Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO Study

Cortese, Bernardo; Micheli, Andrea De; Picchi, Andrea; Coppolaro, Amelia; Bandinelli, Loria; Severi, Silva; Limbruno, Ugo

doi:10.1136/hrt.2010.195057

Cited by 275 publications

(235 citation statements)

References 28 publications

(25 reference statements)

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“…Following screening for replicates, 405 remained; and after screening abstracts for relevance, a further 371 studies were removed. Finally, full text of the remaining 34 studies were screened, of which 17 randomised controlled trials (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34) fulfilled the inclusion criteria and were qualitatively and quantitatively analysed.…”

Section: Resultsmentioning

confidence: 99%

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Patel

Svermova

Burke-Gaffney

et al. 2018

Cardiovasc. Diagn. Ther.

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Background: Efficacy of drug-eluting balloons (DEB) for treatment of de novo coronary lesions remains controversial. The present systematic review and meta-analysis of randomised controlled trials assessed DEB with bare-metal stents (BMS) and also DEB with provisional bail-out stents ('DEB-only' strategy), to other conventional options: plain-old balloon angioplasty (POBA), BMS and drug-eluting stents (DES). Conclusions:The results of this meta-analysis showed that whilst DEB with BMS is superior to BMS alone, the combination is inferior to DES for treatment of de novo coronary lesions. Thus, DEB + BMS should not be applied in de novo lesions unless in patients who have absolute contraindications to DES. DEB alone, however, should be considered for relative contraindications to DES such as small vessel disease and bifurcation lesions.

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Section: Resultsmentioning

confidence: 99%

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Patel

Svermova

Burke-Gaffney

et al. 2018

Cardiovasc. Diagn. Ther.

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“…16) As a first-line interventional treatment for in-stent restenosis during the DES era, the usefulness of DCB has almost been established. 7,8) In contrast, for de novo coronary artery lesions, no definite evidence supporting the superiority of DCB over DES is available, 17,18) while a few registries have shown acceptable results regarding the safety and efficacy of DCB in de novo coronary lesions. 19,20) In the Valentines II, a prospective registry of 109 lesions in 103 patients with stable or unstable angina and/or positive stress test with de novo lesions of > 50% stenosis undergoing plain old balloon angioplasty followed by DCB dilation, the primary endpoint of major adverse cardiac events at 8 months was 8.7% with 1% all-cause death, 1% myocardial infarction, and 2.9% target lesion revascularization (TLR), despite the 11.9% bail-out bare metal stent (BMS) implantation.…”

Section: Discussionmentioning

confidence: 99%

Rotational Atherectomy Followed by Drug-Coated Balloon Dilation in Possible Coronary Sequelae of Kawasaki Disease

et al. 2016

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SummaryRotational atherectomy with/without low-pressure balloon dilation has been a mainstay of interventional treatment for stenosis due to the coronary sequelae of Kawasaki disease (KD). Here, we report a restenosis case of probable coronary sequelae of KD treated with rotational atherectomy with low-pressure 2.5-mm balloon dilation 6 months previously. Under the guidance of optical frequency domain imaging, we performed rotational atherectomy followed by 2.5-mm drug-coated balloon (DCB) dilation for an atherosclerotic restenosis at the inlet of a calcified aneurysm in the proximal left anterior descending coronary artery. Coronary angiography 6 months later showed no apparent progression of vessel narrowing, and we could defer repeat intervention. The present case suggests that rotational atherectomy followed by DCB dilation could be an alternative revascularization therapy of choice in coronary KD sequelae complicated with atherosclerosis. (Int Heart J 2016; 57: 367-371) Key words: Optical frequency domain imaging, Fractional flow reserve, Atherosclerosis, Dyslipidemia C oronary sequelae of Kawasaki disease (KD) has a variety of morphological manifestations, such as aneurysm, stenosis, and total occlusion concomitant with nonatherosclerotic intimal thickening and frequent severe calcification, while a few reports have demonstrated early atherosclerosis progression in young adults with prior KD.1-3) Since these stiff calcified lesions have risk of stent underexpansion and neo-aneurysmal formation ascribed to high-pressure balloon inflation, rotational atherectomy with/without additional low-pressure balloon dilation alone has been a mainstay of interventional treatment for stenosis due to the coronary sequelae of KD. [4][5][6] In contrast, drug-coated balloons (DCB) now play a central role in the treatment of in-stent restenosis through their inhibition of neointimal hyperplasia, despite the lack of evidence for de novo coronary artery disease. 7,8) We describe here our experience with an atherosclerotic-restenosis case of probable coronary sequelae of KD previously treated with rotational atherectomy with additional low-pressure balloon dilation 6 months before, 3) in which rotational atherectomy followed by DCB dilation could defer any subsequent repeat intervention. Case ReportAn asymptomatic 47 year-old male was admitted to our hospital to undergo 6-month follow-up coronary angiography (CAG). Six months previously, based on a diagnosis of silent myocardial ischemia due to possible sequelae of KD, we had performed rotational atherectomy with 1.5/2.0 mm burrs followed by low-pressure dilation using a balloon catheter 2.5/15 mm at 4 atm for a stenosis at the inlet of a calcified aneurysm in the proximal segment of the left anterior descending coronary artery (LAD) ( Figure 1A, 1B). Although he had no apparent history of KD, he was hospitalized for 40 days due to fever of unknown cause with systemic eruption at the age of 6 months. His coronary risk factor was dyslipidemia, and under medication consisting ...

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“…But, only two relatively small studies evaluated the efficacy of DCB in small vessels (9,10). One of which was terminated early since the very early generation DCB used failed to reduce neointimal proliferation.…”

Section: Editorial Best Percutaneous Coronary Intervention Approach Fmentioning

confidence: 99%

Best percutaneous coronary intervention approach for small caliber coronary arteries

Solomonica

Roguin

2016

J. Thorac. Dis.

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Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO Study

Abstract: Dior PCB failed to show equivalence to Taxus DES regarding angiographic end points during PCI of small coronary arteries. CLINICAL TRIAL REGISTRATION NUMBER (EUDRACT CODE): 2009-012268-15.

Cited by 275 publications

References 28 publications

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions—a systematic review and meta-analysis

Rotational Atherectomy Followed by Drug-Coated Balloon Dilation in Possible Coronary Sequelae of Kawasaki Disease

Best percutaneous coronary intervention approach for small caliber coronary arteries

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