Dataset Information

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

ABSTRACT:

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 second-generation 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?ConclusionWe found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.

SUBMITTER: Merinopoulos I

PROVIDER: S-EPMC7862512 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Merinopoulos Ioannis I Gunawardena Tharusha T Wickramarachchi Upul U Richardson Paul P Maart Clint C Sreekumar Sulfi S Sawh Chris C Wistow Trevor T Sarev Toomas T Ryding Alisdair A Gilbert Tim T Perperoglou Aris A Vassiliou Vassilios S VS Eccleshall Simon C SC

Clinical research in cardiology : official journal of the German Cardiac Society 20200902 2

<h4>Objectives</h4>We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI).<h4>Background</h4>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.<h4 ...[more]

PMID: 32876814

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Project description:BackgroundNumerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB.MethodsThis was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months.ResultsPatients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014).ConclusionsSuperiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Project description:Background and objectiveThe de novo coronary lesions are the most common form of coronary artery disease, and stent implantation still is the main therapeutic strategy. This network meta-analysis aims to evaluate the efficacy of drug-coated balloons only (DCB only) and DCB combined with bare-metal stents (DCB+BMS) strategies vs. drug-eluting stents (DES) and BMS approaches in coronary artery de novo lesion.MethodPubMed, EMBASE, and Cochrane Library databases were retrieved to include the relevant randomized controlled trials that compared DCB approaches and stents implantation in patients with de novo coronary artery diseases. The primary outcome was major adverse cardiac events (MACE). The clinical outcomes included target lesion revascularization (TLR), all-cause death, and myocardial infarction. The angiographic outcomes consisted of in-segment late lumen loss (LLL) and binary restenosis. The odds ratio (OR) and 95% confidence intervals (95% CIs) for dichotomous data, and weighted mean differences for continuous data were calculated in the Bayesian network frame.ResultA total of 26 randomized controlled trials and 4,664 patients were included in this study. The DCB-only strategy was comparable with the efficacy of MACE, clinical outcomes, and binary restenosis compared with DES. In addition, this strategy can significantly reduce the in-segment LLL compared with the first-generation (MD -0.29, -0.49 to -0.12) and the second-generation DES (MD -0.15, -0.27 to -0.026). However, subgroup analysis suggested that DCB only was associated with higher in-segment LLL than DES (MD 0.33, 0.14 to 0.51) in patients with acute coronary syndrome. Compared with DES, the DCB+BMS strategy had a similar incidence of myocardial infarction and all-cause death, but a higher incidence of MACE, TLR, and angiographic outcomes. In addition, DCB+BMS was associated with a similar incidence of myocardial infarction and all-cause death than BMS, with a lower incidence of MACE, TLR, and angiographic outcomes.ConclusionThe DCB only is associated with similar efficacy and lower risk of LLL compared with DES. In addition, the DCB+BMS strategy is superior to BMS alone but inferior to DES (PROSPERO, CRD 42021257567).Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/#recordDetails.

Dataset Information

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

Objectives

Background

Methods

Results

Publications

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

Similar Datasets

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