Abstract
Background
Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a therapeutic option for cardiac allograft vasculopathy (CAV). Biodegradable polymer (BP)-DES, designed to promote vessel healing and reduce inflammation compared with durable polymer (DP)-DES, has been developed. In this study, we aimed to compare the efficacy of BP-DES and DP-DES in patients with CAV.
Methods
In this single-center retrospective study, we evaluated patients with CAV who underwent their first PCI between 2010 and 2024; the patients were categorized into the BP-DES and DP-DES groups. Clinical (all-cause death or heart retransplantation) and angiographic outcomes (in-stent restenosis [ISR], target lesion revascularization [TLR], target vessel revascularization [TVR], target vessel nontarget lesion revascularization [TVNLR], and nontarget vessel revascularization [NTVR]) were assessed.
Results
Among 178 patients who underwent PCI, 40, 106, 11 received the BP-DES, DP-DES, and both, respectively. The average age at PCI was 60.3 ± 13.1 years. Survival from all-cause death or heart retransplantation after PCI was similar between the groups (p = 0.093). Of 90 BP-DES implanted, 60 were reassessed during follow-up catheterization, whereas 171 of 221 DP-DES implanted were reassessed. Both groups exhibited similar ISR, TLR, TVR, and NTVR rates; however, the TVNLR rate was significantly lower in the BP-DES group (p = 0.049). BP-DES implantation was an independent protective factor against TVNLR (hazard ratio 0.42, 95% confidence interval 0.20–0.91, p = 0.027).
Conclusions
PCI with BP-DES was associated with a lower TVNLR than PCI with DP-DES. Both DES resulted in similar clinical outcomes; however, a long-term investigation is warranted.
Keywords: biodegradable polymer, drug-eluting stent, heart transplant, cardiac allograft vasculopathy, revascularization
Cardiac allograft vasculopathy (CAV) is a rapidly progressive, obliterative vascular disease involving the epicardial and microvascular coronary arteries that is driven by immunologic and non-immune mechanisms.1 Despite therapeutic and technological advances in heart transplantation (HT) over the past few decades, CAV remains one of the leading causes of graft failure and mortality after HT.2 Notably, CAV has been reported in 20%, 30%, and 50% of patients after 3, 5, and 10 years of HT, respectively.3
The cornerstones of CAV prevention and treatment are strict control of modifiable risk factors and the use of antiplatelet therapy, statins, and proliferation signal inhibitors. Surgical revascularization is rarely performed because of high mortality rates.4 Although CAV is generally characterized by diffuse stenosis, percutaneous coronary intervention (PCI) can be a treatment option in cases of focal lesions, with better long-term survival observed in patients with CAV amenable to PCI than in those not treatable with PCI.5 Furthermore, PCI with newer second-generation drug-eluting stents (DES) has demonstrated lower in-stent restenosis (ISR) rates than that performed with bare metal stents (BMS) and first-generation DES.6, 7 Hence, PCI with DES is recommended as a class IIa treatment for appropriate discrete lesions in patients with CAV in the current guidelines.8
DES consists of a permanent metallic scaffold, polymer, and antiproliferative drug. The polymer is designed to store and control drug elution into the arterial tissue. However, the permanent presence of durable polymers (DP) can induce hypersensitivity, local inflammation, delayed arterial healing, and neoatherosclerosis.9, 10, 11 To address these concerns, DES with biodegradable polymers (BP) have been developed. In such DES, the polymer gradually degrades into water and carbon dioxide molecules after the drug is fully released, leaving only BMS behind. Multiple studies have investigated the efficacy of BP-DES and have shown non-inferior efficacy to DP-DES in the non-transplant population.12, 13, 14 However, limited data are currently available on the efficacy of PCI with BP-DES in patients with CAV.
As immune-mediated inflammatory injury is one of the factors contributing to CAV progression,1 we hypothesized that BP can be advantageous in suppressing vessel inflammation reducing the risk of restenosis or need for re-intervention in the treated lesion as well as the risk of developing new lesions elsewhere in the treated vessel. Therefore, this study aimed to compare the efficacies of BP-DES and DP-DES in patients with CAV who underwent PCI.
Materials and methods
Study design
In this single-center retrospective observational study, we reviewed the medical records of adult HT recipients (aged >18 years) who underwent their first PCI for CAV between 2010 and 2024. Patients who underwent PCI with thrombectomy only, balloon angioplasty only, BMS, or first-generation DES were excluded. After exclusion, the patients were categorized into 2 groups according to the type of DES used in the index PCI procedure: BP-DES and DP-DES. The BP-DES used was a Synergy stent (Boston Scientific Corporation, Marlborough, Massachusetts, USA), whereas the DP-DES included a Xience stent (Abbott Vascular, Abbott Park, Illinois, USA), Promus stent (Boston Scientific, Marlborough, Massachusetts, USA), and Resolute stent (Medtronic, Minneapolis, Minnesota, USA). The type of stent placed was selected at the physician’s discretion, and the study design is presented in Figure 1.
Figure 1.
Study design. BMS, bare metal stent; BP, biodegradable polymer; DES, drug-eluting stent; DP, durable polymer; PCI, percutaneous coronary intervention; POBA, plain old balloon angioplasty.
PCI was performed according to the standard clinical practice. Intravascular imaging was performed at the discretion of the primary surgeon to ensure proper stent expansion. The Institutional Review Board of the Cedars-Sinai Medical Center approved this study, and all patients provided written informed consent.
Post-PCI management
Dual-antiplatelet therapy was prescribed for a minimum of 6 months after the index PCI. The patients were followed up at a Heart Transplant clinic. Follow-up angiography was performed within 6 to 12 months after the index PCI and subsequently, as clinically indicated. The study participants were followed up until December 31, 2024.
Study outcomes
Clinical and angiographic outcomes were evaluated. The clinical outcomes were based on per-patient data, including all-cause death or re-HT. The following angiographic outcomes were assessed on a per-lesion basis: ISR, target lesion revascularization (TLR), target vessel revascularization (TVR), target vessel nontarget lesion revascularization (TVNLR), and nontarget vessel revascularization (NTVR).
ISR was defined as a >50% diameter stenosis inside the stent or within 5 mm of either side of the stent edge during follow-up catheterization, and TLR referred to revascularization of the ISR lesion. TVR was defined as revascularization of any lesion in the same stented vessel, including the stented lesion, whereas NTVR was defined as the treatment of vessels other than the stented vessel. TVNLR was defined as revascularization of the target vessel, excluding the ISR lesion (i.e., excluding the stented lesion).
Statistical analyses
Categorical variables are presented as proportions and continuous variables as means ± standard deviation or median (interquartile range). Statistical analyses were performed using R (version 4.2.2; R Foundation for Statistical Computing, Vienna, Austria). All p-values were 2-sided, and statistical significance was set at p < 0.05. We evaluated the differences between the BP-DES group and DP-DES group using Student’s t test or Mann–Whitney U test for continuous variables and χ2-test or Fisher’s exact test for categorical variables.
Patients who received both the BP-DES and DP-DES during index PCI were excluded from the clinical outcome analysis. Event-free survival analyses were performed using the Kaplan–Meier method and compared using a log-rank test.
A univariate Cox proportional hazards model was used to evaluate each parameter of the TVNLR. In addition to BP-DES, all variables (p < 0.05) were included in the multivariate Cox proportional hazards model. The results of the Cox proportional hazard models were expressed as hazard ratios with 95% confidence intervals.
Results
Of 178 patients who underwent their first PCI between 2010 and 2024, 21 were excluded based on the exclusion criteria. The remaining 157 patients were included in the analysis and categorized as follows: 40, 106, and 11 patients received BP-DES (BP-DES group), DP-DES (DP-DES group), and both BP-DES and DP-DES during index PCI, respectively (Figure 1). The mean age at HT was 51.3 ± 13.0 years, and 120 (82.2%) patients were male.
Table 1 shows the baseline characteristics of the patients; no significant differences in age at HT, sex, body mass index, reason for HT, or medical history were observed between the 2 groups. The time from HT to first PCI was 9.6 ± 6.7 and 8.8 ± 5.5 years in the BP-DES and DP-DES groups, respectively (p = 0.50). Routine angiography was the most common indication for PCI. Serum levels of low-density lipoprotein cholesterol, hemoglobin A1c, and creatinine, as well as the incidence of de novo donor-specific antibodies, were comparable between the 2 groups. The use of statins, proliferation signal inhibitors, and insulin at the time of PCI was similar between the 2 groups.
Table 1.
Comparison of Baseline and Clinical Findings in the BP-DES and DP-DES Groups
| Variables | BP-DES group (N = 40) | DP-DES group (N = 106) | p value |
|---|---|---|---|
| Recipient profile | |||
| Age at HT, years | 53.7±12.1 | 50.4±13.2 | 0.18 |
| Sex, Male | 31 (77.5%) | 89 (84.0%) | 0.36 |
| Ethnicity, Hispanic | 5 (12.5%) | 14 (13.2%) | 0.91 |
| Body mass index, kg/m2 | 26.1±4.0 | 25.3±4.2 | 0.32 |
| Reasons for transplant | |||
| Idiopathic | 16 (40.0%) | 44 (41.5%) | |
| Ischemic | 13 (32.5%) | 47 (44.3%) | |
| Others | 11 (27.5%) | 15 (14.2%) | 0.14 |
| Pre-transplant medical history | |||
| Smoking | 13 (32.5%) | 43 (40.6%) | 0.37 |
| Hypertension | 21 (52.5%) | 49 (46.2%) | 0.50 |
| Diabetes mellitus | 10 (25.0%) | 26 (24.5%) | 0.95 |
| PCI profile | |||
| Age at PCI, years | 63.2±11.7 | 59.2±13.4 | 0.11 |
| Time from HT to first PCI, years | 9.6±6.7 | 8.8±5.5 | 0.50 |
| PCI indication | |||
| Acute coronary syndrome | 4 (10.0%) | 4 (3.7%) | |
| Worsening heart failure | 5 (12.5%) | 12 (11.2%) | |
| Angina | 3 (7.5%) | 11 (10.3%) | |
| Routine angiogram | 28 (70.0%) | 80 (74.8%) | 0.48 |
| Laboratory parameters at the time of PCI | |||
| LDL-C (mg/dl) | 84 (73−115) | 93 (77−118) | 0.20 |
| HDL-C (mg/dl) | 44 (37−57) | 46 (36−56) | 0.95 |
| Creatinine (mg/dl) | 1.4 (1.2−1.6) | 1.3 (1.1−1.7) | 0.52 |
| HbA1c (%) | 5.9 (5.6−6.8) | 6.1 (5.5−7.0) | 0.64 |
| De novo DSA | 12 (30.0%) | 25 (23.6%) | 0.43 |
| Drug therapy at the time of PCI | |||
| Statin | 36 (90.0%) | 94 (88.7%) | 0.82 |
| Proliferation signal inhibitors | 16 (40.0%) | 53 (50.0%) | 0.28 |
| Insulin | 10 (25.0%) | 27 (25.5%) | 0.95 |
BP, biodegradable polymer; DES, drug-eluting stent; DP, durable polymer; DSA, donor-specific antibody; HbA1c, hemoglobin A1c; HDL-C, high-density lipoprotein cholesterol; HT, heart transplantation; LDL-C, low-density lipoprotein cholesterol; PCI, percutaneous coronary intervention.
The angiographic and procedural characteristics are summarized in Table 2. Overall, 90 BP-DESs and 221 DP-DESs were implanted in 75 and 188 lesions, respectively. Of the 221 implanted DP-DES, 183, 25, and 13 were Xience, Resolute, and Promus, respectively. Intravascular ultrasound was more frequently used in the DP-DES group than in the BP-DES group; however, the difference was not statistically significant (p = 0.077). The most commonly targeted vessel was the left anterior descending artery (53.6%). The stent diameter and length were 3.0 ± 0.62 and 22.0 ± 9.7 mm, respectively, in the BP-DES group and 3.0 ± 0.61 and 20.2 ± 8.4 mm, respectively, in the DP-DES group; no significant differences were observed between the groups. Of the 90 BP-DESs, 60 stents (66.7%) were reassessed during a follow-up catheterization, whereas 171 of the 221 DP-DESs (77.4%) were reassessed.
Table 2.
Comparison of Angiographic and Procedural Characteristics in the BP-DES and DP-DES Groups
| Characteristics | BP-DES group | DP-DES group | p value |
|---|---|---|---|
| Number of lesions treated | 75 | 188 | |
| Pre-procedure percent stenosis, % | 84.7±10.9 | 86.3±10.2 | 0.22 |
| Intravascular ultrasound guidance | 41/70 (58.6%) | 118/169 (69.8%) | 0.077 |
| Target vessels PCI | |||
| Left main | 1 (1.3%) | 8 (4.3%) | |
| Left anterior descending | 36 (48.0%) | 105 (55.9%) | |
| Left circumflex | 19 (25.3%) | 38 (20.2%) | |
| Right coronary | 19 (25.3%) | 37 (19.7%) | 0.33 |
| Number of stents placed | 90 | 221 | |
| Stents per lesion | 1.2±0.56 | 1.2±0.55 | 0.94 |
| Average stent diameter, mm | 3.0±0.62 | 3.0±0.61 | 0.62 |
| Average stent length, cm | 22.0±9.7 | 20.2±8.4 | 0.10 |
BP, biodegradable polymer; DES, drug-eluting stent; DP, durable polymer; PCI, percutaneous coronary intervention.
During the follow-up period, 5 deaths and 2 re-HTs occurred in the BP-DES group, whereas 44 deaths and 18 re-HTs occurred in the DP-DES group. Notably, 2 (40%) and 17 (38.6%) patients in the BP-DES and DP-DES groups, respectively, died due to graft failure or cardiovascular causes. Figure 2 presents the Kaplan–Meier survival curves for all-cause death and re-HT. The 1-, 3-, and 5-year freedom from death or re-HT were 97.5%, 94.5%, and 78.5%, respectively, in the BP-DES group and 88.4%, 76.9%, and 54.5%, respectively, in the DP-DES group. No significant differences were observed between the groups (p = 0.093).
Figure 2.
Kaplan-Meier curves for death or heart re-transplantation after PCI in the BP-DES and DP-DES groups. BP, biodegradable polymer; DES, drug-eluting stent; DP, durable polymer; PCI, percutaneous coronary intervention.
Angiographic outcomes are shown in Figure 3. The 1-, 3-, and 5-year ISR rates were 1.8%, 26.6%, and 26.6%, respectively, in the BP-DES group and 3.9%, 15.7%, and 27.7%, respectively, in the DP-DES group, showing no significant between-group differences (p = 0.34, Figure 3A). Furthermore, there were no significant differences in the incidence rates of TLR (p = 0.38, Figure 3B), TVR (p = 0.19, Figure 3C), or NTVR (p = 0.47, Figure 3E) between the 2 groups. However, the 1-, 3-, and 5-year TVNLR rates were 7.2%, 21.4%, and 21.4%, respectively, in the BP-DES group and 11.2%, 35.0%, and 46.4%, respectively, in the DP-DES group, demonstrating significant differences (p = 0.049, Figure 3D).
Figure 3.
Kaplan-Meier curves for angiographic outcomes in the BP-DES and DP-DES groups. Kaplan-Meier curves for ISR (A), TLR (B), TVR (C), TVNLR (D) and NTVR (E). ISR, In-stent restenosis; NTVR, Non-target vessel revascularization; TLR, target lesion revascularization; TVNLR, target vessel non-target lesion revascularization; TVR, target vessel revascularization.
Table 3 presents the results of the univariate and multivariate Cox proportional hazard models. In the multivariate analysis, BP-DES was associated with a significantly decreased TVNLR risk (hazard ratio: 0.42; 95% confidence interval: 0.20–0.91; p = 0.027), whereas male sex (hazard ratio: 8.01; 95% confidence interval: 1.12–58.3; p = 0.039) and body mass index ≥ 30 kg/m2 (hazard ratio: 2.22; 95% confidence interval: 1.20–4.11; p = 0.011) were associated with increased TVNLR risk.
Table 3.
Univariate and Multivariate Cox Proportional Hazard Analyses of Parameters Predicting TVNLR
| Parameter | Univariate analysis |
Multivariate analysis |
||
|---|---|---|---|---|
| Hazard ratio (95% confidence interval) | p value | Hazard ratio (95% confidence interval) | p value | |
| Age at PCI >65 years | 1.59 (0.94−2.71) | 0.085 | ||
| Sex, male | 7.76 (1.07−56.1) | 0.042 | 8.07 (1.12−58.3) | 0.039 |
| Body mass index >30 kg/m2 | 2.06 (1.12−3.78) | 0.021 | 2.22 (1.20−4.11) | 0.011 |
| Diabetes mellitus | 1.25 (0.74−2.13) | 0.41 | ||
| Insulin user | 0.76 (0.40−1.44) | 0.40 | ||
| Proliferation signal inhibitors | 1.16 (0.69−1.95) | 0.58 | ||
| Total stent ≥2 | 0.85 (0.48−1.49) | 0.56 | ||
| Small vessel ≤3 mm | 0.63 (0.35−1.13) | 0.12 | ||
| Long lesion ≥20 mm | 1.07 (0.62−1.85) | 0.81 | ||
| BP-DES | 0.48 (0.23−1.01) | 0.054 | 0.42 (0.20−0.91) | 0.027 |
BP, biodegradable polymer; DES, drug-eluting stent; PCI, percutaneous coronary intervention; TVNLR, target vessel non-target lesion revascularization.
Parameters that were statistically significant are shown in bold.
Discussion
In this study, we investigated the efficacy of PCI with a BP-DES in patients with CAV and found no significant differences between the BP-DES and DP-DES groups in terms of clinical outcomes—as indicated by all-cause death or re-HT after PCI. Although the ISR, TLR, TVR, and NTVR rates were comparable between the 2 groups, the BP-DES group exhibited a significantly lower rate of TVNLR than the DP-DES group. Moreover, BP-DES implantation was identified as a significant independent factor in the prevention of TVNLR.
With advancements in stent technology, DES have shown lower rates of restenosis than BMS in patients with CAV.15, 16 Our group previously investigated the outcome of 132 second-generation everolimus-eluting stents, including Xience and Promus stents, through 3 years. We found that PCI with second-generation everolimus-eluting stents was associated with a low binary restenosis rate of 10.0 ± 4.3% at 3 years; however, the 3-year TVR rate remained high at 46.2 ± 7.8%.17 Although the ISR rate decreased with DES, the progression of remote coronary stenosis within the stented vessel, requiring multiple PCI procedures, remains a significant concern.
Unlike atherosclerosis that is characterized by eccentric plaque formation, CAV results from a combination of immune- and non-immune-mediated local and systemic inflammatory responses. These processes lead to endothelial dysfunction, chronic vascular injury, and concentric intimal proliferation,2, 18 all of which contribute to the diffuse nature of CAV and make CAV management particularly challenging. Jonas et al. demonstrated that CAV progression occurs not only at the sites of prior intervention but also in non-intervened segments. Furthermore, ISR in transplanted hearts strongly correlates with disease progression in untreated lesions, with both sharing common histopathological features.19 Notably, this phenomenon was absent in native atherosclerosis patients undergoing stenting, emphasizing the distinct pathophysiology of CAV.19
DES effectively reduced neointimal proliferation, thereby decreasing the incidence of restenosis. However, despite its effectiveness in limiting localized neointimal hyperplasia, DES does not mitigate the heightened lymphoproliferative response in the tunica intima, tunica media, and tunica externa. This persistent inflammatory response is believed to drive the progressive and diffuse nature of CAV, extending beyond the stented lesions.20
The Synergy stent features an abluminal coating of everolimus in an ultrathin bioabsorbable poly-DL-lactide-co-glycolide polymer, which is fully degraded within 4 months, as reported in an animal study.21 Koppara et al. reported facilitated endothelial recovery and reduced thrombogenicity following BP-DES implantation.22 Additionally, BP-DES demonstrated a lower inflammatory response to stent implantation and faster neointimal coverage than the permanent polymer DES.23 Mori et al. compared the inflammatory reaction, including inflammatory and fibrin content scores, between Synergy and Promus stents using a porcine model.24 They reported that on the 14th day following stent implantation, these parameters were significantly lower in the Synergy stent.24 We believe that these advantages contributed to the lower TVNLR rates observed in the BP-DES group in the present study.
Despite the advantages of BP-DES in reducing the TVNLR, our study did not show any significant improvements in all-cause death or re-HT. Although PCI is considered a viable short-term or palliative treatment option in patients with focal coronary stenosis, to date, there is insufficient evidence suggesting that PCI provides better survival compared to medical management in patients with CAV.23 Further research is required to assess the long-term effects of BP-DES on clinical outcomes.
To the best of our knowledge, this is the first study to examine the effect of different polymer types on PCI using a DES for CAV. Our findings highlight the potential role of BP-DES in reducing the TVNLR, which is clinically relevant. Nevertheless, this study has some limitations. First, this retrospective study was conducted at a single center with a small cohort of patients. Second, most patients in the BP-DES group underwent PCI several years later compared to those in the DP-DES group. Therefore, the number of patients who underwent follow-up coronary angiography was relatively low in the BP-DES group. Third, intravascular imaging was not performed in this study. Finally, we did not evaluate the donor information because some donor data were missing.
In conclusion, PCI with BP-DES was associated with lower rates of TVNLR than PCI with DP-DES. However, no significant differences were observed in the clinical outcomes between the 2 groups. Given the progressive nature of CAV, further long-term investigations are warranted to determine the impact of BP-DES on clinical outcomes and disease progression.
Declaration of Competing Interest
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Masaki Tsuji reports a relationship with the Japanese Circulation Society for studying overseas that includes: funding grants. Masaki Tsuji reports a relationship with the Fukuda Foundation for Medical Technology that includes: funding grants. Andriana Nikolova reports a relationship with Alnylam Pharmaceuticals Inc that includes: funding grants. David Chang reports a relationship with Abbott Laboratories that includes: equity or stocks. David Chang reports a relationship with AbbVie Inc that includes: equity or stocks. David Chang reports a relationship with Amarin Pharmaceuticals Ireland Limited that includes: equity or stocks. David Chang reports a relationship with Repligen Corporation that includes: equity or stocks. Jon Kobashigawa reports a relationship with CareDx Inc that includes: funding grants. Jon Kobashigawa reports a relationship with CSL BEHRING PHARMA that includes: funding grants. Jon Kobashigawa reports a relationship with Sanofi Genzyme Science Center that includes: funding grants. Jon Kobashigawa reports a relationship with TransMedics Inc that includes: board membership. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgments
The authors express their gratitude to California Heart Center research team members who enabled this long-term comprehensive study.
References
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