DRUG-COATED BALLOONS FOR THE TREATMENT OF STENT EDGE RESTENOSIS

Authors

  • MW JAN Department of Cardiology, Peshawar Institute of Cardiology Hayatabad Peshawar, KPK, Pakistan
  • S IKRAMULLAH Cat-C Hospital Wari Dir Upper, KPK, Pakistan
  • M MAGSI Department of Cardiology, Shaikh Muhammad Bin Zayant al Nahyan Institute of Cardiology Quetta, Balochistan, Pakistan
  • A HADEE Department of Cardiology, CMH Muzaffarabad, AJK, Pakistan
  • N KHAN Demonstrator Pharmacology, PGMI/AMC, Lahore, Punjab, Pakistan
  • T SAFDAR Department of Medicine, Fauji Foundation Hospital Rawalpindi, Punjab, Pakistan

DOI:

https://doi.org/10.54112/bcsrj.v2023i1.468

Keywords:

Drug-Coated Balloon, Drug-Eluting Stents, Coronary Restenosis, Stent Edge Restenosis

Abstract

This study aimed to compare the effectiveness of Drug-Coated Balloon (DCB) treatment with New-Generation Drug-Eluting Stent (DES) implantation for Stent Edge Restenosis (SER). The study was conducted at LRH Peshawar from 11-02-2022 to 11-02-2023 and included 130 patients with stent edge restenosis. Ethical approval was obtained from the hospital's ethical committee, and informed consent was taken from all patients. Patients were divided into two groups, Group A (DES) and Group B (DCB), and their clinical outcomes were analyzed using propensity score matching (PSM). The study showed that DCB therapy reduced the risk of target lesion revascularization (TLR) compared to DES during a median follow-up period of 1080 days. After conducting PSM, there was no significant difference in the risk of TLR between the two groups. Moreover, there were no significant differences in the risk of all-cause death, major adverse cardiovascular events (MACE), or TLR between Group A and Group B. In conclusion, DCB treatment for SER was found to be equally as effective as new-generation DES following PSM. Therefore, DCB can be considered a viable alternative to the new-generation DES for treating SER.

Downloads

Download data is not yet available.

References

Byrne, R. A., Joner, M., and Kastrati, A. (2015). Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014. European heart journal 36, 3320-3331.

Cortese, B., D’Ascenzo, F., Fetiveau, R., Balian, V., Blengino, S., Fineschi, M., Rogacka, R., Lettieri, C., Pavei, A., and D’Amico, M. (2018). Treatment of coronary artery disease with a new-generation drug-coated balloon: final results of the Italian Elutax SV rEgistry-DCB-RISE. Journal of Cardiovascular Medicine 19, 247-252.

Cortese, B., Di Palma, G., Guimaraes, M. G., Piraino, D., Orrego, P. S., Buccheri, D., Rivero, F., Perotto, A., Zambelli, G., and Alfonso, F. (2020). Drug-coated balloon versus drug-eluting stent for small coronary vessel disease: PICCOLETO II randomized clinical trial. Cardiovascular Interventions 13, 2840-2849.

Costa, M. A., Angiolillo, D. J., Tannenbaum, M., Driesman, M., Chu, A., Patterson, J., Kuehl, W., Battaglia, J., Dabbons, S., and Shamoon, F. (2008). Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial). The American journal of cardiology 101, 1704-1711.

Coughlan, J., Aytekin, A., Koch, T., Wiebe, J., Lenz, T., Cassese, S., Joner, M., Koppara, T., Xhepa, E., and Ibrahim, T. (2022). Long‐term clinical outcomes after drug eluting stent implantation with and without stent overlap. Catheterization and Cardiovascular Interventions 99, 541-551.

Cutlip, D. E., Windecker, S., Mehran, R., Boam, A., Cohen, D. J., van Es, G.-A., Steg, P. G., Morel, M.-a., Mauri, L., and Vranckx, P. (2007). Special Reports.

Funayama, N., Kayanuma, K., Sunaga, D., and Yamamoto, T. (2021). Serial assessment of de novo coronary lesions after drug-coated balloon treatment analyzed by intravascular ultrasound: A comparison between acute coronary syndrome and stable angina pectoris. International Journal of Cardiology 330, 35-40.

Giacoppo, D., Alfonso, F., Xu, B., Claessen, B. E., Adriaenssens, T., Jensen, C., Pérez-Vizcayno, M. J., Kang, D.-Y., Degenhardt, R., and Pleva, L. (2020). Drug-coated balloon angioplasty versus drug-eluting stent implantation in patients with coronary stent restenosis. Journal of the American College of Cardiology 75, 2664-2678.

Gogas, B. D., Garcia-Garcia, H. M., Onuma, Y., Muramatsu, T., Farooq, V., Bourantas, C. V., and Serruys, P. W. (2013). Edge vascular response after percutaneous coronary intervention: an intracoronary ultrasound and optical coherence tomography appraisal: from radioactive platforms to first-and second-generation drug-eluting stents and bioresorbable scaffolds. JACC: Cardiovascular Interventions 6, 211-221.

Ino, Y., Kubo, T., Matsuo, Y., Yamaguchi, T., Shiono, Y., Shimamura, K., Katayama, Y., Nakamura, T., Aoki, H., and Taruya, A. (2016). Optical coherence tomography predictors for edge restenosis after everolimus-eluting stent implantation. Circulation: Cardiovascular Interventions 9, e004231.

Jeger, R. V., Eccleshall, S., Wan Ahmad, W. A., Ge, J., Poerner, T. C., Shin, E.-S., Alfonso, F., Latib, A., Ong, P. J., and Rissanen, T. T. (2020a). Drug-coated balloons for coronary artery disease: third report of the international DCB consensus group. Cardiovascular Interventions 13, 1391-1402.

Jeger, R. V., Farah, A., Ohlow, M.-A., Mangner, N., Möbius-Winkler, S., Weilenmann, D., Woehrle, J., Stachel, G., Markovic, S., and Leibundgut, G. (2020b). Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. The Lancet 396, 1504-1510.

Jensen, C. J., Richardt, G., Tölg, R., Erglis, A., Skurk, C., Jung, W., Neumann, F.-J., Stangl, K., Brachmann, J., and Fischer, D. (2018). Angiographic and clinical performance of a paclitaxel-coated balloon compared to a second-generation sirolimus-eluting stent in patients with in-stent restenosis: the BIOLUX randomised controlled trial. Eurointervention: Journal of Europcr in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 14, 1096-1103.

Jimba, T., Ikutomi, M., Tsukamoto, A., Matsushita, M., and Yamasaki, M. (2021). Effect of hinge motion on stent edge-related restenosis after right coronary artery treatment in the current drug-eluting stent era. Circulation Journal 85, 1959-1968.

Kang, S.-J., Cho, Y.-R., Park, G.-M., Ahn, J.-M., Kim, W.-J., Lee, J.-Y., Park, D.-W., Lee, S.-W., Kim, Y.-H., and Lee, C. W. (2013). Intravascular ultrasound predictors for edge restenosis after newer generation drug-eluting stent implantation. The American Journal of Cardiology 111, 1408-1414.

Kim, Y. G., Oh, I.-Y., Kwon, Y.-W., Han, J.-K., Yang, H.-M., Park, K.-W., Lee, H.-Y., Kang, H.-J., Koo, B.-K., and Kim, H.-S. (2013). Mechanism of Edge Restenosis After Drug-Eluting Stent Implantation–Angulation at the Edge and Mechanical Properties of the Stent–. Circulation Journal 77, 2928-2935.

Kitahara, H., Okada, K., Kimura, T., Yock, P. G., Lansky, A. J., Popma, J. J., Yeung, A. C., Fitzgerald, P. J., and Honda, Y. (2017). Impact of stent size selection on acute and long-term outcomes after drug-eluting stent implantation in de novo coronary lesions. Circulation: Cardiovascular Interventions 10, e004795.

Kleber, F. X., Schulz, A., Waliszewski, M., Hauschild, T., Böhm, M., Dietz, U., Cremers, B., Scheller, B., and Clever, Y. P. (2015). Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clinical Research in Cardiology 104, 217-225.

Kokkinidis, D. G., Prouse, A. F., Avner, S. J., Lee, J. M., Waldo, S. W., and Armstrong, E. J. (2018). Second‐generation drug‐eluting stents versus drug‐coated balloons for the treatment of coronary in‐stent restenosis: A systematic review and meta‐analysis. Catheterization and Cardiovascular Interventions 92, 285-299.

Kufner, S., Joner, M., Schneider, S., Tölg, R., Zrenner, B., Repp, J., Starkmann, A., Xhepa, E., Ibrahim, T., and Cassese, S. (2017). Neointimal modification with scoring balloon and efficacy of drug-coated balloon therapy in patients with restenosis in drug-eluting coronary stents: a randomized controlled trial. JACC: Cardiovascular Interventions 10, 1332-1340.

Lin, T.-C., Huang, C.-Y., Chen, P.-L., Lee, C.-Y., Shih, C.-C., and Chen, I.-M. (2018). Edge stenosis after covered stenting for long superficial femoral artery occlusive disease: risk factor analysis and prevention with drug-coated balloon angioplasty. Journal of Endovascular Therapy 25, 313-319.

Peng, N., Liu, W., Li, Z., Wei, J., Chen, X., Wang, W., and Lin, H. (2020). Drug-coated balloons versus everolimus-eluting stents in patients with in-stent restenosis: a pair-wise meta-analysis of randomized trials. Cardiovascular therapeutics 2020.

Serruys, P. W., Foley, D. P., Suttorp, M.-J., Rensing, B. J., Suryapranata, H., Materne, P., van den Bos, A., Benit, E., Anzuini, A., and Rutsch, W. (2002). A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study. Journal of the American College of Cardiology 39, 393-399.

Song, C.-x., Zhou, C., Hou, W., Yin, Y., Lu, S., Liu, G., Duan, C., Li, M., and Zhang, H. (2020). Drug-eluting balloons versus drug-eluting stents for small vessel coronary artery disease: a meta-analysis. Coronary Artery Disease 31, 199-205.

Tamez, H., Secemsky, E. A., Valsdottir, L. R., Moussa, I. D., Song, Y., Simonton, C. A., Gibson, C. M., Popma, J. J., and Yeh, R. W. (2021). Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries. Eurointervention: Journal of Europcr in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 17, e380-e387.

Ullrich, H., Olschewski, M., Muenzel, T., and Gori, T. (2021). Coronary in-stent restenosis: predictors and treatment. Deutsches Ärzteblatt International 118, 637.

Zhang, D.-M., and Chen, S. (2020). In-stent restenosis and a drug-coated balloon: insights from a clinical therapeutic strategy on coronary artery diseases. Cardiology Research and Practice 2020.

Zhu, Y., Liu, K., Kong, X., Nan, J., Gao, A., Liu, Y., Han, H., Li, H., Zhu, H., and Zhang, J. (2021). Comparison of drug-coated balloon angioplasty vs. drug-eluting stent implantation for drug-eluting stent restenosis in the routine clinical practice: a meta-analysis of randomized controlled trials. Frontiers in Cardiovascular Medicine 8, 766088.

Downloads

Published

2023-10-16

How to Cite

JAN, M., IKRAMULLAH, S., MAGSI, M., HADEE, A., KHAN, N., & SAFDAR, T. (2023). DRUG-COATED BALLOONS FOR THE TREATMENT OF STENT EDGE RESTENOSIS. Biological and Clinical Sciences Research Journal, 2023(1), 468. https://doi.org/10.54112/bcsrj.v2023i1.468

Most read articles by the same author(s)