Clinical outcomes of percutaneous coronary intervention for severely calcified lesions: comparison between the morphologies of severely calcified coronary lesions.

Existing studies evaluating the comparison of clinical outcome of percutaneous coronary intervention (PCI) for severe calcified coronary lesions are limited, and the clinical outcomes of PCI for different morphologies of calcified lesions are controversial. Overall, consecutive 576 lesions with severe calcification that were treated with PCI from 2010 to 2021 at Nagoya Heart Center were investigated. All lesions were assessed using invasive coronary angiogram (CAG) or computed tomography-CAG at 12 months after DES implantation. We divided the patients into three groups based on the results of intravascular ultrasound (IVUS) imaging (concentric calcified lesion [CC] n = 273, eccentric calcified lesion [EC] n = 217, calcified nodule [CN] n = 86). The clinical and angiographic outcomes of each group were investigated retrospectively to compare the prognosis between the three groups and identify predictive factors for the device-oriented composite end points (DoCE). There were no differences in patient characteristics among the three groups, except that there were significantly more patients on dialysis in the CN group. The incidence of DoCE was significantly higher in the CN group than in the other groups (CC; 18.3% vs. EC; 23.5% vs. CN; 36.0%; Log-Rank test; p = 0.001). Cox regression analysis showed that the independent predictors of DoCE were CN, insulin use, hemodialysis, right coronary artery lesions, and calcium cracks. The incidence of DoCE was significantly higher in the CN group. Calcium cracks are crucial for improving outcomes in severely calcified lesions, being key predictors of DoCE.

Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial.

BACKGROUND: Diabetes mellitus is associated with higher risk of target lesion failure (TLF) after percutaneous coronary intervention. We studied the 5-year outcome in patients with diabetes mellitus treated with biodegradable polymer stents. METHODS: The SORT OUT VII was a randomised trial comparing the ultrathin sirolimus-eluting Orsiro stent (O-SES) and the biolimus-eluting Nobori stent (N-BES) in an all-comer setting. Patients (n = 2525) were randomised to receive O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). Endpoints were TLF (a composite of cardiac death, target-lesion myocardial infarction (MI), target lesion revascularization (TLR)), definite stent thrombosis and a patient related outcome (all-cause mortality, MI and revascularization) within 5 years. RESULTS: Patients with diabetes mellitus had higher TLF (20.6% vs 11.0%, (Rate ratio (RR) 1.85 95% confidence interval (CI): (1.42-2.40) and patient related outcome (42.0% vs 31.0%, RR 1.43 95% CI: (1.19-1.71)) compared to patients without diabetes. Among patients with diabetes mellitus, TLF after 5 years did not differ between O-SES and N-BES (21.2% vs 20.0%), RR 1.05 95% CI: (0.70-1.58), p = 0.81). Cardiac death, MI, TLR, and definite stent thrombosis did not differ between the groups. CONCLUSION: In patients with diabetes mellitus, 5-year outcomes were similar among patients treated with biodegradable polymer O-SES or N-BES. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01879358.

A Meta-Analysis of 3-Year Outcomes of Drug-Coated Balloons Versus Drug-Eluting Stents for Small-Vessel Coronary Artery Disease.

Background: Drug-coated balloons (DCBs) may be a viable alternative to drug-eluting stents (DES) for de novo small caliber coronary artery lesions. However, there remains a lack of data regarding the long-term efficacy of this approach. Objectives: The purpose of this study was to compare the rates of major adverse cardiovascular events (MACE) after 3-year follow-up among patients randomized to DCB versus DES for the treatment of small caliber coronary arteries with reference vessel diameter between 2 and 3 mm. Methods: We systematically searched MEDLINE, EMBASE, and CENTRAL databases from their inception to July 2023 for randomized controlled trials comparing DCB versus DES for small caliber coronary artery disease. The primary end point was MACE at 3-year follow-up. Risk of bias was assessed using the Cochrane Risk of Bias Tool (RoB 2). Pooled risk ratios (RRs) and 95% CIs were estimated using random effects meta-analytic models. Results: Four randomized controlled trials (n = 1,402) were included. In total, 706 patients were randomized to DCB and 696 to DES. Participants were mostly male (74%), with a mean/median age ranging from 60 to 68 years. Pooled data across trials for MACE showed wide CIs, with little indication of DES superiority over DCB (RR: 0.71; 95% CI: 0.36-1.41). Most individual components of MACE were inconclusive. There was a potential signal for a reduction of target vessel thrombosis with DCB compared to DES (RR: 0.25; 95% CI: 0.06-1.08). Conclusions: Although sample sizes are small, 3-year outcomes suggest that DCB may be a reasonable alternative to DES for the treatment of small coronary arteries.

Drug-coated balloon versus drug-eluting stent for femoropopliteal total occlusions: intraluminal versus subintimal approaches.

Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach.Clinical Trial Registration: NCT02748226.

Immediate, Short-Term, Intermediate, and Long-Term Clinical Outcomes of True Bifurcation Stenting.

INTRODUCTION: Coronary artery bifurcation lesion is an epicardial stenosis that, when compared to non-bifurcation lesions, poses a greater risk of adverse events and can compromise prognosis. This study aims to investigate the clinical efficacy of different stenting techniques, particularly in terms of their immediate, short-term, intermediate, and long-term outcomes in patients with true bifurcation lesions. METHODOLOGY: This retrospective observational cohort study was conducted in a tertiary cardiac hospital in Islamabad, from February 1, 2015, to February 28, 2021. A total of 172 patients who met the inclusion criteria and underwent percutaneous coronary intervention were selected using a consecutive sampling technique. Follow-up was maintained for three years to assess procedural outcomes. RESULTS: Of the 172 participants, the majority were males (69%) and only 4% were above 75 years of age. A significant relation between major adverse cardiac events (MACEs) with acute coronary syndrome (ACS) and previous percutaneous coronary intervention (PCI) (p < 0.000) was observed. Procedural success was good in all patients using the drug-eluting stent. The MAC rate was 6.9% and the final kissing balloon inflation, stenting technique, and bifurcation involvement were significantly associated with MACE occurrence (p < 0.01), and mortality was reported in two patients (1.16%). MACEs were associated with mortality; previous PCI and hypertension increased the risk of mortality. CONCLUSION: The two-stent strategy can be used with good long-term outcomes and low complication rates.

Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery.

BACKGROUND: Current guidelines recommend the perioperative continuation of aspirin in patients with coronary drug-eluting stents (DES) undergoing noncardiac surgery. However, supporting evidence is limited. OBJECTIVES: This study aimed to compare continuing aspirin monotherapy vs temporarily holding all antiplatelet therapy before noncardiac surgery in patients with previous DES implantation. METHODS: We randomly assigned patients who had received a DES >1 year previously and were undergoing elective noncardiac surgery either to continue aspirin or to discontinue all antiplatelet agents 5 days before noncardiac surgery. Antiplatelet therapy was recommended to be resumed no later than 48 hours after surgery, unless contraindicated. The primary outcome was a composite of death from any cause, myocardial infarction, stent thrombosis, or stroke between 5 days before and 30 days after noncardiac surgery. RESULTS: A total of 1,010 patients underwent randomization. Among 926 patients in the modified intention-to-treat population (462 patients in aspirin monotherapy group and 464 patients in the no-antiplatelet therapy group), the primary composite outcome occurred in 3 patients (0.6%) in the aspirin monotherapy group and 4 patients (0.9%) in the no antiplatelet group (difference, -0.2 percentage points; 95% CI: -1.3 to 0.9; P > 0.99). There was no stent thrombosis in either group. The incidence of major bleeding did not differ significantly between groups (6.5% vs 5.2%; P = 0.39), whereas minor bleeding was significantly more frequent in the aspirin group (14.9% vs 10.1%; P = 0.027). CONCLUSIONS: Among patients undergoing low-to-intermediate risk noncardiac surgery >1 year after stent implantation primarily with a DES, in the setting of lower-than-expected event rates, we failed to identify a significant difference between perioperative aspirin monotherapy and no antiplatelet therapy with respect to ischemic outcomes or major bleeding. (Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery [ASSURE-DES]; NCT02797548).

Long-term effect of biodegradable vs durable polymer everolimus-eluting stents on neoatherosclerosis in ST-segment elevation myocardial infarction: the CONNECT trial.

BACKGROUND AND AIMS: Neoatherosclerosis is a leading cause of late (>1 year) stent failure following drug-eluting stent implantation. The role of biodegradable (BP) versus durable polymer (DP) drug-eluting stents on long-term occurrence of neoatherosclerosis remains unclear. Superiority of biodegradable against durable polymer current generation thin-strut everolimus-eluting stent (EES) was tested by assessing the frequency of neoatherosclerosis 3 years after primary percutaneous coronary intervention (pPCI) among patients with ST-segment elevation myocardial infarction (STEMI). METHODS: The randomized controlled, multicentre (Japan and Switzerland) CONNECT trial (NCT03440801) randomly (1:1) assigned 239 STEMI patients to pPCI with BP-EES or DP-EES. The primary endpoint was the frequency of neoatherosclerosis assessed by optical coherence tomography (OCT) at 3 years. Neoatherosclerosis was defined as fibroatheroma or fibrocalcific plaque or macrophage accumulation within the neointima. RESULTS: Among 239 STEMI patients randomized, 236 received pPCI with stent implantation (119 BP-EES; 117 DP-EES). A total of 178 patients (75%; 88 in the BP-EES group and 90 in the DP-EES group) underwent OCT assessment at 3 years. Neoatherosclerosis did not differ between the BP-EES (11.4%) and DP-EES (13.3%; odds ratio 0.83, 95% confidence interval 0.33-2.04, p=0.69). There were no differences in the frequency of fibroatheroma (BP-EES 9.1% vs DP-EES 11.1%, p=0.66) or macrophage accumulation (BP-EES 4.5% vs DP-EES 3.3%, p=0.68), and no fibrocalcific neoatherosclerosis was observed. Rates of target lesion failure did not differ between groups (BP-EES 5.9% vs DP-EES 6.0%, p=0.97). CONCLUSIONS: Use of BP-EES for primary PCI in patients presenting with STEMI was not superior to DP-EES regarding frequency of neoatherosclerosis at 3 years.

Comparative long-term efficacy and safety of two paclitaxel-coated balloons with different coating strategies for the treatment of drug-eluting coronary stent restenosis.

BACKGROUND: We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined. METHODS: 262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years. RESULTS: At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices. CONCLUSIONS: In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495).

A quantitative study of the effects of a dual layer coating drug-eluting stent on safety and efficacy.

A key strategy for increasing drug mass (DM) while maintaining good safety is to improve the drug release profile (RP). We designed a dual layer coating drug-eluting stent (DES) that exhibited smaller concentration gradients between the coating and the artery wall and significantly impacted the drug RP. However, a detailed understanding of the effects of the DES designed by our team on safety and efficacy is still lacking. The objective of this study was to provide a comprehensive multiscale computational framework that would allow us to probe the safety and efficacy of the DES we designed. This framework consisted of four coupled modules, namely (1) a mechanical stimuli module, simulating mechanical stimuli caused by percutaneous coronary intervention through a finite element analysis, (2) an inflammation module, simulating inflammation of vascular smooth muscle cells (VSMCs) induced by mechanical stimuli through an agent-based model (ABM), (3) a drug transport module, simulating drug transport through a continuum-based approach, and (4) a mitosis module, simulating VSMC mitosis through an ABM. Our results indicated that when the DM increased to two times the initial DM value, the DES we designed had higher safety and lower efficacy values than a conventional DES. When the DM increased to five times the initial DM value, the DES we designed had higher safety than a conventional DES, and negligible differences in efficacy compared with a conventional DES. In summary, the DES we designed exhibited a significant advantage in safety, but a slightly reduced efficacy compared with that of a conventional DES.

Ten-year clinical outcomes of everolimus- and biolimus-eluting coronary stents vs. everolimus-eluting bioresorbable vascular scaffolds-insights from the EVERBIO-2 trial.

Background: Bioresorbable vascular scaffolds (BVSs) have been developed as a potential solution to mitigate late complications associated with drug-eluting metallic stents (DESs) in percutaneous coronary intervention for coronary artery disease. While numerous studies have compared BVSs to DESs, none have assessed clinical outcomes beyond 5 years. Objectives: This study aimed to compare the 10-year clinical outcomes of patients treated with BVSs vs. DESs. Methods: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) is a single-center, assessor-blinded, randomized controlled trial that enrolled 240 patients allocated in a 1:1:1 ratio to receive BVSs, everolimus-eluting stents, or biolimus-eluting stents (BESs). Clinical follow-up was scheduled for 10 years. Results: Clinical follow-up was completed in 222 patients (93%) at the 10-year mark. The rate of device-oriented composite events (DOCE) was 28% in the DES group and 29% in the BVS group (p = 0.72) at 10 years. Similarly, the rate of patient-oriented composite events (POCE) was 55% in the DES group and 49% in the BVS group (p = 0.43) at 10 years. Notably, the rate of myocardial infarction (MI) within the target vessel was 5% in the BVS group and 0% in the BES group (p = 0.04), while the rate of any MI was 10% in the BVS group and 2% in the BES group (p = 0.04). In addition, the rate of Academic Research Consortium (ARC) possible stent thrombosis was 3% in the BVS group and 0% in the DES group (p = 0.04). Conclusions: Over 10 years, the rates of clinical DOCE and POCE were similar between the BVS and DES groups but individual outcomes of stent thrombosis were higher (3%) in the BVS group compared to the DES group. Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT01711931).

Long-Term Results of Bioresorbable Vascular Scaffolds in Patients With In-Stent Restenosis: The RIBS VI Study.

BACKGROUND: In patients with in-stent restenosis (ISR) bioresorbable vascular scaffolds (BVS) provide similar results to drug-coated balloons (DCBs) but are inferior to drug-eluting stents (DES) at 1 year. However, the long-term efficacy of BVS in these patients remains unknown. OBJECTIVES: This study sought to assess the long-term safety and efficacy of BVS in patients with ISR. METHODS: RIBS VI (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment; NCT02672878) and RIBS VI Scoring (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon; NTC03069066) are prospective multicenter studies designed to evaluate the results of BVS in patients with ISR (N = 220). The inclusion and exclusion criteria were identical to those used in the RIBS IV (ISR of DES) (Restenosis Intra-stent of Drug-eluting Stents: Drug-eluting Balloon vs Everolimus-eluting Stent; NCT01239940) and RIBS V (ISR of bare-metal stents) (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent; NCT01239953) randomized trials (including 249 ISR patients treated with DCBs and 249 ISR patients treated with DES). A prespecified comparison of the long-term results obtained with these treatment modalities (ie, DES, DCBs, and BVS) was performed. RESULTS: Clinical follow-up at 3 years was obtained in all (100%) 718 patients. The 3-year target lesion revascularization rate after BVS was 14.1% (vs 12.9% after DCBs [not significant], and 5.2% after DES [HR: 2.80; 95% CI: 1.47-5.36; P = 0.001]). In a landmark analysis (>1 year), the target lesion revascularization rate after BVS was higher than after DES (adjusted HR: 3.41; 95% CI: 1.15-10.08) and DCBs (adjusted HR: 3.33; 95% CI: 1.14-9.70). Very late vessel thrombosis was also more frequent with BVS (BVS: 1.8%, DCBs: 0.4%, DES: 0%; P = 0.03). CONCLUSIONS: In patients with ISR, late clinical results of DES are superior to those obtained with DCBs and BVS. Beyond the first year, DCBs are safer and more effective than BVS.

Long-Term Outcomes of Percutaneous Coronary Intervention in Patients with Prior Coronary Artery Bypass Graft - A Retrospective Experience.

OBJECTIVE: To evaluate the long-term clinical outcomes of percutaneous coronary intervention (PCI) in patients who had previously undergone coronary artery bypass grafting (CABG). METHOD: A total of 219 patients who had a history of CABG and underwent PCI at tertiary care centre were retrospectively enrolled in this study. Clinical endpoints such as major adverse cardiac events (MACE; cardiac death, non-fatal myocardial infarction [MI], and target vessel revascularization), any death, cardiac death, MI, target vessel revascularization (TVR), and target lesion revascularisation (TLR) were reported at long-term follow-up. RESULTS: About 66.6% patients were treated on the native vessel, and 24.2% on grafts vessel. In all, 360 stents [83.3% drug-eluting stent (DES) and 16.6% bare metal stent (BMS)] were implanted. Diabetes mellitus (p=0.03), LVEF<55% for PCI (p=0.04), stent type [BMS (p<0.001) and DES (p<0.001)] and chronic kidney disease [(CKD) p<0.01] were appeared to be the significant predictors of mortality. Age at CABG>50 years (p=0.04), stent type [BMS (p=0.03) and DES (p<0.01)] and CKD (p<0.01) as independent predictors for MACE. Higher event rate was reported in graft-vessel PCI group as compared to native-vessel PCI group: ISR (p<0.01), TLR (p=0.01), mortality (p=0.04), MACE (p<0.01) and MI (p=0.05). Mortality (p<0.001), MACE (p<0.001) and MI (p<0.001) were significantly lower in DES vs. BMS groups. CONCLUSION: Native-vessel PCI was associated with better clinical outcomes than graft-vessel PCI that also with the use of DES as the first choice in patients with a history of CABG.

Drug-coated balloon angioplasty versus drug-eluting stent implantation in ACS patients with different angiographic patterns of in-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) angioplasty and drug-eluting stents (DES) are two widely used treatments for in-stent restenosis (ISR). Focal and non-focal types of ISR affect the clinical outcomes. The present study aims to compare DES reimplantation versus DCB angioplasty in acute coronary syndrome (ACS) patients with focal ISR and non-focal ISR lesions. METHODS: Patients with ISR lesions underwent percutaneous coronary intervention (PCI) were retrospectively evaluated and divided into DES group and DCB group. The primary endpoint was the incidence of target lesion failure (TLF) at 24 months follow up. Propensity score matching (PSM) was conducted to balance the baseline characteristics. RESULTS: For focal ISR, TLF was comparable in the DES and DCB groups at 24 months of follow-up (Before PSM, hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.39-1.27; p = 0.244; After PSM, HR: 0.83; 95% CI: 0.40-1.73; p = 0.625). For non-focal ISR, TLF was significantly decreased in DES compared with DCB group (Before PSM, HR: 0.43; 95% CI: 0.29-0.63; p < 0.001; After PSM, HR: 0.33; 95% CI: 0.19-0.59; p < 0.001), which was mainly attributed to the lower incidence of clinically indicated target lesion revascularization (CD-TLR) (Before PSM, HR: 0.39; 95% CI: 0.26-0.59; p < 0.001; After PSM, HR: 0.28; 95% CI: 0.15-0.54; p < 0.001). CONCLUSIONS: The clinical outcomes for DES and DCB treatment are similar in focal type of ISR lesions. For non-focal ISR, the treatment of DES showed a significant decrease in TLF which was mainly attributed to a lower incidence of CD-TLR.

Sirolimus-coated balloon versus drug-eluting stent for complex coronary lesions. A propensity matched comparison.

INTRODUCTION: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI. METHODS: Net adverse cardiovascular events (NACE: all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions. RESULTS: Among 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR: 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR: 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group. CONCLUSIONS: SCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions.

High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment.

PURPOSE: Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed. METHODS: This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death. RESULTS: A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05). CONCLUSIONS: This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group. CLINICAL IMPACT: One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.

Correlation between the Atherogenic Index of Plasma and Progression of Non-target Lesion Vascular Disease Following Percutaneous Coronary Intervention Using Drug-eluting Stents.

OBJECTIVE: To examine the correlation between Atherogenic Index of Plasma (AIP) levels and the progression of non-target lesion vascular disease following the deployment of drug-eluting stents (DES). METHODS: We retrospectively enrolled patients who had undergone successful treatment for CAD with DES and subsequently underwent a coronary angiography follow-up at the Cardiology Department of Tianjin Third Central Hospital from January 2017 to July 2022. The annual change in Gensini Score (GS) was calculated according to two angiographic evaluations in order to assess the progression of non-target lesion vascular disease; a change greater than 1 indicated progression, while a change of 1 or less indicated stability. AIP was calculated according to serum lipid parameters. Multivariate Logistic regression model was used to evaluate the relationship between AIP level and progression of non-target coronary artery lesions. The ROC curve analysis was performed to evaluate the diagnostic value of AIP for coronary artery non-target lesion vascular disease progression. RESULTS: Out of the 344 patients who were monitored over a median duration of 1.2 years, 113 exhibited progression of non-target lesion vascular disease. Initially, baseline AIP levels were notably higher in the progression group compared to the non-progression group (0.30 [0.14, 0.43] vs. 0.11 [-0.06, 0.31]), and this difference remained significant during the follow-up period (0.19 [0.06, 0.34] vs. 0.11 [-0.06, 0.22]). Multivariate logistic regression revealed that AIP is an independent predictor for the progression of non-target lesion vascular disease following DES treatment. Individuals in the highest tertile of AIP faced a considerably elevated risk compared to those in the lowest tertile (OR = 4.88, 95% CI: 2.12-11.21, P < 0.001). Moreover, utilizing receiver operating characteristic curve analysis, a 0.15 AIP level cut-off was determined for diagnosing disease progression, with a sensitivity of 73.5% and specificity of 56.7%, and an area under the curve of 0.672 (95% CI: 0.613-0.731, P < 0.01). CONCLUSION: AIP significantly correlates with the progression of non-target lesion vascular disease among patients with coronary artery disease who have undergone DES treatment, establishing itself as an independent risk factor in addition to conventional predictors.

One-year Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon for Femoropopliteal Artery Lesions: BEASTARS Study Results.

BACKGROUND: Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease. MATERIALS AND METHODS: Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently. RESULTS: After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm2 vs 14 mm2, p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014). CONCLUSION: In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more). CLINICAL IMPACT: The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.

Using XGBoost for Predicting In-Stent Restenosis Post-DES Implantation: Role of Lymphocyte-to-Monocyte Ratio and Residual Cholesterol.

Objective: This study aims to investigate their correlation and predictive utility for in-stent restenosis (ISR) in patients with acute coronary syndrome (ACS) following percutaneous coronary intervention (PCI). Methods: We collected medical records of 668 patients who underwent PCI treatment from January 2022 to December 2022. Based on follow-up results (ISR defined as luminal narrowing ≥ 50% on angiography), all participants were divided into ISR and non-ISR groups. The XGBoost machine learning (ML) model was employed to identify the optimal predictive variables from a set of 31 variables. Discriminatory ability was evaluated using the area under the receiver operating characteristic (ROC) curve (AUC), while calibration and performance of the prediction models were assessed using the Hosmer-Lemeshow (HL) test and calibration plots. Clinical utility of each model was evaluated using decision curve analysis (DCA). Results: In the XGBoost importance ranking of predictive factors, LMR and RC ranked first and fourth, respectively. The AUC of the entire XGBoost ML model was 0.8098, whereas the model using traditional stepwise backward regression, comprising five predictive factors, had an AUC of 0.706. The XGBoost model showed superior predictive performance with a higher AUC, indicating better discrimination and predictive accuracy for ISR compared to traditional methods. Conclusion: LMR and RC are identified as cost-effective and reliable biomarkers for predicting ISR risk in ACS patients following drug-eluting stent (DES) implantation. LMR and RC represent cost-effective and reliable biomarkers for predicting ISR risk in ACS patients following drug-eluting stent implantation. Enhances the accuracy and clinical utility of ISR prediction models, offering clinicians a robust tool for risk stratification and personalized patient management.

Ticagrelor monotherapy in ST-elevation myocardial infarction: An individual patient-level meta-analysis from TICO and T-PASS trials.

BACKGROUND: Patients with ST-elevation myocardial infarction (STEMI) tend to be excluded or under-represented in randomized clinical trials evaluating the effects of potent P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy (DAPT). METHODS: Individual patient data were pooled from randomized clinical trials that included STEMI patients undergoing drug-eluting stent (DES) implantation and compared ticagrelor monotherapy after short-term (≤3 months) DAPT versus ticagrelor-based 12-month DAPT in terms of centrally adjudicated clinical outcomes. The co-primary outcomes were efficacy outcome (composite of all-cause death, myocardial infarction, or stroke) and safety outcome (Bleeding Academic Research Consortium type 3 or 5 bleeding) at 1 year. FINDINGS: The pooled cohort contained 2,253 patients with STEMI. The incidence of the primary efficacy outcome did not differ between the ticagrelor monotherapy group and the ticagrelor-based DAPT group (1.8% versus 2.0%; hazard ratio [HR] = 0.88; 95% confidence interval [CI] = 0.49-1.61; p = 0.684). There was no difference in cardiac death between the groups (0.6% versus 0.7%; HR = 0.89; 95% CI = 0.32-2.46; p = 0.822). The incidence of the primary safety outcome was significantly lower in the ticagrelor monotherapy group (2.3% versus 4.0%; HR = 0.56; 95% CI = 0.35-0.92; p = 0.020). No heterogeneity of treatment effects was observed for the primary outcomes across subgroups. CONCLUSIONS: In patients with STEMI treated with DES implantation, ticagrelor monotherapy after short-term DAPT was associated with lower major bleeding without an increase in the risk of ischemic events compared with ticagrelor-based 12-month DAPT. Further research is necessary to extend these findings to non-Asian patients. FUNDING: This study was funded by Biotronik (Bülach, Switzerland).