Survival After Coronary Revascularization With Paclitaxel-Coated Balloons

Scheller, Bruno; Vukadinović, Davor; Jeger, Raban; Rissanen, Tuomas T.; Scholz, Sean S.; Byrne, Robert A.; Kleber, Franz X.; Latib, Azeem; Clever, Yvonne P.; Ewen, Sebastian; Böhm, Michael; Yang, Yiping; Lansky, Alexandra J.; Mahfoud, Felix

doi:10.1016/j.jacc.2019.11.065

Cited by 96 publications

(62 citation statements)

References 56 publications

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“…We have demonstrated that there is no evidence of increased late mortality associated with paclitaxel DCB compared to non-paclitaxel second-generation DES for de novo coronary artery disease up to 5 years of follow-up. In fact, there was actually a trend towards better survival with DCB, a finding consistent with the most recent meta-analysis [20]. Furthermore, we specifically investigated a late paclitaxel effect by analysing only patients who were alive at 2 years, with no evidence of increased late mortality associated with paclitaxel DCB either.…”

Section: Discussionsupporting

confidence: 78%

“…In addition, it is difficult to draw definitive conclusions from that study for late mortality relating to paclitaxel, as this was a subgroup analysis and the patient groups were heterogeneous given the previous stent implantations including bare metal stents and paclitaxel DES. A most recent meta-analysis specifically investigating the mortality of paclitaxel DCB for coronary intervention did not show increased mortality with DCB [20]. However, this meta-analysis included significantly heterogeneous studies comparing paclitaxel DCB with control treatments such as plain old balloon angioplasty, bare metal stents, paclitaxel and non-paclitaxel drug-eluting stent mostly in the setting of in-stent restenosis.…”

Section: Discussionmentioning

confidence: 97%

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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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Section: Discussionsupporting

confidence: 78%

Section: Discussionmentioning

confidence: 97%

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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“…Although recent alarming data from a large meta-analysis in patients with peripheral arterial diseases (PADs) indicated that the use of paclitaxel-coated balloons or paclitaxel DESs was associated with a higher risk of late mortality compared with alternative therapeutic modalities, these concerns did not influence the use of drug-coated balloons in coronary arteries [ 47 , 48 ]. Multiple randomized clinical trials and meta-analyses have shown the safety and efficacy of PCBs in patients with ISR [ 49 , 50 ].…”

Section: Further Perspectivementioning

confidence: 99%

In-Stent Restenosis and a Drug-Coated Balloon: Insights from a Clinical Therapeutic Strategy on Coronary Artery Diseases

Zhang

Chen

2020

Cardiology Research and Practice

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Coronary heart disease is a major cause of death and disability in developed countries. Stent implantation has become an efficacious treatment for a culprit lesion vessel of the coronary artery. However, 10%–20% restenosis is still an important complication that restricts the clinical safety and efficacy of drug-eluting stents. In-stent restenosis may lead to the recurrence of major cardiovascular adverse events, including angina pectoris, acute myocardial infarction, and even sudden cardiac death. These events are currently serious problems that occur after coronary stent implantation. Clinical physicians face a difficult choice for in-stent restenosis treatment. Recent studies indicate that a drug-coated balloon has promising clinical efficacy similar to the drug-eluting stents for treating coronary in-stent restenosis. Therefore, in this study, we highlight the progress of coronary intervention and the use of drug-coated balloons in the treatment of in-stent restenosis (ISR).

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“…Following the successful treatment of ISR, DCB was investigated for its efficacy and safety in de novo coronary artery lesions, based on the hypothesis that foregoing metallic stent implantation in coronary arteries could improve the clinical events [ 9 – 13 ]. Recently, a patient-level meta-analysis compared DCB with non-DCB devices in both de novo and coronary ISR lesions; DCB was associated with a trend toward lower mortality [ 14 ]. However, several studies evaluating the DCB for the treatment of de novo coronary artery disease yielded controversial results.…”

Section: Introductionmentioning

confidence: 99%

Drug-Coated Balloon for De Novo Coronary Artery Lesions: A Systematic Review and Trial Sequential Meta-analysis of Randomized Controlled Trials

Liu

Zhang

Chen

et al. 2020

Cardiovascular Therapeutics

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Objective. To investigate the efficacy of drug-coated balloon (DCB) treatment for de novo coronary artery lesions in randomized controlled trials (RCTs). Background. DCB was an effective therapy for patients with in-stent restenosis. However, the efficacy of DCB in patients with de novo coronary artery lesions is still unknown. Methods. Eligible studies were searched on PubMed, Web of Science, EMBASE, and Cochrane Library Database. Systematic review and meta-analyses of RCTs were performed comparing DCB with non-DCB devices (such as plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES)) for the treatment of de novo lesions. Trial sequential meta-analysis (TSA) was performed to assess the false positive and false negative errors. Results. A total of 2,137 patients enrolled in 12 RCTs were analyzed. Overall, no significant difference in target lesion revascularization (TLR) was found, but there were numerically lower rates after DCB treatment at 6 to 12 months follow-up (RR: 0.69; 95% CI: 0.47 to 1.01; P=0.06; TSA-adjusted CI: 0.41 to 1.16). TSA showed that at least 1,000 more randomized patients are needed to conclude the effect on TLR. A subgroup analysis from high bleeding risk patients revealed that DCB treatment was associated with lower rate of TLR (RR: 0.10; 95% CI: 0.01 to 0.78; P=0.03). The systematic review illustrated that the rate of bailout stenting was lower and decreased gradually. Conclusions. DCB treatment was associated with a trend toward lower TLR when compared with controls. For patients at bleeding risk, DCB treatment was superior to BMS in TLR.

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Survival After Coronary Revascularization With Paclitaxel-Coated Balloons

Cited by 96 publications

References 56 publications

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

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

In-Stent Restenosis and a Drug-Coated Balloon: Insights from a Clinical Therapeutic Strategy on Coronary Artery Diseases

Drug-Coated Balloon for De Novo Coronary Artery Lesions: A Systematic Review and Trial Sequential Meta-analysis of Randomized Controlled Trials

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