Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Abstract

Background: The drug-eluting balloon (DEB) is a promising tool to prevent restenosis after coronary angioplasty. However, data on the outcomes of DEB in de novo lesions are scarce. Vessel recoil and constrictive remodeling are the dominant causes of restenosis after angioplasty. The use of cutting balloons (CB) may effectively reduce elastic recoil after balloon dilation. In this study, we evaluate the efficacy and safety of DEB in treating de novo coronary artery lesions, using a predilation strategy with cutting balloon (CB) dilation before DEB angioplasty. Methods/Design: We present the design of a prospective, single-center, open-label, randomized, 2-arm clinical trial aiming to assess whether or not the strategy of CB dilation before DEB angioplasty reduces the primary end point of late lumen loss (LLL) compared with drug-eluting stent (DES) implantation alone for de novo coronary artery lesions. A total of 120 patients will be randomly enrolled into the DEB or DES group (1:1 ratio). The primary end point is insegment LLL at 12 months as measured by optical coherence tomography (OCT). Secondary end points include procedural success, such as angiographic success and device success, and clinical outcomes including all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. Discussion: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEB after CB dilation compared with DES for the treatment of de novo coronary artery lesions guided by OCT.

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

“…There may also be other niche indications including high-risk restenotic lesions such as bifurcations, long lesions, diffuse disease in diabetic patients and small vessel disease (43). The PEPCAD-BIF trial was the first randomised controlled trial to explore DEB-only use in side branch and/or distal main branch lesions (18).…”

Inhibitory effect of melatonin on necroptosis via repressing the Ripk3‐PGAM5‐CypD‐mPTP pathway attenuates cardiac microvascular ischemia–reperfusion injury

“…Thus, no matter how efficiently and rapidly the blood flow is restored to the epicardial artery, if there is a microvascular IR injury (capillary perfusion defect), the myocardial tissue will remain without efficient perfusion. 4 Furthermore, based on our clinical observations, 5,6 microvascular IR injury (also termed the no-reflow phenomenon in clinical practice) develops within minutes of established reperfusion and persists for at least 1 week, which is a major contributor to the final infarct size and is an independent predictor of long-term morbidity/mortality. 7 After the great success of therapies to reduce cardiomyocyte IR injury, it is time to shift focus to therapies to reduce microcirculatory reperfusion damage, which is a critical player in the fate of the myocardium and occurs in up to one-half of the patients submitted to apparently successful revascularization.…”

Drug-Eluting Balloon Technology for Native Non-Small Coronary Artery Disease: Another Crusade against Skepticism!

“…In the latest issue of Cardiology , Li et al [14] provide an interesting study protocol for a prospective, single-center, open-label, randomized trial with 2 arms, which aims to assess if the strategy of predilatation with a cutting balloon (CB) before DEB angioplasty guided by optical coherence tomography (OCT) reduces the primary end point LLL at the 12-month follow-up compared with DES implantation alone for de novo non-small coronary artery lesions (diameter: 2.5-3.5 mm). Both devices elute paclitaxel.…”

“…The study by Li et al [14] remains of interest in view of the systematic use of CB for predilatation, and it may improve current knowledge about DEB behavior in native vessel disease, thanks also to the systematic OCT analysis at 1-year follow-up. Moreover, this study could introduce a new setting for the employment of this device that is presently seldom taken into consideration by most interventionists.…”