Rationale: Chronic total coronary occlusions (CTOs) are documented in approximately 16-18% of
diagnostic coronary angiograms. New developments such as retrograde approach and dissection
re-entry techniques have resulted in more widespread application of percutaneous coronary
intervention (PCI) of CTOs, and this technique now serves as a viable alternative to optimal
medical therapy alone or coronary artery bypass surgery. In general, PCI CTO is accompanied
by extensive stenting of the coronary artery beyond the original occlusive segment itself.
Unfortunately, stent length and diameter are directly related to poorer outcome, which is
related to an increased rate of in-stent restenosis and thrombosis. An alternative to
stenting is the application of drug-coated balloons (DCB). This strategy may prove
beneficial, as it could significantly reduce stent length, among other things. However, data
on the use of DCBs in the context of PCI CTO are currently lacking.
Objective: To investigate the value of DCB treatment in the residual disease of the coronary
artery after successful recanalization and stenting of the actual CTO body as compared with
complete stenting in a randomized fashion.
Study design: This is an investigator-initiated, randomized, single-blind (patients will be
masked), multicenter, non-inferiority clinical trial.
Study population: 154 patients with a CTO eligible for PCI based on a formal local heart team
decision will be screened for potential inclusion in the study.
Intervention: Patients with a CTO who are eligible for PCI will be randomized in a 1:1 ratio
to additional DCB treatment or stenting of residual disease.
Main study parameters/endpoints: The primary endpoint is percentage diameter stenosis at
1-year follow-up as assessed by intravascular ultrasound (IVUS). Secondary invasive imaging
objectives include minimal lumen diameter, late luminal loss, in-segment binary restenosis,
and target vessel re-occlusion at 1-year follow-up. Secondary clinical objectives are
evaluation of the occurrence of major adverse cardiac events (MACE) at 1-year follow-up.
Nature and extent of the burden and risks associated with participation, benefit and
group-relatedness: Participation in this study entails additional measurements, namely
follow-up coronary angiography at 12 months, CCTA-scan at 12 months (if participating in
substudy), and telephonic follow-up at 30 days and 12 months.
All patients included in the trial will have a clinical indication for percutaneous
revascularization. Since there are no randomized controlled trials which advocate the use of
either DES or DCB over one another in this setting, the risk of the PCI procedure will not be
related to study participation. All patients will undergo coronary angiography after 1-year
follow-up and will thus be exposed to the risks of invasive coronary angiography. Coronary
angiography is characterized by a low complication rate (<0.5%). Repeat angiography also
carries a low amount of radiation exposure. Patients participating in the CCTA substudy will
be exposed to additional radiation. The ionized contrast agents used in both coronary
angiography and CCTA substudy can be nephrotoxic and can elicit allergic reactions.
A DCB facilitated minimal stenting strategy for treatment of chronic total occlusions may
significantly reduce stent length, number of used stents, as well as compression of the
distal lumen with undersized stents. While DCB is expected to be non-inferior to DES
regarding the in-segment diameter stenosis (primary endpoint), possible benefits may be
observed in the secondary endpoints. Consequently, this trial could influence current
guidelines on the application of DCBs in CTO procedures.
