Abstract
Objectives
The aim of this study is to evaluate the role of drug-coated balloons (DCB) for the management of bioresorbable vascular scaffold (BVS) restenosis.
Methods and results
In a series of 25 BVS restenosis discovered during systematic angiographic follow up of 246 consecutive BVS implantations at our institution, DCB was used as a primary therapeutic tool in 9 patients and 3 different types of DCB were used. Follow-up coronary angiography at 12 months after DCB treatment was performed to all the patients. Among the 9 patients treated with DCB, angiographic follow up revealed failure in two patients that experienced type III restenosis (both of them treated with the same type of DCB). Both patients were treated with drug eluting stent implantation.
Conclusions
In this case series of consecutive patients with BVS restenosis, the use of certain types of DCB is safe and effective in order to maintain vessel patency at mid-term follow up. Despite the small sample size and the study limitations, DCB can provide therefore an alternative treatment option in this setting, avoiding the implantation of further metallic stents in a patient where a different strategy was initially planned.
Highlights
- •
In patients with BVS restenosis, DCB is safe and effective in order to maintain vessel patency at mid-term follow up;
- •
DCB can provide an alternative treatment option in this setting, avoiding the implantation of further metallic prosthesis;
- •
Larger studies to address the etiology of BVS failure and to assess the role of DCB in such lesions are needed.
1
Introduction
The use of drug-coated balloons (DCB) is one of the treatments of choice for both bare metal stent and drug-eluting stent (DES) restenosis . Bioresorbable vascular scaffolds (BVS) are one of the most recent revolutionary steps in interventional cardiology. Studies are ongoing to evaluate the long-term efficacy of these biodegradable devices in a real world setting. There are limited data regarding the clinical outcome following target lesion revascularization (TLR) for BVS failure, with the optimal management currently unclear . Several treatments are commonly used in this setting, including DES, re-BVS and DCB use. Currently, only few data are addressing the safety and the efficacy of DCB in the management of BVS restenosis.
The aim of this study, in the form of case series of consecutive patients, is indeed to evaluate the role of DCB in the management of BVS restenosis.
2
Methods
Out of 246 consecutive BVS implantations (Abbott Vascular, Santa Clara, CA, USA) between January 2013 and December 2015 performed at our institution, 210 underwent scheduled angiographic follow up after institutional review board approval and patient’s informed consent. At a mean of 12 months, coronary angiography revealed 26 in-scaffold restenosis, defined as >50% restenosis at treatment site: 4 of them were left untreated due to the absence of evident signs of myocardial ischemia, 9 underwent DES implantation, 3 underwent further BVS implantation due to edge-restenosis, 1 underwent coronary artery bypass grafting and 9 patients received revascularization with DCB. At 12 months, a second coronary angiography was scheduled for the patients treated with DCB. Quantitative coronary angiography (QCA) performed by one single expert operator was used for the assessment of all procedures. Optical coherence tomography (OCT) (Ilumien, St. Jude Medical, MN, USA) was used for the assessment of the scaffold failure. Angiographic pattern of scaffold restenosis was classified according to Mehran’s classification . Data are presented as mean ± SD. Categorical variables are expressed as count and percentages.
2
Methods
Out of 246 consecutive BVS implantations (Abbott Vascular, Santa Clara, CA, USA) between January 2013 and December 2015 performed at our institution, 210 underwent scheduled angiographic follow up after institutional review board approval and patient’s informed consent. At a mean of 12 months, coronary angiography revealed 26 in-scaffold restenosis, defined as >50% restenosis at treatment site: 4 of them were left untreated due to the absence of evident signs of myocardial ischemia, 9 underwent DES implantation, 3 underwent further BVS implantation due to edge-restenosis, 1 underwent coronary artery bypass grafting and 9 patients received revascularization with DCB. At 12 months, a second coronary angiography was scheduled for the patients treated with DCB. Quantitative coronary angiography (QCA) performed by one single expert operator was used for the assessment of all procedures. Optical coherence tomography (OCT) (Ilumien, St. Jude Medical, MN, USA) was used for the assessment of the scaffold failure. Angiographic pattern of scaffold restenosis was classified according to Mehran’s classification . Data are presented as mean ± SD. Categorical variables are expressed as count and percentages.
3
Results
From the analysis of our data emerges a complex population. Table 1 describes the clinical characteristics of the patient and baseline procedural data, whereas Table 2 describes the procedural characteristics of the DCB procedure. At baseline, 6 patients had type B1 lesions, 1 type C lesion and 2 had type II ISR. Mean BVS diameter was 2.7 ± 0.35 mm and mean scaffold length was 24.7 ± 5 mm. The average time from the index procedure to scaffold failure was 12 ± 3 months. At index procedure, all the lesions were predilated by semi-compliant balloons in order to reach a <30% lesion stenosis. The mean diameter of the DCB was 2.6 ± 0.33 mm while the mean DCB length was 24.3 ± 7.8 mm ( Table 2 ) and 3 different types of DCB were used.
| Patient 1 | Patient 2 | Patient 3 | Patient 4 | Patient 5 | Patient 6 | Patient 7 | Patient 8 | Patient 9 | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical characteristics | Age | 56 | 42 | 57 | 70 | 55 | 76 | 81 | 58 | 79 |
| Sex | Female | Male | Male | Male | Male | Male | Male | Male | Male | |
| DM | No | No | Yes | No | Yes | No | No | Yes | No | |
| Initial Procedure (BVS implantation) | Vessel | LCX-OM1 | D2 | Distal LAD | Prox. RCA | Proximal LCX | RI | Distal. RCA | LCX-OM1 | Prox. LAD |
| Lesion length (mm) | 25 | 18 | 25 | 25 | 15 | 25 | 25 | 24 | 15 | |
| RVD (mm) | 2.75 | 2.5 | 2.5 | 3.5 | 2.5 | 2.5 | 3 | 2.5 | 3 | |
| MLD (mm) | 0.75 | 0.1 | 0.75 | 0.4 | 0.5 | 0.3 | 0.1 | 0 | 0.3 | |
| % Stenosis | 70 | 99 | 70 | 90 | 80 | 90 | 99 | 100 | 90 | |
| Lesion type | B1 | B1 | B1 | B1 | B1 | Type II ISR | Type II ISR | C | B1 | |
| Degree of calcification | No | No | Mild | No | Mild | No | No | Mild | No | |
| Pre-dilatation | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Scaffold length (mm) | 28 | 18 | 28 | 28 | 18 | 28 | 28 | 28 | 18 | |
| Scaffold diameter (mm) Mean= 2.66 ± 0.35 mm | 2.5 | 2.5 | 2.5 | 3.5 | 2.5 | 2.5 | 2.5 | 2.5 | 3 | |
| Post-dilatation | yes | yes | yes | yes | yes | yes | yes | yes | yes | |
| MLD | 2.5 | 2.5 | 2.5 | 3.5 | 2 | 2.5 | 3 | 2.5 | 3 | |
| Residual stenosis post-procedure(%) | 0 | 0 | 0 | 0 | 20 | 0 | 0 | 0 | 0 | |
| Acute again (mm) | 2 | 2.4 | 1.75 | 3.1 | 16 | 2.2 | 2.9 | 2.5 | 2.7 |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
