A Randomized Multicenter Study Comparing a Paclitaxel Drug-Eluting Balloon With a Paclitaxel-Eluting Stent in Small Coronary Vessels

Latib, Azeem; Colombo, Antonio; Castriota, Fausto; Micari, Antonio; Cremonesi, Alberto; Felice, Francesco De; Marchese, Alfredo; Tespili, Maurizio; Presbitero, Patrizia; Sgueglia, Gregory A.; Buffoli, Francesca; Tamburino, Corrado; Varbella, Ferdinando; Menozzi, Alberto

doi:10.1016/j.jacc.2012.09.020

Cited by 293 publications

(179 citation statements)

References 24 publications

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“…These high restenosis rates in patients treated with a DCB and an additional BMS were explained by geographical mismatch that was present in 77% of patients with restenosis but only in 19% in patients without restenosis. In addition, there were 2 randomized trials in the field 21, 22. The PICCOLETO (Paclitaxel‐Eluting Balloon Versus Paclitaxel‐Eluting Stent in Small Coronary Artery Diseases) study compared a paclitaxel‐eluting balloon (Dior; Eurocor, Bonn, Germany) to a first‐generation paclitaxel‐eluting stent (Taxus; Boston Scientific) in small coronary vessels.…”

Section: Discussionmentioning

confidence: 99%

“…In BASKET‐SMALL 2, predilatation and avoidance of geographical mismatch was therefore a prerequisite before randomization into a treatment arm. This new concept of DCB treatment (eg, optimal lesion preparation by conventional plain old balloon angioplasty and drug delivery with DCB in case of a good angiographic result) is novel and based on current guidelines 22, 23…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the duration of dual antiplatelet therapy can be shortened to 4 weeks with DCB 19, 20. However, given the variety of tested devices and inconsistencies in trial designs, published randomized controlled trial data show contradictory results for the use of DCB in native small vessel coronary artery disease 21, 22…”

Section: Introductionmentioning

confidence: 99%

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Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Gilgen

Farah

Scheller

et al. 2018

Clinical Cardiology

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The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug‐eluting stents (DES) have limited efficacy due to increased rates of instent‐restenosis, mainly caused by late lumen loss. Drug‐coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten‐Effektivitäts Trial: Drug‐Coated Balloons vs. Drug‐Eluting Stents in Small Vessel Interventions (BASKET‐SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty‐eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target‐vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long‐term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long‐term safety and efficacy for the treatment of SVD in a large all‐comer population.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Gilgen

Farah

Scheller

et al. 2018

Clinical Cardiology

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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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A Randomized Multicenter Study Comparing a Paclitaxel Drug-Eluting Balloon With a Paclitaxel-Eluting Stent in Small Coronary Vessels

Abstract: Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES. (Balloon Elution and Late Loss Optimization [BELLO]; Study NCT01086579).

Cited by 293 publications

References 24 publications

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

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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