Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies

Condition(s) studied

Investigational drug(s) / intervention(s)

Drug-coated balloon-based intervention: In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover.

Drug-eluting stent-based intervention: In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice.

Study summary

The goal of this clinical trial is to find out whether a treatment strategy based on a drug-coated balloon (DCB) achieves coronary artery function at 6 months that is not worse than a strategy using only drug-eluting stents (DES) by more than a prespecified amount. The study will enroll adults undergoing percutaneous coronary intervention (PCI) for a new coronary artery narrowing (de novo lesion).

The main questions are:

1. Is fractional flow reserve (FFR) at 6 months noninferior after DCB-based PCI compared with DES-only PCI? FFR is a pressure-based measure used to assess blood flow through a coronary artery.
2. Does the DCB-based strategy reduce the number and total length of stents implanted?
3. What cardiovascular events or medical problems, such as cardiovascular death, myocardial infarction, repeat coronary procedures, or bleeding, occur during follow-up?

Investigators will randomly assign 100 participants to one of two treatment strategies. In the DCB-based group, the lesion will first be prepared with a balloon. A DCB will be used if lesion preparation produces a suitable result; a DES may be implanted if needed to achieve a safe and adequate result. In the DES-only group, the lesion will be treated with a DES.

Participants will:

1. Receive treatment according to their assigned strategy.
2. Undergo follow-up coronary angiography and FFR measurement at approximately 6 months. For clinical reasons, this examination may take place up to 9 months after the procedure.
3. Be followed for cardiovascular events through 12 months after randomization.

Eligibility

Primary outcome measure(s)

• Distal FFR at the target or culprit lesion — 6 months (±30 days; up to 9 months if necessary)
  Follow-up coronary angiography will be performed at 6 months (±30 days; up to 9 months if necessary), and distal FFR beyond the target or culprit lesion will be measured with a commercially available pressure wire as the primary outcome.

Trial sites (4)

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