DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR

Official title

Drug Coated Balloons Versus Drug-Eluting Stents for Severe Coronary Calcification After Optimal Calcium Modification Assessed by QFR (PRECISE CAL Study)

Overview

The goal of this clinical trial is to learn if the short and long term effect of drug coated balloon (DCB) is non-inferior to drug eluting stent (DES) in patients with severe coronary calcification after optimal calcium modification assessed by quantitative flow ratio (QFR). The main questions it aims to answer are: 1. Researchers will compare to see if DCB is non-inferior to DES when evaluated by major cardiovascular adverse events (MACE) one year after percutaneous coronary intervention (PCI). 2. Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions. 3. Researchers will compare to see if the QFR is different between DCB and DES treated lesions one year after PCI. Participants with severe coronary calcification diagnosed by coronary angiography or intravascular ultrasound (IVUS) will receive calcium modification through rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), or intravascular lithotripsy (IVL). Then, QFR will be measured based on angiographic image. QFR \>0.8 will be defined as optimal calcium modification and patients will be randomized 1:1 to DCB or DES treated groups. Telephone follow-ups will be conducted at 1 month, 6 months after PCI and .angiophraphy follow-up will be performed at 12 months after PCI.

Detailed description

Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.

Definite or probable thrombosis in DCB or DES treated vessels will be documented.

After randomization, if a dissection with restricted blood flow occurs after DCB treatment, DES will be implanted.

Interventions

• Device rotational atherectomy (RA)
  Rotational atherectomy (RA) is a procedure that uses a diamond-coated, high-speed rotating burr to shave and remove calcified plaque from coronary arteries
• Device excimer laser coronary angioplasty (ELCA)
  Excimer laser coronary angioplasty (ELCA) is a minimally invasive procedure that uses pulses of ultraviolet light to vaporize plaque in a blocked coronary artery. The procedure involves inserting a catheter with a laser fiber optic tip into an artery in the groin or arm, guiding it to the blockage using X-ray guidance, and then using the laser to ablate the plaque and improve blood flow.
• Device Intravascular Lithotripsy (IVL)
  An IVL catheter with emitters is inserted into the artery, and it delivers pulsatile shock waves to crack the calcium, which then allows for a balloon or stent to be safely expanded to restore blood flow.

Primary outcome measures

• Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction. [Time frame: One year after treatement.]

Secondary outcome measures (2)

• Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal. [Time frame: From treatment to hospital discharge]
• QFR at one year post PCI [Time frame: one year after treatment]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years

• Moderate to severe calcified lesions assessed by coronary angiography

• In situ coronary artery calcification

• Target lesion with indications for coronary intervention

• Target lesion vessel diameter ≥ 2.25 mm and ≤ 4.0 mm

• Calcification modification treatment performed using rotational atherectomy, intravascular lithotripsy (IVL), or excimer laser coronary angioplasty (ELCA).

• QFR > 0.8 after calcification modification

Exclusion criteria

• Patients with ST-segment elevation myocardial infarction:

• Patients with renal failure requiring dialysis or currently undergoing dialysis.

• Patients whose coronary angiography quality is unsuitable for QFR analysis.

• Patients with in-stent restenosis.

⑤ Patients with other medical conditions and a life expectancy of <1 year.

⑥ Patients scheduled for surgery within 6 months post-procedure, and whose surgery would interfere with continued use of antiplatelet therapy.

⑦ Patients who cannot tolerate dual antiplatelet therapy.

⑧ Patients who cannot adhere to the protocol-required follow-up, or whose participation in the trial is deemed risky by the investigator.

⑨ Patients who cannot provide written informed consent or cannot follow the trial protocol.

⑩ Patients currently participating in another clinical trial for coronary interventional devices.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Zhongshan Hospital, Fudan University — Shanghai

Publications

• Joh HS, Kwon W, Shin D, Lee SH, Hong YJ, Hong D, Lee SY, Park H, Kim S, Lee SY, Koh JS, Kim H, Kim CJ, Choo EH, Yoon HJ, Park SD, Jeon KH, Bae JW, Ahn SG, Kim SE, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention. JACC Asia. 2024 Jun 18;4(7):519-531. doi: 10.1016/j.jacasi.2024.04. PMID 39101114
• 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. Cardiov PMID 36847902
• Shin ES, Bang LH, Jun EJ, Her AY, Chung JH, Garg S, Lee JM, Doh JH, Nam CW, Koo BK, Tang Q. Provisional drug-coated balloon treatment guided by physiology on de novo coronary lesion. Cardiol J. 2021;28(4):615-622. doi: 10.5603/CJ.a2020.0105. Epub 2020 Aug 13. PMID 32789835
• Guedeney P, Claessen BE, Mehran R, Mintz GS, Liu M, Sorrentino S, Giustino G, Farhan S, Leon MB, Serruys PW, Smits PC, von Birgelen C, Ali ZA, Genereux P, Redfors B, Madhavan MV, Ben-Yehuda O, Stone GW. Coronary Calcification and Long-Term Outcomes According to Drug-Eluting Stent Generation. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1417-1428. doi: 10.1016/j.jcin.2020.03.053. PMID 32553329

Identifiers

NCT: NCT07277114 · KY2025283

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗