Drug-coated Balloon Treatment Research Articles

Changes of angiography-derived coronary microcirculatory resistance before and after drug-coated balloon treatment

Abstract Background Drug coated balloon (DCB) is a treatment option for a lesion in a small coronary artery. The effect of DCB is proven in mechanistic and clinical outcomes, however, its influence on the microvascular function has not been elucidated. In addition, because there are differences in the types of drugs and coatings among different DCBs, their effects on microvascular function may vary. Angiography-derived microcirculatory resistance (AMR) is a novel angiographic parameter calculated from angiography-derived quantitative flow ratio and flow velocity estimation. AMR is reported to have a good correlation with the wire-based index of microvascular resistance. Purpose To investigate the AMR in coronary vessels treated with sirolimus or paclitaxel coated balloon. Methods This is a subanalysis of the TRANSFORM I (The TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon) trial. TRANSFORM I is a prospective, randomized, multi-center, open-label noninferiority trial conducted in Europe that enrolled 121 patients (126 vessels) with stabilized acute coronary syndrome or chronic coronary syndrome who had at least one de novo coronary artery lesion in a small coronary vessel. Patients were randomized 1:1 to treatment with the sirolimus coated balloon (SCB) or paclitaxel coated balloon (PCB). The SCB is coated with phospholipid encapsulated sirolimus nanocarrier, whereas the PCB is coated with crystalline paclitaxel. In this subanalysis, angiography at baseline and post-procedure were analyzed to calculate the AMR by an imaging core lab. Coronary microvascular dysfunction (CMD) was defined as AMR≧2.5 mmHg*s/cm. Results In the total of 126 vessels, 63 were included in each of the SCB and PCB group. Angiography both at baseline and post-procedure were analyzable for AMR in 59 vessels in SCB and in 59 vessels in PCB group. In SCB group, the median AMR increased significantly after procedure (baseline; 2.03 [1.58-2.42], post-procedure;2.21 [1.78-2.53], p=0.03). However, the proportion of vessels with CMD did not significantly change (baseline; 22.0% [13/59], post-procedure; 32.2% [18/59], p=0.19) (Figure). In the PCB group, the median AMR increased significantly after procedure (baseline; 2.22 [1.66-2.53], post-procedure;2.45 [1.93-2.96], p=0.003). Furthermore, the proportion of vessels with CMD significantly increased (baseline; 27.1% [16/59], post-procedure; 47.5% [28/59], p=0.046) (Figure). The AMR measurement was not significantly different between SCB and PCB at baseline (p=0.53), but it was significantly higher in PCB than in SCB at post-procedure (p=0.04). Conclusion After DCB treatment, AMR significantly increased in both arms. The proportion of the vessel with CMD after procedure did not significantly change in the SCB group but increased in the PCB group. The potential mechanism of increase in AMR after DCB treatment (e.g. embolization of small crystals) may warrant further investigation.Proportion of AMR≥2.5

Drug-coated balloon versus drug-eluting stent revascularization in the treatment of de novo acute myocardial infarction

Abstract Objective To assess the efficacy and safety of a drug-coated balloon (DCB) revascularization on percutaneous coronary intervention (PCI) in patients with de novo acute myocardial infarction (AMI). Background Data on DCB-only treatment in the context of AMI are limited. Methods A total of 96 patients with de novo AMI successfully treated with DCB alone were retrospectively enrolled. Visual residual stenosis ≤ 30% without flow-limiting dissection was considered a satisfactory pre-balloon angioplasty and followed by DCB treatment. We compared it with 96 propensity-matched patients treated with second-generation drug-eluting stent (DES) from the PTRG-DES registry (n = 13,160 patients). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent or target lesion thrombosis, target vessel revascularization, and major bleeding (Bleeding Academic Research Consortium bleeding type 3 or greater) at 1 year. Results Baseline clinical characteristics were comparable between the groups. The mean device diameter was larger in DES group (2.7 ± 0.3 mm vs. 3.1 ± 0.4 mm, P < 0.001). No abrupt vessel closure requiring treatment occurred after treatment with DCB. The MACE was comparable in both groups (6.2% in DCB group vs. 7.3% in DES group, P = 0.790) at 1-year follow-up. Conclusions In de novo AMI patients, DCB-only treatment approach had comparable clinical outcomes at 1-year follow-up. DCB-only treatment may be a safe and effective alternative to DES in carefully selected patients who had satisfactory pre-dilation results.

Long-term clinical outcomes of drug-coated balloon angioplasty for de novo coronary lesions in patients with diabetes mellitus.

We investigated whether drug-coated balloon (DCB) treatment is effective for all de novo cases of coronary artery disease (CAD) in patients with diabetes mellitus. Furthermore, we also investigated the relationship between the degree of diabetes mellitus and clinical outcomes after DCB treatment. In this study, we included 516 consecutive patients with de novo CAD who were treated with DCB. The patients were divided into the diabetic and non-diabetic groups. Patients with diabetes mellitus were further classified into non-insulin-treated diabetes mellitus (NITDM) and insulin-treated diabetes mellitus (ITDM). The primary endpoints were major adverse cardiovascular ischemic events (MACE) and clinically driven target lesion revascularization (CD-TLR). Within a mean clinical follow-up period of 2.5years, the incidence of MACE among patients with diabetes mellitus (22.1%) was almost twice that of non-diabetic patients (11.9%) with a relative risk of 1.86 (95% CI 1.24-2.79, p = 0.002). The 3-year CD-TLR occurred in 28 patients with diabetes mellitus (10.6%) and 13 non-diabetic patients (5.1%, p = 0.02). ITDM patients had a significantly higher rate of MACE compared with non-diabetic patients with a relative risk of 2.86 (95% CI 1.76-4.63, p = 0.0002). ITDM remained an independent predictor of 3-year MACE with an odd ratio of 1.96 (95% CI 1.00-3.83, p = 0.05). In patients undergoing DCB, the presence of DM was associated with a higher risk of MACE and CD-TLR. Particularly in DCB, treatment was still inadequately effective for ITDM patients.

TCT-437 Short-Term Clinical Outcomes After Drug-Coated Balloon Treatment in Denovo Coronary Artery Disease

TCT-437 Short-Term Clinical Outcomes After Drug-Coated Balloon Treatment in Denovo Coronary Artery Disease

TCT-315 Acute and Long-Term Safety and Efficacy of IVUS-Guided Drug Coated Balloon Treatment for Carotid In-Stent Restenosis

TCT-315 Acute and Long-Term Safety and Efficacy of IVUS-Guided Drug Coated Balloon Treatment for Carotid In-Stent Restenosis

TCT-438 Long-Term Efficacy of Drug-Coated Balloon Treatment for De Novo Left Anterior Descending Artery Disease

TCT-438 Long-Term Efficacy of Drug-Coated Balloon Treatment for De Novo Left Anterior Descending Artery Disease

TCT-443 Lesion Preparation With Scoring Balloon Improves the Efficacy of Drug-Coated Balloon Treatment in Patients With De Novo Coronary Artery Disease

TCT-443 Lesion Preparation With Scoring Balloon Improves the Efficacy of Drug-Coated Balloon Treatment in Patients With De Novo Coronary Artery Disease

TCT-495 The Impact of Cutting Balloon Predilation on the Outcomes of Paclitaxel Drug-Coated Balloon Treatment for Coronary In-Stent Restenosis

TCT-495 The Impact of Cutting Balloon Predilation on the Outcomes of Paclitaxel Drug-Coated Balloon Treatment for Coronary In-Stent Restenosis

TCT-454 Procedural Predictors of Optimal Angiographic Lesion Outcomes After Drug-Coated Balloon Treatment for De Novo Coronary Artery Disease

TCT-454 Procedural Predictors of Optimal Angiographic Lesion Outcomes After Drug-Coated Balloon Treatment for De Novo Coronary Artery Disease

Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Rivaroxaban and Aspirin in Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis: A Retrospective Cohort Study

BackgroundAfter drug-coated balloon (DCB) treatment of the femoropopliteal artery in-stent restenosis (ISR), a certain proportion of patients also experience target lesion restenosis. The purpose of this study was to explore the efficacy and safety of rivaroxaban combined with aspirin in the treatment of ISR after DCB intervention. MethodsPatients who underwent DCB treatment for ISR after femoropopliteal artery intervention at our center from March 2017 to February 2022 were included consecutively. According to the drug treatment after DCB intervention of ISR, the patients were divided into rivaroxaban and aspirin group (RA Group) and dual antiplatelet therapy (DAPT) group. The outcomes of two groups during the 12-month follow-up after DCB intervention were compared. ResultsA total of 92 patients were included in final analysis, with 43 in RA group and 49 in DAPT group. During 12-month follow-up, a total of 15 cases of recurrent ISR were detected, and the recurrence rate of ISR and clinically driven TLR in the RA group were lower than those in the DAPT group (P<0.05). The vascular patency rate in the RA group was higher than that in the DAPT group at 6 and 12 months of follow-up (P<0.05). During the follow-up, there were no adverse events such as death, myocardial infarction, stroke, amputation, or major bleeding, and only a total of 5 cases of minor bleeding occurred. ConclusionCompared with the standard DAPT regimen, rivaroxaban combined with aspirin can safely improve the follow-up outcome after DCB for femoropopliteal ISR.

Predictors of target lesion failure after percutaneous coronary intervention with a drug-coated balloon for de novo lesions.

There are limited data about determinant factors of target lesion failure (TLF) in lesions after percutaneous coronary intervention (PCI) using a drug-coated balloon (DCB) for de novo coronary artery lesions, including optical coherence tomography (OCT) findings. The present study aims to investigate the associated factors of TLF in de novo coronary artery lesions with DCB treatment. We retrospectively enrolled 328 de novo coronary artery lesions in 328 patients who had undergone PCI with a DCB. All lesions had been treated without a stent, and both pre- and post-PCI OCT had been carried out. Patients were divided into two groups, with or without TLF, which was defined as a composite of culprit lesion-related cardiac death, myocardial infarction, and target lesion revascularisation, and the associated factors of TLF were assessed. At the median follow-up period of 460 days, TLF events occurred in 31 patients (9.5%) and were associated with patients requiring haemodialysis (HD; 29.0% vs 10.8%), with a severely calcified lesion (median maximum calcium arc 215° vs 104°), and with the absence of OCT medial dissection (16.1% vs 60.9%) as opposed to those without TLF events. In Cox multivariable logistic regression analysis, HD (hazard ratio [HR]: 2.26, 95% confidence interval [CI]: 1.00-5.11; p=0.049), maximum calcium arc (per 90°, HR: 1.34, 95% CI: 1.05-1.72; p=0.02), and the absence of post-PCI medial dissection on OCT (HR: 8.24, 95% CI: 3.15-21.6; p<0.001) were independently associated with TLF. In de novo coronary artery lesions that received DCB treatment, factors associated with TLF were being on HD, the presence of a severely calcified lesion, and the absence of post-PCI medial dissection.

Serial angiography and angioscopy of late lumen enlargement after drug-coated balloon for dysfunctional arteriovenous fistula.

The use of a drug-coated balloon (DCB) to treat dysfunctional arteriovenous fistula (AVF) has shown promising results. After percutaneous coronary intervention with DCB, late lumen enlargement (LLE) often develops in the early follow-up phase, but questions regarding the natural history of changes in lesions after DCB angioplasty have not been clearly elucidated. Here, we reported on a patient in whom angiography and angioscopy were performed immediately and 4 months after DCB angioplasty to treat cephalic vein stenosis of the dysfunctional AVF. Immediately after DCB application, angiography showed good dilatation and blood flow and mild vascular dissection that did not affect blood flow. Angioscopy showed that although the balloon had damaged the intima and the paclitaxel particles had adhered to the vessel wall. Four months after DCB treatment, follow-up angiography and angioscopy were performed. Angiography showed LLE in the cephalic vein of the AVF that had been treated by DCB angioplasty. Angioscopy showed that the intima of the vessel had almost completely healed, and the paclitaxel particles had disappeared. LLE might occur when DCB is used for AVF.

Clinical Value of the Quantitative Flow Ratio to Predict Long-term Target Vessel Failure in Patients with In-stent Restenosis after Drug-coated Balloon Angioplasty.

The study sought to investigate the clinical predictive value of quantitative flow ratio (QFR) for the long-term target vessel failure (TVF) outcome in patients with in-stent restenosis (ISR) by using drug-coated balloon (DCB) treatment after a long-term follow-up. This was a retrospective study. A total of 186 patients who underwent DCB angioplasty for ISR in two hospitals from March 2014 to September 2019 were enrolled. The QFR of the entire target vessel was measured offline. The primary endpoint was TVF, including target vessel-cardiac death (TV-CD), target vessel-myocardial infarction (TV-MI), and clinically driven-target vessel revascularization (CD-TVR). The follow-up time was 3.09±1.53 years, and 50 patients had TVF. The QFR immediately after percutaneous coronary intervention (PCI) was significantly lower in the TVF group than in the no-TVF group. Multivariable Cox regression analysis indicated that the QFR immediately after PCI was an excellent predictor for TVF after the long-term follow-up [hazard ratio (HR): 5.15×10-5 (6.13×10-8-0.043); P<0.01]. Receiver-operating characteristic (ROC) curve analysis demonstrated that the optimal cut-off value of the QFR immediately after PCI for predicting the long-term TVF was 0.925 (area under the curve: 0.886, 95% confidence interval: 0.834-0.938; sensitivity: 83.40%, specificity: 88.00; P<0.01). In addition, QFR≤0.925 post-PCI was strongly correlated with the TVF, including TV-MI and CD-TVR (P<0.01). The QFR immediately after PCI showed a high predictive value of TVF after a long-term follow-up in ISR patients who underwent DCB angioplasty. A lower QFR immediately after PCI was associated with a worse TVF outcome.

Effect of Drug-Coated Balloon Versus Stent Angioplasty in Patients With Symptomatic Intracranial Atherosclerotic Stenosis.

Drug-coated balloons (DCBs) have exhibited promising results in coronary and peripheral artery diseases, but conclusive evidence is lacking in intracranial vasculature. We assessed the safety and efficacy of DCBs vs stent angioplasty for symptomatic intracranial atherosclerotic stenosis (sICAS) and initially identified patients who might have benefited most from DCB treatment. A single-center, retrospective cohort study was conducted from June 2021 to May 2022 with 154 patients with sICAS divided into 2 treatment groups: a DCB group (with or without remedial stenting, n = 47) and a stent group (n = 107). The treatment outcomes were compared using 1:2 propensity score matching. The primary safety end point was perioperative stroke or mortality, and the primary efficacy end point was the rate of target vessel restenosis at 12 months. The degree of luminal change was analyzed as a subgroup, defined as the difference between the degree of stenosis at follow-up and immediately after intervention. One hundred eighteen patients were enrolled using propensity score matching, with 43 patients in the DCB group and 75 in the stent group. The incidence of perioperative adverse events was 2.3% in the DCB group and 8.0% in the stent group (P = .420). At a median follow-up of 12 months, the incidence of restenosis (11.9% [5/43] vs 28.0% [21/75], P = .045) and the median degree of stenosis (30% [20%, 44%] vs 30% [30%, 70%], P = .009, CI [0-0.01, 0.2]) were significantly lower in the DCB group than in the stent group. DCB angioplasty effectively prevented adverse events in the target vessel area and significantly reduced the degree of luminal change in the M1 segment of the middle cerebral artery (0 [0, 15%] vs 10% [0, 50%], P = .016). DCB angioplasty might be a safe and effective alternative to stent angioplasty to treat sICAS, particularly among patients with M1 segment of the middle cerebral artery stenosis.

Clinical outcomes and risk factors associated with drug-coated balloon treatment for femoropopliteal artery disease in patients on maintenance hemodialysis.

The effect of drug-coated balloons (DCB) on hemodialysis (HD) in patients with femoropopliteal (FP) disease remains uncertain. This study aimed to investigate the outcomes of DCB therapy in patients with FP artery disease on HD. A total of 185 patients with FP lesions (140 HD patients) who underwent DCB treatment were included in the study. The incidence of restenosis and target lesion revascularization (TLR) at 12months were measured. Risk factors for TLR were also investigated. The mean age was 71.7years, and diabetes was observed in 82.3% of patients. The mean duration of receiving dialysis was 8.8years. The mean lesion length was 11.0cm, and approximately half of the lesions were severely calcified. Severe dissection after DCB therapy was observed in 19.5% of patients. During the follow-up period, 74 restenosis, 68 TLRs, 8 major amputations, and 28 deaths were observed. The freedom rates from restenosis and TLR at 12months were 63.8% and 71.3%, respectively. The freedom rates after low- and high-dose DCB at 12months were 61.9% and 70.6% for restenosis (P = 0.49) and 66.4% and 79.4% for TLR (P = 0.095), respectively. Independent risk factors for TLR at 12months of age were diabetes, chronic limb-threatening ischemia, and severe calcification. When patients were divided into four groups according to the number of these three risk factors, the rates of freedom from TLR at 12months were 100%, 94.8%, 76.7%, and 30.3% in the groups with no risk factors, any one risk factor, any two risk factors, and all risk factors, respectively (P < 0.0001). Clinical outcomes after endovascular therapy in HD patients with FP disease remain unsatisfactory, even if they are treated with DCB. In particular, patients on HD with diabetes, chronic limb-threatening ischemia, and severe calcification have poor outcomes.

Excimer laser coronary angioplasty combined with drug-coated balloon in the treatment of in-stent restenosis.

The aim of this study is to investigate the safety and efficacy of excimer laser coronary angioplasty (ELCA) combined with drug-coated balloons(DCBs) in the treatment of in-stent restenosis (ISR), and to explore whether the contrast injection technique would improve the neointimal tissue ablation of ELCA. We studied patients diagnosed with ISR between January 2019 and October 2022 at two medical centers. These patients underwent DCB angioplasty guided by optical coherence tomography (OCT). Based on whether ELCA was performed before DCB treatment, patients were categorized into two groups: the ELCA + DCB group and the DCB group. All patients underwent clinical follow-up 1 year after the procedure. The primary endpoint was the 1-year rate of target lesion revascularization (TLR), which was defined as any repeat percutaneous intervention or bypass surgery on the target vessel conducted to address restenosis or other complications related to the target lesion. The secondary endpoints including immediate luminal gain (ΔMLA, defined as the difference in minimum lumen area before and after the intervention). A total of 85 lesions in 75 patients were included. The mean age of the study population was 64.2 ± 12.0 years, with 81.3% male. Baseline clinical characteristics were well-balanced, and procedural success was 100% in both groups. The ELCA + DCB group (n = 24) exhibited a greater ΔMLA compared to the DCB group (n = 61) (3.57 ± 0.79 mm² vs. 2.50 ± 1.06 mm², [95% confidence interval,CI: 0.57-1.69], p < 0.001), The reduction in 1-year TLR was more frequently observed in patients from the ELCA + DCB group compared to the DCB group (hazard ratio 0.33 [95% CI: 0.11-0.99]; log-rank p = 0.048). The exploratory analysis showed that ELCA with contrast infusion is associated with greater acute lumen gain compared to ELCA with saline infusion (p < 0.001). The combination of ELCA and DCB is a safe and effective treatment strategy for in-stent stenosis. Additionally, compared with saline injection, ELCA with contrast injection is associated with greater acute lumen gain. However, the optimal contrast agent concentration and long-term outcome of the contrast injection technique need confirmation through larger sample sizes and prospective studies.

Comparison of angiographic change in side-branch ostium after drug-coated balloon vs. drug-eluting stent vs. medication for the treatment of de novo coronary bifurcation lesions

ObjectivesData on side-branch (SB) ostial effect after drug-coated balloon (DCB) treatment in the context of de novo coronary bifurcation lesions are limited. We aimed to investigate the angiographic outcomes of SB ostium after DCB treatment compared with drug-eluting stents (DESs) implantation in the main vessel (MV) or optimal medical therapy (OMT) for the treatment of de novo coronary bifurcation lesions.MethodsSerial angiographic changes in the SB ostium were compared between DCB, DES, and medication alone for MV treatment. Δ value was calculated by subtracting the follow-up value from the pre-procedure value.ResultsA total of 132 bifurcation lesions were included for analysis (44 lesions in DCB group; 38 lesions in DES group; 50 lesions in OMT group). The minimal lumen diameter (MLD) of SB ostium showed an increase at follow-up in the DCB group, whereas a decrease was observed in both the DES and OMT groups (ΔMLD: −0.16 ± 0.45 mm for DCB group vs. 0.50 ± 0.52 mm for DES group vs. 0.08 ± 0.38 mm for OMT group, p < 0.001). The diameter stenosis (DS) of SB ostium showed a marked decrease at follow-up in the DCB group, in contrast to an increase observed in both the DES and OMT groups (ΔDS: 8.01 ± 18.96% for DCB group vs. −18.68 ± 18.60% for DES group vs. −2.05 ± 14.58% for OMT group, p < 0.001).ConclusionsIn de novo coronary bifurcation lesions, DCB treatment on the MV demonstrated favorable angiographic outcomes in the SB ostium at 6–9 month follow-up compared to DES implantation or OMT.

Drug-coated balloon in the treatment of coronary artery de-novo large lesions angiography.

The superiority of drug-coated balloon (DCB) in treating small vessels, branching lesions, and high-risk bleeding lesions in coronary heart disease patients has been confirmed. However, its safety and efficacy in large vessels are still unclear. We aimed to investigate whether the efficacy of DCB in large vessels is not inferior to that of drug-eluting stent (DES). From November 2019 to April 2022, a total of 88 patients in our hospital who underwent coronary angiography for the first time and decided to receive DCB or DES treatment were selected. Indicators including late lumen loss (LLL), major adverse cardiovascular event (MACE) rate, major bleeding and all-cause mortality were evaluated at 9 months and 1-year post percutaneous coronary intervention (PCI) therapy. The primary endpoint of 9-month LLL was -0.07 in the DCB group and 0.19 mm in the DES group (p value＜0.001). 1-year cumulative MACE rates were similar in the DCB and DES groups (3.03% vs. 7.23%, P=0.519), TLR rates were similar (3.03% vs. 7.23%, P=0.519), Major bleeding was similar (3.03% vs. 5.45%, P=0.580), and 1 case of Cardiac death in DES group. For LLL, the DCB-only strategy was non-inferior to DES in treating de novo large lesions in the coronary arteries. Furthermore, the efficacy of DCB was comparable to DES at 1 year of follow-up for secondary clinical endpoints.

Remote Ischemic Preconditioning Before Drug-Coated Balloon Implantation can Improve the Long-Term Prognosis of Patients with CAD.

Drug-coated balloons (DCBs) have become increasingly vital to percutaneous coronary intervention, offering many advantages. However, a significant challenge is that many patients are intolerant to the myocardial ischemia caused by DCB dilation. Remote ischemic preconditioning (RIPC) is known to enhance heart's tolerance to ischemia and hypoxia. This study investigated whether preoperative RIPC could extend the tolerated DCB inflation time and improve the long-term prognosis of patients with coronary artery disease (CAD). A total of 653 patients with CAD were recruited and randomized into a RIPC group (n = 323) and a control (n = 330) group. The RIPC group underwent RIPC on the left upper limb twice daily, starting three days before the DCB implantation. The patients were followed up for one year after the operation, and 197 patients returned for coronary angiography (CAG) examination where the quantitative flow ratio (QFR) of the target vessels was measured. The primary endpoint of the study was the incidence of target lesion failure (TLF), which included target lesion revascularization (TLR), target vessel myocardial infarction, and cardiac death. The secondary endpoint was the rate of QFR loss in the target vessels. The findings revealed a significantly lower incidence of TLR in the RIPC group compared to the control group. Additionally, at the one-year follow-up, the rate of QFR loss in target vessels was lower in the RIPC group than in the control group. The preoperative application of RIPC effectively extended the duration patients could tolerate DCB inflation. Furthermore, this approach positively impacted the long-term prognosis of CAD patients undergoing DCB treatment. NCT04766749.