ABSTRACT
OBJECTIVES: To investigate the relative performance of treatment with a paclitaxel-eluting balloon (PEB) compared with an everolimus-eluting stent (EES) for in-stent restenosis (ISR) in patients with diabetes mellitus (DM). BACKGROUND: ISR remains a challenge in contemporary clinical practice, particularly in patients with DM. METHODS: In the multicenter randomized DARE trial, patients with BMS or DES ISR were randomized in a 1:1 fashion to treatment with a PEB or an EES. Patients underwent angiographic follow-up after 6 months. For the purpose of this analysis, the relative performance of PEB versus EES in diabetic patients was investigated. RESULTS: Of 278 patients enrolled in DARE, 88 (32%) had DM, of whom 46 were randomized to EES and 42 to PEB treatment. Of patients with DM, 48 (55%) had DES-ISR. Angiographic follow-up was available in 30 patients (72%) in the PEB group and 36 patients (78%) in the DES group. There were no differences in terms of 6-months minimal lumen diameter in diabetic patients treated with EES (1.46 ± 0.66 mm) versus PEB (1.78 ± 0.58 mm, P = 0.15). Adverse events at one year follow-up were similar in both groups, with Major Adverse Events (MAE, death, target vessel MI, or TVR) occurring in 17.4% in the EES group versus 11.9% in the PEB group, P = 0.44. CONCLUSIONS: In patients with ISR and DM, use of a PEB resulted in similar 6-months in-segment minimal lumen diameter and comparable rates of MAE. In-segment late loss at 6 months was significantly lower in the PEB arm. Although larger trials in DM patients with ISR are necessary, PEB is a promising treatment option obviating the need for additional stent implantation.
Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiac Catheters , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Coronary Artery Disease/therapy , Coronary Restenosis/therapy , Diabetes Mellitus , Drug-Eluting Stents , Everolimus/administration & dosage , Paclitaxel/administration & dosage , Percutaneous Coronary Intervention/instrumentation , Aged , Angioplasty, Balloon, Coronary/adverse effects , Cardiovascular Agents/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Diabetes Mellitus/diagnosis , Everolimus/adverse effects , Female , Humans , Male , Middle Aged , Netherlands , Paclitaxel/adverse effects , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Prosthesis Design , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR). BACKGROUND: The treatment of ISR remains challenging in contemporary clinical practice. METHODS: In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months. RESULTS: A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65). CONCLUSIONS: In patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.
Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiac Catheters , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Coronary Restenosis/surgery , Drug-Eluting Stents , Everolimus/administration & dosage , Paclitaxel/administration & dosage , Percutaneous Coronary Intervention/instrumentation , Aged , Angioplasty, Balloon, Coronary/adverse effects , Cardiovascular Agents/adverse effects , Coronary Angiography , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Everolimus/adverse effects , Female , Humans , Male , Middle Aged , Netherlands , Paclitaxel/adverse effects , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , Reoperation , Time Factors , Treatment OutcomeABSTRACT
A 77-year-old woman presented with dyspnoea and respiratory-related thoracic pain, which was accompanied by dizziness and fatigue but no syncopal attacks. Auscultation of the heart disclosed an opening snap with mid-diastolic murmur. Laboratory assessment revealed no abnormalities but an elevated D-dimer level (1.49âmg/l). Electrocardiography was normal. The chest radiograph showed an enlarged heart without other abnormalities. Computed tomography (CT) scan for a suspected diagnosis of pulmonary embolism was performed. The CT scan did not reveal pulmonary embolism, but a large cardiac tumour in the left atrium.
