Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies (FLOW-DCB)
Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies (FLOW-DCB): A Multicenter, Prospective, Randomized Controlled, Non-inferiority Trial
The goal of this clinical trial is to find out whether a treatment strategy based on a drug-coated balloon (DCB) achieves coronary artery function at 6 months that is not worse than a strategy using only drug-eluting stents (DES) by more than a prespecified amount. The study will enroll adults undergoing percutaneous coronary intervention (PCI) for a new coronary artery narrowing (de novo lesion).
The main questions are:
- Is fractional flow reserve (FFR) at 6 months noninferior after DCB-based PCI compared with DES-only PCI? FFR is a pressure-based measure used to assess blood flow through a coronary artery.
- Does the DCB-based strategy reduce the number and total length of stents implanted?
- What cardiovascular events or medical problems, such as cardiovascular death, myocardial infarction, repeat coronary procedures, or bleeding, occur during follow-up?
Investigators will randomly assign 100 participants to one of two treatment strategies. In the DCB-based group, the lesion will first be prepared with a balloon. A DCB will be used if lesion preparation produces a suitable result; a DES may be implanted if needed to achieve a safe and adequate result. In the DES-only group, the lesion will be treated with a DES.
Participants will:
- Receive treatment according to their assigned strategy.
- Undergo follow-up coronary angiography and FFR measurement at approximately 6 months. For clinical reasons, this examination may take place up to 9 months after the procedure.
- Be followed for cardiovascular events through 12 months after randomization.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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Background and objective Drug-coated balloons (DCBs) deliver an antiproliferative drug to the vessel wall during balloon inflation without leaving a permanent metallic implant. Drug-eluting stents (DESs) provide a permanent metallic scaffold that releases an antiproliferative drug. A DCB-based strategy prioritizes DCB treatment after adequate lesion preparation while allowing DES implantation when the procedural result is unsuitable for DCB treatment. Whether this strategy preserves coronary physiological function at follow-up compared with routine DES implantation remains uncertain. The FLOW-DCB trial will test whether DCB-based percutaneous coronary intervention (PCI) is noninferior to DES-only PCI with respect to fractional flow reserve (FFR) measured distal to the target or culprit lesion at approximately 6 months.
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Study design and population FLOW-DCB is an investigator-initiated, multicenter, prospective, randomized, parallel-group noninferiority trial conducted at four hospitals in the Republic of Korea. A total of 100 adults with angina or myocardial infarction requiring PCI for a de novo coronary lesion will be randomized 1:1 after diagnostic coronary angiography and before lesion preparation. The target or culprit lesion must be suitable for either strategy and have a reference vessel diameter of at least 2.25 mm. Randomization is web-based and stratified by center and clinical diagnosis at PCI (acute vs. chronic coronary syndrome).
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Treatment strategies In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover.
In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice. Intravascular ultrasound or optical coherence tomography may be used in either group at the operator's discretion. Antiplatelet and other medical treatments will be individualized according to current practice, the actual procedure, and the participant's bleeding and ischemic risks.
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Assessments and outcomes Follow-up coronary angiography and FFR measurement are planned at 6 months after randomization, with a ±30-day window; follow-up testing may be performed up to 9 months after the procedure for clinical reasons. A pressure-sensing wire will be placed distal to the treated lesion, and FFR will be recorded during maximal hyperemia. Proximal FFR and the pressure difference across the lesion (trans-lesion ΔFFR) will be recorded when feasible. Pressure drift will be checked at the end of measurement. FFR before or immediately after PCI may be obtained but is not mandatory.
The primary endpoint is mean FFR distal to the target or culprit lesion at follow-up. Secondary physiological and angiographic outcomes include trans-lesion ΔFFR, quantitative coronary angiographic measures, and the total number and length of implanted stents. Exploratory analyses will assess the effect of follow-up timing and changes in FFR when a baseline measurement is available. Clinical events, including death, myocardial infarction, repeat coronary revascularization, lesion or stent thrombosis, and clinically relevant bleeding, will be assessed through 12 months after randomization. Clinical events and safety data will be reviewed by an independent committee.
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Statistical considerations The noninferiority margin for the difference in mean distal FFR (DCB-based PCI minus DES-only PCI) is -0.05. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval for this difference exceeds -0.05 (one-sided alpha 0.025). The protocol targets at least 25 evaluable FFR measurements per group and randomizes 50 per group to account for unavailable follow-up measurements. The primary analysis will use available FFR measurements within the protocol-defined follow-up window, according to the randomized treatment group; per-protocol and exploratory as-treated analyses are planned. The trial is designed to assess physiological noninferiority and is not powered to establish differences in clinical events.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Dong Oh Kang, MD, PhD
- Telefonnummer: 82-2-2626-3184
- E-post: gelly9@naver.com
Studera Kontakt Backup
- Namn: Soohyung Park, MD, PhD
- Telefonnummer: +82-2-2626-1108
- E-post: shp503@naver.com
Studieorter
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Seoul, Sydkorea, 02841
- Korea University Anam Hospital
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Kontakt:
- Jung-Joon Cha, MD, PhD
- Telefonnummer: +82-920-5445
- E-post: jungjoon@kumc.or.kr
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Seoul, Sydkorea, 08308
- Korea University Guro Hospital
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Kontakt:
- Dong Oh Kang, MD, PhD
- Telefonnummer: +82-2-2626-3184
- E-post: gelly9@naver.com
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Kontakt:
- Soohyung Park, MD, PhD
- E-post: shp503@naver.com
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Seoul, Sydkorea, 04763
- Hanyang University Seoul Hospital
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Kontakt:
- Woohyeun Kim, MD, PhD
- Telefonnummer: +82-2-2290-8114
- E-post: coincidence1@naver.com
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Seoul, Sydkorea, 01450
- Hanil General Hospital
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Kontakt:
- Ji Bak Kim, MD, PhD
- Telefonnummer: +82-2-901-3114
- E-post: dr3120@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adults aged 19 years or older.
- Patients requiring coronary revascularization for angina or myocardial infarction.
- A target or culprit lesion suitable for both DCB and DES treatment.
- Reference vessel diameter of the target or culprit lesion ≥2.25 mm.
- Voluntary written informed consent after an explanation of the study objectives and procedures.
- For foreign nationals, ability to communicate in Korean.
Exclusion Criteria:
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Active bleeding, a clinically significant bleeding tendency, or a coagulation disorder.
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Hypersensitivity or a contraindication to aspirin, P2Y12 inhibitors, or components of a DES or DCB (drug, polymer, or metal).
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Refractory cardiogenic shock.
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Angiographic exclusion:
- Target lesion in ISR (in-stent restenosis).
- Target lesion in a bypass graft.
- Chronic total occlusion
- Left main coronary artery disease.
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History of stent thrombosis.
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Expected survival of less than 1 year because of comorbid illness.
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Left ventricular ejection fraction ≤20%.
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Pregnancy or breastfeeding.
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In the investigator's judgment, unsuitable for study participation for clinical or anatomical reasons.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: DCB-based PCI group
In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover. |
In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover.
Andra namn:
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Aktiv komparator: DES-only PCI group
In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice. |
In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Distal FFR at the target or culprit lesion
Tidsram: 6 months (±30 days; up to 9 months if necessary)
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Follow-up coronary angiography will be performed at 6 months (±30 days; up to 9 months if necessary), and distal FFR beyond the target or culprit lesion will be measured with a commercially available pressure wire as the primary outcome. |
6 months (±30 days; up to 9 months if necessary)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Trans-lesion ΔFFR
Tidsram: 6 months (±30 days; up to 9 months if necessary)
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Difference between FFR measured proximal and distal to the target or culprit lesion. |
6 months (±30 days; up to 9 months if necessary)
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Intermediate-term pressure gain (exploratory)
Tidsram: 6 months (±30 days; up to 9 months if necessary)
|
Change in distal FFR from baseline to follow-up in patients with a preprocedural FFR measurement. |
6 months (±30 days; up to 9 months if necessary)
|
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Overall stent burden
Tidsram: Immediately after index procedure
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Between-group differences in the total number and length of implanted stents |
Immediately after index procedure
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Quantitative coronary angiography (QCA) measures
Tidsram: 6 months (±30 days; up to 9 months if necessary)
|
Between-group differences in minimum lumen diameter and percentage diameter stenosis of the target or culprit lesion |
6 months (±30 days; up to 9 months if necessary)
|
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Physiological outcomes by follow-up timing (exploratory)
Tidsram: 6-7 months vs. 8-9 months
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Distal FFR and trans-lesion ΔFFR at 6-7 versus 8-9 months. |
6-7 months vs. 8-9 months
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Cardiovascular death
Tidsram: From randomization through 12 months
|
Number of participants who die from cardiovascular causes, including sudden cardiac death; death due to acute myocardial infarction, heart failure, or cardiogenic shock; other cardiovascular causes; and death of unknown cause without an undisputed noncardiovascular cause. |
From randomization through 12 months
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All-cause death
Tidsram: From randomization through 12 months
|
Number of participants who die from any cause during follow-up. |
From randomization through 12 months
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Target-Vessel Myocardial Infarction
Tidsram: From randomization through 12 months
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Number of participants with myocardial infarction attributed to the target vessel treated during the index procedure. Myocardial infarction is adjudicated using the protocol criteria adapted from the Fourth Universal Definition of Myocardial Infarction. |
From randomization through 12 months
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Nonfatal Myocardial Infarction
Tidsram: From randomization through 12 months
|
Number of participants with myocardial infarction that does not result in death. Spontaneous and procedure-related myocardial infarctions are included when they meet the protocol criteria adapted from the Fourth Universal Definition of Myocardial Infarction. |
From randomization through 12 months
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Clinically Indicated Target-Lesion Revascularization
Tidsram: From randomization through 12 months
|
Number of participants undergoing repeat percutaneous coronary intervention of the target lesion or coronary bypass surgery for target-lesion disease when revascularization is clinically indicated. The protocol requires diameter stenosis of at least 50% by quantitative coronary angiography together with corresponding ischemia on functional testing, ischemic electrocardiographic changes at rest, typical ischemic symptoms, a positive invasive physiological test (FFR ≤0.80 or instantaneous wave-free ratio ≤0.89), or diameter stenosis of at least 70% even without another ischemic criterion. |
From randomization through 12 months
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Clinically Indicated Target-Vessel Revascularization
Tidsram: From randomization through 12 months
|
Number of participants undergoing repeat percutaneous coronary intervention or coronary bypass surgery involving any segment of the target vessel when revascularization is clinically indicated. Clinical indication is determined using the protocol criteria for angiographic stenosis and symptoms, electrocardiographic changes, functional testing, or invasive physiological testing. |
From randomization through 12 months
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Any Revascularization
Tidsram: From randomization through 12 months
|
Number of participants undergoing any coronary revascularization after the index procedure, including percutaneous coronary intervention or coronary bypass surgery in a target or nontarget vessel, regardless of whether the procedure is classified as clinically indicated. |
From randomization through 12 months
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Definite or Probable Lesion or Stent Thrombosis
Tidsram: From randomization through 12 months
|
Number of participants with definite or probable thrombosis involving the treated target lesion or an implanted stent. Stent thrombosis is classified according to Academic Research Consortium criteria. For an unstented drug-coated balloon-treated lesion, definite lesion thrombosis is angiographically confirmed thrombus at the treated site with evidence of acute ischemia, or pathologically confirmed thrombus. Probable lesion thrombosis is myocardial infarction associated with documented acute ischemia in the treated lesion's territory, without angiographic confirmation of thrombus or another obvious cause. |
From randomization through 12 months
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Cardiovascular Death or Target-Vessel Myocardial Infarction
Tidsram: From randomization through 12 months
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Number of participants who experience cardiovascular death or myocardial infarction attributed to the target vessel, whichever occurs first. Components are defined according to the protocol criteria. |
From randomization through 12 months
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All-Cause Death or Nonfatal Myocardial Infarction
Tidsram: From randomization through 12 months
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Number of participants who die from any cause or experience a nonfatal myocardial infarction, whichever occurs first. Myocardial infarction is defined according to the protocol criteria. |
From randomization through 12 months
|
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Target-Vessel Failure
Tidsram: From randomization through 12 months
|
Number of participants who experience cardiovascular death, target-vessel myocardial infarction, or clinically indicated target-vessel revascularization, whichever occurs first. |
From randomization through 12 months
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Target-Lesion Failure
Tidsram: From randomization through 12 months
|
Number of participants who experience cardiovascular death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization, whichever occurs first. |
From randomization through 12 months
|
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Clinically Relevant Bleeding
Tidsram: From randomization through 12 months
|
Number of participants with Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. These categories include overt bleeding requiring clinical evaluation or treatment (type 2), major bleeding (type 3), and probable or definite fatal bleeding (type 5), as defined in the protocol. |
From randomization through 12 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Dong Oh OK Kang, MD, PhD, Cardiovascular Center, Korea University Guro Hospital
Publikationer och användbara länkar
Allmänna publikationer
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- 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. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
- Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
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- Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
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- Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
- Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.
- Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.
- 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.
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Avslutad studie (Beräknad)
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Först inskickad som uppfyllde QC-kriterierna
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Uppdateringar av studier
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Andra studie-ID-nummer
- FLOW-DCB_KUGH
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Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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