Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon

Ali, Rosli Mohd; Kader, M.A.S.K. Abdul; Ahmad, Wan Azman Wan; Ong, Tiong Kiam; Liew, Houng Bang; Omar, Alfazir; Zuhdi, Ahmad Syadi Mahmood; Nuruddin, Amin Ariff; Schnorr, Beatrix; Scheller, Bruno

doi:10.1016/j.jcin.2018.11.040

Cited by 113 publications

(76 citation statements)

References 41 publications

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“…In other applications such as in the coronary circulation, sirolimus has shown better long-term safety and efficacy compared to paclitaxel [ 14 ]. The drug is generally seen to be better than paclitaxel because of better late lumen loss and reduced restenosis rates [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

“…In light of these concerns, attention has turned away recently from paclitaxel-based technologies to sirolimus coated platforms [ 13 ]. Sirolimus, like paclitaxel, is a potent antiproliferative agent, which has been found to prevent restenosis in the coronary bed [ 14 ] and more recently in the peripheral vasculature [ 15 ] but to date has not been studied in AVF circuits.…”

Section: Introductionmentioning

confidence: 99%

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Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial

et al. 2020

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Background The aim of this pilot study was to evaluate the safety and efficacy of the MagicTouch ™ sirolimus-coated balloon (SCB) catheter ( Concept Medical Inc ., Tampa, FL, US) on improving the patency of failing arterio-venous fistulas (AVF) with de novo and recurrent stenoses. MATILDA reports early outcomes at 3- and 6 months post intervention. Methods Single-centre, single-arm prospective pilot study of 33 (18 males; mean age 64.7±11.6 years) end-stage renal failure Asian patients with a dysfunctional AVF, who underwent SCB angioplasty between May 2019-January 2020. All procedures were performed under local anaesthetic without sedation and as day surgery. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 3 and 6 months. Results 47 stenotic target lesions treated and 24/33 (72.7%) patients were for restenosis. Main indications for intervention was low/dropping access flow (21/33; 63.6%) and most common target lesion was in the juxta-anastomosis (19/47; 40.4%). There was 100% technical and procedural success. There were no peri-procedural complications related to the SCB. The target lesion primary patency rates at 3 and 6 months were 46/47 (97.9%) and 29/35 (82.9%) respectively. Circuit access patency rates at 3 and 6 months were 31/33 (93.9%) and 17/25 (68%) respectively. There was one (2.9%) death at 6 months and 4/33 (12.1%) overall to date, all from patients’ underlying co-morbidities. Conclusions SCB angioplasty for dysfunctional AVF circuits is a safe and efficacious modality in Asian haemodialysis patients at six months comparable if not better than the paclitaxel data reported to date in the literature.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial

et al. 2020

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“…Thus far, it has an established role in the treatment of in-stent restenosis [4] with a growing number of studies showing excellent results in de novo coronary artery disease [5][6][7][8][9]. The great majority of DCB used are coated with paclitaxel, but encouraging results have emerged over the last year for the use of sirolimus-coated balloons in coronary artery disease [10,11]. However, a recent systematic review and meta-analysis of summary-level data raised concerns about the use of paclitaxel-containing devices for peripheral arterial disease, suggesting a signal of increased late mortality associated to the paclitaxel dose-time product [12].…”

Section: Introductionmentioning

confidence: 99%

Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study

et al. 2020

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Objectives We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI). Background Safety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel. Methods We compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel secondgeneration drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan-Meier curves and Cox regression statistical models. Results We present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES (p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis. Conclusion We found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel secondgeneration DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.

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“…erefore, our findings only reflected the effect of paclitaxel-coated balloons for the treatment of ISR. Recently, a novel sirolimus-coated balloon was investigated in DES-ISR patients compared with paclitaxel-coated balloons [29]. e efficacy of the novel DCB for the treatment DES-ISR is still an ongoing exploration.…”

Section: Discussionmentioning

confidence: 99%

Drug-Coated Balloons versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis: A Pair-Wise Meta-Analysis of Randomized Trials

Peng

Liu

et al. 2020

Cardiovascular Therapeutics

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Objective. This study aimed to compare the effectiveness of drug-coated balloons (DCB) with everolimus-eluting stents (EES) in the treatment of in-stent restenosis (ISR) and the differential relative effect of DCB in patients with drug-eluting stents (DES)-ISR and bare metal stents (BMS)-ISR. Background. The efficiency and safety of DCB and EES need to be assessed for the treatment of ISR. Methods. A systematic literature search was conducted using PubMed and EMBASE to identify all relevant studies. Angiographic results and clinical events were separately assessed. Subgroup meta-analyses were performed according to the type of restenosed stent. Results. Six randomized trials with 1134 patients were included. The overall pooled outcomes indicated that DCB was associated with lower minimum lumen diameter (mean difference MD=−0.17, 95% CI = −0.29 to −0.05, P=0.006) and higher target lesion revascularization (risk ratio RR=2.38, 95% CI = 1.36 to 4.18, P=0.002) than EES. However, the subgroup meta-analyses showed that DCB was inferior to EES only in DES-ISR patients, with lower minimum lumen diameter (MD=−0.25, 95% CI = −0.37 to −0.14, P<0.001), higher percent diameter stenosis (MD=5.37, 95% CI = 1.33 to 9.42, P=0.009), more binary restenosis (RR=2.07, 95% CI = 1.20 to 3.58, P=0.009), and higher incidence of target vessel revascularization (RR=2.07, 95% CI = 1.22 to 3.50, P=0.007) and target lesion revascularization (RR=2.43, 95% CI = 1.28 to 4.22, P=0.002). No differences in angiographic results and clinical events were found between DCB and EES in BMS-ISR patients. Conclusions. DCB was inferior to EES in DES-ISR and comparable in BMS-ISR in terms of angiographic results and clinical events.

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Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon

Cited by 113 publications

References 41 publications

Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial

Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial

Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study

Drug-Coated Balloons versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis: A Pair-Wise Meta-Analysis of Randomized Trials

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