Target Vessel Revascularization Research Articles

Drug-coated balloon-based versus drug-eluting stent-only revascularization in patients with diabetes and multivessel coronary artery disease

BackgroundData on drug-coated balloon (DCB) treatment in the context of diabetes mellitus (DM) and multivessel coronary artery disease (CAD) are limited. We aimed to investigate the clinical impact of DCB-based revascularization on percutaneous coronary intervention (PCI) in patients with DM and multivessel CAD.MethodsA total of 254 patients with multivessel disease (104 patients with DM) successfully treated with DCB alone or combined with drug-eluting stent (DES) were retrospectively enrolled (DCB-based group) and compared with 254 propensity-matched patients treated with second-generation DES from the PTRG-DES registry (n = 13,160 patients) (DES-only group). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years.ResultsThe DCB-based group was associated with a reduced risk of MACE in patients with DM (hazard ratio [HR] 0.19, 95% confidence interval [CI] 0.05–0.68, p = 0.003], but not in those without DM (HR 0.52, 95% CI 0.20–1.38, p = 0.167) at the 2-year follow-up. In patients with DM, the risk of cardiac death was lower in the DCB-based group than the DES-only group, but not in those without DM. In both patients with or without DM, the burdens of DES and small DES (less than 2.5 mm) used were lower in the DCB-based group than in the DES-only group.ConclusionsIn multivessel CAD, the clinical benefit of a DCB-based revascularization strategy appears to be more evident in patients with DM than in those without DM after 2 years of follow-up. (Impact of Drug-Coated Balloon Treatment in De Novo Coronary Lesion; NCT04619277)

Analysis of Risk Factors for Major Adverse Cardiovascular Events in Patients with Coronary Stent Restenosis after Revascularization.

To investigate the risk factors for myocardial infarction, recurrent in-stent restenosis (ISR) and target vessel revascularization (TVR) in patients with coronary ISR within 4 years after revascularization. A total of 1884 patients who were hospitalized at Fuwai Hospital for ISR and successfully treated with coronary intervention between January 2017 and December 2018 were included to determine whether there were myocardial infarction, recurrent ISR, TVR and other major adverse cardiovascular events (MACEs) within 4 years after intervention. The patients were divided into the MACE group (215 patients) and the non-MACE group (1669 patients). The clinical data of patients in the two groups were compared, and the risk factors for postoperative MACEs in the ISR patients were obtained by multivariate logistic regression analysis. The receiver operating characteristic (ROC) curve was used to determine the optimal prediction threshold for postoperative MACEs in ISR patients. The difference in survival curves between the two groups was compared using Kaplan‒Meier survival analysis. The albumin (43.42 4.77 vs. 44.17 4.46, p = 0.021), direct bilirubin (2.5 (2, 3.5) vs. 2.8 (2.07, 3.73), p = 0.036) and free triiodothyronine (FT3) (2.85 0.43 vs. 2.92 0.42, p = 0.019) levels in the MACE group were significantly lower than those in the non-MACE group, and there was a significant negative correlation between albumin and FT3 and MACEs. The results of univariate and multivariate logistic regression analyses revealed that FT3 was an independent predictor of postoperative MACEs in ISR patients (Odds Ratio (OR) = 0.626, 95% CI: 0.429-0.913, p = 0.015). The ROC curve analysis determined that an FT3 value of 2.785 pmol/L was the optimal prediction threshold. According to the threshold, ISR patients were divided into the FT3 2.785 group and the FT3 2.785 group. The Kaplan‒Meier analysis revealed that the postoperative recurrence rate of MACEs of the FT3 2.785 group was substantially greater than that of the FT3 2.785 group (Hazard Ratio (HR) = 0.76, 95% CI: 0.58-0.994, p = 0.044). FT3 can be used as an independent predictor of postoperative myocardial infarction, recurrent ISR and TVR in ISR patients. When FT3 is 2.785 pmol/L, the incidence of postoperative myocardial infarction, recurrent ISR and TVR in ISR patients increases significantly.

P110 INTRAVASCULAR LITHOTRIPSY FOR THE TREATMENT OF SEVERELY CALCIFIED LEFT MAIN CORONARY STENOSIS

Abstract Background Even if pilot studies have been conducted to validate Intravascular Lithotripsy, most challenging cases were excluded, including unprotected Left Main (LM) coronary stenosis. Methods We retrospectively enrolled patients treated with IVL in a real–world multicenter registry from 21 centers among Italy and Spain from January 2020 to November 2021. The primary safety endpoint was freedom from major adverse cardiovascular events (cardiac death, target vessel revascularization, stent thrombosis) at 30 days. The primary effectiveness endpoint was procedural success (defined as stent delivery with a residual stenosis <20% and without intra–procedural MACE). Secondary endpoint were 6–months and 12–months MACE rates. Results From a total amount of 470 patients enrolled in our registry, 41 underwent IVL to LM stenosis. Most of them were males (78.0%). The clinical presentation was acute coronary syndrome (ACS) in 41.4% of cases. Mechanical circulatory support was necessary in 4 cases (9.7%). IVL before stent implantation was planned in 90% of cases. The primary safety endpoint occurred in 97.6%. of patients. The primary effectiveness endpoint was achieved in 97.6% of cases. Interestingly, at 6 months and 12 months, no MACE was recorded. Conclusions Intravascular lithotripsy for the treatment of severely calcified Left Main stenosis seems to be a safe and effective option with very high procedural success rate and low MACE rate at follow–up.

P201 DRUG–COATED BALLOON AND DIABETES MELLITUS: A MATTER OF SURVIVAL

Abstract Background Patients with diabetes mellitus (DM) are at higher risk of restenosis and stent thrombosis after percutaneous coronary intervention and drug eluting stent (DES) positioning. Limited although interesting data are available on prognosis after revascularization with drug–coated balloon (DCB) in this group of patients. The aim of this study is to evaluate the prognostic impact of DCB use in patients affected by DM. Methods Patients with DM enrolled in a retrospective multicenter registry were identified and matched to a control population of diabetic patients treated with DES enrolled in another retrospective registry, according to a propensity score calculated on the independent predictors of main adverse cardiac events (MACE). The primary study endpoint was the occurrence of MACE, a composite of death, myocardial infarction, and target vessel revascularization. Secondary endpoints were the independent components of the primary endpoint, or target lesion failure (TLF). Results 150 patients were identified in the DCB group and matched with 150 DES–treated patients. However, patients treated with DCB displayed more often a previous cardiovascular history and received a more complete pharmacological therapy. Target vessel diameter and the percentage of stenosis were lower in DCB patients, whereas binary in–stent restenosis was more common. At a median follow–up of 545.5 days, MACE occurred in 54 (19.4%) of the patients, with no difference according to the PCI strategy. Although a trend toward higher TLF was found (p=0.06), overall death was significantly reduced in diabetic patients (3.6% vs 10.9%; adjusted HR[95%CI]= 0.27[0.08–0.91], p=0.03). Conclusion Although limited by some differences among the groups, the present propensity–matched study shows that, among patients with DM undergoing PCI for in–stent restenosis or de novo lesions, the use of DCB is associated to a similar rate of MACE and a possible increase in TLF, but a significantly improved survival as compared to use of DES.

P107 EARLY TRANSITION FROM CANGRELOR TO ORAL P2Y12I IS NOT ASSOCIATED WITH INCREASE OF ADVERSE EVENTS

Abstract Intro Cangrelor, an intravenous P2Y12 receptor inhibitor (P2Y12i), characterized by rapid onset and offset of antiplatelet action, is approved by guidelines for patients P2Y12i naïve undergoing percutaneous coronary intervention (PCI). Cangrelor infusion duration and time of transition to oral P2Y12i are still debated, although there is a general indication to an infusion of at least 2 hours. The aim of our study is to evaluate the efficacy and the safety of an early transition to oral P2Y12i strategy. Methods Our prospective observational monocentric study enrolled consecutive patients who received Cangrelor during PCI (bolus + infusion iv starting at time of PCI). Clopidogrel and Prasugrel were administered immediately upon discontinuation of Cangrelor infusion, while Ticagrelor was started up to 30 min before Cangrelor was discontinued. Transition was defined as early when Cangrelor infusion duration was less than 2 hours. Endpoints of interest were major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction (MI), stroke and target vessel revascularization (TLR) and stent thrombosis (ST). Safety endpoints were bleeding events divided as major events (BARC 3–5) and minor events (BARC 1–2). Results 133 patients were enrolled: mean age was 69,3±11 years, men were 97 (73%), diabetics 24 (18%). 112 (84%) presented with acute coronary syndrome (tab1). 90% of interventions were done by radial approach, 19% of patients received Clopidogrel as oral P2Y12i. In–hospital MACE were 3, in absence of fatal events; 2 cases of MI (type 4a). The only case of ST was observed with OCT performed during staged PCI of non culprit lesion, with patient totally asymptomatic, without troponin increase and on Clopidogrel as oral P2Y12i. There were 2 BARC 3 events. Patients who received early transition strategy did not presented significant differences of ischemic/bleeding events (tab2). Conclusions Cangrelor demonstrated efficacy and safety in patients undergoing PCI. An early transition strategy to oral P2Y12i was not associated with an increase in both efficacy and safety adverse events in this early phase of our study.

C51 INTRAVASCULAR LITHOTRIPSY FOR THE TREATMENT OF SEVERELY CALCIFIED CORONARY STENOSIS IN ACUTE MYOCARDIAL INFARCTION

Abstract Background Little is known about intraprocedural and mid–term results of intravascular lithotripsy (IVL) use in patients with acute MI. Methods In Our retrospective analysis, data from 21 Centers in Italy and Spain between January 2020 and November 2021 were collected. Patients were allocated to the AMI–group when IVL was performed during an acute MI. Primary safety endpoint was defined as freedom from major adverse cardiac events (MACE: cardiac death, myocardial infarction (MI), target vessel revascularization (TLR) or stent thrombosis (ST)) within 30 days of the index procedure, and primary effectiveness endpoint was procedural success (defined as stent delivery with a residual stenosis <20% and without intraprocedural MACE). The mid–term endpoint was 6–months MACE. Results A total of 468 patients were retrospectively enrolled. The primary safety endpoint was achieved in 98.8% of patients in the AMI–group and in 98.5% in the non–AMI group (p=NS). We showed a lower incidence of the primary effectiveness endpoint in the AMI–group (89.8%) vs Non AMI–group (94.8%) (p=0.048). The secondary endpoint of 6–months MACE was similar between groups (6.7% vs 4.9% respectively for AMI group and Non AMI–group), but death for cardiac causes occurred more frequently in the AMI–group (4.3% vs 0%, p=0.01). Conclusions Intravascular lithotripsy demonstrated to be a safe tool for the treatment of calcified coronary lesions during Acute Myocardial infarction, even if we showed some concern for lower procedural success.

Prognostic value of high-sensitivity C-reactive protein among chronic kidney disease patients undergoing percutaneous coronary intervention

BackgroundData on the prognostic value of high-sensitivity C-reactive protein (hs-CRP) levels in patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) are limited. MethodsPatients undergoing PCI at a tertiary center from January 2012 to December 2019 were included. CKD was defined as a glomerular filtration rate (GFR) <60 mL/min/1.73m2 and elevated hs-CRP was defined as >3 mg/L. Acute myocardial infarction (MI), acute heart failure, neoplastic disease, patients undergoing hemodialysis, or hs-CRP >10 mg/L were exclusion criteria. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, MI, and target vessel revascularization at 1-year after PCI. ResultsOut of 12,410 patients, 3029 (24.4 %) had CKD. Elevated hs-CRP levels were found in 31.8 % of CKD and 25.8 % of no-CKD patients. At 1 year, MACE occurred in 87 (11.0 %) CKD patients with elevated hs-CRP and 163 (9.5 %) with low hs-CRP (adj. HR 1.26, 95 % CI 0.94–1.68); among no-CKD patients, in 200 (10 %) and 470 (8.1 %), respectively (adj. HR 1.21, 95 % CI 1.00–1.45). Hs-CRP was associated with an increased risk of all-cause death in both CKD (Adj. HR 1.92, 95 % CI 1.07–3.44) and no-CKD patients (adj. HR 3.02, 95 % CI 1.74–5.22). There was no interaction between hs-CRP and CKD status. ConclusionsAmong patients undergoing PCI without acute MI, elevated hs-CRP values were not associated with a higher risk of MACE at 1 year, but with increased mortality hazards consistently in patients with or without CKD.

Efficacy of Primary Percutaneous Coronary Intervention (PCI) Performed Through a Transradial Approach in Patients with ST- Segment Elevation Myocardial Infarction (STEMI) at a Tertiary Care Cardiac Center

Objective of Study: The study aimed to evaluate the clinical outcomes, safety, and efficacy of primary percutaneous coronary intervention (PCI) performed through a transradial approach in patients with ST- Segment elevation myocardial infarction (STEMI) at a tertiary care cardiac center. Place of Study: The study was conducted at the National Institute of Cardiovascular Diseases, Karachi, Pakistan Duration of Study: The study was conducted over a period of six months, from April, 2022 to September, 2022. Methods: A total of 250 consecutive patients who underwent primary PCI through a transradial approach were included in the study. Demographic, clinical, procedural, and angiographic data were collected. The primary outcome measure was the incidence of major adverse cardiovascular events (MACE), including death, myocardial infarction, target vessel revascularization, and stroke at 30 days and six months' post-procedure. Secondary outcomes included procedural success, access site complications, and door-to-balloon time. Results: The mean age of participants was 58.7 ± 10.2 years, with 72.8% being male. The procedural success rate was 96.4%. The incidence of MACE at 30 days and six months was 5.6% and 8.8%, respectively. Access site complications were observed in 2.8% of patients, and the mean door-to-balloon time was 81.3 ± 25.6 minutes. Multivariate analysis identified diabetes mellitus and triple-vessel disease as independent predictors of MACE. Conclusion: Primary PCI through a transradial approach at a tertiary care cardiac center in Karachi, Pakistan, demonstrated high procedural success rates, favorable clinical outcomes, and a low incidence of access site complications. This approach may be considered a safe and effective treatment option for patients with acute coronary syndromes. Keywords: primary percutaneous coronary intervention, transradial approach, ST- segment elevation myocardial infarction, major adverse cardiovascular events, tertiary care cardiac center, access site complications, door-to-balloon time

Predictors of bail-out stenting in patients with small vessel disease treated with drug-coated balloon percutaneous coronary intervention.

Drug-coated balloons (DCBs) have showncomparable results with drug-eluting stents in small vessel disease (SVD) percutaneous coronary intervention (PCI) in terms of target vessel revascularization and a reduced incidence of myocardial infarction. However, the relatively high rate of bail-out stenting (BOS) still represents a major drawback of DCB PCI. The aim of the study was to investigate the clinical, anatomic, and procedural features predictive of BOS after DCB PCI in SVD. We included all consecutive patients undergoing PCI at our institution between January 2020 and May 2022 who were treated with DCB PCI of a de novo lesion in a coronary vessel with a reference vessel diameter (RVD) between 2.0and 2.5 mm. Angiographic success was defined as a residual stenosis <30% without flow-limiting dissection. Patients who did not meet these criteria underwent BOS. A total of 168 consecutive patients and 216 coronary stenoses were included. The rate of bail-out stent was 13.9%. On multivariate analysis, DCB/RVD ratio (odds ratio [OR]: 4.39, 95% confidence interval [CI]: 1.71-11.29, p < 0.01), vessel tortuosity (OR: 7.00, 95%CI: 1.66-29.62, p < 0.01), distal vessel disease (OR: 5.66, 95%CI: 2.02-15.83, p < 0.01), and high complexity (Grade C of ACC/AHA classification) coronary stenoses (OR: 6.31, 95%CI: 1.53-26.04, p = 0.01) were independent predictors of BOS. BOS isnot an infrequent occurrence in DCB PCI of small vessels and is correlated with vessel tortuosity, distal diffuse vessel disease, higher lesion complexity, andballoon diameter oversizing.

O061 A dilemma faced by vascular surgeons - biodegradable versus non-biodegradable drug-releasing stents: a systematic review and meta-analysis

Abstract Introduction Vascular stents are the best-known interventional treatment for cardiovascular disease, with variation in available stents increasing significantly over time. Despite the rapidity of new prototype releases, critical cross-comparisons fail to uphold the same rate, therefore causing confusion for vascular surgeons. Research is lacking between biodegradable-polymer sirolimus-eluting stents (BP-SES) and permanent-polymer sirolimus-eluting stents (PP-SES). Subsequently, a systematic review with meta-analysis was conducted evaluating clinical outcomes. Methods Medline, Embase, and Scopus databases were searched using relevant synonyms of biodegradable, sirolimus and stent, with the final search being conducted on the 4th of November 2022. Reference lists were also screened. The clinical outcomes investigated were stent thrombosis, myocardial infarction, target vessel revascularisation, target lesion revascularisation, and death. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Results Five clinical trials directly comparing clinical outcomes between BP-SES and PP-SES were ultimately identified for inclusion. For all five outcomes investigated, no statistically significant difference (p&amp;gt;0.05) was found between the BP-SES and the PP-SES recipients. Pooled odds ratios of 0.86 (95% CI:0.44-1.65), 0.75 (95% CI:0.32-1.74), 1.12 (95% CI:0.54-2.32), 1.14 (95% CI:0.38-3.38) and 0.95 (95% CI:0.51-1.77) were calculated for stent thrombosis, myocardial infarction, target vessel revascularisation, target lesion revascularisation and death respectively. Conclusion Although there is some evidence to suggest BP-SES are noninferior to PP-SES, concrete conclusions cannot yet be drawn due to the paucity of research in this field. Further clarity from randomised control trials will aid additional examination and improvement in stent materials and outcomes.

Predicting 30-Day Mortality Using ST-Segment Elevation Resolution in ST-Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: An Indian Scenario.

The relationship between ST-segment elevation (STE) resolution and 30-day mortality has been evaluated, although limitedly, in non-Indian patients undergoing primary percutaneous coronary intervention (pPCI). We aimed to evaluate the prognostic utility of STE resolution in predicting 30-day mortality in Indian patients undergoing pPCI for ST-elevation myocardial infarction (STEMI). This prospective, single-center, observational study investigated the correlation between 30-day mortality rate and extent of STE resolution in real-world Indian patients undergoing pPCI for STEMI. A total of 64 patients underwent pPCI for STEMI at a tertiary care center in India. The patients were classified into three groups based on the extent of STE resolution: complete resolution (≥70%), partial resolution (30-70%), and no resolution (<30%). The primary endpoint of the study was occurrence of major adverse cardiovascular events consisting of all-cause death, reinfarction, disabling stroke, and ischemia-induced target vessel revascularization at 30 days follow-up. The study enrolled 56 patients. The mean age of patients was 59.7±6.8 years and there were 46 (82.1%) males. Complete STE resolution (≥70%) occurred in 7.1%, partial resolution (<70-30%) in 82.1% and no resolution (<30%) in 10.7%. The mortality rate was 2.1% and 33.3% in patients with partial and no STE resolution. No mortality was seen in patients with complete STE resolution. The 30-day survival analysis revealed significant differences between the three groups (P<0.01). STE resolution served as an independent predictor of 30-day mortality across all clinical variables, including patients with post-PCI thrombolysis in myocardial infarction (TIMI) 3 flow. Persistent STE after PCI is a reliable indicator of 30-day mortality in real-world STEMI patients. The extent of STE resolution can be used as a simple and affordable tool to stratify patients by the risk of mortality soon after the acute event. Due to their higher mortality at 30 days follow-up, individuals with persistent STE should be the focus for further treatment interventions.

High dose tirofiban versus standard therapy in primary PCI for ST-segment elevation myocardial infarction (STEMI)

Background: The goal of this randomized controlled study was to evaluate the safety and efficacy of high-dose tirofiban compared to standard care in patients undergoing primary PCI for ST-segment elevation myocardial infarction (STEMI). Methods: This study was carried out at the Tertiary care hospital Rawalpindi (Pakistan) from June 2021 to December 2022. The administration of high-dose tirofiban or usual treatment was randomly assigned to a total of 600 individuals. The main outcome was the 30-day composite of major adverse cardiovascular events (MACE), that involved stroke, target vessel revascularization, repeat myocardial infarction, and all-cause mortality. Aside from problems related to bleeding, stent thrombosis was one of the secondary outcomes. Results: When compared to the group receiving conventional medication, the rate of the main endpoint was significantly reduced in the tirofiban group (5.7% vs. 10.3%, p=0.03). This was principally caused by a decline in target vessel revascularization and recurring myocardial infarction in the tirofiban category. In terms of stent thrombosis or hemorrhage problems, there wasn't no discernible difference among both groups. Conclusion: In patients receiving primary PCI for STEMI, high-dose tirofiban added to conventional treatment lowers the risk of MACE at 30 days.

Treatment of Ostial Right Coronary Artery Narrowings: Outcomes From the Multicenter Prospective e-ULTIMASTER Registry.

Treatment of right coronary artery (RCA) aorto-ostial (AO) lesions with bare-metal stents and first-generation drug-eluting stents (DES) was associated with worse outcomes. This study aimed to assess the effect of RCA-AO stenting with current-generation DES on the clinical outcome. The large all-comer, multicontinental e-ULTIMASTER registry included 37,198 patients of whom 4775 underwent ostial and proximal RCA percutaneous coronary intervention (PCI) using the Ultimaster stent (Terumo). The primary clinical end point was 1-year target lesion failure (TLF), a composite of cardiac death; target vessel-related myocardial infarction; or clinically indicated target lesion revascularization. We compared 591 (12.4%) patients who underwent RCA-AO PCI with 4184 (87.6%) patients who underwent proximal RCA PCI. The RCA-AO group included more men and recorded significantly more comorbidities and more complex coronary anatomy. After propensity matching, the primary end point TLF occurred in 4.49% of the RCA-AO group compared with 3.00% of the proximal RCA group (P = .06). Target vessel revascularization (3.29% vs 1.90%; P = .03) and stent thrombosis (1.23% vs 0.42%, P = .01) were significantly higher among patients with RCA-AO lesions than those among patients with proximal RCA lesions. All-cause mortality was similar between the groups (2.97% vs 2.26%; P = .30). The treatment of RCA-AO with DES is feasible, with similar rates of TLF but with an increased risk of target vessel revascularization and stent thrombosis.

E-9 | Intravascular Ultrasound Guided Percutaneous Coronary Intervention for Complex Calcified Lesion Requiring Rotational Atherectomy

Intravascular ultrasound (IVUS) is a very useful tool for accurate lesion assessment and optimal stent implantation in complex coronary intervention. We sought to evaluate the impact of IVUS guidance on percutaneous coronary intervention (PCI) using rotational atherectomy (RA) for complex calcified lesion. Five-hundred fourteen patients with calcified coronary artery disease who underwent PCI using RA and second-generation drug-eluting stent between January 2010 and October 2019 at 9 tertiary centers, from the ‘ROtational atherectomy in Calcified lesions in Korea (ROCK)’ registry, were included in this study. Primary endpoint was a composite of cardiac death, myocardial infarction or target vessel revascularization. Secondary endpoints included individual components of primary endpoint. Among the overall study population, IVUS was used in 242 patients (47.1%) during complex PCI using RA. The IVUS-guided PCI group had higher prevalences of accompanying left main disease (23.7% vs. 5.9%; p < 0.001) and left anterior descending artery as a target vessel (77.6% vs 68.1%; p=0.023), and more frequent uses of adjunctive post-dilatation (88.0% vs. 73.8%; p < 0.001), dual antiplatelet therapy (99.6% vs 94.1%; p<0.001) and beta blocker (75.4% vs 66.9%; p=0.04) at discharge, compared with the angiography-guided PCI group. During a median follow-up of 20 [9-39] months, MACE rate was not significantly different between the two groups (19.1% vs. 31.4%; hazard ratio (HR): 0.855; 95% confidence interval (CI): 0.530 to 1.377; p = 0.519). However, IVUS-guided PCI was associated with a significantly lower risk of cardiac death or MI compared with angiography-guided PCI (9.6% vs. 23.5%; HR: 0.478; 95% CI: 0.253 to 0.904; p=0.02). Multivariate analysis showed that IVUS guidance was independently associated with a lower risk of cardiac death or MI (adjusted HR: 0.414, 95% CI: 0.198–0.862; p=0.019). IVUS guidance should be considered when performing PCI with RA for complex calcified lesion.

B-28 | Management of Clinical Stent-In-Stent Restenosis (SISR) in High Risk Coronary Artery Disease Patients With Percutaneous Coronary Intervention (PCI) Followed by Coronary Intravascular Brachytherapy (IVBT)

In-stent-restenosis (ISR) is seen in 10% of patients with DES and is often treated with a repeat DES placement. Recurrent ISR or SISR has a high repeat failure rates, requiring target vessel revascularization (TVR). A combination of the presence of multiple layers of stents, previous restenosis, and other additional comorbidities make this patient population complex and higher risk. Angioplasty followed by IVBT is one possible treatment option in the high-risk patients. This study reviewed the efficacy and safety of PCI followed by IVBT for coronary artery disease in high-risk patients experiencing SISR. A retrospective study was performed which reviewed 78 patients treated between 2016-2021 with SISR involving a total of 91 vessels. All patients underwent PCI with balloon angioplasty followed by IVBT. These patients received localized IVBT radiation using the Novoste Beta-Cath System using a strontium-90 isotope. Radiation dose was delivered based on the vessel diameter, with vessels ≥ 3.5mm in diameter receiving 23 Gy, while vessels of <3.5mm in diameter received 18.4 Gy. Major adverse cardiac events (MACE) were defined as all-cause death, myocardial infarction (MI), and stroke. All patients in the cohort had 2 previously placed DESs in the target lesion. Of total 91 treatments, 67% and 33% treatments were delivered to the LAD or the RCA and circumflex vessel or the marginal arteries, respectively. One patient had intraprocedural cardiac arrest due to suspected intracoronary thrombosis. All patients were symptomatic pre-IVBT and 44% experienced symptomatic reduction after treatment. MACE after IVBT includes MI in 18%, stroke in 5%, and all-cause death occurred in 16% of patients at a median time of 9.3 months post treatment with median follow-up being 22.8 months. Of total, 77% retained patency of the irradiated lesion, while 23% percent experienced restenosis requiring TVR. Coronary restenosis post-deployment of multiple layers of DES remains an ongoing challenge in current times. PCI followed by balloon angioplasty with IVBT is a safe and efficacious treatment option for high-risk coronary artery disease patients with SISR, who have very few treatment options otherwise.

B-19 | Follow-Up Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention: Insights from the PROGRESS-CTO Registry

There is limited information on follow-up major adverse cardiac events (MACE) after chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We examined the clinical and angiographic characteristics, as well as procedural and follow-up outcomes of patients who underwent CTO PCI at 38 US and non-US centers between 2012 and 2022 and had follow-up. Of the 3,488 patients with follow-up, 246 (7.1%) experienced MACE, including 73 deaths, 102 acute myocardial infarctions, and 122 target vessel revascularizations (with PCI or coronary artery bypass graft surgery [CABG]). The mean and median follow-up periods were 268±335 and 98 days, respectively. The incidence of MACE at 1, 2, and 3 years was 12%, 23%, and 27%, respectively. Patients with follow-up MACE were more likely to have comorbidities and had more complex lesions as indicated by higher Japanese CTO (J-CTO) scores (2.52 vs 2.33; p=0.026), and longer procedure (135 vs 110 min; p<0.001) and fluoroscopy (48.9 vs 40.0 min; p=0.006) times, higher contrast volume (250 vs 200 mL; p<0.001) and air kerma radiation dose (2.86 vs 2.20; p<0.001). The antegrade crossing strategy was less commonly the successful crossing strategy in patients with follow-up MACE (40.4%) compared with patients without follow-up MACE (58.3%; p<0.001). Cox regression analysis identified parameters associated with follow-up death, acute coronary syndrome, repeat target vessel PCI and target vessel coronary artery bypass graft surgery. Several parameters are associated with follow-up MACE after CTO PCI.

Five-Year Outcomes After Fractional Flow Reserve-Guided Deferral of Revascularization in Infarct-Related Artery Lesions.

Little evidence is available about the long-term safety of fractional flow reserve (FFR)-guided deferral of revascularization in infarct-related artery (IRA) lesions, especially when measuring FFR in the late setting after myocardial infarction (MI). This study aimed to assess the long-term outcomes after deferral of revascularization in IRA lesions based on FFR assessed in the late phase of post-MI. From the J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), data on 1447 lesions (1263 patients) were divided into 2 groups: the IRA and non-IRA groups. The primary study end point was the cumulative 5-year incidence of target vessel failure (TVF), such as cardiac death, target vessel-related MI, and clinically driven target vessel revascularization. Of the 1447 lesions, 138 (9.5%) were classified into the IRA group. The median duration of FFR measurement was 716 days after MI. The frequency of visual-functional mismatches (ie, FFR >0.80 and percent diameter stenosis ≥50% or FFR ≤0.80 and percent diameter stenosis <50%) was comparable between the IRA and non-IRA groups (31.9% vs 36.3%). The cumulative 5-year incidence of TVF did not differ between the groups (9.2% vs 11.8%; inverse probability-weighted hazard ratio, 1.18, 95% confidence intervals, 0.48-2.91, P = .71). Similar results were observed irrespective of regional wall motion assessed by ultrasonic cardiography and acute MI type. The 5-year TVF rate did not differ between the IRA and non-IRA lesions when deferring revascularization guided by FFR in the late setting of post-MI.

5-Year Outcomes of Drug-Coated Balloons for Peripheral Artery In-Stent Restenosis, Long Lesions, and CTOs

BackgroundLong-term data on drug-coated balloon (DCB) outcomes in complex femoropopliteal atherosclerotic lesions are limited. ObjectivesThe authors sought to report 5-year safety and effectiveness outcomes of a paclitaxel DCB for the treatment of de novo in-stent restenosis (ISR), long lesions (LL), or chronic total occlusions (CTOs) in the prespecified imaging cohorts of the IN.PACT Global Study. MethodsThe IN.PACT Global study was a prospective, international single-arm study. Assessments through 5 years included freedom from clinically driven target lesion revascularization (CD-TLR), a safety composite (freedom from device- and procedure-related death to 30 days, and freedom from major target limb amputation and freedom from clinically driven target vessel revascularization within 60 months), and major adverse events. ResultsThe prespecified imaging cohorts enrolled 132 de novo ISR, 158 LL, and 127 CTO participants. Kaplan-Meier estimates of freedom from CD-TLR through 5 years were 58.0% (ISR), 67.3% (LL), and 69.8% (CTO). The cumulative incidences of the composite safety endpoint were 56.0% (ISR), 65.7% (LL), and 69.8% (CTO). The 5-year freedom from all-cause mortality with vital status update were 81.4% (ISR), 75.2% (LL), and 78.2% (CTO). Within the ISR cohort, 15.9% of participants experienced 2 or more TLRs, compared with 9.5% and 5.5% in the LL and CTO groups, respectively. ConclusionsResults demonstrate long-term safety and effectiveness of this DCB in all 3 cohorts, with low reintervention rates in the LL and CTO cohorts and no safety issues. These results support the inclusion of this DCB into the treatment algorithm for complex femoropopliteal disease.

Comparison of rotational and orbital atherectomy: A systematic review of efficacy and safety in patients who underwent percutaneous coronary intervention

Background: To assess the clinical results of CAD patients who underwent orbital atherectomy (OA) and rotational atherectomy (RA). Methods: PICO criteria for publication in the last 5 years and preferred reporting elements for systematic reviews and meta-analyses (PRISMA) were used to systematically choose publications. Boolean operators were used to search for keywords. The effectiveness of each chosen article was evaluated using the STROBE checklist. Results: Five articles of non-randomized observational analysis were selected, which involved 72.982 patients whom underwent RA, while 6.431 others underwent OA which is a new atherectomy method that was approved for use in coronary arteries in 2003. Although some studies still showed varying results due to different data collection tools, overall data showed there was no difference between the two techniques in terms of contrast volume, outcomes of coronary artery dissection, periprocedural myocardial infarction (MI), arterial perforation caused by device, cardiac tamponade, in-hospital mortality, slow flow/no reflow, 30-day of mortality, target vessel revascularization (TVR), MI and major adverse cardiovascular events (MACE). The burr size and rotational speed for RA may lead to complication rates. Conclusion: Except for a shorter fluoroscopy time with OA, there are no discernible differences between OA and RA in patients with calcified CAD undergoing PCI.

Prognostic Value of Angiography-Derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease Undergoing Rotational Atherectomy.

Rotational atherectomy (RA) is the major tool used to treat severely calcified lesions in patients with coronary artery disease (CAD). The relationship between coronary microvascular dysfunction and RA remains unknown. Therefore, we attempted to explore the predictive implications of the coronary angiography-derived index of microcirculatory resistance (angio-IMR) in CAD patients undergoing RA. This retrospective study included 118 patients with severe coronary calcification who underwent a successful RA from January 2018 to June 2021. The angio-IMR was calculated based on computed flow and pressure dynamic principles to assess coronary microcirculatory function. Follow-up was performed on all patients for major adverse cardiovascular events (MACEs), including all-cause death, non-fatal myocardial infarction, target vessel revascularization (TVR), and stroke. The mean angio-IMR for all patients was 25.58 7.93. Patients were stratified the groups based on a mean angio-IMR of 25, fifty-four (45.8%) patients had angio-IMR 25. The logistic regression analysis showed that angiography-derived fractional flow reserve was significantly associated with coronary microvascular dysfunction. After median follow-up of 21.7 (15.1-24.0) months, MACEs occurred in 30.6%, including 12.5% all-cause deaths, 6.4% non-fatal myocardial infarction, 14.5% TVR, and 0.9% stroke. Kaplan-Meier analysis demonstrated that patients with angio-IMR 25 had greater cumulative MACEs (41.6%) and TVR (20.7%) than patients with preserved angio-IMR. COX regression analysis indicated that angio-IMR 25 and reduced left ventricular ejection fraction were independent predictors of MACEs. In addition, angio-IMR 25 and lowered minimum luminal area independently predicted TVR occurrence. In CAD patients undergoing RA, angio-IMR 25 was an independent and significant predictor of MACEs and TVR. NCT05435898.