Diffuse coronary artery disease management with drug-coated balloons

Abstract

Drug-coated balloons (DCB) have emerged as a valid alternative for drug-eluting stents in the treatment of in-stent restenosis and de-novo lesions in small vessels. In the past years, a significant effort has been made to investigate the role of this strategy in larger vessel disease, with promising preliminary results being reported for several clinical scenarios, including complex lesions, such as bifurcations, chronic total occlusions and diffuse, long lesions. A DCB strategy appears to be of significant interest in diffuse coronary disease, as the total stent length represents an independent predictor for target-vessel failure and a surgical approach does not seem to improve mid- and long-term results compared to optimal medical treatment. Several studies have investigated the safety and efficacy of a non-stent-based approach in this complex setting, and as promising results have been reported, it is fair to assume that reducing the amount of implanted metal in diffusely affected vessels could become the standard of care for these patients if a full or blended therapy with DCB is adopted. However, long-term results from large-scale studies are awaited to confirm these preliminary and intriguing results.

Keywords

Drug-coated balloon / diffuse coronary artery disease / long coronary lesions

References

[1] Morice M,Sousa E.A randomized comparison of a sirolimus eluting stent with a standard stent for coronary revascularization.ACC Current Journal Review2002;11:61

[2] Neumann FJ.‘Ten commandments’ for the 2018 ESC/EACTS guidelines on myocardial revascularization.Eur Heart J2019;40:79-80

[3] Costopoulos C,Naganuma T.The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease.JACC Cardiovasc Interv2013;6:1153-9

[4] van Beek KAJ,Vervaat FE.Single center experience in the treatment of hemodynamically significant diffuse coronary artery disease of the left anterior descending.Int J Cardiol2022;352:40-4

[5] Cortese B.Back to the future: DCB use instead of DES for the treatment of complex, native coronary artery disease.Eur Heart J Suppl2021;23:E63-7 PMCID:PMC8503473

[6] Youn YJ,Kim YI.Impact of the ultra-long 48 mm drug-eluting stent on procedural and clinical outcomes in patients with diffuse long coronary artery disease.Clin Cardiol2023;46:416-24 PMCID:PMC10106662

[7] Brugaletta S,Ortega-Paz L.10-year follow-up of patients with everolimus-eluting versus bare-metal stents after ST-segment elevation myocardial infarction.J Am Coll Cardiol2021;77:1165-78

[8] Kufner S,Cassese S.ISAR-TEST-5 Investigators10-year outcomes from a randomized trial of polymer-free versus durable polymer drug-eluting coronary stents.J Am Coll Cardiol2020;76:146-58

[9] Shlofmitz E,Waksman R.Restenosis of drug-eluting stents: a new classification system based on disease mechanism to guide treatment and state-of-the-art review.Circ Cardiovasc Interv2019;12:e007023

[10] Chen Z,Mintz GS.Prevalence and impact of neoatherosclerosis on clinical outcomes after percutaneous treatment of second-generation drug-eluting stent restenosis.Circ Cardiovasc Interv2022;15:e011693

[11] Konigstein M,Ben-Yehuda O.Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation-individual patient data pooled analysis from 6 randomized controlled trials.Am Heart J2019;213:105-11 PMCID:PMC7051011

[12] Cassese S,Tada T.Incidence and predictors of restenosis after coronary stenting in 10 004 patients with surveillance angiography.Heart2014;100:153-9

[13] Alfonso F,Giacoppo D,Byrne RA.Management of in-stent restenosis.EuroIntervention2022;18:e103-23 PMCID:PMC9904384

[14] Généreux P,Palmerini T.Stent thrombosis and dual antiplatelet therapy interruption with everolimus-eluting stents: insights from the xience V coronary stent system trials.Circ Cardiovasc Interv2015;8:e001362

[15] Taniwaki M,Zaugg S.Mechanisms of very late drug-eluting stent thrombosis assessed by optical coherence tomography.Circulation2016;133:650-60

[16] Condello F,Sorrentino S,Stefanini GG.Stent thrombosis and restenosis with contemporary drug-eluting stents: predictors and current evidence.J Clin Med2023;12:1238 PMCID:PMC9917386

[17] Lee CW,Lee JY.OPERA Steering Committee and InvestigatorsLong-term (8 year) outcomes and predictors of major adverse cardiac events after full metal jacket drug-eluting stent implantation.Catheter Cardiovasc Interv2014;84:361-5

[18] Kjøller-Hansen L,Christiansen EH.Predictors of 10-year stent-related adverse outcomes after coronary drug-eluting stent implantation: the importance of stent size.Cardiology2021;146:705-12

[19] Kong MG,Kang JH.CollaboratorsClinical outcomes of long stenting in the drug-eluting stent era: patient-level pooled analysis from the GRAND-DES registry.EuroIntervention2021;16:1318-25 PMCID:PMC9724862

[20] Lee CH,Han M.IRIS-DES Registry InvestigatorsDifferential cutoff points and clinical impact of stent parameters of various drug-eluting stents for predicting major adverse clinical events: an individual patient data pooled analysis of seven stent-specific registries and 17,068 patients.Int J Cardiol2019;282:17-23

[21] Coughlan JJ,Koch T.Long-term clinical outcomes after drug eluting stent implantation with and without stent overlap.Catheter Cardiovasc Interv2022;99:541-51

[22] Şaylık F,Selçuk M,Hayıroğlu MI.Comparison of outcomes between single long stent and overlapping stents: a meta-analysis of the literature. Herz 2023.

[23] Mangner N,Ohlow MA.BASKET-SMALL 2 InvestigatorsSafety and efficacy of drug-coated balloons versus drug-eluting stents in acute coronary syndromes: a prespecified analysis of BASKET-SMALL 2.Circ Cardiovasc Interv2022;15:e011325

[24] Mahfoud F,Ohlow MA.Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial.Clin Res Cardiol2022;111:806-15 PMCID:PMC9242956

[25] Cortese B,Guimaraes MG.Drug-coated balloon versus drug-eluting stent for small coronary vessel disease: PICCOLETO II randomized clinical trial.JACC Cardiovasc Interv2020;13:2840-9

[26] El-Mokdad R,Cortese B.Long-term follow-up after sirolimus-coated balloon use for coronary artery disease. Final results of the Nanolutè study.Catheter Cardiovasc Interv2020;96:E496-500

[27] Yu X,Ji F.A non-inferiority, randomized clinical trial comparing paclitaxel-coated balloon versus new-generation drug-eluting stents on angiographic outcomes for coronary de novo lesions.Cardiovasc Drugs Ther2022;36:655-64 PMCID:PMC9270292

[28] Uskela S,Eränen J.Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: an all-comers registry study.Catheter Cardiovasc Interv2019;93:893-900

[29] Rosenberg M,Chin K.Prospective, large-scale multicenter trial for the use of drug-coated balloons in coronary lesions: the DCB-only All-Comers registry.Catheter Cardiovasc Interv2019;93:181-8

[30] Rosenberg M,Krackhardt F.Drug coated balloon-only strategy in de novo lesions of large coronary vessels.J Interv Cardiol2019;2019:6548696 PMCID:PMC6739788

[31] Yamamoto T,Uzu K,Kawai H.Possible mechanism of late lumen enlargement after treatment for de novo coronary lesions with drug-coated balloon.Int J Cardiol2020;321:30-7

[32] Basavarajaiah S,Shannon J.Drug-eluting balloon in the treatment of in-stent restenosis and diffuse coronary artery disease: real-world experience from our registry.J Interv Cardiol2014;27:348-55

[33] Basavarajaiah S,Kalogeras K.Mid-term clinical outcomes from use of Sirolimus coated balloon in coronary intervention; data from real world population.Catheter Cardiovasc Interv2021;98:57-65

[34] Ielasi A,Geraci S.Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: the “no more metallic cages” multicentre pilot experience.EuroIntervention2016;11:e1589-95

[35] Merinopoulos I,Wickramarachchi U.Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study.Clin Res Cardiol2021;110:220-7 PMCID:PMC7862512

[36] Yang YX,Li JY.Comparisons of drug-eluting balloon versus drug-eluting stent in the treatment of young patients with acute myocardial infarction.J Cardiovasc Dev Dis2023;10:29 PMCID:PMC9865202

[37] Wickramarachchi U,Maart CA,Eccleshall SC.24 drug coated balloon-only angioplasty in chronic total occlusions, a UK single centre experience.Heart2017;103:A11Available from: https://heart.bmj.com/content/103/Suppl_7/A11.1. [Last accessed on 10 Jul 2023]

[38] Köln PJ,Liew HB.Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting - a feasibility and safety study.Int J Cardiol2016;225:262-7

[39] Jun EJ,Teoh EV.Clinical outcomes of drug-coated balloon treatment after successful revascularization of de novo chronic total occlusions.Front Cardiovasc Med2022;9:821380 PMCID:PMC9043519

[40] Pan L,Han Z.Clinical outcomes of drug-coated balloon in coronary patients with and without diabetes mellitus: a multicenter, propensity score study.J Diabetes Res2021;2021:5495219 PMCID:PMC8342102

[41] Ielasi A,Pellicano M.A hybrid approach evaluating a drug-coated balloon in combination with a new-generation drug-eluting stent in the treatment of de novo diffuse coronary artery disease: the HYPER pilot study.Cardiovasc Revasc Med2021;28:14-9

[42] Yang X,Pan L.Long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions.Front Cardiovasc Med2022;9:935263 PMCID:PMC9537625

[43] Shin ES,Kim S.Clinical impact of drug-coated balloon-based percutaneous coronary intervention in patients with multivessel coronary artery disease.JACC Cardiovasc Interv2023;16:292-9

[44] Corrigendum to: paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study).Eur Heart J2020;41:3728 PMCID:PMC7666865

[45] Cortese B,Alfonso F.Reply: seeking an appropriate primary endpoint for trials comparing DCB and DES.JACC Cardiovasc Interv2021;14:710-1