Applications of three-dimensional printing in percutaneous closure of aortic-to-right ventricle fistula after transcatheter aortic valve replacement: a case report.

Background: Percutaneous closure of aortic-to-right ventricle (ARV) fistula has emerged as an alternative to surgical management in selected cases. The use of three-dimensional (3D) printing in interventional planning for structural heart disease provides a concrete understanding, and it is useful in diagnostic assessment and to guide treatment approaches and to simulate procedures. Case summary: We report a case of a 70-year-old male presenting in cardiogenic shock due to severe aortic stenosis and reduced left ventricular ejection fraction. The patient had several comorbidities and was deemed not eligible for cardiac surgery. After transcatheter aortic valve replacement (TAVR), an ARV fistula was discovered on the TTE. Due to complex anatomical considerations, a 3D printed model of the patient's anatomy was employed to supplement the decision-making process and technical planning of percutaneous ARV closure. Successful closure of the fistula with the use of the Amplatzer atrial septal occluder was subsequently performed. Discussion: Three-dimensional printing improves the understanding of complex structures of cardiac diseases, allowing for enhanced planning and simulation of the procedure. This case, demonstrating the effective percutaneous closure of a TAVR-related ARV fistula facilitated by the use of 3D printed anatomical models in the pre-procedural phase, highlights the technology's potential in advancing patient-specific treatment approaches.

Changes in Right Ventricular-to-Pulmonary Artery Coupling After Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation.

BACKGROUND: Preprocedural right ventricular-to-pulmonary artery (RV-PA) coupling is a major predictor of outcome in patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge-to-edge mitral valve repair (M-TEER). However, clinical significance of changes in RV-PA coupling after M-TEER is unknown. OBJECTIVES: The aim of this study was to evaluate changes in RV-PA coupling after M-TEER, their prognostic value, and predictors of improvement. METHODS: This was a retrospective observational study, including patients undergoing successful M-TEER (residual mitral regurgitation ≤2+ at discharge) for SMR at 13 European centers and with complete echocardiographic data at baseline and short-term follow-up (30-180 days). RV-PA coupling was assessed with the use of echocardiography as the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP). All-cause death was assessed at the longest available follow-up starting from the time of the echocardiographic reassessment. RESULTS: Among 501 patients included, 331 (66%) improved their TAPSE/PASP after M-TEER (responders) at short-term follow-up (median: 89 days; IQR: 43-159 days), whereas 170 (34%) did not (nonresponders). Lack of previous cardiac surgery, low postprocedural mitral mean gradient, low baseline TAPSE, high baseline PASP, and baseline tricuspid regurgitation were independently associated with TAPSE/PASP improvement after M-TEER. Compared with nonresponders, responders had lower New York Heart Association functional class and less heart failure hospitalizations at short-term follow-up. Improvement in TAPSE/PASP was independently associated with reduced risk of mortality at long-term follow-up (584 days; IQR: 191-1,243 days) (HR: 0.65 [95% CI: 0.42-0.92]; P = 0.017). CONCLUSIONS: In patients with SMR, improvement in TAPSE/PASP after successful M-TEER is predicted by baseline clinical and echocardiographic variables and postprocedural mitral gradient, and is associated with a better outcome.

Temporal trend and potential impact of angiotensin receptor neprilysin inhibitors on transcatheter edge-to-edge mitral valve repair.

INTRODUCTION AND OBJECTIVES: Transcatheter edge-to-edge repair (TEER) should be considered in patients with heart failure and secondary mitral regurgitation (MR). Angiotensin receptor-neprilysin inhibitors (ARNIs) have been demonstrated to improve prognosis in heart failure. We aimed to evaluate the impact ARNIs on patient selection and outcomes. METHODS: The population of the Spanish TEER prospective registry (March 2012 to January 2021) was divided into 2 groups: a) TEER before the ARNI era (n=450) and b) TEER after the recommendation of ARNIs by European Guidelines (n=639), with further analysis according to intake (n=52) or not (n=587) of ARNIs. RESULTS: A total of 1089 consecutive patients underwent TEER for secondary MR. In the ARNI era, there was a reduction in left ventricle dilation (82mL vs 100mL, P=.025), and better function (35% vs 38%, P=.011). At 2 years of follow-up, mortality (10.6% vs 17.3%, P <.001) and heart failure readmissions (16.6% vs 27.8%, P <.001) were lower in the ARNI era, but not recurrent MR. In the ARNI era, 1- and 2-year mortality were similar irrespective of ARNI intake but patients on ARNIs had a lower risk of readmission+mortality at 2 years (OR, 0.369; 95%CI, 0.137-0.992; P=.048), better NYHA class, and lower recurrence of MR III-IV (1.9% vs 14.3%, P=.011). CONCLUSIONS: Better patient selection for TEER has been achieved in the last few years with a parallel improvement in outcomes. The use of ARNIs was associated with a significant reduction in overall events, better NYHA class, and lower MR recurrence.

A Score to Assess Mortality After Percutaneous Mitral Valve Repair.

BACKGROUND: Risk stratification for transcatheter edge-to-edge mitral valve repair (TEER) is paramount in the decision-making process for treating severe mitral regurgitation (MR). OBJECTIVES: This study sought to create and validate a user-friendly score (MitraScore) to predict the risk of mortality in patients undergoing TEER. METHODS: The derivation cohort was based on a multicentric international registry that included 1,119 patients referred for TEER between 2012 and 2020. Score discrimination was assessed using Harrell's c-statistic, and the calibration was evaluated with the Gronnesby and Borgan goodness-of-fit test. An external validation was carried out in 725 patients from the GIOTTO registry. RESULTS: After multivariate analysis, we identified 8 independent predictors of mortality during the follow-up (2.1 ± 1.8 years): age ≥75 years, anemia, glomerular filtrate rate <60 mL/min/1.73 m2, left ventricular ejection fraction <40%, peripheral artery disease, chronic obstructive pulmonary disease, high diuretic dose, and no therapy with renin-angiotensin system inhibitors. The MitraScore was derived by assigning 1 point to each independent predictor. The c-statistic was 0.70. Per each point of the MitraScore, the relative risk of mortality increased by 55% (HR: 1.55; 95% CI: 1.44-1.67; P < 0.001). The discrimination and calibration for mortality prediction was better than those of EuroSCORE II (c-statistic 0.61) or Society of Thoracic Surgeons score (c-statistic 0.57). The MitraScore maintained adequate performance in the validation cohort (c-statistic 0.66). The score was also predictive for heart failure rehospitalization and was correlated with the probability of clinical improvement. CONCLUSIONS: The MitraScore is a simple prediction algorithm for the prediction of follow-up mortality in patients treated with TEER.

Procedural and clinical outcomes after repeat edge-to-edge transcatheter mitral valve repair.

BACKGROUND AND OBJECTIVES: Evidence regarding redo percutaneous interventions for recurrent mitral regurgitation is scarce. We ought to evaluate procedural and clinical outcomes of repeated edge-to-edge transcatheter mitral valve repair (TMVR) interventions. METHODS: This multicenter study collected individual data from eight high-volume TMVR Centers in Spain. Between 2012 and 2020, all patients undergoing a second edge-to-edge TMVR intervention (Redo) were included in the study. RESULTS: Among a total of 1028 procedures, 31 patients (3%) with residual MR ≥ 3 at follow-up underwent a second procedure (Redo). Redo intervention was mainly conducted between the first and second year after the first procedure. The most common cause of MR progression was partial detachment (46.7%) followed by LV remodeling (35.5%). Procedural success was achieved in 87% of cases. After a mean follow-up of 1.75 ± 1.54 years, all-cause and cardiovascular mortality were 48.1% and 25%, respectively. Nearly half of the patients (48.1%) required at least one hospital admission for CHF within the follow-up period. However, most of the patients presented symptomatic improvement as depicted by an NYHA class ≤2. Elective mitral surgery was conducted in only one patient at follow-up due to insufficient MR reduction. CONCLUSIONS: According to our findings, redo edge-to-edge TMVR interventions were feasible and safe with a high procedural success rate. Clinical and echocardiographic follow-up showed however modest long-term results in this specific setting.

Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT).

AIMS: There is a lack of evidence regarding the benefits of ß-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). METHODS AND RESULTS: The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of ß-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to ß-blocker therapy (agent and dose according to treating physician) or no ß-blocker therapy. The primary endpoint is a composite of all-cause death, non-fatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analysed according to the intention-to-treat principle. CONCLUSION: The REBOOT trial will provide robust evidence to guide the prescription of ß-blockers to patients discharged after MI without reduced LVEF.

Conservative, surgical, and percutaneous treatment for mitral regurgitation shortly after acute myocardial infarction.

AIMS: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. METHODS AND RESULTS: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01). CONCLUSIONS: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

Safety and Feasibility of MitraClip Implantation in Patients with Acute Mitral Regurgitation after Recent Myocardial Infarction and Severe Left Ventricle Dysfunction.

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)-35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF < 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded.

Percutaneous Mitral Valve Repair: Outcome Improvement with Operator Experience and a Second-Generation Device.

BACKGROUND AND AIM: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. METHODS: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. RESULTS: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively; p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group; p = 0.032). CONCLUSIONS: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.

Diagnostic accuracy of regadenoson stress echocardiography: concordance with gated-spect myocardial perfusion imaging.

Regadenoson Stress Echocardiography (RSE) can detect myocardial ischemia, and its diagnostic accuracy should be evaluated. We sought to investigate the agreement between RSE and gated-SPECT myocardial perfusion imaging (MPI) and appraise its diagnostic accuracy. Consecutive patients (n = 202) referred for non-invasive evaluation of myocardial ischemia, with (38.6%) or without a previous coronary artery disease (CAD) diagnosis, were enrolled. Both tests were performed simultaneously. Invasive coronary angiography (CA) is considered the gold standard. The mean age was 70.9 (9.8) years, and 59.9% were male. The prevalence of cardiovascular risk factors (arterial hypertension [81.7%], diabetes mellitus [37.6%], hypercholesterolemia [71.8%], and smoking [18.8%]) was high. Forty-four patients (21.8%) had a non-interpretable electrocardiogram, 15 (34.1%) of them were a result of ventricular paced-rhythm, while 29 (65.9%) were a result of advanced left ventricular branch block. The overall agreement between both diagnostic techniques was good: Gwet's AC1 0.66 (CI95% 0.55 to 0.76), and it was higher in patients without a previous CAD diagnosis: 0.76 (CI95% 0.65 to 0.87). In the biased sample (those who underwent CA), RSE and nuclear study sensitivity was 0.50 and 0.78 and specificity was 0.75 and 0.75, respectively. We noted a dramatic reduction in sensitivity for RSE after debiasing (debiased sensitivity of 0.16), and the negative predictive value was similar to the biased and debiased samples. RSE is in strong agreement with gated-SPECT MPI. However, its low sensitivity and negative predictive value preclude its use as a bedside test to detect myocardial ischemia.

Clinical Outcomes Following Urgent vs. Elective Percutaneous Mitral Valve Repair.

AIM: To examine procedural and clinical outcomes among patients undergoing percutaneous mitral valve repair (PMVR) within an admission for acute-decompensated heart failure (ADHF). METHODS AND RESULTS: Prospective registry of all consecutive patients with symptomatic mitral regurgitation (MR) grade 3+ or 4+ who underwent PMVR our centre and classified in 2 groups: elective group and urgent PMVR group (within the index admission for ADHF). Echocardiographic, procedural and clinical outcomes were compared between groups. 85 patients (median age 77.0 [67.8-83.4] years, 64.7% male) were treated within the recruitment period. Among them, 17 (20%) underwent urgent MitraClip®. Urgent PMVR were at a higher risk for conventional surgery (p = 0.002) and had worse estimated prognosis according to HF risk scores (p < 0.001). Overall technical success was 100%, without differences between groups. At 30 days, no differences were found in mortality, MR reduction and in NYHA functional improvement between groups. Cumulative estimated survival free from all-cause death was 92.9% (82.4% vs. 95.6%), 89.4% (82.4% vs. 91.1%), 76.3% (82.4 vs. 74.9%) at 6 months, 1-year and 2-years, respectively, with no significant differences between urgent or elective PMVR (p = 0.769). CONCLUSION: MitraClip® implantation can be considered as an urgent therapy during admission for ADHF.

Acute Kidney Injury After Percutaneous Edge-to-Edge Mitral Repair.

BACKGROUND: In catheter-based procedures, acute kidney injury (AKI) is a frequent, serious complication ranging from 10% to 30%. In MitraClip (Abbott Vascular, Santa Clara, California), a usually contrast-free procedure, there is scarce data about its real incidence and impact. OBJECTIVES: This study aimed to evaluate incidence, predictive factors, and midterm outcomes of AKI in patients with significant mitral regurgitation (MR) undergoing transcatheter valve repair with MitraClip. METHODS: A total of 721 patients undergoing MitraClip were included. AKI was defined as an absolute or a relative increase in serum creatinine of >0.3 mg/dl or ≥50%, respectively, or the need for hemodialysis during index hospitalization. RESULTS: The mean age of the patients was 72 ± 11 years (28.3% women). Median estimated glomerular filtration rate (eGFR) was 43.7 ml/min/1.73 m2 (interquartile range: 30.9 to 60.1 ml/min/1.73 m2), and was <60 ml/min/1.73 m2 in 74.9% of the patients. AKI after MitraClip occurred in 106 patients (14.7%). Baseline hemoglobin (<11 g/dl) (odds ratio [OR]: 1.97; p = 0.003), urgent procedure (OR: 3.44; p = 0.003), and absence of device success (OR: 3.37; p < 0.001) were independent predictors of AKI. Patients with AKI had worse outcomes compared to those without AKI, including a higher proportion of in-hospital bleeding events (3.8% vs. 0.8%; p = 0.011), 2-year all-cause mortality (40.5% vs. 18.7%; p <0.001), and major adverse cardiac events (63.6% vs. 23.5%; p <0.001). Combination of AKI with significant residual MR after the procedure conferred even worst outcomes (2-year all-cause mortality 50.0% vs. 19.6%; p = 0.001, and major adverse cardiac events 70.0% vs. 18.9%; p < 0.001). CONCLUSIONS: Despite being a "zero-contrast" procedure, one-sixth of patients undergoing transcatheter mitral valve repair had AKI, linked to device failure or other severe conditions. The occurrence of AKI was associated with worse outcomes, highlighting the importance to detect and reduce this complication in high-risk population.

Percutaneous mitral repair: current and future devices.

Mitral regurgitation (MR) is the second most common valvular heart disease and its prevalence is increasing with population ageing. In the recent years we have witnessed the development of several transcatheter devices to correct MR in patients at high-risk for surgery. The majority of evidence regarding safety and efficacy of this new therapy comes from MitraClip studies. However, new alternatives on the field of valve repair have emerged with promising results. The aim of this review is to portrait the landscape of transcatheter mitral repair alternatives, from currently used devices to those that will have a role in the near future.

Percutaneous Mitral Valve Repair Vs. Stand-Alone Medical Therapy in Patients with Functional Mitral Regurgitation and Heart Failure.

BACKGROUND: Functional mitral regurgitation (FMR) is a common finding among patients with heart failure (HF) and it is related to adverse events. Outcomes in patients undergoing transcatheter mitral valve repair (TMVR) are still a matter of debate. We performed a meta-analysis to assess mid- and long-term outcomes of patients with FMR treated with MitraClip® compared to medical management. METHODS: We conducted an electronic database search of all published data PubMed Central, Embase, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Google Scholar databases. The primary end-point was all-cause mortality. The secondary end-points were hospitalizations for HF, need for heart transplantation or left ventricular assist device, unplanned mitral valve surgery, myocardial infarction and stroke. RESULTS: Five studies (n = 1513 patients) were included in the analysis. The summary estimate including all the available studies showed a statistically significant reduction in all-cause mortality favoring MitraClip® (HR 0.56, CI 95% [0.38-0.84]) and HF hospitalizations (HR 0.65; CI 95% [0.46-0.92]). A significant reduction in the indication for advanced HF therapies (OR 0.48; CI 95% [0.25-0.90]) or the need for unplanned mitral valve surgery (OR 0.20; CI 95% [0.07-0.57]) was also found in the group of patients that underwent TMVR. No differences in the incidence of myocardial infarction or stroke were found between both groups of treatment. No publication bias was detected. CONCLUSION: TMVR with MitraClip® system was related to a significant reduction in all-cause mortality, hospitalizations for HF and the need for HF transplant, left ventricular assist device or unplanned surgery beyond 1-year follow up.

Previously diagnosed cancer and mortality after ST-segment elevation acute myocardial infarction treated with primary angioplasty.

OBJECTIVE: We investigated if a previous cancer diagnosis influences the outcome of patients with STEMI treated with primary coronary intervention (PCI). BACKGROUND: ST-segment myocardial infarction (STEMI) and a history of cancer can coexist because both have a high incidence and prevalence. METHODS: Prospective cohort observational study, The primary end-point was total mortality. RESULTS: We included 917 patients, 53 of them (5.8%) were cancer survivors. During follow-up (median, 643 days [interquartile range, 258 to 1,015 days]), 100 patients died, 88 (10.2%) patients without a cancer diagnosis and 12 (22.6%) patients with a previous cancer diagnosis, which was significantly different (log-rank test = 8.4, p = .004). Cancer patients were older (73.4 (11.5) vs. 65.2 (13.8) years, p < .001), with a lower prevalence of previous stroke (1.1% vs. 2.2%, p = .002). Their hemoglobin concentration was also lower (13.4 (2.1) vs. 14.4 (1.7) g/L, p = .001). A trend towards a lower use of coronary stents in cancer survivors was noted (p = .061). Cancer was associated with a high probability of death (HR = 2.37, 95% confidence interval [CI] 1.30-4.34, p = .005). When confounding variables were included, this association was no longer significant (HR = 1.63, 95% CI 0.84-3.18, p = .150). CONCLUSIONS: Patients with a previous cancer diagnosis who had an acute STEMI treated by primary PCI did not seem to have a worse prognosis. The difference in the crude mortality rate can be explained by the baseline differences between both groups. Previous cancer diagnosis should not be included in the clinical decision process when a patient is having an acute STEMI.

Safety and Efficacy of New Biodegradable Polymer-based Sirolimus-Eluting Stents in a Preclinical Model.

INTRODUCTION AND OBJECTIVES: New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. METHODS: We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. RESULTS: The stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. CONCLUSIONS: In this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.