ABSTRACT
We aimed to compare the long‐term efficacy and safety of drug‐coated balloon (DCB) and drug‐eluting stent (DES) following atherectomy for coronary arteries with severely calcified lesions. Of the 258 consecutive patients and 422 de novo lesions treated with DCB at Kanazawa Medical University Hospital, we retrospectively enrolled highly calcified de novo lesions treated with atherectomy, rotablator, and/or orbital atherectomy system (OAS), followed by the use of either DCB (94 cases, 191 lesions) or DES (159 cases, 216 lesions) were retrospectively examined. The primary endpoint was target lesion revascularization (TLR), and the secondary endpoint was major adverse cardiac event (MACE) during 3 years of follow‐up. Regarding patient background, there was a significant difference in age (All DCB vs. DES: 69.5 ± 11.4 vs. 73.2 ± 8.6; p < 0.001), and the DCB group included more dialysis cases (28.3% vs. 15.3%; p < 0.01). No significant difference was observed in the lesion background. The balloon size of the DCB was 2.56 ± 0.40 mm. Acute closure was not observed after DCB. Late lumen loss (LLL) was −0.07 ± 0.34 mm (DCB) versus 0.46 ± 0.65 mm (DES). Late lumen engagement (LLE) was observed in 56 lesions (56/129 [43.4%]) in the DCB group. As adjunctive treatment after atherectomy for calcified lesions, no significant difference was observed in TLR (16.2% vs. 13.4%; log‐rank, p = 0.08) and MACE (18.3% vs. 16.2%; log‐rank, p = 0.13). For highly calcified coronary lesions, relative to DES, treatment with DCB after atherectomy could provide clinically acceptable favorable results in terms of TLR and MACE at 3 years.
Keywords: atherectomy, coronary artery calcification lesion, drug coated balloon, drug eluting stent
1. Introduction
Drug‐eluting stents (DES) have become the standard treatment method for percutaneous coronary intervention (PCI) and have been confirmed to be safe and effective over a long period of time. However, calcified lesions of the coronary arteries have been reported to have a negative impact on the outcomes. It is recognized that the expansion of the stent is limited by the existence of calcification and that insufficient dilatation of the stent strongly affects subsequent target lesion revascularization (TLR) [1]. Drug‐coated balloons (DCB) are associated with better results than plain balloons [2]. In addition, the use of DCB has the potential to realize stentless strategies. However, the effects of calcified lesions of the coronary arteries. The purpose of this study was to investigate the safety and efficacy of DCB angioplasty for vessels with a high degree of calcification for which atherectomy was performed (Rotablator and/or Orbital atherectomy system: OAS), in comparison to DES.
2. Methods
2.1. Populations
This retrospective observational study included vessels from de novo calcified coronary artery lesions treated with DCB or DES after continuous atherectomy (Rotablator/Orbital atherectomy system) at Kanazawa Medical University Hospital from 2016 to march 2023. The exclusion criteria included hybrid cases of in which DES and DCB simultaneously used, as well as DCB treatment on the lateral branches jailed with stents.
The study protocol complied with the Declaration of Helsinki and was approved by the ethics committee of Kanazawa Medical University on day. Informed consent was obtained in the form of an opt‐out option on our hospital website. Individuals who opted out were not included in the study. The personal details of the patients were removed so that they could not be identified in any way during data analysis.
2.2. PCI Procedure
All procedures were performed in a standard manner and were based on PCI methods, balloons, DCB and DES diameters, lengths, dilation pressures, and types of atherectomy devices {Rotablator (Boston Scientific, USA))/orbital atherectomy system (Abbott, USA)}. It is up to the operator to decide whether to use a DCB or DES after atherectomy. Patients for whom DES was used were selected for second‐ or third‐generation DES. All patients were treated with aspirin (100 mg/day), clopidogrel (75 mg/day) or prasugrel (3.75 mg/day) for at least 5 days before PCI. After PCI, dual antiplatelet therapy (DAPT) is administered for 3–6 months. Thereafter, either clopidogrel (75 mg/day) or prasugrel (3.75 mg/day) was continued.
The SeQuent Please®/SeQuent Please NEO® (B. Braun, Germany and NIPRO, JAPAN) or AGENT (Boston Scientific, USA) were used as DCB. All PCI procedures were self‐recorded by the operator and independently reviewed off‐line by 2 coronary interventionalists, with differences resolved by consensus.
2.3. Clinical Endpoints and Follow‐Up Observations
The primary clinical endpoint was target lesion revascularization (TLR) within 3 years after the procedure. TLR was defined as ≥ 90% stenosis on angiography requiring revascularization.
The secondary endpoints were major adverse cardiac events (MACE). MACE was defined as target lesion revascularization (TLR), myocardial infarction and cardiac death.
Coronary angiography (CAG) was performed before and immediately after PCI. Follow‐up CAG is not mandatory but is performed with the consent of the patient when ischemic symptoms and ischemic findings are observed. Patients who did not undergo follow‐up CAG were followed to detect clinical events. When details could not be confirmed at the outpatient clinic, the patient's status was checked through telephone interviews.
2.4. Quantitative Coronary Angiography
Well‐trained technicians performed QCA before and after PCI and at follow‐up using a computer‐based QCA system (QAngio XA; Medis Medical Imaging System). We measured the reference minimum lumen diameter (MLD), vessel diameter (RVD), percentage diameter stenosis (%DS), and lesion length for each lesion on preprocedure, postprocedure, and follow‐up angiography. Acute gain, late lumen loss (LLL), and late lumen enlargement (LLE) were calculated.
2.5. Statistical Analyses
All statistical analyses were performed using Microsoft Excel 2021 MSO (16.0.17425.20176) 64 bit (Microsoft, CA, USA) and EZR (Easy R) (64‐bit) [3]. Continuous and normally distributed variables are expressed as mean ± SD and compared using unpaired t‐tests. Continuous variables that were not normally distributed were expressed as median and interquartile range (IQR) and compared using the Mann–Whitney U test. Categorical variables are expressed as n (%) and compared using the chi‐squared test. The clinical characteristics of the study participants were analyzed on a patient‐specific basis. The target lesion, procedure, and outcome characteristics were analyzed on a lesion basis.
Univariate and multivariate analyses of factors predicting outcomes were performed using the Cox proportional hazard model. All statistical tests were two‐sided, and P‐values of < 0.05 were considered statistically significant.
Prognostic outcomes were evaluated using the Kaplan–Meier method and compared using the log‐rank test.
3. Results
3.1. Patients and Lesions
The study targeted 422 DCB‐treated lesions in 256 patients treated at Kanazawa Medical University Hospital from 2016 to March 2023. Among these, 191 lesions from 94 patients were treated with atherectomy (rotablator and/or orbital atherectomy system: OAS), followed by DCB treatment (Figure 1). During the same period, 216 lesions from 159 patients who underwent atherectomy followed by DES implantation were enrolled as comparators. Tables 1 and 2 show the patient and lesion backgrounds, respectively. Patients in the DCB group were significantly younger than those in the DES group (all DCB vs. DES: 69.5 ± 11.4 vs. 73.2 ± 8.6 years; p = 0.002). The number of hemo‐dialysis cases in the DCB group was greater than that in the DES group (28.3% vs. 15.3%; p = 0.001). Severe calcification lesions and contains calcified nodule were more prevalent in the DCB group than in the DES group. (61.8% vs. 50.5%; p < 0.0277), (19.4% vs. 1.4%; p < 0.001). No significant difference was observed in the prevalence of type B2 lesion and c lesion (29.8% vs. 23.6%; p = 0.177, 12.6% vs. 14.4%; p = 0.664).
Figure 1.
Study flow chart. DCB, drug coated balloon; DES, drug eluting stent.
Table 1.
Baseline patient characteristics.
| DCB | DES | p value | |
|---|---|---|---|
| Number of patients | n = 94 | n = 159 | |
| Male (%) | 73.8 | 72.2 | 0.738 |
| Age (years) | 69.5 ± 11.4 | 73.2 ± 8.6 | 0.002 |
| BMI (kg/m²) | 24.1 ± 3.9 | 23.4 ± 8.7 | 0.008 |
| Hypertension (%) | 82.7 | 86.1 | 0.41 |
| Dyslipidemia (%) | 68.6 | 75.9 | 0.119 |
| Diabetes mellitus (%) | 61.3 | 58.3 | 0.613 |
| Chronic kidney disease (Cr > 1.5 mg/dL) (%) | 37.7 | 31.5 | 0.21 |
| Hemodialysis (%) | 28.3 | 15.3 | 0.001 |
| Current Smoking (%) | 27.7 | 31.9 | 0.387 |
| History of MI (%) | 22.0 | 17.6 | 0.317 |
| LVEF (%) | 54.1 ± 14.3 | 53.7 ± 12.4 | 0.236 |
Abbreviation: LVEF, left ventricle ejection fraction.
Table 2.
Lesion characteristics.
| DCB | DES | p value | |
|---|---|---|---|
| Number of lesions | n = 191 | n = 216 | |
| Target vessel | |||
| Left anterior descending artery (%) | 52.9 | 51.9 | 0.843 |
| Left circumflex artery (%) | 25.1 | 13.9 | 0.005 |
| Right coronary artery (%) | 18.8 | 23.1 | 0.331 |
| Left main trunk bifurcation (%) | 6 | 24 | 0.002 |
| Bypass graft (%) | |||
| Lesion type (AHA type) | |||
| B1 (%) | 49.7 | 58.8 | 0.073 |
| B2 (%) | 29.8 | 23.6 | 0.177 |
| C (%) | 12.6 | 14.4 | 0.664 |
| Bifurcation (%) | 27.7 | 31.9 | 0.498 |
| Ostium (%) | 16.2 | 13.4 | 0.484 |
| Chronic total occlusion (%) | 3.1 | 4.7 | 0.459 |
| Severe calcification (%) | 61.8 | 50.5 | 0.0277 |
| Calcified nodule (%) | 19.4 | 1.4 | < 0.001 |
Abbreviation: AHA, American Heart Association.
3.2. Characteristics of the Procedural Devices and Acute Procedural Results
There was significant difference in rotablator burr size or burr/artery ratio (B/A ratio) between the DCB and DES groups(69.3 ± 10.4 vs. 58.0 ± 9.9; p < 0.001). In the DCB group, the orbital atherectomy system (OAS) was used significantly more frequently (21.5% vs. 7.4%; p < 0.001). The DES group had a higher rate of scoring balloon use (63.4% vs. 85.2; p < 0.001). In the DCB group, bail‐out stenting was required in four cases (2.1%) (Table 3).
Table 3.
Device characteristics.
| DCB | DES | p value | |
|---|---|---|---|
| Number of patients | n = 191 | n = 216 | |
| Imaging device used | |||
| IVUS | 82.2 | 88.0 | 0.123 |
| OCT (OFDI) | 20.4 | 16.2 | 0.304 |
| Debulking device | |||
| Rotablator (%) | 90.1 | 100.0 | < 0.001 |
| Maximum burr size (mm) | 1.75 ± 0.21 | 1.71 ± 0.23 | 0.234 |
| Rota burr/artery ratio (B/A ratio) | 69.3 ± 10.4 | 58.0 ± 9.9 | < 0.001 |
| Orbital atherectomy system (%) | 21.5 | 7.4 | < 0.001 |
| Scoring balloon use (%) | 63.4 | 85.2 | < 0.001 |
| Cutting balloon (%) | 26.2 | 30.6 | 0.379 |
| Lacrosse NSE/Aperta NSE (%) | 37.7 | 54.6 | < 0.001 |
| Scoring balloon diameter (mm) | 2.55 ± 0.38 | 2.82 ± 0.40 | < 0.001 |
|
Drug coated balloon Drug eluting stent |
|||
| Diameter (mm) | 2.56 ± 0.40 | 3.00 ± 0.42 | ＜0.001 |
| Length (mm) | 21.49 ± 5.65 | 26.91 ± 8.27 | ＜0.001 |
| Bailout stenting after DCB (%) | 4 (2.1) |
Abbreviations: IVUS, intravascular ultrasound; OCT, optical coherence tomography; OFTI, optical frequency domain imaging; DCB, drug coated balloon.
3.3. Clinical Follow‐Up Data
There was no significant difference in the 3‐year TLR rates between the DCB and DES groups (16.2% vs. 13.4%; log‐rank, p = 0.0843) (Figure 2). Similarly, no significant differences were observed in MACE (18.3% vs. 16.2%; log‐rank, p = 0.13) (Figure 3). During the 3‐year observation period, 25 deaths were observed in the DCB group (cardiac death, n = 6; bleeding, n = 4; noncardiac causes, n = 14) and 25 deaths were observed in the DES group (cardiac death, n = 8; bleeding, n = 4; noncardiac causes, n = 13). No thrombus development or thrombosis was observed in the target lesion.
Figure 2.
Kaplan‐Meier estimated rates of freedom from TLR between DCB and DES following atherectomy for severely calcified coronary lesions. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 3.
Kaplan‐Meier estimated rates of freedom from MACE between DCB and DES following atherectomy for severely calcified coronary lesions. [Color figure can be viewed at wileyonlinelibrary.com]
3.4. Quantitative Coronary Angiography
The results of the quantitative coronary angiography are described in Table 4. Preprocedure status showed no difference between DCB group and DES group.
Table 4.
Quantitative angiographic characteristics.
|
DCB n = 191 |
DES n = 216 |
p value | |
|---|---|---|---|
| Preprocedure | |||
| MLD (mm) | 0.95 ± 0.47 | 1.00 ± 0.53 | 0.314 |
| RVD (mm) | 2.25 ± 0.71 | 2.11 ± 0.57 | 0.083 |
| %DS | 56.60 ± 21.41 | 51.11 ± 23.67 | 0.006 |
| Lesion length (mm) | 10.56 ± 10.90 | 10.79 ± 13.35 | 0.065 |
| Postprocedure | |||
| MLD (mm) | 1.76 ± 0.53 | 2.66 ± 0.50 | < 0.001 |
| RVD (mm) | 2.34 ± 0.63 | 2.97 ± 0.49 | < 0.001 |
| %DS | 24.30 ± 13.74 | 10.44 ± 7.04 | < 0.001 |
| Acute gain (mm) | 0.79 ± 0.51 | 1.66 ± 0.61 | < 0.001 |
| Follow‐up | |||
| n = 130 (68.1%) | n = 139 (64.4%) | ||
| MLD (mm) | 1.70 ± 0.52 | 2.20 ± 0.65 | < 0.001 |
| RVD (mm) | 2.21 ± 0.60 | 2.75 ± 0.93 | < 0.001 |
| %DS | 23.28 ± 14.83 | 17.75 ± 17.95 | < 0.001 |
| LLL (mm) | −0.07 ± 0.34 | −0.46 ± 0.65 | < 0.001 |
Abbreviations: %DS, percentage diameter stenosis; LLL, late lumen loss; MLD, minimum lumen diameter; PCI, percutaneous coronary intervention; RVD, reference vessel diameter.
Follow up angiography has been performed in 269 cases, 130 cases (68.1%) in the DCB group and 139 cases (64.4%) in the DES group. The percent diameter stenosis (%DS) postprocedure was larger in the DCB group than in the DES group (24.30 ± 13.74% vs. 10.43 ± 7.04%; p < 0.001). Postprocedure, acute gain was smaller in the DCB group than in the DES group (0.79 ± 0.51 mm vs. 1.66 ± 0.61 mm; p < 0.001). The minimum lumen diameter (MLD) in follow‐up was smaller in the DCB group than in the DES group (1.71 ± 0.52 mm vs. 2.20 ± 0.65 mm; p < 0.001). The reference vessel diameter (RVD) in follow‐up was smaller in the DCB group than in the DES group (2.21 ± 0.60 mm vs. 2.75 ± 0.93 mm; p < 0.001). Percentage diameter stenosis(%DS) in follow‐up was smaller in the DCB group than in the DES group (23.28 ± 14.83 mm vs. 17.75 ± 17.95 mm; p < 0.001). As for late lumen loss (LLL), the value of DCB group was smaller than that of DES group (−0.07 ± 0.34 vs. −0.46 ± 0.65; p < 0.001).
3.5. Predictors for TLR
The independent predictors for each outcome are shown (Tables 5 and 6). Factors with P‐values of < 0.05 in Cox univariate models were incorporated into multivariable Cox regression models. In the DCB group, the univariate analysis revealed Orbital atherectomy system, intravascular ultrasound (IVUS), optical coherence tomography (OCT)/optical frequency domain imaging (OFTI), and preprocedure MLD are predictors of TLR (HR 0.2358%, 95% CI 0.05613–0.9909; p = 0.04856), (HR 0.3149%, 95% CI 0.1504–0.6593; p = 0.002177), (HR 0.2844%, 95% CI 0.1091–0.7416; p = 0.0103), (HR 0.4818%, 95% CI 0.2264–1.025; p = 0.05). Multivariable revealed preprocedure MLD are predictors of TLR (HR 0.4669%, 95% CI 0.2154–1.012; p = 0.05). preprocedure MLD was identified as an independent predictor for TLR (Table 5).
Table 5.
Predictors of TLR on multivariate analysis in DCB group.
| Univariate cox regression | Multivariate cox regression | |||||
|---|---|---|---|---|---|---|
| p value | HR | 95% CI | p value | HR | 95% CI | |
| Treatment for DCB group | ||||||
| Orbital atherectomy system (%) | 0.04856 | 0.2358 | 0.05613–0.9909 | |||
| IVUS | 0.002177 | 0.3149 | 0.1504–0.6593 | |||
| OCT | 0.0103 | 0.2844 | 0.1091–0.7416 | |||
| Preprocedure MLD | 0.05 | 0.4818 | 0.2264–1.025 | 0.05 | 0.4669 | 0.2154–1.012 |
Abbreviation: MLD, minimum lumen diameter.
Table 6.
Predictors of TLR on multivariate analysis in DES group.
| Univariate Cox regression | Multivariate Cox regression | |||||
|---|---|---|---|---|---|---|
| p value | HR | 95% CI | p value | HR | 95% CI | |
| Treatment for DES group | ||||||
| Dyslipidemia (%) | 0.03896 | 4.542 | 1.08–19.11 | |||
| Heart failure (%) | 0.03721 | 0.12 | 0.0163–0.8819 | |||
| RCA (%) | 0.01588 | 2.483 | 1.186–5.2 | 0.0145 | 2.918 | 1.236–6.885 |
| Ostium | 0.02047 | 2.62 | 1.16–5.915 | 0.03631 | 2.3730 | 1.065–6.71 |
| CTO | 0.01002 | 4.016 | 1.394–11.57 | |||
| Severe Calcification | 0.03862 | 2.246 | 1.043–4.836 | 0.06 | 2.181 | 0.966–4.922 |
| Lesion type (AHA type) C (%) | 0.002691 | 3.231 | 1.502–6.95 | |||
| Preprocedure MLD | 0.00312 | 0.3286 | 0.1571–0.6874 | 0.05 | 0.4163 | 0.1689–1.026 |
| Postprocedure MLD | 0.005686 | 0.3359 | 0.155–0.7278 | |||
| Postprocedure %DS | 0.00374 | 1.061 | 1.019–1.104 | |||
Abbreviations: CTO, chronic total occlusion; DS(%), percentage diameter stenosis; MLD, minimum lumen diameter; RCA, right coronary artery.
In the DES group, the univariate analysis revealed Orbital atherectomy system, Dyslipidemia (HR 4.542%, 95% CI 1.08–19.11; p = 0.03896), heart failure (HR 0.12%, 95% CI 0.0163–0.8819; p = 0.03721), right coronary artery (RCA) (HR 2.483%, 95% CI 01.186–5.2; p = 0.01588), ostium (HR 2.62%, 95% CI 1.16–5.915; p = 0.02047), chronic total occlusion (CTO) (HR 4.016%, 95% CI 1.394–11.57; p = 0.01002), severe calcification (HR 2.246%, 95% CI 1.043–4.836; p = 0.03862), lesion type C (AHA type) (HR 3.231%, 95% CI 1.502–6.95; p = 0.002691), preprocedure MLD (HR 0.3286%, 95% CI 0.1571–0.6874; p = 0.00312), postprocedure MLD (HR 0.3359%, 95% CI 0.155–0.7278; p = 0.005686) and postprocedure DS(%) (HR 1.061%, 95% CI 1.019–1.104; p = 0.00374). Multivariable revealed RCA, ostium and preprocedure MLD were strongly predictors of TLR (HR 2.918%, 95% CI 1.236–6.885; p = 0.0145), (HR 2.373, 95% CI 1.065–6.71, p = 0.03631), (HR 0.4163%, 95% CI 0.1689–1.026; p = 0.05) (Table 6).
4. Discussion
In the present retrospective study, we investigated the clinical efficacy and safety of DCB treatment after atherectomy for highly calcified coronary vessel lesions. Our results could provide clinically acceptable favorable results for DCB treatment following atherectomy in terms of TLR and MACE at 3 years.
The existence of a significant amount of calcification in the coronary artery wall has been one of the Achilles heels in PCI. Even for DES, which has revolutionized PCI outcomes, highly calcified lesions have been associated with high rates of MACE and in‐stent thrombosis [4, 5]. In a 2‐year comparison of TLR according to the presence or absence of calcified lesions in patients treated by DES, the TLR for highly calcified lesions was significantly higher [6]. Even after rotablator treatment, which could reduce calcification volume, > 50% of patients with POBA after rotablator treatment showed restenosis after 6 months [7]. Therefore, an adjunctive strategy after calcification debulking with a rotablator is required.
One possible solution for these circumstances might be stentless PCI using DCB, which does not leave the vessel wall [8, 9] and can deliver antiproliferative agents such as paclitaxel into the vessel wall. Regarding the potential influence of lesion calcification on the efficacy of DCB, recent studies have shown that clinical outcomes after DCB treatment are similar to those of calcified lesions [10], and no apparent significant difference was noted in the relationship between the clinical outcome and degree of calcification [11].
As for efficacy in combination with a debulking device, some study reported that DCB after atherectomy might provide a low rate of TLR and MACE (1.5% and 3.1% at 12 and 24 months, respectively) [12], but another reported that DCB following rotablator treatment was associated with a TLR rate of 16.4%.
One possible reason for this inconsistency might be the highly variable clinical background of the study subjects, especially the inclusion of patients on dialysis and those with end‐stage renal disease. Another retrospective study compared DCB and DES following rotablator for calcification lesions. The total MCAE was not significantly difference between the two groups (8% in DES group and 11% in DCB group; p value = 0.3) [13].
After rotational atherectomy for severely calcified lesions of no small vessels, no difference was found between DCB and DES (TLR 4% vs. 8%, p = 0.30) [14]. Similarly, a study using an orbital atherectomy system (OAS) for calcified lesions did not indicate significant differences between DCB and DES performed after rotablator treatment [15]. Volume reduction is important, and differences in the method, rotablator, or orbital atherectomy system (OAS) may have little influence on clinical outcomes.
Comparing these studies, the function and efficacy of DCB can work for highly calcified lesions.
Another important factor to note about DCB is the occurrence of late lumen enlargement, which is typically observed in approximately 50% of patients following treatment for non‐calcified lesions in the coronary arteries [16]. While late lumen enlargement is typically less prevalent in calcified lesions, it is more likely to occur following aggressive volume reduction of such lesions. This can lead to improved drug transfer into the vessel wall and result in positive remodeling. In the present study, measurements of late lumen loss were more favorable in the DCB group than in the DES group. It is possible to recognize that expansion of the lumen with a reduction in calcification volume due to thinning of calcified lesions might promote positive remodeling.
The management of patients undergoing PCI, antiplatelet therapy must be continued.
In a comparison of DCB versus DES, higher rates of bleeding and MACE have been reported in the DES group in the high bleeding risk [17, 18]. In a comparison of dialysis and non‐dialysis patients, higher bleeding and MACE rates were reported in the dialysis patients [19]. These dialysis patients are likely to have highly calcified lesions that require atherectomy. In this our study, the DCB group included more dialysis patients than the DES group. However, there were no significant differences in bleeding rates or MACE. For patients at high bleeding risk, DCB is a safe and effective therapy and can be acceptable treatment.
Another advantage of stentless PCI in DCB therapy is the avoidance of stent thrombosis.
Although stent thrombosis incidence is low, stent thrombosis can develop over a long period, from the acute phase to the chronic phase. Cases of very late stent thrombosis occurring more than 10 years after the procedure have also been reported [20]. Furthermore, stent thrombosis often manifests as acute coronary syndrome, frequently involving myocardial infarction.
The absence of a stent can also be advantageous in TLR. The presence of a stent may limit PCI strategy. Some highly calcified lesions include calcified nodule lesions. calcified nodule may require repeated treatment.
In young patients with coronary artery disease undergoing PCI, stentless PCI with DCB offers significant long‐term efficacy. This is because younger patients require extended follow‐up periods, during which they may require repeat PCI procedures. The long‐term outcomes of PCI remain unclear in many areas, and the placement of foreign bodies within the body should be avoided whenever possible. The absence of a stent placement preserves a broader range of potential treatment options, which is a significant advantage.
However, rather than determining that either DCB or DES is superior, it is preferable to optimally utilize both DCB and DES based on the patient's background and the coronary artery lesion.
4.1. Limitations
The present study was associated with several limitations. First, the patients were classified into the two groups (cases and comparators) without randomization. Second, the retrospective observational nature of this study should be considered. Third, the number of cases was relatively small and the study was conducted in a single center. Larger sample sizes, including multicenter data collection, would overcome these issues and provide more solid evidence of the clinical usefulness of DCB for highly calcified coronary lesions.
5. Conclusion
There was no significant difference in TLR and MACE during 3 years of follow‐up after atherectomy followed by DCB and DES for vessels with highly calcified lesions. DCB therapy can be a safe and effective treatment option for high‐risk cases in DES therapy.
Conflicts of Interest
The authors declare no conflicts of interest.
Takamura T.‐a., Nakagawa C., Masaki M., et al., “Three‐Year Outcome of Drug Coated Balloon Angioplasty Following Atherectomy for Severely Calcified Coronary Lesions,” Catheterization and Cardiovascular Interventions 106 (2025): 3465–3472. 10.1002/ccd.70196.
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