REPORTING FROM CRT 2018
WASHINGTON (FRONTLINE MEDICAL NEWS) – For treating de novo coronary lesions in vessels smaller than 2.75 mm, drug coated balloon angioplasty is as safe and may be as effective as drug-eluting stents, according to a multicenter randomized trial presented as a late-breaker at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The aim of PCI [percutaneous coronary intervention] without leaving any metal behind seems to be feasible and safe with drug coated balloons,” reported Victor A. Jimenez Diaz, MD, of the department of cardiology at University Hospital, Vigo, Spain.
De novo lesions in small coronary vessels are a clinical challenge, according to Dr. Jimenez Diaz. These are associated with relatively high rates of restenosis. They are also associated with a vessel thrombosis rate of 1% within 6 months, and a small but significant risk of major adverse cardiac events, variably estimated to range between 6% and 10% at 1 year. There is no uniformly accepted standard for treatment.
In this study, 94 patients with de novo coronary lesions in small diameter vessels were randomized to treatment with a paclitaxel drug coated balloon (DCB) (IN.PACT Falcon, Medtronic) or a zotarolimus drug-eluting stent (DES) (Resolute Integrity, Medtronic). Lesions in vessels between 2.0 and 2.75 mm in diameter were eligible; 137 lesions were treated in a study with seven participating centers in Spain.
For entry, target lesions had to have a stenosis of at least 70% by visual estimation or at least 50% by quantitative coronary angiography. Lesion length was limited to less than 25 mm, and severely calcified lesions were excluded.
The primary endpoint was a composite major adverse coronary event (MACE) endpoint of cardiac death, myocardial infarction, or revascularization at 12 months of follow-up. Crossovers by discretion of the interventional team were permitted.
At 12 months, MACE had occurred in 4.4% of those in the DCB group and 11.1% of those in the DES group. All primary endpoint events in both groups involved revascularizations. The two events in the DCB group were clinically driven target vessel revascularizations. Only one of the five events in the DES group was a clinically driven target lesion revascularization; the remaining four were revascularizations performed for nontarget vessels.
Four patients (8%) in the DCB group crossed over, each because of a dissection and managed with a bare-metal stent. There were four other dissections in the DCB group; one type F dissection resulted in a bailout and three dissections were managed conservatively. There were no crossovers in the DES group, and of the two dissections in the group, both were managed with the originally assigned stenting strategy.
Calling DCB a safe strategy for small de novo coronary stenosis, Dr. Jimenez Diaz said, “The procedural success rates were comparable.” However, he acknowledged that because of low enrollment, the study was “underpowered for clinical events.” The original power calculation called for a study of 200 patients.
“We can say results are encouraging,” Dr. Jimenez Diaz said.
Several discussants at the late-breaker abstracts agreed that DCB is an intriguing option for a difficult problem. They also agreed that restoring blood flow without leaving a permanent device is an attractive concept. However, they emphasized that a larger study is needed to declare that DCB and DES are equivalent strategies in regard to risk of MACE.
While agreeing that more data powered for events are needed, Cindy Grines, MD , chief of cardiology, Hofstra University, Hempstead, N.Y., was among those who suggested that this approach might be “worth a try.” She indicated that this study, which involved interventionalists at multiple centers, does provide support for the safety of DCB.
SOURCE: Jimenez Diaz VA. CRT 2018.