Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial

Mathey, D; Wendig, Imke; Boxberger, Michael; Bonaventura, Klaus; Kleber, Franz X.

doi:10.4244/eijv7ska11

Cited by 105 publications

(83 citation statements)

References 9 publications

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“…Therefore, DEB without stent treatment mostly focuses on high-risk restenotic lesions, such as small vessels, bifurcations, or ISR [4]. Several clinical trials have confirmed the safety of paclitaxel-coated balloon in patients with de novo lesions in small coronary arteries or in bifurcation lesions [12,13,23,24,25,26,27,28]. However, information on DEB treatment of non-small coronary artery lesions is limited.…”

Section: Discussionmentioning

confidence: 99%

“…However, clinical information on the efficacy and safety in de novo coronary lesions is limited. Moreover, several studies and trials have produced conflicting results in patients with a stable coronary artery disease [8,9,10,11,12,13]. Therefore, we hypothesize that DEB may also be safe for the treatment of non-small coronary artery lesions.…”

Section: Introductionmentioning

confidence: 99%

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Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Ding²,

Tian³

et al. 2016

Cardiology

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Background: The drug-eluting balloon (DEB) is a promising tool to prevent restenosis after coronary angioplasty. However, data on the outcomes of DEB in de novo lesions are scarce. Vessel recoil and constrictive remodeling are the dominant causes of restenosis after angioplasty. The use of cutting balloons (CB) may effectively reduce elastic recoil after balloon dilation. In this study, we evaluate the efficacy and safety of DEB in treating de novo coronary artery lesions, using a predilation strategy with cutting balloon (CB) dilation before DEB angioplasty. Methods/Design: We present the design of a prospective, single-center, open-label, randomized, 2-arm clinical trial aiming to assess whether or not the strategy of CB dilation before DEB angioplasty reduces the primary end point of late lumen loss (LLL) compared with drug-eluting stent (DES) implantation alone for de novo coronary artery lesions. A total of 120 patients will be randomly enrolled into the DEB or DES group (1:1 ratio). The primary end point is insegment LLL at 12 months as measured by optical coherence tomography (OCT). Secondary end points include procedural success, such as angiographic success and device success, and clinical outcomes including all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. Discussion: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEB after CB dilation compared with DES for the treatment of de novo coronary artery lesions guided by OCT.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Ding²,

Tian³

et al. 2016

Cardiology

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“…The data from literature on DEB in this indication is very sparse. In PEPCAD V study 11 on a small number of 28 patients with bifurcation lesion first a dilatation with DEB of both the major and the side branches was performed, and following this BMS was implanted into the main branch with the stent opening towards the side branch with one balloon. Angiography results after 9 months have shown slight late lumen loss in side branches treated mostly with DEB without the stent implantation, and in 3 patients after 6, 8 and 10 months a late and very late thrombosis of the BMS implanted into the main branch was recorded.…”

Section: Raspravamentioning

confidence: 99%

Percutaneous Coronary Interventions with Drug-eluting Balloons: Croatian Experience.

Prvulović¹,

Tomulić²,

Strozzi³

et al. 2014

Cardiol Croat.

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UVod: Lijekom obloženi baloni (DEB) predstavljaju novu tehnološku platformu u području perkutane koronarne intervencije. Jedina prihvaćena indikacija za njihovu uporabu je liječenje in-stent stenoze, a za sve ostale indikacije nema jasnog konsenzusa. CILJ:Evaluirati upotrebu DEB-a u rutinskoj kliničkoj praksi u Republici Hrvatskoj. MeTode:Restrospektivni nerandomizirani multicentrični registar svih liječenih bolesnika u sedam hrvatskih centara između veljače 2011. i siječnja 2014. godine. Podatci su sakupljeni uvidom u dostupnu medicinsku dokumentaciju. Nije bilo kliničkih niti angiografskih isključnih kriterija, niti pisanog zajedničkog protokola za indikacije niti praćenje bolesnika. Praćena su velika nepovoljna događanja (MACE) definirana kao kombinacija srčane smrti, infarkta miokarda na tretiranoj krvnoj žili (MI) ili klinički indicirane reintervencije na tretiranoj krvnoj žili TLR za sve bolesnike tijekom iste hospitalizacije, nakon 6 mjeseci kliničkog praćenja te dostupni angiografski podatci.RezULTaTI: Kod 248 bolesnika tretirane su 284 lezije. Najčešća indikacija bila je in-stent restenoza u 31,4% bolesnika, u 21,4% bolesnika DEB je implantiran u žilama manjim od 2,75 mm, a ostale indikacije su bile: lezije veće od 2,8 mm, bifurkacije, ostijalne lezije, kronične totalne okluzije (redom: 11,3%; 11,3%; 7,3%; 1,6% ). U 39 bolesnika (15,6%) nakon prethodne implantacije običnih metalnih stentova (BMS) rađena je postdilatacija DEB-om. MACE su se tijekom hospitalizacije javili u 1,6% bolesnika: 1 smrt (0,4%), 3 akutne tromboze (1,2%), 1 MI (0,4%). Nakon 6 mjeseci praćenja dostupni su podatci za 83 bolesnika (33%). U 6% bolesnika je rađena TLR, a nije bilo registriranih smrti niti akutnih infarkta miokarda. Angiografska kontrola nakon 6 mjeseci učinjena je u 55 bolesnika (22%). U 69% bolesnika nalaz je opisivan kao potpuno uredan, nesignifikantna stenoza opisana je u 20% bolesnika, a u 11% bolesnika je opisana stenoza u rasponu od >50% do potpune okluzije. zakLJUčak: Naše kliničko iskustvo u svakodnevoj kliničkoj praksi pokazuje da se DEB u Hrvatskoj koristi u najvećem slučaju u prihvaćenim indikacijama in-stent restenoze, ali i u velikom postotku i za indikacije za koje ne postoji jasni konsenzus u literaturi. Akutni angiografski rezultati i rani klinički ishodi su odlični, a uporaba DEB-a je izrazito sigurna. SUMMARY:InTRodUCTIon: Drug-eluting balloons (DEB) represent a new technological platform in the area of percutaneous coronary interventions. The only accepted indication for their use is the treatment of in-stent stenosis, with no clear consensus for all other indications. aIM:To evaluate the use of DEB in routine clinical practice in Croatia. MeThodS:Retrospective nonrandomized multicentric register of all treated patients in seven Croatian centers in the time frame from February 2011 to January 2014. The data were collected from available medical documents. There were no clinical or angiographic exclusion criteria, nor was there any written common protocol for indications or for for the clinical follow...

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“…Over the last several years, we have seen a wide variety of clinical trial designs including lesion sub-sets (i.e., bifurcations, de novo lesions and STEMI) [4,5] (P. Stella, Results of the DEB AMI trial, TCT 2011, Washington DC, US), that have not been sufficiently studied at the experimental setting [1]. Some of these studies, usually small and not properly controlled, have yielded confusing efficacy and safety results thus tainting the clinical potential of this technology.…”

mentioning

confidence: 99%

Paclitaxel coated balloons, the time for awareness has come

Cortese

Sgueglia

Granada

2013

International Journal of Cardiology

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Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial

Cited by 105 publications

References 9 publications

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Percutaneous Coronary Interventions with Drug-eluting Balloons: Croatian Experience.

Paclitaxel coated balloons, the time for awareness has come

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