Drug-coated balloon vs. drug-eluting stent in high-risk coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, multicenter, international, open-label study comparing two percutaneous coronary intervention strategies in complex CAD. Participants are assigned 1:1 to receive either a SeQuent SCB-based strategy or a DES-based strategy for all lesions. The primary outcome is a composite of target vessel failure at 12 and 36 months, including cardiovascular death, TV-MI, ci-TVR, and major bleeding (BARC 3-5). Follow-up visits occur at 3 months, 1 year, 2 years, and 3 years. Eligible patients are adults with CAD and at least one high clinical or anatomical risk feature and must provide informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject must be 18 years of age or older
* Subject can understand risks, benefits, and treatment alternatives of receiving DCB treatment or DES and provide written informed consent before any study-related procedure
* Subject should have a documented angina pectoris or silent ischemia as assessed by non-invasive testing, or functional invasive assessment, or equivalent (dyspnea, arrhythmia, ≥75% diameter stenosis without stress test at staged procedure), or unstable angina, hemodynamically stable NSTEMI and STEMI more than 48 hours after primary PCI and without residual thrombotic material
* Subject must be affiliated with a social security system, where applicable

Subject must have at least one of the high clinical or anatomical risk features:

High clinical risk, defined as:

* DM on treatment (insulin or oral antidiabetic agents), or
* At least 75 years of age, or
* CKD (eGFR \<60 mL/min/1.73 m2), or
* Treated for ACS (unstable angina, hemodynamically stable NSTEMI, hemodynamically stable STEMI more than 48 hours after uneventful primary PCI and without residual thrombotic material), or
* High bleeding risk (defined by Academic Research Consortium criteria - ARC HBR)

OR

High anatomical risk lesions requiring treatment as follows:

* Multivessel treatment (two or three vessels)
* True bifurcation with side branch involvement
* Long lesions (≥36 mm)
* Lesion likely requiring calcium modification

In the case of multivessel (MV) disease, multiple vessels can be treated provided that all lesions are amenable to treatment with either DCB or DES and vessel size at the site of the lesion is \>2.0 mm by visual assessment.

The trial does not restrict the number of target lesions. However, the operator should determine that all target lesions intended to be treated must be suitable for treatment with either DES or DCB. For patients randomized to the DCB arm, the likelihood of requiring provisional stenting must be assessed as less than 30% for each lesion requiring treatment.

Exclusion Criteria:

* Primary PCI (acute STEMI patients)
* Cardiogenic shock
* Subject enrolled in an active interventional trial
* Subject not able or unlikely to comply with the planned follow-ups
* Subject who is pregnant, nursing or planning to become pregnant during the study
* Subject not able to give informed consent
* Subject under judicial protection, guardianship or curatorship or patient deprived of their liberty by judicial or administrative decision (where applicable)
* Subject with a life expectancy \<12 months
* Subjects with known allergies to antiplatelet agents (e.g., acetylsalicylic acid, P2Y12 inhibitors), anticoagulants (e.g., heparin, direct thrombin inhibitors), iodinated contrast media, or mTOR inhibitors (e.g., sirolimus and related compounds)
* Angiographic exclusion criteria:

  1. aorto-ostial lesions,
  2. coronary bypass grafts requiring intervention,
  3. chronic total occlusion requiring intervention
  4. Previous PCI at any time of a vessel intended to be treated (Instent-restenosis lesions excluded)
  5. Previous PCI within 30 days, except for recent STEMI, \>48 hours after uneventful primary PCI and without residual thrombotic material on coronary angiography

Where it's running

• Stadtspital Zürich - Klinik für Kardiologie
  Zurich, Switzerland Recruiting
• Universität des Saarlandes - Klinik für Innere Medizin III
  Homburg, Germany Not yet recruiting
• University Hospital Basel
  Basel, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Raban Jeger, Prof. Dr. med. — Stadtspital Zürich - Klinik für Kardiologie
• Study coordinator: Jiani Wang, Dr.
• Email: Jiani.Wang@bbraun.com
• Phone: +49 151 46206456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.