A Randomized Comparison of Long-Term Healing Between Biodegradable- Versus Durable-Polymer Everolimus Eluting Stents in STEMI

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— CONNECT  

Official title:

A Randomized COmparison of LoNg-Term Vascular HealiNg bEtween Biodegradable -Polymer (BP) Versus Durable Polymer (DP) Everolimus Eluting Stents in Acute ST-Elevation Myocardial InfarCTion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03440801
• Other study ID #: CONNECT1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 3, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2022
• Source: Tokorozawa Heart Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing such as the frequency of malapposed and uncovered stent struts at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.

Description:

DES use has significantly improved clinical outcomes as compared with bare metal stents (BMS), primarily through a notable reduction in the risk of repeat revascularisation. However, durable polymer DES have been associated with an increased risk of late and very late stent thrombosis and the anticipated development of in-stent neoatherosclerosis. In addition, in-vivo study suggest that different types of polymer among current DES might have different responses to acute thrombogenecity after stent implantation.

Patients with STEMI are associated with worse long-term clinical outcomes due to re-infarction and stent thrombosis throughout long-term follow-up. Underlying unstable lesion which includes ruptured plaque and thin-cap fibroatheroma behind stent strut is a predictor of neoatherosclerosis formation.

There is no dedicated randomized trial to comparing biodegradable-polymer versus durable polymer-DES in terms of acute thrombogenecity and long-term healing at 3 years after primary PCI.

Therefore this study is designed to compare the acute thrombogenecity and frequency of neoatherosclerotic lesions and other aspects of long term arterial healing at 3 years among patients treated with either a biodegradable polymer everolimus-eluting stent (Synergy) or a durable polymer everolimus-eluting stent (Xience Alpine) for STEMI.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age =18 years

2. Primary PCI within 24 hours of symptom onset

3. ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguuoius anterior leads

4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents

Exclusion Criteria:

1. Female ofchildbearing potential (age < 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.

2. Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material

3. Inability to understand and provide informed consent

4. Currently participating in another trial before reaching first endpoint

5. Mechanical complications of acute myocardial infarction

6. Acute myocardial infarction secondary to stent thrombosis or restenosis

7. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period

8. Noncardiac comorbid conditions are present with life expectancy <3years or that may result in protocol noncompliance

9. History of bleeding diathesis or known coagulopathy

10. Use of oral anticoagulation

11. Age >90 years

12. LV-function at index procedure <=20%

13. Cancer under active treatment (chemotherapy)

14. Hemodynamic instability following primary PCI

15. Chronic kidey disease (Creatinine - Clearance < 30ml/min)

16. OCT technically not feasible (severe calcification, tortuosity)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Device:
• Synergy
Biodegradable-polymer everolimus-eluting stent Synergy
• Xience
Durable-polymer everolimus-eluting stent Xience

Locations

Country	Name	City	State
Japan	Tokorozawa Heart Center	Tokorozawa

Sponsors (2)

Lead Sponsor	Collaborator
Tokorozawa Heart Center	University Hospital Inselspital, Berne

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of neoatheroslcerosis	Frequency of neoatherosclerosis lesion which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of ? 1 mm at three years.	3 years
Secondary	Athero-thrombotic material area	Athero-thrombotic material area (tissue protorusion + isolated intraluminal detect) within the stent strut after primary PCI	initial day