in patients with ACS. Rates of exposed and/or malaposed stent struts will be analysed and neointimal hyperplasia (NIH) area will be calculated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ACS and clinical indication to PCI

• Presence of 1 or more de novo stenosis equal or greater than 70% in native coronary arteries.

• Patient is > 18 years of age (or minimum age as required by local regulations).

• The patient has consented to participate by signing the "Patient Informed Consent Form".

• The patient is willing and able to cooperate with study procedures and required follow up visits.

• Any type of lesion can be included in this trial unless specifically detailed in the exclusion criteria.

• No other stent implanted before in the target lesion

Exclusion Criteria:

• Patients treated for lesions in venous or arterial grafts.

• Patients treated for in-stent restenosis.

• Patients treated for Unprotected Left Main lesions.

• Patients with left ventricular ejection fraction (LVEF) =30%.

• Patients with chronic kidney disease (creatinine =1.5 mg/dL) .

• Women with known pregnancy or who are lactating.

• Patients with hypersensitivity or allergies to heparin, drugs such as ABT-578 and everolimus, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.

• Contraindication to the use of clopidogrel and/or ASA:

1. History of drug allergy to thienopyridine derivatives or ASA;

2. History of clinically significant or persistent thrombocytopenia or neutropenia

• Active bleeding or significant risk of bleedings, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.

• Current medical condition with a life expectancy of less than 24 months.

• The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial.

• Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Device:
• stent implantation
implantation of everolimus-eluting stent vs zotarolimus-eluting stent

Locations

Country	Name	City	State
Italy	Università della Magna Grecia	Catanzaro
Italy	Careggi Hospital	Florence
Italy	San Raffaele Hospital	Milan
Italy	Ospedale Civile di Mirano	Mirano

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Cardiovascular Research Foundation, New York, Mediolanum Cardio Research

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Jüni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 2010 Jan;31(2):165-76. doi: 10.1093/eurheartj/ehp480. Epub 2009 Nov 4. — View Citation

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. — 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

Tahara S, Bezerra HG, Sirbu V, Kyono H, Musumeci G, Rosenthal N, Guagliumi G, Costa MA. Angiographic, IVUS and OCT evaluation of the long-term impact of coronary disease severity at the site of overlapping drug-eluting and bare metal stents: a substudy of the ODESSA trial. Heart. 2010 Oct;96(19):1574-8. doi: 10.1136/hrt.2009.188037. Epub 2010 Aug 23. — View Citation

Xie Y, Takano M, Murakami D, Yamamoto M, Okamatsu K, Inami S, Seimiya K, Ohba T, Seino Y, Mizuno K. Comparison of neointimal coverage by optical coherence tomography of a sirolimus-eluting stent versus a bare-metal stent three months after implantation. Am J Cardiol. 2008 Jul 1;102(1):27-31. doi: 10.1016/j.amjcard.2008.02.091. Epub 2008 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS.	Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS. The degree of neointimal coverage will be assessed using optical coherence tomography (OCT) calculating the rate of exposed stent struts in the study stents.	6 month	No