Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I)

Summary

This investigator-initiated, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor compared to dual antiplatelet therapy (DAPT) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients undergoing percutaneous coronary intervention (PCI) with the latest generation rapamycin drug-coated balloon (DCB) without stent implantation. The study aims to assess rates of ischemic and bleeding adverse events.

Timeline

Start

2026-05-04

Primary completion

2029-12-31

Completion

2030-12-31

Publications

• Results Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT, et al. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med. 1991 Aug 15;115(4):256-65. doi: 10.7326/0003-4819-115-4-256.
• Results Valgimigli M, Garcia-Garcia HM, Vrijens B, Vranckx P, McFadden EP, Costa F, Pieper K, Vock DM, Zhang M, Van Es GA, Tricoci P, Baber U, Steg G, Montalescot G, Angiolillo DJ, Serruys PW, Farb A, Windecker S, Kastrati A, Colombo A, Feres F, Juni P, Stone GW, Bhatt DL, Mehran R, Tijssen JGP. Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC). Eur Heart J. 2019 Jul 1;40(25):2070-2085. doi: 10.1093/eurheartj/ehy377.
• Results Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
• Results Sabatine MS, Morrow DA, Giugliano RP, Burton PB, Murphy SA, McCabe CH, Gibson CM, Braunwald E. Association of hemoglobin levels with clinical outcomes in acute coronary syndromes. Circulation. 2005 Apr 26;111(16):2042-9. doi: 10.1161/01.CIR.0000162477.70955.5F. Epub 2005 Apr 11.
• Results Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
• Results Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Van de Werf F, Mahaffey KW, Califf RM, Harrington RA. Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes. Am J Cardiol. 2005 Nov 1;96(9):1200-6. doi: 10.1016/j.amjcard.2005.06.056. Epub 2005 Sep 12.
• Results Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
• Results Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
• Results Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
• Results Rasanen A, Karkkainen JM, Eranti A, Eranen J, Rissanen TT. Percutaneous coronary intervention with drug-coated balloon-only strategy combined with single antiplatelet treatment in patients at high bleeding risk: Single center experience of a novel concept. Catheter Cardiovasc Interv. 2023 Feb;101(3):569-578. doi: 10.1002/ccd.30558. Epub 2023 Jan 22.
• Results Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30.
• Results Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945.
• Results Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
• Results Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. 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. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19.
• Results Corballis NH, Wickramarachchi U, Vassiliou VS, Eccleshall SC. Duration of dual antiplatelet therapy in elective drug-coated balloon angioplasty. Catheter Cardiovasc Interv. 2020 Nov;96(5):1016-1020. doi: 10.1002/ccd.28632. Epub 2019 Dec 4.
• Results Musumeci G, Albani S. Drug-coated balloon angioplasty and 1 month DAPT strategy: Insights from the real world. Catheter Cardiovasc Interv. 2020 Nov;96(5):1021-1022. doi: 10.1002/ccd.29339. No abstract available.
• Results Cortese B, Testa L, Di Palma G, Heang TM, Bossi I, Nuruddin AA, Ielasi A, Tespili M, Perez IS, Milazzo D, Benincasa S, Latib A, Cacucci M, Caiazzo G, Seresini G, Tomai F, Ocaranza R, Torres A, Perotto A, Bedogni F, Colombo A. Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry. J Cardiovasc Med (Hagerstown). 2021 Feb 1;22(2):94-100. doi: 10.2459/JCM.0000000000001070.
• Results Mohiaddin H, Wong TDFK, Burke-Gaffney A, Bogle RG. Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review. Cardiol Ther. 2018 Dec;7(2):127-149. doi: 10.1007/s40119-018-0121-2. Epub 2018 Oct 27.
• Results Her AY, Shin ES. Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives. Korean Circ J. 2024 Sep;54(9):519-533. doi: 10.4070/kcj.2024.0148. Epub 2024 Jun 3.
• Results Poerner TC, Duderstadt C, Goebel B, Kretzschmar D, Figulla HR, Otto S. Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography. Clin Res Cardiol. 2017 Jan;106(1):18-27. doi: 10.1007/s00392-016-1019-4. Epub 2016 Jul 5.
• Results Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29.
• Results Corballis N, Bhalraam U, Merinopoulos I, Gunawardena T, Tsampasian V, Wickramarachchi U, Eccleshall S, Vassiliou VS. One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes. J Clin Med. 2024 Aug 2;13(15):4521. doi: 10.3390/jcm13154521.
• Results Kawai K, Kolodgie FD, Kawakami R, Konishi T, Shiraki T, Sekimoto T, Tanaka T, Shen K, Virmani R, Finn AV. Vascular Response, Downstream Effect, and Pharmacokinetics After Sirolimus- and Paclitaxel-Coated Balloons in Porcine Coronary Arteries. Catheter Cardiovasc Interv. 2025 May;105(6):1434-1444. doi: 10.1002/ccd.31482. Epub 2025 Mar 6.
• Results Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.
• Results Cortese B, Malakouti S, Khater J, Munjal A. Magic Touch sirolimus-coated balloon: animal and clinical evidence of a coronary sirolimus drug-coated balloon. Future Cardiol. 2024;20(10):521-535. doi: 10.1080/14796678.2024.2345023. Epub 2024 Aug 6.
• Results Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, Yamaji K, Kohsaka S, Amano T, Kobayashi Y, Ikari Y, Kadota K, Nakamura M; Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT). Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2023 Apr;38(2):166-176. doi: 10.1007/s12928-023-00921-2. Epub 2023 Feb 27.
• Results Somsen YBO, Rissanen TT, Hoek R, Ris TH, Stuijfzand WJ, Nap A, Kleijn SA, Henriques JP, de Winter RW, Knaapen P. Application of Drug-Coated Balloons in Complex High Risk and Indicated Percutaneous Coronary Interventions. Catheter Cardiovasc Interv. 2025 Feb;105(2):494-516. doi: 10.1002/ccd.31316. Epub 2024 Dec 11.
• Results Haq AU, Suhail A, Ahsan W, Maqbool H, Nawal A, Hassan H, Bungish MK, Shahid MA, Wazir HU, Yousaf H, Rehman MEU, Ahmad Cheema H, Alsubari AAAMA, Khan MA, Nadeem B, Ahmed R, Ahmad A. Efficacy of Drug-Coated Balloon versus Drug-Eluting Stent for Patients with De Novo Coronary Artery Disease: A Systematic Review and Meta-Analysis. Med Princ Pract. 2025;34(6):544-554. doi: 10.1159/000547099. Epub 2025 Jun 27.

Drugs

Indications