Stent Placement Timing for Coronary Artery Disease

(STAR Trial)

Overseen By Nancy Stone, MEd, NBC-HWC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saint Luke's Health System

Disqualifiers: Pregnancy, Hearing loss, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

150 Participants Needed

Trial Summary

What is the purpose of this trial?

STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure. The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI, as a prospective, multi-center study of 150 participants with randomization of timing of staged PCI. Five sites will be selected to participate in STAR from a national network of highly experienced CTO-PCI centers across the United States.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment Stent Placement Timing for Coronary Artery Disease?

Research shows that early and late stent placement in heart attack patients have similar long-term outcomes, but early placement may have a higher risk of another heart attack. This suggests that timing can be flexible, but careful consideration is needed for early placement. ^{1 2 3 4 5}

Is stent placement timing generally safe for humans?

Research shows that both early and late stent placement in coronary artery disease patients have similar safety outcomes, with no significant differences in major adverse cardiac events. However, early stent placement may carry a slightly higher risk of recurrent heart attacks compared to late placement. ^{1 2 3 6 7}

How does the timing of stent placement differ from other treatments for coronary artery disease?

The timing of stent placement for coronary artery disease can be early or late, with early placement occurring within a few weeks and late placement happening after a longer period. This approach is unique because it considers the optimal timing for stent placement to potentially improve outcomes, unlike standard treatments that may not focus on timing as a critical factor. ^{1 3 7 8 9}

Eligibility Criteria

The STAR Study is for adults over 18 with chronic total occlusion in coronary arteries who are scheduled for a PCI procedure and have attempted the STAR technique. Participants must speak English and be able to do telephone follow-ups. Pregnant women, prisoners, those with severe kidney disease or dementia, hard of hearing individuals, and anyone already in another study cannot join.

Inclusion Criteria

I am 18 years old or older.

I can communicate effectively in English.

My doctor tried a specific technique to treat my blocked artery and plans another procedure.

Exclusion Criteria

Incarcerated prisoner.

I am not pregnant, as confirmed by a hospital test.

Unable to participate in telephone follow-up

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Procedure

Participants undergo the STAR procedure for CTO-PCI

1 day

1 visit (in-person)

Early Stent Placement

Stent placement occurs 5-7 weeks post-STAR procedure

5-7 weeks

1 visit (in-person)

Later Stent Placement

Stent placement occurs 12-14 weeks post-STAR procedure

12-14 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after stenting

14 weeks

Treatment Details

Interventions

• Stent Placement Timing - Early
• Stent Placement Timing - Late

Trial Overview This trial examines the timing of stent placement—either early or late—in patients undergoing a CTO-PCI procedure. It's a multi-center study involving 150 participants across the U.S., where they're randomly assigned to receive their stents at different times to see which is more effective.

Participant Groups

Group I: Later stent placement Experimental Treatment 1 Intervention

Stent placement 12-14 weeks post-STAR procedure

Group II: Early stent placement Experimental Treatment 1 Intervention

Stent placement 5-7 weeks post-STAR procedure

Stent Placement Timing - Early is already approved in United States for the following indications:

Approved in United States as Stent Placement Timing - Early for:

• Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI)

Who Is Running the Clinical Trial?

Saint Luke's Health System

Lead Sponsor

Trials

42

Recruited

12,600+

Asahi-Intecc

Collaborator

Trials

1

Recruited

150+

Findings from Research

In a study of 115 stroke patients, early stenting (within 14 days of symptoms) was associated with a higher risk of long-term complications, including restenosis and recurrent ischemic strokes, compared to late stenting (after 14 days).

The early stenting group experienced more adverse events, with a total rate of ischemic strokes and other complications being significantly higher than in the late stenting group, indicating that timing of stenting may impact patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus delayed stenting for intracranial atherosclerotic artery stenosis with ischemic stroke. Zhang, Y., Sun, Y., Li, X., et al.[2020]

In a study of 268 STEMI patients undergoing PCI after 3 days of onset, early PCI (3-14 days) and late PCI (>14 days) showed comparable outcomes in terms of all-cause death and major adverse cardiac events, indicating similar efficacy of both timing strategies.

However, early PCI was associated with a significantly higher risk of recurrent myocardial infarction (MI), suggesting that while timing may not affect overall survival, it could influence the likelihood of subsequent heart issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of delayed percutaneous coronary intervention for patients with ST-segment elevation myocardial infarction: A propensity score-matched retrospective study. Xue, YL., Ma, YT., Gao, YP., et al.[2023]

In a study of 1432 patients with acute coronary syndromes (ACS) undergoing staged percutaneous coronary intervention (PCI), early PCI (within 4 weeks) did not show a significant advantage over late PCI (4 weeks or more) in reducing major adverse cardiac events after one year.

Both early and late staged PCI resulted in similar rates of all-cause death, recurrent myocardial infarction, and the need for urgent non-target-vessel PCI, indicating that the timing of the procedure may not critically impact long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Timing of Staged Percutaneous Coronary Intervention on Clinical Outcomes in Patients With Acute Coronary Syndromes. Otsuka, T., Bär, S., Losdat, S., et al.[2022]

In a study of 428 STEMI patients with multivessel disease, staged percutaneous coronary intervention (PCI) performed within 1-2 weeks after primary PCI significantly reduced the risk of major adverse cardiovascular events (MACE) compared to procedures done 2-12 weeks later.

Patients who underwent staged PCI within 1 week had a 60% lower risk of MACE, and those treated within 1-2 weeks had a 46% lower risk, primarily due to fewer repeat revascularizations, highlighting the importance of timely intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal timing of staged percutaneous coronary intervention in ST-segment elevation myocardial infarction patients with multivessel disease. Zhao, XD., Zhao, GQ., Wang, X., et al.[2023]

In a study of 977 STEMI patients, those who underwent early delayed percutaneous coronary intervention (PCI) within 3-14 days had similar long-term outcomes to those who had late delayed PCI within 15-35 days, with no significant difference in major adverse cardiac and cerebrovascular events (MACCE) after 2 years.

Both early and late delayed PCI using drug-eluting stents (DES) showed comparable rates of ischemia-driven target vessel revascularization, indicating that timing of PCI within this range does not adversely affect long-term safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term outcomes of patients with ST-elevation myocardial infarction undergoing early versus late delayed percutaneous coronary intervention using drug-eluting stents]. Song, L., Deng, SB., Guan, CD., et al.[2020]

In a study of 5,678 patients with successful coronary stent placement, the overall rate of stent failure was 2.5% at four weeks, with early events occurring at a rate of 2.0% and late events at 0.5%.

The findings suggest that while the risk of late stent failure is low with a four-week ticlopidine regimen, certain high-risk factors can increase this risk to 2.5%, indicating that a tailored approach to thienopyridine treatment duration is necessary rather than a blanket reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of thrombotic occlusion and major adverse cardiac events between two and four weeks after coronary stent placement: analysis of 5,678 patients with a four-week ticlopidine regimen. Schühlen, H., Kastrati, A., Pache, J., et al.[2019]

In a study of 136 patients with coronary heart disease, immediate stenting after coronary angiography resulted in a 100% angiographic success rate, while delayed stenting (up to a month or more) showed decreasing success rates of 97.6% and 92.3%, respectively.

Delayed stenting was associated with a higher incidence of complications (3.8% in Group 2 and 6.5% in Group 3) and more significant stenosis or occlusion, indicating that timely intervention is crucial for better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of intracoronary stenting made in different periods after diagnostic coronary angiography]. Savchenko, AP., Rudenko, BA., Matchin, IuG.[2006]

An 88-year-old man experienced a ST-segment-elevation myocardial infarction 11 years after receiving a sirolimus-eluting stent, marking one of the longest reported intervals for very late stent thrombosis.

The case highlights the importance of complete endothelialization and the potential risks of neointimal formation and late stent malapposition, raising questions about the optimal duration of antiplatelet therapy for patients with drug-eluting stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very Late Stent Thrombosis 11 Years after Implantation of a Drug-Eluting Stent. Liou, K., Jepson, N.[2018]

In a study involving 140 patients with ST-segment-elevation myocardial infarction, immediate stenting showed a trend towards better outcomes in reducing microvascular obstruction compared to delayed stenting, with significant results after adjusting for the area at risk.

The findings suggest that delayed stenting may not be beneficial and could potentially worsen microvascular obstruction, indicating that immediate stenting is preferable in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Belle, L., Motreff, P., Mangin, L., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Early versus delayed stenting for intracranial atherosclerotic artery stenosis with ischemic stroke. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term outcomes of delayed percutaneous coronary intervention for patients with ST-segment elevation myocardial infarction: A propensity score-matched retrospective study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effect of Timing of Staged Percutaneous Coronary Intervention on Clinical Outcomes in Patients With Acute Coronary Syndromes. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Optimal timing of staged percutaneous coronary intervention in ST-segment elevation myocardial infarction patients with multivessel disease. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Long-term outcomes of patients with ST-elevation myocardial infarction undergoing early versus late delayed percutaneous coronary intervention using drug-eluting stents]. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Incidence of thrombotic occlusion and major adverse cardiac events between two and four weeks after coronary stent placement: analysis of 5,678 patients with a four-week ticlopidine regimen. [2019]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Results of intracoronary stenting made in different periods after diagnostic coronary angiography]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Very Late Stent Thrombosis 11 Years after Implantation of a Drug-Eluting Stent. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. [2022]