Primary percutaneous coronary intervention by drug‐eluting balloon angioplasty: The nonrandomized fourth arm of the <scp>DEB‐AMI</scp> (drug‐eluting balloon in <scp>ST</scp>‐segment elevation myocardial infarction) trial

Nijhoff, Freek; Agostoni, Pierfrancesco; Belkacemi, Anouar; Nathoe, Hendrik M.; Voskuil, Michiel; Samim, Mariam; Doevendans, Pieter A.; Stella, Pieter R.

doi:10.1002/ccd.26060

Cited by 47 publications

(43 citation statements)

References 37 publications

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“…The efficacy of a DCB for the treatment of in‐stent restenosis is well‐established . A trial, however, showed that the angiographic outcome of a DCB‐only strategy was inferior to that of a DES implantation for patients with an acute myocardial infarction. The authors explained that a lack of structural support to the vessel was a crucial drawback of the DCB‐only strategy, and it may have outweighed its benefits such as an antiproliferative action and positive remodeling .…”

Section: Discussionmentioning

confidence: 99%

“…A trial, however, showed that the angiographic outcome of a DCB‐only strategy was inferior to that of a DES implantation for patients with an acute myocardial infarction. The authors explained that a lack of structural support to the vessel was a crucial drawback of the DCB‐only strategy, and it may have outweighed its benefits such as an antiproliferative action and positive remodeling . Thus, so far, the DCB‐alone for the treatment of ACS is seen as a potential alternative strategy only for patients with contraindications to a DES .…”

Section: Discussionmentioning

confidence: 99%

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Real‐life experience of a stent‐less revascularization strategy using a combination of excimer laser and drug‐coated balloon for patients with acute coronary syndrome

Harima¹,

Sairaku

Inoue³

et al. 2018

J Interven Cardiology

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Real‐life experience of a stent‐less revascularization strategy using a combination of excimer laser and drug‐coated balloon for patients with acute coronary syndrome

Harima¹,

Sairaku

Inoue³

et al. 2018

J Interven Cardiology

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“…Nijhoff et al in a subgroup analysis from the DEBAMI trial showed that there was no difference in major adverse cardiac events in 40 patients treated with DCBonly PPCI in comparison with BMS only, BMS + DCB, and paclitaxel-eluting stent implantation at 6 months follow-up [20].…”

Section: Evidence For Dcb Angioplasty In Ppcimentioning

confidence: 99%

Drug-Coated Balloons in STEMI

Wickramarachchi

Eccleshall

2018

Primary Angioplasty

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The management of ST-elevation myocardial infarction (STEMI) has evolved significantly with the introduction of new pharmacological therapies as well as interventional procedures and devices. The GISSI and ISIS-2 studies showed a mortality benefit of streptokinase over standard therapy (heparin ± oral anticoagulation)/placebo which lead to the widespread use of streptokinase in the late 1980s [1,2]. The use of recombinant tissue plasminogen activator (rt-PA) was shown to be more beneficial than streptokinase in the TIMI and GUSTO trials [3,4]. Results of other studies such as CLARITY and COMMIT paved the way for addition of clopidogrel to the drug regime which further reduced mortality [5,6].Primary percutaneous coronary intervention (PPCI) became the preferred choice of treatment for acute STEMI, with balloon angioplasty (BA) showing an improvement in mortality (or the combined endpoint of mortality and MI) over thrombolysis in a number of studies [7,8]. Subsequently, bare-metal stent (BMS) implantation in STEMI showed a reduction in target vessel revascularizations (TVR) in comparison with BA but without a reduction in death or MI in the Stent PAMI and CADILLAC trials [9,10]. The percentage of vessels with TIMI III flow was numerically higher in the BA group as compared to the BMS group, while mortality and MI rates were numerically but not statistically lower [9]. When stenting (BMS) was compared with thrombolysis as in the STAT study, the results were similar with stenting showing a reduction in TVR but no reduction in death or MI [11]. When both first-and second-generation drug-eluting stents (DES) were compared to BMS in the setting

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“…Prompted by the promising DEB-only results from PEPCAD I and V, the investigators behind DEB-AMI established a fourth nonrandomized DEB-only arm [72]. The same inclusion criteria were applied, except that successful predilatation was mandatory before DEB treatment, presumably partly accounting for the low 10% bailout rate.…”

Section: Drug-eluting Balloonsmentioning

confidence: 99%

Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review

2016

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Drug-eluting balloons (DEBs) have emerged as a new application in percutaneous coronary intervention. DEBs have proven successful in the treatment of in-stent restenosis, but their role in de novo lesions is less clear. This paper provides a review of the current studies where DEBs have been used in coronary de novo lesions, either as part of a DEB-only strategy or in combination with another device, mainly a bare metal stent (BMS). By searching Pubmed and Embase we were able to identify 52 relevant studies, differing in design, intervention, and clinical setting, including patients with small vessel disease, bifurcation lesions, complex long lesions, acute myocardial infarction, diabetes mellitus, and elderly. In 23 studies, a DEB was combined with a BMS, 25 studies used a DEB-only strategy with only provisional BMS implantation, and four studies combined a DEB with a drug-eluting stent (DES). In the vast majority of studies, DEB in combination with BMS does not seem to improve clinical or angiographic outcome compared with DES, whereas a DEB-only strategy seems promising, especially when predilatation and geographical mismatch are taken into account. A lower risk of recurrent thrombosis with DEB compared with DES is not evident from the current studies. In conclusion, the main indication for DEB seems to be small vessel disease, especially in clinical scenarios in which a contraindication to dual antiplatelet therapy exists. The main approach should be a DEB-only strategy with only provisional bailout stenting, which has shown interesting results in different clinical scenarios. In general, larger randomized controlled studies with prolonged follow-up comparing DEB with best in class DES are warranted. Technical developments of DEBs including the use of different drugs might potentially improve the efficacy of such treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-016-0064-4) contains supplementary material, which is available to authorized users.

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Primary percutaneous coronary intervention by drug‐eluting balloon angioplasty: The nonrandomized fourth arm of the DEB‐AMI (drug‐eluting balloon in ST‐segment elevation myocardial infarction) trial

Cited by 47 publications

References 37 publications

Real‐life experience of a stent‐less revascularization strategy using a combination of excimer laser and drug‐coated balloon for patients with acute coronary syndrome

Real‐life experience of a stent‐less revascularization strategy using a combination of excimer laser and drug‐coated balloon for patients with acute coronary syndrome

Drug-Coated Balloons in STEMI

Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review

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