Trhombus Aspiration in Hyperglycemic ST-elevation myocardiAl InfarcTIon (TAHITI)

Trhombus Aspiration in Hyperglycemic ST-elevation myocardiAl InfarcTIon (STEMI) Patients: 1-year Follow-up of the Prospective Randomised TAHITI Study

Background. Patients with ST-Elevation Myocardial Infarction (STEMI) and hyperglycemia on admission have high rates of mortality (1). The management of hyperglycemic patients during STEMI is unclear. We evaluate whether the thrombus aspiration (TA) before primary percutaneous coronary intervention (PCI) may improve STEMI outcomes in hyperglycemic patients (2).

Research Design and Methods. Consecutive 990 hyperglycemic patients with first STEMI undergoing quantitative coronary angiography were studied. Patients were categorized in two groups, either treated by thrombus aspiration v/s patients treated without thrombus aspiration. After discharge from the hospital, all patients will be managed and followed quarterly for 12 months month after event, as outpatients, to perform clinical evaluation, routine analyses and cardiovascular evaluation. The cardiovascular endpoint collected in both cohorts will include cardiac mortality, all-cause mortality and hospitalization for coronary disease and heart failure.

Conclusions. We will attend improved outcomes in hyperglycemic patients treated by the TA before PCI, as compared to hyperglycemic patients treated only by PCI.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia
• Intervention / Treatment: Device: percutaneous coronary intervention

Detailed Description

The data analyzed in this study will be obtained from hyperglycemic STEMI patients who underwent primary PCI at the Department of Cardiology of the Cardarelli Hospital in Naples Italy between June 1, 2016, and December 1, 2017. This will be a prospective study to compare two therapeutic strategies: PCI plus thrombus aspiration (TA) versus PCI alone in patients with STEMI and hyperglycemia. According to the recent statement by the American Heart Association, hyperglycemia will be defined as an admission plasma glucose level of >140 mg/dl. Inclusion criteria will include: age of 18 years or greater, presentation to the cardiac catheterization laboratory for PCI in the setting of first STEMI, admission plasma glucose level of >140 mg/dl. All STEMI patients will be referred to the cardiac catheterization laboratory within 12 h of presentation. Patients with left ventricular ejection fraction less than 25%, with previous myocardial infarction or previous PCI or/and coronary by-pass grafting, or had received fibrinolytic therapy will be excluded from the study. The following patients will be referred for urgent invasive diagnostics with the intention of performing PCI: symptom duration of 12 hours or less and ST-segment elevation of 0.1 mV or greater in at least 2 contiguous leads (≥0.2 mV in V1-V3) or presumed new-onset left bundle-branch block. The investigation will be conformed with the principles outlined in the Declaration of Helsinki for use of human tissue or subjects. The Institutional Review Board will approve the protocol.

Outcomes The primary outcome of the THAITI study will be all-cause mortality, cardiovascular deaths, recurrent myocardial infarction, cardiogenic shock, and class IV heart failure within 360 days. Other outcomes will include target vessel revascularisation, stent thrombosis, stroke, and transient ischaemic attack within 360 days.

• Study Type: Observational
• Enrollment (Actual): 990

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • Cardarelli Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We will analyze the consecutive patients presenting with acute myocardial infarction and ST segment elevation (STEMI) admitted to the Department of Cardiology of the Cardarelli Hospital in Naples, Italy. Inclusion criteria will include: age of 18 years or greater, presentation to the cardiac catheterization laboratory for PCI in the setting of first STEMI, admission plasma glucose level ( >140 mg/dl in hyperglycemic Group). All STEMI patients will be referred to the cardiac catheterization laboratory within 12 h of presentation. Patients with left ventricular ejection fraction less than 25%, with previous myocardial infarction or previous PCI or/and coronary by-pass grafting will be excluded.

Description

Inclusion Criteria:

- age of 18 years or greater, presentation to the cardiac catheterization laboratory for PCI in the setting of first STEMI, admission plasma glucose level ( >140 mg/dl in hyperglycemic Group).

Exclusion Criteria:

- patients with left ventricular ejection fraction less than 25%, with previous myocardial infarction or previous PCI or/and coronary by-pass grafting.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEMI TA hyperglycemic subjects; STEMI hyperglycemic patients, percutaneous coronary intervention with TA	Device: percutaneous coronary intervention; Percutaneous coronary intervention. Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion. A minimum of two syringes (40 mL) of aspirate will be recommended. The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter. The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus. PCI procedure will be done without thrombectomy as per the investigator. Direct stenting will not be mandated in either treatment group. Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy. The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.
STEMI without TA hyperglycemic subjects; STEMI hyperglycemic patients, percutaneous coronary intervention without TA	Device: percutaneous coronary intervention; Percutaneous coronary intervention. Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion. A minimum of two syringes (40 mL) of aspirate will be recommended. The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter. The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus. PCI procedure will be done without thrombectomy as per the investigator. Direct stenting will not be mandated in either treatment group. Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy. The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular death	death caused by loss of heart function such as sudden cardiac arrest or heart attack (myocardial infarction). ECG and cardiac damage markers	12 months
recurrent myocardial infarction	Myocardial infarction when there is a blockage in one or more of the arteries to the heart, preventing the heart from receiving enough oxygen-rich blood. If the oxygen in the blood cannot reach the heart muscle, the heart becomes damaged. ECG and cardiac damage markers	12 months
heart failure.	Heart failure develops when the heart, via an abnormality of cardiac function (detectable or not), fails to pump blood at a rate commensurate with the requirements of the metabolizing tissues or is able to do so only with an elevated diastolic filling pressure. ECG and echocardiography	12 months
acute coronary syndrome	non-ST-elevation acute coronary syndromes (ACSs) and unstable angina. ECG and cardiac damage markers	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel revascularisation	Target lesion revascularization was defined as either repeat percutaneous or surgical revascularization for a lesion anywhere within the stent or the 5-mm borders proximal or distal to the stent. Target lesion revascularization was considered to be ischemia-driven if the target lesion diameter stenosis was ≥50% by quantitative analysis with either electrocardiographic changes at rest or a positive functional study in the distribution of the target lesion, or ≥70% with recurrent symptoms only. Angiography study	12 months
stent thrombosis,	Definite or confirmed event with symptoms suggestive of an acute coronary syndrome and angiographic or pathologic confirmation of stent thrombosis.Angiography study	12 months
stroke	The sudden death of brain cells due to lack of oxygen, caused by blockage of blood flow or rupture of an artery to the brain. Symptoms: Sudden loss of speech, weakness, or paralysis of one side of the body. CAT scans	12 months
transient ischaemic attack	.A transient ischemic attack (TIA) is like a stroke, producing similar symptoms, but usually lasting only a few minutes and causing no permanent damage.CAT scans	12 months

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Study Director: Celestino Sardu, MD, PHD, University of Campania "Luigi Vanvitelli"

Publications and helpful links

General Publications

• Jones DA, Rathod KS, Gallagher S, Jain AK, Kalra SS, Lim P, Crake T, Ozkor M, Rakhit R, Knight CJ, Iqbal MB, Dalby MC, Malik IS, Whitbread M, Mathur A, Redwood S, MacCarthy PA, Weerackody R, Wragg A. Manual Thrombus Aspiration Is Not Associated With Reduced Mortality in Patients Treated With Primary Percutaneous Coronary Intervention: An Observational Study of 10,929 Patients With ST-Segment Elevation Myocardial Infarction From the London Heart Attack Group. JACC Cardiovasc Interv. 2015 Apr 20;8(4):575-84. doi: 10.1016/j.jcin.2014.11.021.
• Deedwania P, Kosiborod M, Barrett E, Ceriello A, Isley W, Mazzone T, Raskin P; American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Hyperglycemia and acute coronary syndrome: a scientific statement from the American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2008 Mar 25;117(12):1610-9. doi: 10.1161/CIRCULATIONAHA.107.188629. Epub 2008 Feb 25. Erratum In: Circulation. 2010 Jun 15;121(23):e444.
• Tilsted HH, Olivecrona GK. To Aspirate or Not to Aspirate: That Is the Question. JACC Cardiovasc Interv. 2015 Apr 20;8(4):585-7. doi: 10.1016/j.jcin.2015.01.014. No abstract available.
• Sardu C, Barbieri M, Balestrieri ML, Siniscalchi M, Paolisso P, Calabro P, Minicucci F, Signoriello G, Portoghese M, Mone P, D'Andrea D, Gragnano F, Bellis A, Mauro C, Paolisso G, Rizzo MR, Marfella R. Thrombus aspiration in hyperglycemic ST-elevation myocardial infarction (STEMI) patients: clinical outcomes at 1-year follow-up. Cardiovasc Diabetol. 2018 Nov 29;17(1):152. doi: 10.1186/s12933-018-0795-8. Erratum In: Cardiovasc Diabetol. 2018 Dec 27;17(1):159.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2010
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: June 25, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Myocardial Infarction; Hyperglycemia; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: TAHITI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Monthly for 1 year

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No