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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the optimal timing for placing a stent (a small tube that keeps arteries open) in individuals with coronary artery disease who have a completely blocked artery. Researchers aim to determine whether placing the stent earlier (5-7 weeks) or later (12-14 weeks) after an initial procedure yields better outcomes. The trial includes participants planning to undergo a specific heart procedure for a completely blocked artery and who can communicate in English for follow-up. As an unphased trial, it offers participants the chance to contribute to important research that could enhance future treatment strategies.

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 prior data suggests that this stent placement timing is safe for coronary artery disease patients?

Research has shown that both early and late stent placement for coronary artery disease have been evaluated for safety. Studies on early stent placement indicate it is generally safe, though it might slightly increase the risk of another heart attack compared to later placement. Consequently, some individuals might experience more heart issues after receiving an early stent.

For late stent placement, research suggests that delaying the procedure can improve blood flow and overall heart health. This approach often yields positive results, with many individuals doing well after the procedure. Both early and late stent placements are considered safe, but each carries its own risks and benefits. Prospective trial participants should discuss with their doctor to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the optimal timing for stent placement in patients with coronary artery disease. Unlike the standard approach, which typically involves stent placement soon after diagnosis, this trial investigates whether placing the stent earlier (5-7 weeks) or later (12-14 weeks) after the STAR procedure could improve patient outcomes. By determining the best timing, this trial could potentially enhance recovery and reduce complications, offering a new strategy to refine the care for heart disease patients.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

This trial will compare early stent placement with later stent placement for treating coronary artery disease. Research has shown that early stent placement can reduce the likelihood of hospital readmission and improve blood flow in heart attack patients. Conversely, placing a stent later can enhance blood vessel function and lead to better long-term outcomes, particularly for patients with significant clotting. Both methods have strong evidence supporting their safety and effectiveness for different patient needs. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 can communicate effectively in English.

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

I am scheduled for a procedure to open a completely blocked heart artery.

Exclusion Criteria

Incarcerated prisoner.

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

Unable to participate in telephone follow-up

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3700602/

Contemporary outcomes in vascular patients who require ... We report the vascular operative outcomes in a contemporary cohort of vascular patients who had PCI with coronary stent placement for an acute event.

2. eurointervention.pcronline.com eurointervention.pcronline.com/article/immediate-vs-delayed-stenting-in-acute-myocardial-infarction-a-systematic-review-and-meta-analysis

Immediate vs. delayed stenting in acute myocardial infarction Conclusions: Delayed stent implantation is associated with better angiographic outcomes. Randomised trials are required to assess whether delayed stenting ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015369

10-Year Outcomes of Deferred or Conventional Stent ... CONCLUSIONS: Deferred stenting did not reduce all-cause mortality or the composite primary outcome after 10 years but reduced hospitalization ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11886388/

Outcomes of patients with acute ST-segment elevation ... Deferred PCI strategy is safe and reduces the thrombus burden, improves thrombolysis in myocardial infarction (TIMI) flow, improves myocardial blush grade,

5. cureus.com cureus.com/articles/374943-deferred-versus-immediate-stenting-in-late-presenting-st-segment-elevation-myocardial-infarction-stemi-patients-with-a-high-thrombus-burden-a-retrospective-analysis

Deferred Versus Immediate Stenting in Late-Presenting ST ... In late-presenting STEMI patients with HTB, deferred stenting yielded superior perfusion and clinical outcomes compared to immediate stenting.

6. eurointervention.pcronline.com eurointervention.pcronline.com/article/clinical-outcomes-of-no-stenting-in-patients-with-st-segment-elevation-myocardial-infarction-undergoing-deferred-primary-percutaneous-coronary-intervention

Clinical outcomes of no stenting in patients with ST ... A study comparing outcomes of STEMI patients treated with PCI but no stenting to those treated with immediate stenting found comparable event rates during ...

7. withpower.com withpower.com/trial/phase-coronary-restenosis-11-2021-07444

Stent Placement Timing for Coronary Artery Disease · Info ... However, early stent placement may carry a slightly higher risk of recurrent heart attacks compared to late placement.