Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions

Not Applicable

Recruiting

• Conditions: Platelet Aggregation Inhibitors; Coronary Artery Disease; Percutaneous Coronary Intervention
• Interventions: Other: Algorithm-guided DAPT duration; Other: Standard-of-care DAPT duration

• Registration Number: NCT05732701
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The TAILOR-DAPT trial aims to investigate the benefits of a score-based decision-making algorithm to guide DAPT duration compared to a standard-of-care DAPT duration without the use of risk scores in patients undergoing PCI.

Detailed Description

Background:

The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. European guidelines recommend to implement risk scores to guide the duration of DAPT after stent implantation (class IIb, level of evidence A). However, its adoption rate remains exceedingly low in daily clinical practice in part due to the lack of direct evidence obtained from a randomized controlled trial supporting this strategy.

Aim:

Using a pragmatic study-design, the investigators aim to determine the efficacy and safety of an algorithm-guided strategy for DAPT duration compared to a standard-of-care DAPT without the use of risk scores in patients undergoing PCI with stent implantation.

Methodology:

This investigator-initiated, single-blind, randomized trial will include a total of 2788 patients aged ≥18 years undergoing PCI with stent implantation. Main exclusion criteria are peri-procedural complications potentially affecting DAPT duration. The study will be nested into a well-running registry to minimize study-related costs (pragmatic trial approach). Patients will be randomized to an algorithm-guided DAPT group or a standard-of-care DAPT group in a 1:1 fashion. In the algorithm-guided group, DAPT duration will be determined according to the PRECISE-DAPT score (≥25 or \<25), PCI complexity, and clinical presentation (acute or chronic coronary syndromes). In the standard-of-care DAPT group, treatment duration is at the operator's discretion. The primary endpoint is a composite of net adverse clinical events (NACE) defined as all-cause death, spontaneous myocardial infarction, stroke, definite stent thrombosis or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding at 1 year.

Potential significance:

This will be the first study evaluating the impact of a score-based decision-making algorithm integrating bleeding and ischemic risks for DAPT duration among patients undergoing PCI. The hypothesis is that the proposed simple decision-making algorithm minimizes bleeding risk and maximizes ischemic benefit compared to a standard-of-care DAPT regimen. Prospective data obtained from a pragmatic randomized controlled trial embedded into an on-going, well-managed PCI registry database may further enhance the adoption rate of such a strategy in clinical practice.

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Study Start: 2023-06-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2788

Inclusion Criteria

1. PCI with drug eluting stent (DES) implantation
2. Age ≥18 years
3. Ability to sign informed consent before any study-specific procedure

Exclusion Criteria

1. Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization)
2. Indication for oral anticoagulation
3. Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion/no-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding)
4. Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI
5. Active bleeding requiring medical attention at qualifying PCI
6. The presence of hemodynamic instability (persistent systolic blood pressure below 90mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
7. Life expectancy less than 1 year
8. Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
9. Planned surgery within the next 3 months
10. Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel)
11. Participation in a drug trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Algorithm-guided DAPT duration	Algorithm-guided DAPT duration
Standard	Standard-of-care DAPT duration	Standard-of-care DAPT duration

Primary Outcome Measures

Name	Time	Method
Net adverse clinical events (NACE)	1 year	All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding

Secondary Outcome Measures

Name	Time	Method
Major or clinically relevant non-major bleeding	1 year	Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding
Major adverse cardiovascular events (MACE)	1 year	Cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis or stroke
Major bleeding	1 year	Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding
Any Bleeding Academic Research Consortium (BARC) bleeding	1 year
All-cause death	1 year
Target vessel myocardial infarction	1 year
Target lesion revascularization	1 year
Any revascularization	1 year
Cardiovascular death	1 year
Myocardial infarction	1 year
Spontaneous myocardial infarction	1 year
Target lesion failure	1 year	Cardiac death, target-vessel myocardial infarction or target lesion revascularization
Non-target vessel revascularization	1 year
Transient ischemic attack	1 year
Definite stent thrombosis	1 year
Stroke	1 year
Adherence to DAPT	1 year	According to the traditional classification (Adherent≥80% of the time from randomization to intended DAPT cessation date)
Target vessel revascularization	1 year

Trial Locations

Locations (2)

University Clinical Center of the Republic of Srpska; 🇧🇦 Banja Luka, Bosnia and Herzegovina

Department of Cardiology, Bern University Hospital; 🇨🇭 Bern, Switzerland