Percutaneous Coronary Intervention For In-stent Restenosis Research Articles

An analysis of long-term clinical outcome following the use of excimer laser coronary atherectomy in a large UK PCI center.

Excimer laser atherectomy (ELCA) is an established adjunctive technique to facilitate acute success in percutaneous coronary intervention (PCI). Despite this there are a lack of contemporary outcome data, particulary longer-term, forpatients treated with ELCA PCI. To evaluate the contemporary use ofELCA in PCI, the frequency of periprocedural complications and the longer-term outcomes associated with ELCA PCI. This was a retrospective study that included all patients undergoing PCI (with or without ELCA) between April 2005 and May 2021. Relevant features from all cases were downloaded from the patient record and matched to hospital data on mortality on November 22, 2022. Kaplan Meier curves were used to compare mortality between the ELCA PCI and non-ELCA PCI cohorts with a landmark at 1 year. Multivariable Cox regression was performed to assess whether ELCA PCI was independently associated with long-term mortality. There were 21,256 patients in this analysis, of which 448 (2.1%) were treated with ELCA PCI. ELCA PCI was associated with a higher frequency of any periprocedural complication. Median follow-up was 2812 days (IQR, 1577-4245 days) with higher mortality in ELCA PCI (38.2% vs. 29.0%, p < 0.001). However, on multivariable analysis, ELCA PCI was not independently associated with long-term mortality. The TVR frequency in ELCA PCI was 16.7% but TVR was significantly higher for cases of in-stent restenosis (ISR) (29.5%). Despite ELCA PCI being used in higher risk populations with complex coronary artery disease there was no long-term increased mortality associated with the use of this device. ELCA PCI for ISR is highly effective and safe although TVR in this cohort remains high in long-term follow-up.

Abstract 1060: Association Of Inflammation And Cholesterol With Long-term Clinical Outcomes After In-stent Restenosis Revascularization

Background: Among patients with coronary artery disease, residual inflammatory risk assessed by high-sensitivity C-reactive protein (hsCRP) is at least as strong a predictor of future cardiovascular events as is residual risk assessed by low-density lipoprotein cholesterol (LDL-C). Objectives: To evaluate the relationships between relative importance of hsCRP and LDL-C as determinants of clinical outcomes among patients who underwent percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) lesions. Methods: Between January 2017 and December 2018, a total of 2079 patients who underwent PCI for ISR were consecutively enrolled. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite endpoint of all-cause death, spontaneous myocardial infarction (MI), or repeat revascularization. Quartiles of increasing hsCRP and LDL-C were assessed as predictors of clinical outcomes after adjustment for covariates. Patients were then categorized as four predefined residual risk groups according to hsCRP (≥2 mg/L vs. &lt;2mg/L) and LDL-C levels (≥70mg/dL vs. &lt;70mg/dL). Results: During a median follow-up of 36 months, 436 MACEs occurred. Baseline hsCRP was significantly associated with MACE (highest versus lowest quartile; adjusted hazard ratio [aHR], 1.90 [95% CI, 1.39-2.59]; P&lt;0.001). By contrast, the baseline LDL-C quartile was not associated with MACE (highest versus lowest quartile; aHR, 0.93 [95% CI, 0.71- 1.22]; P=0.59). Compared with patients without residual risk (hsCRP &lt;2 mg/L and LDL-C &lt;70 mg/dL), participants with both residual inflammatory and LDL-C risk (hsCRP ≥2 mg/L and LDL-C ≥70 mg/dL) (aHR, 1.39 [95% CI, 1.06-1.83]; P=0.02) and those with residual inflammatory risk only (hsCRP ≥2 mg/L and LDL-C &lt;70 mg/dL) (aHR, 1.34 [95% CI, 1.01-1.72]; P=0.04) had significantly higher risks of MACE. Conclusions: In the current cohort of patients after ISR PCI, inflammation assessed by hsCRP predicted higher risk of adverse clinical outcomes, whereas the level of LDL-C was not associated with prognosis.

Impact of diabetes mellitus on clinical outcomes after first episode in-stent restenosis PCI: Results from a large registry

BackgroundDiabetes mellitus (DM) is associated with a high rate of major adverse cardiac events (MACE) after de novo coronary artery percutaneous coronary intervention (PCI). Whether patients with DM undergoing PCI for in-stent restenosis (ISR) experience a similar heightened risk of MACE is not known. Hence, we sought to compare the clinical outcomes of patients with and without DM undergoing PCI for ISR. MethodsPatients undergoing first episode ISR PCI between January 2015 and December 2021 were included. The primary outcome of interest was MACE (all-cause death, myocardial infarction [MI], and target lesion revascularization [TVR]) at 1-year. ResultsA total of 3156 patients (56.7% with DM) underwent PCI for ISR during the study period. Patients with DM were younger, more likely to be female, and had a higher prevalence of comorbidities.At 1-year follow-up, DM was associated with a higher rate of MACE (22.4% vs. 18.7%, unadjusted HR 2.03, 95%CI(1.27–3.25), p = 0.003). All-cause mortality and MI were significantly more frequent among people with DM at 1-year follow-up. The rate of TVR was similar in both groups (17.9% vs. 16.0%, unadjusted HR 1.14, 95%CI (0.94–1.37), p = 0.180). On adjusted analysis, there was no significant difference in the rate of MACE (AHR 1.07, 95%CI(0.90 ‐ –1.29), p = 0.444), all-cause death (AHR 1.54, 95%CI(0.93–2.54), p = 0.095) or MI (AHR 1.10, 95%CI(0.74–1.63), p = 0.652). ConclusionISR PCI in patients with DM was associated with a higher rate of MACE at 1-year follow-up. However, this increased risk was no longer significant after adjusting for baseline characteristics.

Prognostic impact of in-stent restenosis in normal weight, overweight, and obese patients undergoing percutaneous coronary intervention.

Amongpatients undergoing percutaneous coronary intervention (PCI), in-stent restenosis (ISR) is related with a worse prognosis, while higher body mass index (BMI) values are associated with better outcomes. It is unclear whether the prognostic impact of ISR varies in function of BMI. Patients undergoing PCI at a large center from 2012 to 2019 not presenting with an acute myocardial infarction (MI) were included. Subjects with BMI < 18.5 kg/m2 or treated with bare metal stents were excluded. Patients were stratified according to type of lesion treated (ISR vs. no-ISR) and into fourBMI categories: normal weight (BMI 18.5-25 kg/m2 ), overweight (25.0-29.9 kg/m2 ), class I obesity (30.0-34.9 kg/m2 ), class II-III obesity (≥35.0 kg/m2 ). The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, MI, and target vessel revascularization (TVR) at 1 year. Out of 16,234 patients, 3694 (23%) underwent PCI for ISR. ISR as compared to no-ISR was associated with a consistent increased risk of MACE within the normal weight (18.8% vs. 7.8%, adj.hazard ratio(HR):1.99, 95%confidence interval[CI]:1.51-2.64), overweight (19.1% vs. 6.4%, adj. HR:2.35, 95% CI: 1.91-2.88), class I obesity (18.3% vs. 6.8%, adj. HR: 1.95, 95% CI: 1.47-2.57), and class II-III obesity (16.4% vs. 7.4%, adj. HR: 1.61, 95% CI: 1.09-2.37) groups (interaction p-value: 0.192). The ISR-related risks were mostly driven by an excess of TVR. At 1 year, ISR was associated with an increased risk of MACE irrespective of BMI, mostly due to an excess of TVR after ISR.

Outcomes of Percutaneous Coronary Intervention for In-Stent Restenosis Versus De Novo Lesions: A Meta-Analysis.

Background In-stent restenosis (ISR) is commonly encountered even in the era of contemporary percutaneous coronary intervention (PCI). There is a paucity of data on the comparative outcomes of PCI for ISR lesions versus de novo lesions. Methods and Results An electronic search was conducted for MEDLINE, Cochrane, and Embase through August 2022 for studies comparing the clinical outcomes after PCI for ISR versus de novo lesions. The primary outcome was major adverse cardiac events. Data were pooled using a random-effects model. The final analysis included 12 studies, with a total of 708 391 patients, of whom 71 353 (10.3%) underwent PCI for ISR. The weighted follow-up duration was 29.1 months. Compared with de novo lesions, PCI for ISR was associated with a higher incidence of major adverse cardiac events (odds ratio [OR], 1.31 [95% CI, 1.18-1.46]). There was no difference on a subgroup analysis of chronic total occlusion lesions versus none (Pinteraction=0.69). PCI for ISR was associated with a higher incidence of all-cause mortality (OR, 1.03 [95% CI, 1.02-1.04]), myocardial infarction (OR, 1.20 [95% CI, 1.11-1.29]), target vessel revascularization (OR, 1.42 [95% CI, 1.29-1.55]), and stent thrombosis (OR, 1.44 [95% CI, 1.11-1.87]), but no difference in cardiovascular mortality (OR, 1.04 [95% CI, 0.90-1.20]). Conclusions PCI for ISR is associated with higher incidence of adverse cardiac events compared with PCI for de novo lesions. Future efforts should be directed toward prevention of ISR and exploring novel treatment strategies for ISR lesions.

Association between lipoprotein(a) and long-term outcomes after percutaneous coronary intervention for lesions with in-stent restenosis

ObjectivesThis study aimed to evaluate the association between increased lipoprotein (a) [Lp(a)] and long-term outcomes in patients undergoing percutaneous coronary intervention (PCI) for in-stent restenosis (ISR). BackgroundElevated Lp(a) is demonstrated to be associated with recurrent ischemic events after PCI. However, the impact of Lp(a) in patients with ISR remains undetermined. MethodsBetween January 2017 and December 2018, a total of 2086 patients who underwent PCI for ISR were consecutively enrolled. Patients were categorized as elevated group (> 30 mg/dL, n=834) and non-elevated group (≤ 30 mg/dL, n=1252) according to baseline Lp(a) levels. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite endpoint of all-cause death, spontaneous myocardial infarction (MI), or repeat revascularization. ResultsDuring a median follow-up of 36 months, the primary outcome occurred in 202 of 1252 patients (26.7%) in the elevated Lp(a) group and 237 of 834 patients (21.8%) in the non-elevated Lp(a) group (adjusted hazard ratio: 1.31; 95% confidence interval: 1.08-1.58; P = 0.007), driven by higher rate of all-cause death (4.1% vs. 2.5%, P = 0.002 by Log-rank test; aHR: 1.77; 95% CI: 1.07-2.94; P = 0.03) and repeat revascularization (22.3% vs. 19.5%, P = 0.04 by Log-rank test; aHR: 1.18; 95% CI: 0.94-1.49; P = 0.16). Adding continuous or categorical Lp(a) to the Cox model led to a significant improvement in C-statistic, net reclassification, and integrated discrimination. The results were consistent across subgroups. ConclusionsIn the current cohort of patients who underwent PCI for ISR, elevated Lp(a) at baseline is associated with higher risk of long-term MACE.

Impact of body mass index on outcomes in patients undergoing percutaneous coronary intervention for in-stent restenosis

Abstract Background Recent advances in drug eluting stents (DES) design have significantly decreased the rates of in-stent restenosis (ISR). Nonetheless, ISR remains a major problem, affecting 5–10% of patients undergoing percutaneous coronary intervention (PCI). Furthermore, PCI for ISR is often a poor prognostic factor for outcomes after the procedure. Historically, obese patients tended to have better outcomes when undergoing PCI, however it is unclear if this trend continues for the same population undergoing PCI for ISR. Purpose Investigate the outcomes of patients undergoing PCI for ISR in the overweight and normal weight population. Methods All patients undergoing PCI with DES implantation at a tertiary care center from January 2012 to December 2019 were included. Normal weight was defined as a body mass index (BMI) greater than or equal to 18.5 kg/m2 and less than 25 kg/m2, while overweight was defined as a BMI greater than or equal to 25 kg/m2. Patients with BMI &amp;lt;18.5 kg/m2, underwent PCI for acute myocardial infarction (MI), or received a bare metal stent (BMS) were excluded. The primary outcome was major events (MACE), a composite of all-cause mortality, myocardial infarction (MI), and target vessel revascularization (TVR) up to one year after PCI. Secondary outcomes included individual components of the primary endpoint. Results Out of 16,234 patients with available data on BMI, 12,444 (76.7%) were overweight and 3,790 (23.3%) were normal weight. Among overweight patients, 2,879 (23.1%) underwent PCI for ISR versus 815 (21.5%) of normal weight patients. Regardless of BMI status, patients undergoing PCI for ISR had higher rates of co-morbidities such as hypertension, hyperlipidemia, and diabetes mellitus than non-ISR counterparts. At one year post PCI, both overweight and normal weight patients undergoing PCI for ISR had increased risk of MACE (overweight: 18.4% vs. 6.7%; HR 2.83; 95% CI 2.50–3.20; normal weight: 18.8% vs. 7.8%, HR 2.43, 95% CI 1.95–3.04) when compared to non-ISR counterparts, mostly driven by TVR (overweight: 16% vs. 4.6%; HR 3.58; 95% CI 3.11–4.13; normal weight: 15.2% vs. 4.1%; HR 3.69; 95% CI 2.80–4.86). However, only overweight patients undergoing PCI for ISR had higher risk of all cause mortality (2.2% vs. 1.5%; HR 1.42; 95% CI 1.03–1.95) and MI (3.0% vs. 1.3%, HR 2.22; 95% CI 1.64–2.99) when compared to non-ISR counterparts (Figure 1). Conclusions PCI for ISR was associated with increased risk of MACE, irrespective of body weight. The risks of all-cause mortality and MI in ISR vs non-ISR patients only reached statistical significance in overweight patients. Funding Acknowledgement Type of funding sources: None.

Changes in high-sensitivity troponin according to optical characteristics of neointima and treatment modality of in-stent restenosis

Abstract Background Intravascular imaging studies of native vessel percutaneous coronary intervention (PCI) have shown a relationship between presence of lipid-rich plaques or large necrotic cores and occurrence of periprocedural myocardial injury (PMI). However, limited evidence exists on the relationship between neointimal tissue characteristics, and PMI following PCI of in-stent restenosis (ISR) lesions. Beside neointimal tissue characteristics, treatment modality may represent an additional mechanism influencing PMI in the setting of ISR-PCI. Current ESC guidelines recommend either drug-coated balloon (DCB) or drug-eluting stent (DES) as treatment options for ISR. Purpose To investigate the impact of increasing neointimal inhomogeneity and neoatherosclerotic changes of the neointima, as well as of ISR treatment modality on the occurrence of PMI. Methods Patients with normal or stable/falling increased baseline high-sensitivity troponin T (hs-cTnT) undergoing intravascular optical coherence tomography (OCT) and subsequent DCB or DES treatment of ISR lesions were included. PMI was classified as “minor” or “major” according to the definitions of a recent ESC/EAPCI consensus document. Quadrant-based neointimal characterization was performed at the frame displaying the maximal % area stenosis and the 5 preceding and following analyzed frames. Neointimal tissue was categorized as homogeneous or inhomogeneous, the latter including heterogeneous, layered or neoatherosclerosis quadrants. Hs-cTnT was measured at the time of admission, 3–6 h after PCI, at 6 h intervals in case of rising values, and on a daily basis thereafter. Results Overall, 128 patients were subdivided into low (n=64) and high (n=64) neointimal inhomogeneity groups, based on the median of distribution of non-homogeneous quadrants. No significant between-group differences were detected in terms of hs-cTnT changes (28.0 [12.0–65.8] vs. 25.5 [9.8–65.0] ng/L; p=0.355), or major PMI occurrence (31.2% vs. 31.2%; p=1.000). Similarly, no differences were observed between DCB and DES treated groups in terms of hs-cTnT changes (27.0 [10.0–64.0] vs. 28.0 [11.0–73.0] ng/L; p=0.795), or occurrence of major PMI (28.9% vs. 35.6%; p=0.566). Of note, no significant interaction was observed between optical neointimal characteristics and treatment modality in terms of changes in hs-cTnT (p int = 0.432). There were no significant differences in PMI occurrence between low and high neoatherosclerosis subgroups. Conclusion The present study, which combined a detailed, quadrant-based multi-frame neointimal characterization coupled to systematic pre- and post-procedural hs-cTnT measurements in patients undergoing PCI for ISR, showed no association between increasing neointimal inhomogeneity, or increasing expression of neoatherosclerosis, and occurrence of PMI. PMI occurrence was not influenced by the ISR treatment modality (DCB vs. DES), a finding that supports the safety of DCB treatment for ISR. Funding Acknowledgement Type of funding sources: None.

Neointimal vulnerability on optical coherence tomography and slow flow during percutaneous coronary intervention of healed neointima

Abstract Backgrounds Healed plaques in native coronary artery indicate the repair phenomenon of ruptured fibrous caps and erosions [1, 2, 3]. Healed plaques associated with plaque vulnerability [4]. A similar phenomenon is considered to occur in neointima after stent implantation [5]. However, there are few reports in the literature regarding neointimal vulnerability and procedure outcomes of healed tissue in neointima. Objective The aims of this study are to investigate clinical characteristics, slow flow during percutaneous coronary intervention (PCI), and neointimal vulnerability of healed neointima by optical coherence tomography (OCT). Methods We treated 67 lesions by PCI for in-stent restenosis (ISR) and conducted OCT examinations. Healed neointima was defined as neointima having one or more layers with different optical densities and a clear demarcation from underlying components. ISR with healed neointima was found in 49% (33/67) of the lesions. The angiographic slow flow was defined as a decrease of at least 1 grade in TIMI flow during PCI or final TIMI flow grade 0 and 1 or 2, with no evidence of thrombus, spasm, or dissection. Stents with a strut thickness ≥100 μm were classified as thick [6]. Results Compared to ISR without healed neointima, ISR with healed neointima showed significantly longer stent age (102±72 months vs. 31±39 months, p&amp;lt;0.001), lower high-density lipoprotein cholesterol (HDL-C) at ISR (42±12 mg/dl vs. 53±16 mg/dl, p=0.005), higher triglycerides at ISR (178±84 mg/dl vs. 138±67 mg/dl, p=0.039), lower frequency of dual antiplatelet therapy (42% [14/33] vs. 74% [25/34], P=0.017), lower use of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker (ACE-I or ARB) (61% [20/33] vs. 91% [31/34], P=0.028), lower usage of second-generation drug-eluting stents (DESs) (36% [12/33] vs. 63% [22/34], P=0.029), higher usage of thick-strut stents (42% [14/33] vs. 15% [5/34], P=0.012), larger neointimal area (6.8±2.6 mm2 vs. 5.2±1.8 mm2, P=0.005), higher incidence of lipid-laden neointima (70% [23/33] vs. 32% [11/34], P=0.002), thin-cap fibroatheromas (58% [19/33] vs. 21% [7/34], P=0.002), neointimal rupture (45% [15/33] vs. 9% [3/34], P=0.001), thrombus (36% [12/33] vs. 3% [1/34], P=0.001), macrophage accumulation (70% [23/33] vs. 15% [5/34], P&amp;lt;0.001), microvessels (73% [24/33] vs. 32% [11/34], P=0.001), neoatherosclerosis (76% [25/33] vs. 38% [13/34], P=0.002), and lower incidence of stent underexpansion (15% [5/33] vs. 44% [15/34], P=0.010). There were no relations between with healed neointima and slow flow during PCI or procedural myocardial infarction. Conclusions ISR with healed neointima was associated with neointimal vulnerability, stent age, stent type, stent strut thickness, stent expansion, antiplatelet therapy, HDL-C and triglycerides levels, and use of ACE-I or ARB. There were no relations between with healed neointima and slow flow during PCI. Funding Acknowledgement Type of funding sources: None.

Rates of Intracoronary Imaging Optimization in Contemporary Percutaneous Coronary Intervention: A Report From the BMC2 Registry.

Intracoronary imaging (ICI) during percutaneous coronary intervention (PCI) improves outcomes, yet hospital- and physician-level variabilities in ICI and its impact on ICI use in contemporary PCI remain unknown. This study was performed to evaluate hospital- and physician-level use of ICI to optimize PCI. Using data from a large statewide registry, patients undergoing PCI between July 2019 and March 2021 were studied. The primary measure of interest was ICI (intravascular ultrasound or optical coherence tomography) optimization during PCI. A fitted hierarchical Bayesian model identified variables independently associated with ICI optimization. The performing hospital and physician were included as random effects in the model. Among 48 872 PCIs, ICI optimization was performed in 8094 (16.6%). Median [interquartile range] hospital- and physician-level frequencies of ICI were 8.8% [3.1%, 16.0%] and 6.1% [1.1%, 25.0%], respectively. Bayesian modeling identified left main PCI (adjusted odds ratio [aOR], 4.41; 95% credible interval [3.82, 5.10]), proximal left anterior descending artery PCI (aOR, 2.28 [2.00, 2.59]), PCI for in-stent restenosis (aOR, 1.55 [1.40, 1.72]), and surgical consult prior to PCI (aOR, 1.21 [1.07, 1.37]) as independent predictors of ICI optimization. The hospital-level median odds ratio, an estimate of the contribution of inter-hospital variability in odds of ICI use, was 3.48 (2.64, 5.04). Physician-level median odds ratio was 3.81 (3.33, 4.45). Substantial hospital- and physician-level variation in ICI was observed. Except for performance of left main PCI, the hospital and physician performing the PCI were more strongly associated with ICI optimization than any patient or procedural factors.

Clinical Performance of a Paclitaxel Drug-Coated Balloon in Real-World Percutaneous Coronary Intervention Practice: The PEARL Registry.

Randomized controlled trials for in-stent restenosis (ISR) and de novo lesions in small-diameter vessels have shown promising results, but data on DCB use in real-world practice are still scarce. The aim of the PEARL (Paclitaxel-Eluting Angioplasty Balloon in the Real-World) registry was to evaluate the safety and efficacy of a paclitaxel DCB in real-world percutaneous coronary intervention (PCI) practice. Between 2014 and 2019, a total of 513 patients treated with the Protégé paclitaxel DCB (Wellinq) were prospectively included at 4 hospitals in the Netherlands. The primary endpoint was 2-year major adverse cardiac event (MACE), defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization (TLR). DCB was used for ISR in 382 patients and for de novo lesions in 131 patients. Acute coronary syndrome was the reason for presentation in 58.9% of patients. At lesion level, 34.1% of lesions were classified as type B2 and 36.1% as type C. Predilation was performed in 62.2% and noncompliant DCB was used in 40.7% of lesions. DCB-related procedural complications were infrequent (3.3%, mostly coronary dissection [2.3%]). Bailout stenting was required in 3.1%. MACE during 2-year follow-up occurred in 17.1% of patients treated for ISR and 9.7% of patients treated for de novo lesions. The incidence of TLR was 11.7% of ISR patients and 2.9% of de novo patients. History of coronary artery bypass grafting and lesion length were predictors of MACE in patients treated for ISR. The use of Protégé paclitaxel DCB for PCI of ISR and de novo lesions is safe and effective during 2-year follow-up.

Periprocedural myocardial injury according to optical characteristics of neointima and treatment modality of in-stent restenosis

AimsAim of the present study was to investigate the impact of increasing neointimal inhomogeneity and neoatherosclerosis as well as of treatment modality of in-stent restenosis (ISR) on the occurrence of periprocedural myocardial injury (PMI).Methods and resultsPatients with normal or stable/falling increased baseline high-sensitivity troponin T (hs-cTnT) undergoing intravascular optical coherence tomography (OCT) and subsequent percutaneous coronary intervention (PCI) of ISR by means of drug-coated balloon (DCB) or drug-eluting stent (DES) were included. Overall, 128 patients were subdivided into low (n = 64) and high (n = 64) inhomogeneity groups, based on the median of distribution of non-homogeneous quadrants. No significant between-group differences were detected in terms of hs-cTnT changes (28.0 [12.0–65.8] vs. 25.5 [9.8–65.0] ng/L; p = 0.355), or the incidence of major PMI (31.2 vs. 31.2%; p = 1.000). Similarly, no differences were observed between DCB- and DES-treated groups in terms of hs-cTn changes (27.0 [10.0–64.0] vs. 28.0 [11.0–73.0] ng/L; p = 0.795), or the incidence of major PMI (28.9 vs. 35.6%; p = 0.566). Additionally, no significant interaction was present between optical neointimal characteristics and treatment modality in terms of changes in hs-cTnT (Pint = 0.432). No significant differences in PMI occurrence were observed between low and high neoatherosclerosis subgroups.ConclusionsIn patients undergoing PCI for ISR, there was no association between increasing neointimal inhomogeneity, or increasing expression of neoatherosclerotic changes and occurrence of PMI. PMI occurrence was not influenced by the treatment modality (DCB vs. DES) of ISR lesions, a finding that supports the safety of DCB treatment for ISR.Graphical abstract

In-hospital and 1-Year Outcomes of Repeated Percutaneous Coronary Intervention for In-stent Restenosis With Acute Coronary Syndrome Presentation

In-stent restenosis (ISR) is the Achilles' heel of percutaneous coronary intervention (PCI). There have been controversial data about outcomes of repeated PCI (redo-PCI) for ISR. This study aims to determine the predictors of major adverse cardiac events (MACE) in patients underwent redo-PCI for ISR. In this retrospective study, all patients with acute coronary syndrome who were underwent successful PCI for ISR at Tehran Herat Center (between 2004 and 2019) were eligible for inclusion. Patients with moderate to severe valvular heart disease and/or hematological disorders were excluded. Participants were divided into 2 groups based on the occurrence of the MACE [composite of cardiovascular death, myocardial infarction (MI), coronary artery bypass grafting, target vessel revascularization, and target lesion revascularization]; then, the study variables were compared between the 2 groups. Finally, the predictors of MACE were identified using Cox regression analysis. Of 748 redo-PCI patients (mean age: 65.2 ± 10.1; 71.0% males), 631 patients had met the inclusion criteria. Fifty-four patients (9.8%) developed MACE within a 1-year follow-up period. Multivessel disease, primary PCI, Ad-hoc PCI, history of non-ST-segment elevation MI, and diabetes mellitus were independent predictors for MACE. In a subgroup analysis, 30 patients who experienced third PCI (target lesion revascularization/target vessel revascularization) were followed more as 1-year MACE. Among these patients, 14 MACEs were observed during the last follow-up (till June 2020). Multivessel disease, primary PCI, and history of non-ST-segment elevation MI were the predictors of higher 1-year MACE, whereas Ad-hoc PCI and diabetes mellitus had a protective effect on MACE.

Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of In-Stent Restenosis

ObjectivesThis study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR). BackgroundDCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies. MethodsThis is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24 months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization. ResultsA total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6 months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4 ± 13% and the median value was 53% (IQR 46.4–59.5). In the DES-ISR subgroup, these parameters were 52.6 ± 10% and 55.2% (IQR 49.3–58.5), respectively. In-segment LLL was 0.25 ± 0.43 mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6 months, 13.3% at 12 months, and 13.3% at 24 months. ConclusionsIn this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR. SummaryWe sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4 ± 13% and the median value was 53% (IQR 46.4–59.5). In the DES-ISR subgroup, corresponding values were 52.6 ± 10% and 55.2% (IQR 49.3–58.5), respectively. The observed in-segment LLL was 0.25 ± 0.43 mm and binary restenosis rate was 7.7%. TLF was 10% at 6 months and 13.3% at 12 and 24 months.

Impact of hyperuricemia on clinical outcomes after percutaneous coronary intervention for in-stent restenosis

BackgroundThere have been limited data on the impact of hyperuricemia on long-term clinical outcomes after percutaneous coronary intervention (PCI) for in-stent restenosis (ISR).MethodsFrom January 2009 to July 2015, 317 patients who underwent repeat PCI for ISR were divided into two groups: patients with normal serum uric acid (UA) levels (normal UA group) and patients with higher serum UA levels (higher UA group). The higher UA group included patients with serum UA levels > 6.8 mg/dL or patients who were taking anti-hyperuricemic medication.ResultsDuring a median follow-up period of 1088 days, the cumulative incidence rates of major adverse event (MAE), including a composite of all-cause death, non-fatal myocardial infarction, and any revascularization, were similar between the two groups (higher UA 36.4% vs. normal UA 29.9%, p = 0.389, log-rank p = 0.367). Follow-up angiographic data showed similar outcomes of late lumen loss (0.8 ± 0.9 mm vs. 0.8 ± 1.1 mm, p = 0.895) and binary restenosis rate (28.1% vs. 34.7%, p = 0.622). Multivariate Cox regression analysis indicated higher levels of low-density lipoprotein cholesterol (hazard ratio [HR] 1.011, 95% confidence interval [CI] 1.003–1.019, p = 0.006) and lower left ventricular ejection fraction (HR 0.972, 95% CI 0.948–0.996, p = 0.022), but not UA levels, to be the independent risk predictors of MAE.ConclusionHyperuricemia is not associated with poor clinical outcomes after repeat PCI for ISR lesions.

Long-Term Clinical Outcomes after Treatment with Excimer Laser Coronary Atherectomy for In-Stent Restenosis of Drug-Eluting Stent.

Excimer laser coronary atherectomy (ELCA) has been used for the treatment of complex percutaneous coronary intervention (PCI) such as in-stent restenosis (ISR). However, little information was provided about the clinical outcomes after treatment with ELCA for ISR of drug-eluting stents (DES). This study aimed to investigate the long-term clinical outcomes after PCI with ELCA for ISR of DES.A total of 81 consecutive patients with 87 lesions who underwent PCI for ISR of DES were included. Patients were classified into a PCI with ELCA group (23 patients with 24 lesions) and a PCI without ELCA group (58 patients with 63 lesions). The major adverse cardiac events (MACE) were evaluated. The mean duration of clinical follow-up was 29.8 ± 11.6 months. The incidences of diffuse restenosis and AHA/ACC type B2 or C lesion in the PCI with ELCA group were higher than in the PCI without ELCA group. Quantitative coronary angiography showed the acute luminal gain in the PCI with ELCA group was greater than in the PCI without ELCA group (1.64 ± 0.48 mm versus 1.26 ± 0.42 mm, P < 0.001). There were no significant differences in all-cause death, myocardial infarction, or target lesion revascularization between the 2 groups. Multivariate analysis due to a Cox proportional-hazards model showed that multivessel disease was an independent predictor of MACE (hazard ratio 3.05, 95% confidence interval 1.22 to 7.61, P = 0.02). ELCA was effective as an atherectomy device for lumen enlargement and optimal lesion preparation. Even though ELCA was used for ISR of DES in significantly more complex lesions, the long-term clinical outcomes were favorable and similar.

Abstract 12924: Morphological Mechanisms Underlying Efficacy of Paclitaxel-Coated Balloon Against Repeated In-Stent Restenosis

Background: In-stent restenosis (ISR) has been an important issue even after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Recently, paclitaxel-coated balloon (PCB) has emerged as a potential alternative to the conventional treatment of ISR (plain balloon angioplasty [PBA]) with lower incidence of re-ISR. However, detailed mechanisms underlying the clinical efficacy of PCB have been still unknown morphologically. Methods: Consecutive 32 patients whose in-stent restenotic lesions were treated by intravascular ultrasound (IVUS)-guided PBA (n=15) or PCB (n=17). Optical coherence tomography (OCT) and angiographic follow-up was done at 9 months after PCI for ISR, and the detailed IVUS/OCT and angiographic findings were compared to elucidate the differences in qualitative and quantitative characteristics of in-stent intima between the groups. Results: Compared with PBA group, re-ISR rate was significantly lower in PCB group (24% vs. 80%, p=0.005). Although post-PCI minimum lumen angiographic diameter (MLD) and IVUS area (MLA) were comparable between the groups (2.9±0.8mm vs. 2.8±0.8mm, p=0.7; 3.5±1.1mm 2 vs. 4.1±1.0mm 2 , p=0.9, respectively), MLD and MLA at follow-up were kept significantly larger in PCB group (2.7±0.9mm vs. 1.3±1.0mm, p=0.02; 4.3±2.8mm 2 vs. 2.1±0.9mm 2 , p=0.02, respectively), mainly attributable to smaller intimal area at MLA site (1.2±0.6mm 2 vs. 4.1±2.9mm 2 , p=0.03). Interestingly, post-PCB intima was significantly regressed in spite of the progression of post-PBA intima (-1.0±1.4mm 2 vs. 0.5±1.6mm 2 , p=0.01, Figure ). In terms of OCT-derived tissue characteristics of in-stent intima, post-PCB intima was more homogeneous rather than heterogeneous/layered (homogeneous/heterogeneous/layered: 60%/27%/13% vs. 18%/41%/41%, p=0.04). Conclusion: Clinical usefulness of PCB for DES-ISR might be based on not only smaller intimal area but also more stable intimal tissue of the regressed post-PCB intima.

Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: A Multicenter Italian Experience.

Treatment of in-stent restenosis (ISR) is still challenging. In this setting, the use of bioresorbable vascular scaffold (BVS) seems attractive because it allows drug delivery combined with transient vessel scaffolding. We aimed to investigate the long-term results after BVS use in ISR lesions. A prospective analysis was performed on all patients who underwent percutaneous coronary intervention with BVS implantation for ISR at 7 Italian Centers. Primary end point was the device-oriented composite end point (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) at the longest follow-up available. From April 2012 to June 2014, 116 patients (127 lesions) underwent percutaneous coronary intervention for ISR with BVS implantation. Among the ISR lesions, the majority were drug-eluting stent ISR (78, 61.6%), de novo ISR (92, 72.4%), and diffuse ISR (81, 63.8%). Procedural success was achieved for all (100%) patients. No in-hospital death, myocardial infarction, or revascularization occurred. At 15 months of follow-up, the incidence of the device-oriented composite end point estimated with the Kaplan-Meier method was 9.1%. No significant differences were reported between drug-eluting stent and bare-metal stent ISR groups in terms of device-oriented composite end point (10.9% versus 6.4%; hazard ratio, 1.7; 95% confidence interval, 0.5-6.5; P=0.425) and its singular components (cardiac death: 2.8% versus 2.0%, hazard ratio, 1.3; 95% confidence interval, 0.1-14.1, P=0.843; target vessel myocardial infarction: 1.5% versus 0%, P=0.421; ischemia-driven target lesion revascularization: 9.6% versus 4.4%, hazard ratio, 2.3; 95% confidence interval, 0.5-10.8, P=0.309). Our registry suggests that the use of BVS implantation for the treatment of complex drug-eluting stent and bare-metal stent ISR lesions might be associated with acceptable long-term clinical outcomes.

Impact of Neointimal Calcifications on Acute Stent Performance during the Treatment of In-Stent Restenosis

Optical coherence tomography (OCT) has become the invasive imaging modality of choice for coronary stent assessment due to its unmatched spatial resolution. Neointimal calcification (NC) is a rare finding, observed in 5-10% of in-stent restenosis (ISR) neointima. The impact of NC on percutaneous coronary intervention of ISR is unknown. We therefore present the outcome of six unique cases of ISR and NC in which OCT was used to evaluate the impact of NC on the quality of stent-in-stent deployment for the treatment of ISR. This series demonstrates for the first time the impact of NC on stent expansion, a finding which might help guiding percutaneous coronary intervention for ISR with NC.

The clinical characteristics and prognosis of lesions with in-stent eccentric tissue proliferation and strong signal attenuation detected by optical coherence tomography

There are still some patients who require repeat revascularization despite of drug-eluting stent (DES) implantation. The present study aimed to investigate the relationship between optical coherence tomography (OCT) findings and recurring target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for in-stent restenosis (ISR). We reviewed 50 patients (54 coronary lesions) who underwent PCI for ISR, which included 25 DES-ISR lesions. The PCI strategy depended on the interventionalist's discretion, and DES implantation was performed for 38 (70%) lesions. Tissue characteristics were assessed qualitatively and quantitatively using the frame showing maximal lumen narrowing (minimal lumen area). In qualitative analysis, OCT detected coexistence of eccentric tissue proliferation and strong signal attenuation (ESA). ESA was observed in six lesions (11%) in five patients (10%). Hemodialysis (80 vs. 20%, p=0.013) and DES-ISR (100 vs. 40%, p=0.0069) were significantly more frequent in ESA patients/lesions than in others. One-year follow-up revealed that re-TLR was more frequently performed for ESA lesions (83 vs. 8%, p=0.0002). The findings reveal that ESA detected in OCT images of ISR is related to TLR after PCI for DES-ISR especially in patients undergoing maintenance hemodialysis.