The aim of our study is to compare one-year outcomes in terms of major adverse cardiovascular events (all cause death, reinfarction, any revascularization and stroke) of 2 different strategies in patients with non-STEMI and multivessel coronary…
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study endpoints are defined as the incidence of MACE (Composite
endpoint of all cause death, non-fatal Myocardial Infarction, any
revascularisation and stroke) at 12 months.
Secondary outcome
• Primary endpoint in subgroups at 12 and 24 months in the subgroup of
patients.
• Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite
endpoint of Cardiac death, Myocardial Infarction, any
revascularisation, Stroke and major bleeding at 12, 24 and 36 months.
• Composite endpoint hospitalisation for heart failure and unstable angina
pectoris at 12, 24 and 36 months.
• All-cause mortality or Myocardial infarction at 12, 24 and 36 months..
• Any revascularisation at 12, 24 and 36 months.
• Stent thrombosis at 12, 24 and 36 months.
• Bleeding (major and minor) at 48 hr and 12 months
• Primary endpoint at 36 months as well as outcomes of each component of the
primary endpoint at 12 and 24 and 36 months.
• Left ventricular ejection fraction at 12 (MIBI scan, MRI or Echocardiography)
Background summary
Patients with ST-elevation myocardial infarction (STEMI) and multivessel
disease (MVD) have worse prognosis compared to STEMI patients with single
vessel disease. Several randomised clinical trials and meta-analysis showed
that multivessel percutaneous coronary intervention (MV-PCI) compared with
infarct related artery only PCI (IRA-PCI) resulted in reduced major adverse
cardiovascular events (MACE), mainly due to repeated revascularisation.
Patients with non-ST elevation myocardial infarction (non-STEMI), as compared
with STEMI patients, have a higher risk profile, a higher incidence of MVD and
less favourable outcome. However, there is no clear evidence regarding the
role of ischemia driven complete coronary revascularization by PCI in patients
with non-STEMI during the index procedure. Furthermore, both the American and
the European guidelines are unclear as to which coronary revascularization
strategy to suggest in multivessel non-STEMI patients .
Previous studies showed that MV-PCI in non-STEMI patients reduces
revascularization rates without affecting MACE. However, others found also
MACE reduction after MV-PCI. In the SMILE trial MV-PCI during the index
procedure in non-STEMI patients with MVD was superior to multistage PCI during
the index hospitalization in terms of major adverse cardiovascular and
cerebrovascular events. This was mainly due to repeat coronary
revascularization, without significant effect on cardiac death and
reinfarction. In the above mentioned trials assessment of lesion severity was
mostly performed visually and in the SMILE trial FFR measurements were only
performed in approximately 25% of the patients.
Study objective
The aim of our study is to compare one-year outcomes in terms of major adverse
cardiovascular events (all cause death, reinfarction, any revascularization and
stroke) of 2 different strategies in patients with non-STEMI and multivessel
coronary artery disease: FFR guided complete revascularization by PCI during
the index procedure (MV-PCI) versus usual treatment (discretion of the operator
and or Heart team).
Study design
Eligible patients will be randomized to complete revascularization by PCI
during the index procedure, or culprit only PCI and treatment of non-culprit
lesions will be at the discretion of the operator and or heart team. Treatment
will be assigned on the basis of a 1:1 ratio.
Intervention
Patients will be enrolled and randomised in a 1:1 fashion between the ischemia
driven (FFR) revascularisation strategy, versus usual care, after completion of
a successful culprit lesion PCI. All patients who present at least with one
lesion with a stenosis of approximately 50% or more in a non-IRA with a
diameter of >= 2.0 mm and fulfil the inclusion and exclusion criteria will be
enrolled.
In the ischemia driven complete revascularisation strategy group all flow
limiting (FFR <= 0.89) lesions will receive treatment by PCI and stenting. The
non-IRA PCI should be performed during the same intervention. Exceptions can be
made for complex lesions where the operator estimates that the
revascularisation procedure will require significant contrast overload, which
may lead to deterioration of cardiac and renal function of the patient. Such
procedures can be performed in a second procedure which should take place
within the same hospitalisation, preferably within 72 hours.
In the randomised to usual care group the procedure will stop after the PCI of
the culprit artery and the patient will be referred to his treating
cardiologist and/ or heart team who will decide whether a staged PCI of the
non- IRA artery should take place. If the treating cardiologist (after advise
of the heart team) decides to perform the non-IRA PCI revascularisation, than
such treatment should take place within six weeks from the primary PCI in order
to count as a scheduled staged PCI procedure. Any other revascularizations of
any lesions after these 6 weeks are identified as unscheduled and therefore
counted as an event.
All revascularisations procedures will be defined as clinically indicated or
not clinically indicated by the independent clinical event committee.
Non-clinically indicated revascularisation will be counted as an event.
Study burden and risks
More contrast and more raditioan. Howver we do not expect this causes
significant the damage patients health. Furthermore, we expect that complite
revascularisation will improve patients outcome.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
Non-STEMI patients undergo successful PCI of the culprit lesion and have at
least one stenosis of >=50% in a non-culprit lesion feasible for treatment with
PCI.
Exclusion criteria
• Left main stem disease (stenosis > 50%)
• Chronic total occlusion of a non-culprit lesion
• Indication for or previous Coronary artery bypass grafting
• Known severe cardiac valve dysfunction that will require surgery or TAVI in
the follow-up period.
• Killip class III or IV during the completion of culprit lesion treatment.
• Life expectancy of less than 1 year
• Intolerance to Aspirin, or thienopyridine inhibitors or Heparin
• Planned elective surgical procedure necessitating interruption of
thienopyridines during the first 3 months post enrolment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL63602.096.17 |