Drug coated balloons in coronary artery disease

Drug coated balloons in coronary artery disease

Drug coated balloons are a novel therapeutic option in certain situations of coronary artery disease. An established use of drug coated balloon is for in-stent restenosis of both bare metal and drug eluting stents.
Drug coated balloon transfers antiproliferative drugs into the vessel wall during single balloon inflation. This is done by means of a lipophilic matrix. The advantage over drug eluting stent is that there is no permanent implant.
Drug eluting stents have the disadvantages of neo-atherosclerosis and stent thrombosis. Even temporary implants like bioresorbable scaffolds have elevated thrombotic risk.
Other potential indications for drug coated balloons are in small vessel disease and in those with high bleeding risk with limitation on the use of dual antiplatelet agents.
The lesions are prepared by optimal angioplasty prior to delivery of the drug with a drug coated balloon. Optimal lesion preparation may be assessed by angiography, intravascular imaging or physiology.
If the lesions cannot be prepared adequately with balloon dilatation alone, ablative procedures like rotablation, laser or orbital atherectomy may be needed. Stent implantation may be needed if the results are suboptimal after lesion preparation. These include dissection and significant recoil.
Sometimes stenting may be required as a bailout after the application of a drug coated balloon. Bare metal stents may be enough in such situations to scaffold the vessel. No post dilatation is done after the use of drug coated balloon as it will disperse the drug which has been delivered.
DAEDALUS study was an individual patient data meta-analysis of 10 randomized clinical trials comparing paclitaxel coated balloon angioplasty vs. drug eluting stenting for the treatment of coronary in-stent restenosis.
The analysis showed that in patients with coronary in-stent restenosis, repeat stenting with drug eluting stent was moderately more effective than angioplasty with drug coated balloon at reducing target vessel revascularization at 3 years.
Composite of all-cause mortality, myocardial infarction or target lesion thrombosis was similar between the groups. The rates of individual end points were also not statistically significantly different between the groups.
Drug coated balloons are similarly effective as drug eluting stents in reducing revascularization for in-stent restenosis of bare metal stents. Patients with drug eluting stent in-stent restenosis are a selected high risk population with primary failure of local drug delivery by the stent.
The potential relative efficacy of drug coated balloons vs drug eluting stent may be different as the underlying tissue substrate is different – neointimal hyperplasia vs neoatherosclerosis.
Though the initial drug coated balloons used taxane compounds like paclitaxel, sirolimus coated balloons are also now available. SABRE trial with sirolimus coated balloon, was a first in human study which showed excellent procedural success and 6 month late lumen loss in line with other stent free options for in-stent restenosis.
DEBUT trial evaluated the role of drug coated balloon in de-novo coronary lesions in patients with high bleeding risk.
It was a single-blind, randomized, non-inferiority trial involving 208 patients. Vessel diameters ranged from 2.5 to 4 mm. Drug coated balloon was shown to be superior to bare metal stents in patients at bleeding risk.
Those with ST elevation myocardial infarction, bifurcation lesions needing two stents, in-stent restenosis, flow limiting dissection and those with more than 30% recoil after target lesion predilation were excluded from the study.

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