Drug Coated Balloon-Only Strategy in De Novo Lesions of Large Coronary Vessels

Abstract

Objectives. We analyzed the efficacy of drug coated balloons (DCB) as a stand-alone-therapy in de novo lesions of large coronary arteries. DCBs seem to be an attractive alternative for the stent-free interventional treatment of de novo coronary artery disease (CAD). However, data regarding a DCB-only approach in de novo CAD are currently limited to vessels of small caliber. Methods. By means of propensity score (PS) matching 234 individuals with de novo CAD were identified with similar demographic characteristics. This patient population was stratified in a 1:1 fashion according to a reference vessel diameter cut-off of 2.75 mm in small and large vessel disease. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 9 months. Results. Patients with small vessel disease had an average reference diameter of 2.45 ± 0.23 mm, while the large vessel group averaged 3.16 ± 0.27 mm. Regarding 9-month major adverse cardiac event (MACE), 5.7% of the patients with small and 6.1% of the patients with large vessels had MACE (p=0.903). Analysis of the individual MACE components revealed a TLR rate of 3.8% in small and 1.0% in large vessels (p=0.200). Of note, no thrombotic events in the DCB treated coronary segments occurred in either group during the 9-month follow-up. Conclusions. Our data demonstrate for the first time that DCB-only PCI of de novo lesions in large coronary arteries (>2.75 mm) is safe and as effective. Interventional treatment for CAD without permanent or temporary scaffolding, demonstrated a similar efficacy for large and small vessels.

Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study

“…In the de novo lesion group, key lesion morphological attributes were challenging with 33.2% calcification, 33.7% B2/C lesions, and 2.63 ± 0.37 mm vessel diameters. Nevertheless, the technical success rate was 99.7% which is in agreement with the corresponding success rates of 99.2% from the Rosenberg registry [11,12] and success rates from other registries ranging from 96.9% [13] to 98.9% [14].…”

“…An established electronic data capture system [11][12][13][14] was utilized to document baseline and follow-up data (www.studiesportal.com). The respective national principal investigators ensured the accuracy of the datasets whenever system integrated plausibility checks revealed inaccuracies, which initiated source data verification in the affected centers.…”

“…Previous study designs entailed either the use of different DCB devices [8] following lesion preparation with the same scoring balloon or different lesion preparation strategies [9] for one particular DCB device. Therefore, we set out to study the routine combination of a low-profile SBA with non-slip nylon elements [9,10] and clinically proven iopromide-paclitaxel balloon angioplasty [11][12][13][14] in an unselected patient population with a focus on de novo coronary lesions.…”

Management of acute myocardial infarction in a patient with idiopathic thrombocytopenic purpura, the value of optical coherence tomography: a case report

“… 9 Moreover, it requires more aggressive lesion preparation with pre-dilatation having a balloon-to-vessel ratio of 0.8–1.0. 10 This increases the risk of dissection mandating stent implantation, the thing we were trying to avoid. We used percutaneous old balloon angioplasty because it gave us the flexibility to discontinue DAPT if PC dropped.…”

Comparing efficacy of drug-coated balloon-only approach and stent approach in treating de novo coronary artery lesions

“…However, most of the above-mentioned studies focused on interventions in small coronary vessels with diameters <2.8 mm (or <3.0 mm), which only constitute about 35% of all the coronary catheter-based procedures. [ 20 ] And several recently published clinical trials [ 21 , 22 ] have claimed that, for patients who received DCB as a stand-alone treatment for de novo lesions, the large vessel disease (LVD) group has comparable rates of MACE and TLR than the small vessel disease (SVD) group, suggesting that the DCB-only approach of de novo lesions in large coronary arteries may be as safe and effective as that in small coronary arteries.…”