Gated-SPECT in the Planning of Ischemia Guided PCI in STEMI Patients

Closed for proposals

Project Type

Coordinated Research Project

Project Code

E13045

CRP

2053

Approved Date

12 December 2016

Status

Closed

Start Date

16 March 2017

Expected End Date

20 September 2022

Completed Date

23 May 2023

Participating Countries

Brazil
Cuba
India
Italy
Mexico
Pakistan
Philippines
Serbia
Singapore
Spain
Türkiye
Uruguay

Description

Primary percutaneous coronary intervention (PPCI) is the standard of care for ST-segment elevation myocardial infarction (STEMI), when performed by experienced groups in a timely manner. Although initial observational studies have shown conflicting results, evidence from four randomized controlled trials suggests that a post-primary percutaneous intervention (PPCI) strategy of staged PCI of the non-culprit vessel(s)  is beneficial and safe in STEMI patients. Importantly, for this application, issues related to the evaluation of ischemia in the STEMI patient with multivessel coronary artery disease (CAD) focusing on PCI in the non-culprit lesion have not been fully addressed. When considering that 40-70% of STEMI patients have multivessel disease, alternative approaches for post-PPCI non-culprit lesion intervention need to be considered. The current application proposes a primary objective of applying gated-SPECT MPI as a guide to post-PPCI non-culprit coronary lesion intervention as compared to standard approaches which use post-PPCI intervention of all non-culprit lesions (based on anatomy alone).  The successful completion of this protocol will help establish the value of gated-SPECT MPI protocol with pharmacological stress to guide efficacious multivessel PCI in STEMI patients.

Objectives

To guide which patients with multivessel disease (who have undergone primary PCI) should be treated in a staged procedure through documentation of inducible myocardial ischemia on gated SPECT MPI

Specific objectives

To assess whether gated-SPECT MPI can guide the selection of which patients should be treated in a staged multivessel PCI in STEMI patients that lead to reduce ischemic burden

Impact

Cardiovascular diseases (CVDs) are the leading cause of death globally.
According to WHO:
- An estimated 17.9 million people died from CVDs in 2019, representing 32% of all global deaths.
- Of these deaths, 85% were due to heart attack and stroke. Over three quarters of CVD deaths take place in low- and middle-income countries.
- Out of the 17 million premature deaths (under the age of 70) due to noncommunicable diseases in 2019, 38% were caused by CVDs.
- Most cardiovascular diseases can be prevented by addressing behavioral risk factors such as tobacco use, unhealthy diet and obesity, physical inactivity and harmful use of alcohol.
- It is important to detect cardiovascular disease as early as possible so that management with counselling and medicines can begin.

Among CDV - Ischemic heart disease (IHD) represents the largest share of morbidity and mortality globally. Also referred to as coronary artery disease (CAD) and atherosclerotic cardiovascular disease (ACD), IHD manifests clinically as myocardial infarction and ischemic cardiomyopathy.
The evaluation and management of ischemic heart disease has evolved significantly over the past decade. In particular, several clinical trials have documented the benefits of revascularization in patients with acute ischemic syndromes as well as the efficacy of medical therapy, including lifestyle modification in patients with stable coronary disease.
A fundamental premise in establishing new listing criteria for IHD mortality, morbidity and disability is the linking of anatomic or structural evidence of coronary heart disease (CHD) with both functional impairment and severe anginal symptoms. Because many patients with IHD are unable to exercise, standard stress electrocardiographic criteria for ischemia (the sole determinant of objective ischemia assessment in past years) have been expanded significantly to encompass non-exercise modalities (including nuclear imaging and echocardiography provoked by pharmacologic vasodilator stress) to assess the presence of severe inducible ischemia.

Primary percutaneous coronary intervention (PPCI) is the standard of care for ST-segment elevation myocardial infarction (STEMI), when performed by experienced groups in a timely manner. Although initial observational studies have shown conflicting results, evidence from four randomized controlled trials suggests that a post-primary percutaneous intervention (PPCI) strategy of staged PCI of the non-culprit vessel(s) is beneficial and safe in STEMI patients. Importantly, for this application, issues related to the evaluation of ischemia in the STEMI patient with multivessel coronary artery disease (CAD) focusing on PCI in the non-culprit lesion have not been fully addressed. When considering that 40-70% of STEMI patients have multivessel disease, alternative approaches for post-PPCI non-culprit lesion intervention need to be considered. The current application proposes a primary objective of applying gated-SPECT MPI as a guide to post-PPCI non-culprit coronary lesion intervention as compared to standard approaches which use post-PPCI intervention of all non-culprit lesions (based on anatomy alone).

We performed an international, randomized, non-inferiority trial comparing ischemia-guided non-culprit vessel angioplasty to routine non-culprit vessel angioplasty, following primary PCI for STEMI. The Ischemia-guided versus routine non-culprit vessel angioplasty for patients with ST segment elevation myocardial infarction and multi-vessel disease - the IAEA SPECT STEMI trial - Clinical trial registration number: CTRI/2018/08/015384

In the ischemia-guided arm, non-culprit PCI was performed if patients were symptomatic or had a positive stress myocardial perfusion imaging (MPI). In the routine non-culprit vessel PCI arm, all non-culprit vessels with angiographically significant lesions were treated within 6 weeks of randomization. The primary outcome was the difference in percent ischemic myocardium at follow-up stress MPI between the two arms. All MPI images were processed and analyzed at a central core lab, blinded to treatment allocation.

The hypothesis : "A strategy of ischemia-guided non-culprit vessel PCI is non-inferior to a routine non-culprit vessel PCI" was proved, thus helping to establish the value of gated-SPECT MPI protocol with pharmacological stress to guide efficacious multivessel PCI in STEMI patients.

This CRP contributes to achieve the SDG goal 3.4, by 2013 reduce by 30% the premature mortality due to NCDs. Which is in line with the objective of programme 2.2. of Supporting MS to address their health needs related to the prevention, diagnosis and treatment using radiation medicine.

Relevance

The 2013 American College of Cardiology Foun­dation/ American Heart Association/Society for Cardiovascular Angiography and Interventions guideli­nes (ACC/AHA) recommended complete revascularization (CR) strategy as Class III (with potential harm) during PCI of STEMI, with evidence derived largely from observational studies. In a recent 2015 focused update on PPCI in STEMI patients. However, within the interventional cardiology com­munity, agreement with this recommendation is not uniform.

The nuclear cardiology community is in need of a study to address this question of ischemia-guided revascularization of non­culprit obstructive coronary artery disease in the setting of STEMI. As previously discussed, a large proportion of patients with STEMI have multivessel disease at the time of STEMI, with rates ranging from approximately 40 to 70%. We propose another option, based on the FAME trials and supported by published SPECT trial as well, that employs non-invasive assessment of ischemia to guide staged intervention of all non-culprit lesions. Gated-SPECT MPI with stress (either exercise or pharmacological) would allow evaluation of the extent and severity of myocardial ischemia, regional wall motion, and left ventricular function, including local­ization of ischemia, as well as measurement of the infarct extent. Prior studies have shown safety in performing pharmacologic nuclear stress testing post myocardial infarction.

In patients with multi-vessel disease presenting with ST elevation myocardial infarction (STEMI), the efficacy and safety of ischemia-guided, versus routine non-culprit vessel angioplasty has not been adequately studied.

The IAEA SPECT STEMI trial is an international, randomized, non-inferiority trial comparing ischemia-guided non-culprit vessel angioplasty to routine non-culprit vessel angioplasty, following primary PCI for STEMI. In the ischemia-guided arm, non-culprit PCI was performed if patients were symptomatic or had a positive stress myocardial perfusion imaging (MPI). In the routine non-culprit vessel PCI arm, all non-culprit vessels with angiographically significant lesions were treated within 6 weeks of randomization. The primary outcome was the difference in percent ischemic myocardium at follow-up stress MPI between the two arms. All MPI images were processed and analyzed at a central core lab, blinded to treatment allocation.

In all, 109 patients were enrolled from 9 member states. In the ischemia-guided arm, 25/48 (47%) patients underwent non-culprit vessel PCI following stress MPI. In the routine non-culprit PCI arm, 43/56 (77%) patients underwent angioplasty (86% within 6 weeks of randomization). The median percentage of ischemic myocardium on follow-up imaging (mean 16.5 months) was low, and identical (2.9%) in both arms (difference 0.13%, 95%CI -1.3-1.6%, p for non-inferiority <0.0001). There were no differences in clinical outcomes.

We conclude that a strategy of ischemia-guided non-culprit PCI resulted in low ischemia burden and was non-inferior to a strategy of routine non-culprit vessel PCI in reducing ischemia burden. Selective non-culprit PCI following STEMI offers the potential for cost-savings and may be particularly relevant to low-resource settings.

The IAEA STEMI trial contributed to fill this gap in medical evidence by proving that a strategy of ischemia-guided non-culprit vessel PCI is non-inferior to a routine non-culprit vessel PCI, thus helping to establish the value of gated-SPECT MPI protocol with pharmacological stress to guide efficacious multivessel PCI in STEMI patients.

CRP Publications

Type

Peer review journal - Journal of Nuclear Cardiology August 2018

Year

2018

Publication URL

https://link.springer.com/article/10.1007/s12350-018-1368-7

Description

Review Article

Country/Organization

IAEA

Type

Peer review journal - Journal of Nuclear Cardiology August 2018

Year

2018

Publication URL

https://link.springer.com/article/10.1007/s12350-018-1368-7

Description

Review Article

Country/Organization

IAEA

Type

Peer review journal

Year

2022

Description

Value of Gated-SPECT MPI for Ischemia-Guided PCI of non-culprit vessels in STEMI Patients with Multivessel Disease after primary PCI summited for publication to the Journal of Nuclear Medicine in July 2022 awaiting approval

Country/Organization

IAEA

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