Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty (OCTOPUS-2)

University of Jena

Status and phase: Completed; Phase 4

Conditions: Stable Angina; Coronary Stenosis

Treatments: Device: FFR - guided DEB angioplasty; Device: Provisional bare metal stenting

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02120859

UKJ-TCP-2

Details and patient eligibility

About

We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions.

Full description

Restenosis rates after plain-old balloon angioplasty (POBA) are with 30-50 % very high. Therefore, this interventional concept is of limited use today. However, dual antiplatelet therapy (DAPT) is not necessary after POBA. Contrary, 3rd generation drug-eluting stents (DES) proved to be very effective showing delayed restenosis only in 5-15%, but require DAPT for at least 6 months. Drug-eluting balloons (DEB) might be a promising trade-off between POBA and DES, since they effectively inhibit neointimal proliferation despite minimal duration of DAPT. However, there is still very limited data on this interventional strategy. Thus, we aimed to investigate feasibility of fractional flow reserve (FFR) - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions, evaluating the 6-month outcomes by angiography and optical coherence tomography (OCT).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for elective PCI according to the guidelines of European Society of Cardiology, American Heart Association and American College of Cardiology
• Age > 18 years, written consent
• Native de novo coronary lesion suitable for angioplasty and OCT imaging

Exclusion criteria

• Pregnancy and breast feeding mother
• Co-morbidity with an estimated life expectancy of < 50 % at 1 year
• Scheduled major surgery in the next 6 months
• Not able to give informed written consent or non-compliance
• Participation in other PCI trial
• Acute coronary syndromes and cardiogenic shock
• Known allergy to aspirin, thienopyridines or against taxol derivates
• Culprit lesion within the proximal 10 mm of the right or left coronary artery
• Saphenous vein grafts
• Estimated lesion length > 30 mm

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

FFR - guided DEB angioplasty

Experimental group

Description:

DEB-only angioplasty is attempted in all patients. At baseline, quantitative coronary angiography (QCA) and fractional flow reserve (FFR) using an intracoronary standard bolus of adenosine are performed. If FFR at baseline is greater than 0.8, PCI is deferred, otherwise predilation with a non-coated balloon is performed. In case of severe recoil (\> 50% residual stenosis) or flow-limiting dissection the procedure is deemed not suitable for DEB-only angioplasty and stent implantation is performed at the discretion of the operator. In all other cases, the lesion is treated using a Sequent Please® paclitaxel-eluting balloon (DEB). QCA and FFR measurements are repeated and the result is considered satisfactory if there is no flow-limiting dissection, residual stenosis \< 40% and FFR \> 0.8.

Treatment:

Device: FFR - guided DEB angioplasty

DEB angioplasty with provisional bare metal stenting

Other group

Description:

In case of suboptimal results after the FFR-guided DEB angioplasty described above, a bare metal stent is implanted inside the segment previously treated by DEB.

Treatment:

Device: FFR - guided DEB angioplasty

Device: Provisional bare metal stenting