Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)

Coronary Artery Disease Clinical Trial

Official title:

Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348022
• Other study ID #: 2009-0361
• Status: Completed
• Phase: N/A
• First received: April 22, 2011
• Last updated: November 18, 2015
• Start date: August 2009
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is a multicenter, open label, prospective, single arm trial

Single arm group; following angiography, eligible patients with unprotected LMCA stenosis >50% by visual estimation, which is equally treatable by the both treatment strategy (EES stenting or CABG), will be treated with EES

Description:

The primary objective of the PRECOMBAT-2 trial is to establish the safety and effectiveness of coronary stenting with the everolimus-eluting Xience V stent (EES) compared with the historical control (PRE-COMBAT-1) of bypass surgery and sirolimus-eluting stent (SES) for the treatment of an unprotected LMCA stenosis. The primary alternative hypothesis is that the experimental starategy (coronary stenting with the everolimus-eluting stents) is not inferior to the standard strategy (CABG) or SES.

All consecutive patients with unprotected LMCA diseases at participating centers, who are treated with Xience V stent, will be evaluated for the entry into the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: September 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient must be at least 18 years of age.

2. Significant de novo left main stenosis (>50% by visual estimation) with or without any additional target lesions (>70% by visual estimation)

3. Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and CABG

4. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia

5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications:

• Heparin

• Aspirin

• Both Clopidogrel and TIclopidine

• Everolimus, paclitaxel, ABT 578

• Stainless steel and/or

• Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).

2. Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.

3. Any previous PCI within 1 year

4. Previous bypass surgery

5. Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year

6. Intention to treat more than one totally occluded major epicardial vessel

7. Acute MI patients within 1 week

8. Patients with EF<30%.

9. Patients with cardiogenic shock

10. Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months

11. Creatinine level 2.0mg/dL or dependence on dialysis.

12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).

13. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.

14. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.

15. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.

16. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.

17. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

18. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

19. Subject unable or unwilling to follow-up with visits required by protocol

20. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Kwangju Christian Hospital	Kwangju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Veterans Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	Abbott, CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE free survival	Death (all-cause mortality) Cerebrovascular accident Non-fatal myocardial infarction (Q wave and non-Q wave) Ischemia-driven target vessel revascularization either percutaneous or surgical treatment	at 2 year	Yes
Secondary	Death(all cause and cardiac)		5 years	Yes
Secondary	Myocardial Infarction		5 years	Yes
Secondary	Cerebrovascular accident		5 years	Yes
Secondary	Target vessel revascularization		5 years	No
Secondary	Target lesion revascularization		5 years	No
Secondary	Stent thrombosis		5 years	Yes
Secondary	Binary restenosis in both in-stent and in-segment	angiographic follow-up	9 months	No
Secondary	Late luminal loss in both in-stent and in-segment	angiographic follow-up	9 months	No
Secondary	pattern of restenosis	angiographic follow-up	9 months	No
Secondary	Angina status		5 years	Yes
Secondary	Re-hospitalization with a cardiac cause		5 years	Yes