Target Lesion Failure Rate Research Articles

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention for acute myocardial infarction with cardiogenic shock

Abstract Background Intravascular ultrasound (IVUS) potentially improves short and long-term clinical outcomes of percutaneous coronary intervention (PCI). However, evidence regarding its efficacy in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI) is limited. Objectives This study investigated the impact of IVUS-guided PCI in patients with AMI and CS. Methods From the pooled data based on a series of Korean AMI registries during 2011–2020, we identified 1,418 consecutive patients who underwent PCI with second generation drug-eluting stent (DES) for AMI and CS. The primary endpoint was the 1-year rate of target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction, and ischemic-driven target lesion revascularization. Results Among the patients, 294 (20.7%) and 1,124 (79.3%) underwent IVUS-guided and angiography-guided PCI with second generation DES implantation, respectively. No significant difference was observed in the 1-year TLF between both groups after IPTW analysis (hazard ratio 0.93, 95% confidence interval 0.65–1.34, p=0.70) (Figure A). Additionally, the adjusted landmark analysis for TLF at 30 days and between 30 days and 1 year after PCI demonstrated no significant difference between the groups (Figure B). Conclusions In patients with AMI and CS who underwent PCI with second-generation DES, IVUS-guided PCI did not improve clinical outcomes with respect to 1-year TLF compared with angiography-guided PCI.Figure

Comparison of ridaforolimus-eluting and zotarolimus-eluting coronary stents: 5-Year outcomes from the BIONICS and NIREUS trials

Abstract Introduction Despite similarities between different modern drug eluting stents (DES), their comparative short and long-term safety and efficacy has generated much interest and yielded conflicting results. The BIONICS and the NIREUS randomized clinical trials showed non-inferiority of the Ridaforolimus eluting stent (RES) compared to the Zotarolimus-eluting stent (ZES) with respect to 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss. Aim To evaluate clinical outcomes between treatment groups over 5 years follow-up Methods BIONICS and NIREUS were prospective, randomized, single-blind multicenter trials comparing RES and ZES in patients undergoing PCI. Patients were blinded to treatment assignment and randomized to RES or ZES in a 1:1 fashion in BIONICS, and in 2:1 fashion in NIREUS. Clinical events were assessed during hospital stay, at 30 days, 1 year, and yearly thereafter, up to 5 years. The The primary endpoint in the current study was the 5-year rate of target lesion failure (TLF). Results The study population included 2221 patients enrolled in the BIONICS (n=1919) and NIREUS (n=302) studies. Median follow-up was 1822 days (interquartile range 1783 to 1847 days). Mean age was 63.2±10.3 years, and most patients were men (79.7%). Clinical presentation with ACS was similar between groups (38.9% versus 37.9%, RES versus ZES, respectively, p=0.38). Procedural characteristics were similar for patients treated with RES and ZES. A mean of 1.6±0.9 and 1.5±0.8 stents were implanted in RES and ZES patients, respectively, p=0.08. Post dilatation was performed more frequently in the RES group (63.3% versus 60.1%, p=0.02) and procedure duration was longer in RES versus ZES patients (47.0±31.8 minutes versus 44.6±29.2 minutes, p=0.01). Device success was high in both groups but slightly higher in the ZES group (98.2% versus 99.5% for RES and ZES, respectively, p=0.002) yet with similar procedural success (97.9% versus 97.3%, p=0.49). At 5 years, the primary endpoint of TLF was similar between treatment groups (12.2% RES versus 11.3% ZES, p=0.52). Rates of TLR (7.6% RES versus 6.8% ZES, p=0.42), target vessel-related MI (4.8% RES versus 4.9% ZES, p=0.95) and stent thrombosis (0.9% RES versus 0.9% ZES, p=0.87), also did not differ between groups. Target vessel revascularization (TVR) and cardiac death were higher among the RES group (12.3% versus 9.5% p=0.037, and 3.6% versus 2.2 % p=0.042, respectively). However, after correction for baseline characteristics there was no significant difference in cardiac death between groups. Conclusions In a pooled analysis of two randomized trials, 5-year clinical outcomes were similar between patients undergoing PCI with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of patients with coronary artery disease.Central illustrationZES vs. RES

The feasibility of double stent strategy in left main true bifurcation with small and large angle change between diastole and systole: The Milan and New-Tokyo (MITO) registry.

Provisional single stenting strategy (PSS) is a default strategy for percutaneous coronary intervention (PCI) of unprotected left main distal bifurcation lesions (ULMD). Previous study reported that a bifurcation angle change (BAC) between end diastole and systole was associated with outcomes after PCI with double stent strategy (DSS) for ULMD. However, there are no data comparing outcomes after PCI with PSS versus DSS according the degree of BAC. We evaluated outcomes after PCI with PSS versus DSS for true ULMD with small and large BAC. We identified 566 patients with true ULMD underwent PCI in three high-volume centers. We calculated the BAC in ULMD between end-diastole and systole before stenting with 2-dimensional quantitative coronary angiographic assessment. We defined small (BAC < 7.0°) and large BAC (≥7.0°) group. We compared clinical outcomes after PCI with PSS versus DSS in each cohort after propensity score adjustment. The primary endpoint was target-lesion failure (TLF), which was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. In small BAC cohort, TLF rate was significantly lower in DSS group than in PSS group (12.5% vs. 20.1%, adjusted HR 0.45; 95% CI, 0.26-0.79; p = 0.006). In contrast, in large BAC cohort, TLF rate was significantly higher in DSS group than in PSS group (54.9% vs. 29.0%, adjusted HR 2.25; 95% CI, 1.50-3.38; p < 0.001). The TLF rate after PCI with DSS was significantly lower in true ULMD with small BAC compared to PSS even after propensity score adjustment. In contrast, it was significantly higher in those with large BAC.

Clinical Outcomes of Double-Kissing Crush or Double-Kissing Culotte in Nonleft Main Bifurcation Lesions: The ROUTE Trial.

Double-kissing (DK) crush and DK culotte are the recommended 2-stent strategies in true coronary bifurcation lesions. However, it is a matter of curiosity about which of the DK crush and DK culotte stenting techniques will have superior results. We aimed to compare the clinical outcomes of DK crush and DK culotte stenting in nonleft main coronary artery bifurcation. Consecutive patients who received DK crush or DK culotte technique for de novo true nonleft main coronary artery bifurcation lesion were categorized according to which treatment they received. The primary end point of the study was target lesion failure as a composite end point of target lesion revascularization, target vessel myocardial infarction, and cardiac death. Secondary end points were all-cause death and definite stent thrombosis. A total of 202 patients were categorized as DK crush (101 patients) or DK culotte (101 patients) techniques. The target lesion failure had occurred frequently in the DK crush (10.9%) compared with the DK culotte (3.0%; P=0.028) that was mainly driven by increased target lesion revascularization (9.9% in the DK crush versus 3.0% in the DK culotte; P=0.045). The number of patients with target vessel myocardial infarction (3.0% in the DK crush versus 2.0% in the DK culotte; P=0.651) and cardiac death (1.0% in the DK crush versus 0.0% in the DK culotte; P=0.315) was higher in the DK crush. There were no differences in terms of definite stent thrombosis and all-cause death between groups. In the present analysis, DK culotte was associated with lower 1-year target lesion failure rates compared with DK crush in true nonleft main coronary artery bifurcations. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04789161.

Polymer free biolimus coated stents to treat acute ST-elevation myocardial infarction in Asian patients.

Patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment-elevation myocardial infarction (STEMI) have a high thrombotic burden and often have a high bleeding risk (HBR). Asian patients have different patterns of thrombotic and bleeding risk from other populations which may be particularly relevant in the setting of PPCI for STEMI. To assess the safety and efficacy of the polymer free biolimus coated coronary stent (PF-BCS, BioFreedomTM, Biosensors International) in Asian STEMI patients. Patients with acute STEMI who received at least one PF-BCS were invited to participate after their index procedure. Follow-up was performed at 1, 4, and 12 months. The primary endpoint was the rate of target lesion failure (TLF) at 1 year. A performance goal was derived from the biolimus eluting stent arm of the COMFORTABLE AMI study which was the only prior dedicated study of biolimus eluting stents in patients with STEMI. A total of 914 patients with STEMI were enrolled. Mean patient age was 60 ± 13 years, diabetes was present in 23.2% and 43% were active smokers. According to the ARC definition, 12.4% of the patients were HBR. TLF rate was 2.54% [95% CI: 1.52-3.56], p-value for non-inferiority <0.0001, p-value for superiority = 0.0004). The rate of definite/probable stent thrombosis was 0.44% [95% CI: 0.16-1.16]. There was a trend toward more BARC 3 to 5 bleeding in ARC-HBR patients (3.69% vs 1.46%, HR = 2.74, [95% CI: 0.87-8.62], p = 0.07). In Asian patients undergoing PPCI for STEMI and treated with variable durations of DAPT, the use of a PF-BCS was associated with low rates of TLF and stent thrombosis (NCT03609346).

Renal Function-Stratified Comparison of Short- and Long-Term Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention With Third-Generation Drug-Eluting Stents - Post Hoc Analysis From the HOST-IDEA Randomized Clinical Trial.

The optimal duration of dual antiplatelet therapy (DAPT) in patients with chronic kidney disease undergoing percutaneous coronary intervention (PCI), especially with third-generation drug-eluting stents (DES), remains unknown. We conducted a prespecified post hoc analysis of the HOST-IDEA trial, randomizing patients undergoing PCI with third-generation DES to 3- to 6-month or 12-month DAPT. In all, 1,997 patients were grouped by their estimated glomerular filtration rate (eGFR): high (>90 mL/min/1.73 m2), intermediate (60-90 mL/min/1.73 m2), and low (<60 mL/min/1.73 m2). The primary outcome was net adverse clinical events (NACE), a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, or major bleeding (Bleeding Academic Research Consortium Type 3 or 5) at 12 months. Secondary outcomes were target lesion failure (TLF) and major bleeding. The low eGFR group had the highest rates of NACE, TLF, and major bleeding compared with the other 2 groups (P<0.001). Rates of NACE were similar in the 3- to 6-month and 12-month DAPT in the high (2.9% vs. 3.2%; P=0.84), intermediate (2.1% vs. 2.8%, P=0.51), and low (8.9% vs. 9.1%; hazard ratio 0.99; P=0.97; Pinteraction=0.88) eGFR groups. TLF and major bleeding events showed similar trends. In patients undergoing PCI with third-generation DES, 3- to 6-month DAPT was comparable to 12-month DAPT for clinical outcomes regardless of renal function.

Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry

ObjectiveWe evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary...

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

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). 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. 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). 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.

Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents: Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial.

The efficacy and safety of each third-generation drug-eluting stent with ultrathin struts and advanced polymer technology remain unclear. We investigated the clinical outcomes of percutaneous coronary intervention using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. The HOST-IDEA trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy), initially designed with a 2×2 factorial approach, sought to randomize patients undergoing percutaneous coronary intervention based on dual antiplatelet therapy duration (3 versus 12 months) and stent type (Coroflex ISAR versus Orsiro). Despite randomizing 2013 patients for dual antiplatelet therapy duration, the stent arm transitioned to a registry format during the trial. Among these, 328 individuals (16.3%) were randomized for Coroflex ISAR or Orsiro SES, while 1685 (83.7%) underwent percutaneous coronary intervention without stent-type randomization. In this study, the Coroflex ISAR (n=559) and Orsiro groups (n=1449) were matched using a propensity score. The prespecified primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 12 months. The baseline patient and procedural characteristics were well balanced between the Coroflex ISAR and Orsiro groups after propensity score matching (n=559, each group). The Coroflex ISAR group was significantly associated with a higher rate of target lesion failure, mainly driven by clinically driven target lesion revascularization, compared with the Orsiro group (3.4% versus 1.1%; hazard ratio, 3.21 [95% CI, 1.28-8.05]; P=0.01). A higher risk of target lesion failure in the Coroflex ISAR group was consistently observed across various subgroups. The rates of any bleeding (hazard ratio, 0.85 [95% CI, 0.51-1.40]; P=0.52) and major bleeding (hazard ratio, 1.58 [95% CI, 0.61-4.08]; P=0.34) were comparable between the 2 groups. In this propensity score-matched analysis of the stent arm registry from the HOST-IDEA trial, the Orsiro SES was associated with significantly better outcomes in terms of 1-year target lesion failure, mainly driven by clinically driven target lesion revascularization, than the Coroflex ISAR SES. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02601157.

The Absorb GT1 Bioresorbable Vascular Scaffold System - 5-Year Post-Market Surveillance Study in Japan.

The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available.Methods and Results: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations. Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.

One-Year Outcomes of Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stent in Acute Coronary Syndrome: A Patient-Level Pooled Analysis from Two Indian Registries

Introduction: This pooled analysis was conducted to assess the clinical safety and performance of the Supra family (Sahajanand Medical Technologies Ltd., Surat, India) of sirolimus-eluting stents (SES) in patients with acute coronary syndromes (ACSs) including ST-segment elevation myocardial infarction (STEMI) from two real-world all-comers Indian registries at 1 year. Methods: We evaluated 1,824 patients with ACS who underwent percutaneous coronary intervention with the Supra family of SES from two real-world Indian registries (891 patients from T-Flex registry and 933 patients from Tetriflex real-world registry). The primary endpoint was the incidence of target lesion failure (TLF) defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR) at 1-year follow-up. The safety endpoint was stent thrombosis at 1-year follow-up. Results: Among a total of 1,824 patients with ACS, 689 (37.8%) patients presented with STEMI. In ACS and STEMI groups, 47.6% and 41.8% patients had multivessel disease, respectively. Of 2,128 lesions in ACS group, 76.7% lesions were type B2/C and 16.2% lesions were totally occluded. In the STEMI group, out of 784 treated lesions, 76.7% were type B2/C lesions and 21.9% were totally occluded. At 1-year follow-up, incidence of TLF was 5.3% (cardiac death: 0.9%, TV-MI: 2.5%, TLR: 1.9%) in patients with ACS and 6.2% (cardiac death: 1.4%, TV-MI: 2.1%, TLR: 2.7%) in patients with STEMI. The 1-year rate of definite/probable stent thrombosis was 0.3% and 0.7% in patients with ACS and STEMI, respectively. Conclusion: This patient-level pooled analysis provides evidence for the safe and effective use of the Supra family of SES in complex patient populations such as ACS and even in STEMI with favorable rates of TLF and stent thrombosis at 1-year follow-up.

One-Year Outcomes of Long Coronary Drug-Eluting Stents (≥40 MM) in Patients With Diffuse Coronary Artery Disease: Findings From a Tertiary Care Hospital in North India.

Background and objective Diffuse coronary artery disease (CAD) is associated with extensive involvement of coronary arteries, necessitating the useof long (≥40 mm) drug-elutingstents (DES) based on the lesion length. However, these long DES can lead to complications such as in-stent restenosis (ISR) and stent thrombosis. This study aimed to assess the safety, efficacy, and one-year clinical outcomes of using long DESin patients with diffuse CAD undergoing PCI at a tertiary care hospital in north India. Methodology Patients with diffuse CAD undergoingPCI with longDESbetween January 2017 and June 2022 were included in the study. Baseline characteristics were recorded, and patients were followed up telephonically or in the outpatient department (OPD) at one, three, six, and 12 months following the PCI. The primary endpointwas the target lesion failure (TLF) rate, with secondary endpoints constituting all-cause mortality, major adverse cardiovascular events (MACE), subacute stent thrombosis, and ISR. Results A total of 200 patients were recruited and followed up for one year. The median age of the patients was 58 years (range: 48.25-63 years), and 82% were men. The most frequently stented artery was the left anterior descending (LAD, 48%), followed by the right coronary artery (RCA, 36%). A total of 388 stents (mean: 1.94 ±0.79) were implanted, including both long and short stents. The mean length and diameter of long stents were 43.64 ±3.58 mm and 3 ±0.37 mm, respectively. At the one-year follow-up, patients undergoing PCI with long DES ≥40 mm had an overall TLF rate of 5%, all-cause mortality of 6% (12 patients), MACE of 6% (12 patients), subacute stent thrombosis of 4% (eight patients), and ISR of 1% (two patients).A large proportion of patients (90%) had an uneventful follow-up of up to a year. At the one-year follow-up, all 10 (5%)patients with a primary outcomehad a smallerstent diameterthan those without a primary outcome (2.5 ±0.25 mm vs. 3.03 ±0.35 mm, p=0.015). Conclusions Our results suggest that using extremely long stents (>40 mm) for diffuse coronary lesions is safe, efficacious, and associated with relatively low event rates. In addition, the stent diameter has a substantial correlation with the primary outcome. Further studies with larger sample sizes as well as longer follow-up periods are required to validate our findings.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention for acute myocardial infarction with cardiogenic shock.

The benefits of intravascular ultrasonography (IVUS)-guided percutaneous coronary intervention (PCI) in the clinical context of cardiogenic shock (CS) complicating acute myocardial infarction are lacking. We aimed to investigate the impact of IVUS-guided PCI in patients with AMI and CS. From the pooled data based on a series of Korean AMI registries during 2011-2020, we identified 1418 consecutive patients who underwent PCI with second generation drug-eluting stent (DES) for AMI and CS. The primary endpoint was the 1-year rate of target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction, and ischemic-driven target lesion revascularization. In total, 294 (20.7%) and 1124 (79.3%) underwent IVUS-guided and angiography-guided PCI with second generation DES implantation, respectively. The 1-year TLF was not significantly different between groups after IPTW analysis (hazard ratio 0.93, 95% confidence interval 0.65-1.34, p = 0.70). Additionally, the adjusted landmark analysis for TLF at 30days and between 30days and 1year after PCI demonstrated no significant difference between the groups. In conclusion, in patients with AMI and CS who underwent PCI with second-generation DES, IVUS-guided PCI did not improve the 1-year TLF compared with angiography-guided PCI.Registration: URL: http://cris.nih.go.kr . KCT0000863 and KCT0008355.

Ultrathin-strut versus thin-strut stent healing and outcomes in preclinical and clinical subjects.

Compared with thin-strut durable-polymer drug-eluting stents (DP-DES), ultrathin-strut biodegradable-polymer sirolimus-eluting stents (BP-SES) improve stent-related clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). Reduced stent strut thickness is hypothesised to underlie these benefits, but this conjecture remains unproven. We aimed to assess the impact of strut thickness on stent healing and clinical outcomes between ultrathin-strut and thin-strut BP-SES. First, we performed a preclinical study of 8 rabbits implanted with non-overlapping thin-strut (diameter/thickness 3.5 mm/80 μm) and ultrathin-strut (diameter/thickness 3.0 mm/60 μm) BP-SES in the infrarenal aorta. On day 7, the rabbits underwent intravascular near-infrared fluorescence optical coherence tomography (NIRF-OCT) molecular-structural imaging of fibrin deposition and stent tissue coverage, followed by histopathological analysis. Second, we conducted an individual data pooled analysis of patients enrolled in the BIOSCIENCE and BIOSTEMI randomised PCI trials treated with ultrathin-strut (n=282) or thin-strut (n=222) BP-SES. The primary endpoint was target lesion failure (TLF) at 1-year follow-up, with a landmark analysis at 30 days. NIRF-OCT image analyses revealed that ultrathin-strut and thin-strut BP-SES exhibited similar stent fibrin deposition (p=0.49) and percentage of uncovered stent struts (p=0.63). Histopathological assessments corroÂborated these findings. In 504 pooled randomised trial patients, TLF rates were similar for those treated with ultrathin-strut or thin-strut BP-SES at 30-day (2.5% vs 1.8%; p=0.62) and 1-year follow-up (4.3% vs 4.7%; p=0.88). Ultrathin-strut and thin-strut BP-SES demonstrate similar early arterial healing profiles and 30-day and 1-year clinical outcomes.

Long-term outcomes following double kissing crush or mini-culotte stenting for complex coronary bifurcation lesions: the EVOLUTE-CRUSHIV study.

This study aimed to evaluate the long-term outcomes of double kissing crush stenting (DKC) and mini-culotte technique (MCT) in patients with complex bifurcation lesions. This retrospective study enrolled 236 patients who underwent percutaneous coronary intervention (PCI) for complex coronary bifurcation disease between January 2014 and November 2022. The primary endpoint was target lesion failure (TLF), defined as the combination of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). The secondary endpoint was major cardiovascular and cerebral events (MACCE) including all-cause death, MI, TLR, stroke, or stent thrombosis. The regression models were adjusted by applying the inverse probability weighted (IPW) approach to reduce treatment selection bias. The initial management strategy was DKC in 154 (65.3%) patients and MCT in 82(34.7%) patients (male: 194 [82.2%], mean age: 60.85 ± 10.86years). The SYNTAX scores were similar in both groups. The rates of long-term TLF and MACCE rates were 17.4% and 20%, respectively. The rate of TLF (26.8% vs. 12.3%, p = 0.005) was higher in patients treated with MCT than those treated with the DKC technique, mainly driven by more frequent TLR (15.9% vs. 7.1%, p = 0.035). The long-term TLF and MACCE rates were notably lower in the DKC group compared to the others: adjusted hazard ratio (HR; IPW): 0.407, p = 0.009 for TLF, and adjusted HR(IPW): 0.391 [95% CI: 0.209-0.730], p = 0.003 for MACCE. At long-term follow-up, the rates of TLF and MACCE were 17.4% and 20%, respectively. However, long-term TLF was significantly higher in patients treated with MCT than those treated with the DKC technique, primarily due to amore frequent occurrence of clinically driven TLR.

Effectiveness and Safety of a Novel Intravascular Lithotripsy System for Severe Coronary Calcification: The CALCI-CRACK Trial

BackgroundIntravascular lithotripsy is effective and safe for managing coronary calcification; however, available devices are limited, and complex lesions have been excluded in previous studies. This study aimed to investigate the effectiveness and safety of a novel intravascular lithotripsy system for severe calcification in a population with complex lesions. MethodsCALCI-CRACK (treatment of severe calcified coronary lesions with a novel intracoronary shock wave lithotripsy system) (ChiCTR2100052058) was a prospective, single-arm, multicentre study. The primary end point was the procedural success rate. Major safety end points included major adverse cardiovascular events (MACE) and target lesion failure (TLF) at 30 days and 6 months, and severe angiographic complications. Calcification morphology was assessed in the optical coherence tomography (OCT) subgroup. ResultsIn total, 242 patients from 15 high-volume Chinese centres were enrolled, including 26.45% of patients with true bifurcation lesions, 3.31% with severely tortuous vessels, and 2.48% with chronic total occlusion, respectively. The procedural success rate was 95.04% (95% confidence interval 91.50%-97.41%), exceeding the prespecified performance goal of 83.4% (P < 0.001). The 30-day and 6-month MACE rates were 4.13% and 4.55%, respectively. TLF rates at those time points were 1.24% and 1.65%, respectively. Severe angiographic complications occurred in 0.42% of patients. In the OCT subgroup (n = 93), 93.55% of calcified lesions were fractured, and minimal lumen area increased from 1.55 ± 0.55 mm2 to 4.91 ± 1.22 mm2 after stent implantation, with acute gain rate of 245 ± 102%. ConclusionsThe novel intravascular lithotripsy system is effective and safe for managing severely calcified coronary lesions in a cohort that included true bifurcation lesions, severely tortuous vessels, and chronic total occlusion. Clinical Trial RegistrationChinese Clinical Trial Registry (ChiCTR), number ChiCTR2100052058

One-Year Outcome of Drug-Coated Balloon vs. Drug-Eluting Stent in Patients Undergoing Initial Percutaneous Coronary Intervention (PCI) for De Novo Lesion.

Drug-eluting stents (DES) are the major treatment option in percutaneous coronary intervention (PCI). Recently, drug-coated balloon (DCB) utilization has been increasing globally, leading to the expected new strategy of "stent-less PCI." This study aimed to evaluate the one-year outcome of DCB compared to DES. Patients who underwent initial PCI for de novo lesions in our institution from January 2018 to December 2021 (n=337) were subjected to retrospective analysis. Among them, 75 patients were treated with DCB, while 262 patients were treated with DES. Target lesion failure (TLF) was evaluated during the follow-up period. The proportion of PCIs for ACS was significantly lower in the DCB group (DCB, n=23, 30.7% vs. DES, n=143, 54.6%; p=0.001). The median device diameter and length in the DES group were larger than those in the DCB group (DCB, 2.60 mm vs. DES, 2.98 mm; p<0.001; DCB, 19.1 mm vs. DES, 25.2 mm; p<0.001). There was no significant difference between the DCB and DES groups in lesion calcification. The proportion of ostial lesions was significantly higher in the DCB group (DCB, n=13, 17.3% vs. DES, n=21, 8.0%; p=0.018). The cumulative rate of TLF (DCB, n=5, 6.7% vs. DES, n=18, 6.9%; p=0.951) did not significantly differ between the DCB and DES groups. DCB may be as effective a strategy as DES in the patient who underwent initial PCI for a de novo lesion.

Quantitative Coronary Angiography vs Intravascular Ultrasonography to Guide Drug-Eluting Stent Implantation

Although intravascular ultrasonography (IVUS) guidance promotes favorable outcomes after percutaneous coronary intervention (PCI), many catheterization laboratories worldwide lack access. To investigate whether systematic implementation of quantitative coronary angiography (QCA) to assist angiography-guided PCI could be an alternative strategy to IVUS guidance during stent implantation. This randomized, open-label, noninferiority clinical trial enrolled adults (aged ≥18 years) with chronic or acute coronary syndrome and angiographically confirmed native coronary artery stenosis requiring PCI. Patients were enrolled in 6 cardiac centers in Korea from February 23, 2017, to August 23, 2021, and follow-up occurred through August 25, 2022. All principal analyses were performed according to the intention-to-treat principle. After successful guidewire crossing of the first target lesion, patients were randomized in a 1:1 ratio to receive either QCA- or IVUS-guided PCI. The primary outcome was target lesion failure at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The trial was designed assuming an event rate of 8%, with the upper limit of the 1-sided 97.5% CI of the absolute difference in 12-month target lesion failure (QCA-guided PCI minus IVUS-guided PCI) to be less than 3.5 percentage points for noninferiority. The trial included 1528 patients who underwent PCI with QCA guidance (763; mean [SD] age, 64.1 [9.9] years; 574 males [75.2%]) or IVUS guidance (765; mean [SD] age, 64.6 [9.5] years; 622 males [81.3%]). The post-PCI mean (SD) minimum lumen diameter was similar between the QCA- and IVUS-guided PCI groups (2.57 [0.55] vs 2.60 [0.58] mm, P = .26). Target lesion failure at 12 months occurred in 29 of 763 patients (3.81%) in the QCA-guided PCI group and 29 of 765 patients (3.80%) in the IVUS-guided PCI group (absolute risk difference, 0.01 percentage points [95% CI, -1.91 to 1.93 percentage points]; hazard ratio, 1.00 [95% CI, 0.60-1.68]; P = .99). There was no difference in the rates of stent edge dissection (1.2% vs 0.7%, P = .25), coronary perforation (0.2% vs 0.4%, P = .41), or stent thrombosis (0.53% vs 0.66%, P = .74) between the QCA- and IVUS-guided PCI groups. The risk of the primary end point was consistent regardless of subgroup, with no significant interaction. Findings of this randomized clinical trial indicate that QCA and IVUS guidance during PCI showed similar rates of target lesion failure at 12 months. However, due to the lower-than-expected rates of target lesion failure in this trial, the findings should be interpreted with caution. ClinicalTrials.gov Identifier: NCT02978456.

The impact of the bifurcation angle for the Nano-Crush two-stent coronary bifurcation technique on long-term outcomes in a real-world clinical population

AimThis study aims to assess the direct impact of bifurcation angle (BA) on immediate procedural outcomes and patient prognosis post-Nano-Crush stenting for coronary bifurcation lesions. MethodsA retrospective analysis was conducted for all consecutive patients treated with the Nano-Crush technique across two high-volume interventional centers from January 2020 to October 2022. Primary endpoint: comparison of target lesion failure rate in two cohorts based on bifurcation angle (<70° vs. ≥70°), with secondary endpoints including side branch ostium coverage, rate of successful final kissing balloon inflation (FKBI), need for conversion to another technique, and procedure length. ResultsBaseline demographics included 71 patients in the BA<70° group and 49 in the BA≥70° group, with well-balanced characteristics. Angiographic characteristics revealed similar trends, including anatomic and morphological lesion characteristics (referencing Syntax score, Medina classification, and presence of calcifications). Both groups predominantly had complex coronary disease, with a baseline mean Syntax score of 24.18 ± 8.19 in the BA<70° group and 23.91 ± 7.29 in the BA≥70° group, respectively. A dedicated debulking device for lesion preparation was used in 25.35 % of patients in the first group and in 28.57 % of patients in the second group.The primary endpoint occurred in 5.63 % of patients in the BA<70° group and in 4.08 % of patients in the BA≥70° group (P = 0.7014) after ≥ 2 years of clinical follow-up. Angiographic success was achieved in 100 % of both groups, with procedural time averaging 74.99 ± 25.55 min in the BA≥70° and 76.94 ± 27.81 min in the BA<70° (P = 0.6922). The rate of successful final kissing balloon inflation was 98.59 % in the BA<70° group and 95.91 % in the BA≥70° group (P = 0.3566). The mean contrast volume was 189.54 ± 73.74 ml in BA<70° and 168.9 ± 62.77 ml in BA≥70° (P = 0.1126). Clinical follow-ups at 30 days and 2 years revealed similar outcomes and complications for each group, as summarized in Table 3. ConclusionsOur results demonstrate that the bifurcation angle does not significantly impact long-term clinical outcomes or procedural parameters, such as side branch ostium coverage, conversion to a modified DK Crush technique, FKBI success rate, and procedure length. These findings suggest that the Nano-Crush technique can be a viable option for bifurcation lesions, irrespective of the bifurcation angle, achieving optimal side branch ostium coverage while preventing excessive protrusion into the main vessel.

Intervención coronaria percutánea guiada por tomografía de coherencia óptica frente a guiada por ecografía intravascular en pacientes con infarto agudo de miocardio

Introduction and objectivesOptical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) yields clinical outcomes comparable to intravascular ultrasound (IVUS)-guided PCI in patients with stable ischemic heart disease. However, there is a scarcity of data comparing the clinical outcomes of OCT-guided and IVUS-guided PCI in the setting of acute myocardial infarction (AMI). We sought to compare the clinical outcomes of OCT-guided vs IVUS-guided PCI for patients with AMI in the era of second-generation drug-eluting stent (DES). MethodsWe identified 5260 consecutive patients who underwent PCI with a second-generation DES for AMI under IVUS or OCT guidance from pooled data derived from a series of Korean AMI registries between 2011 and 2020. The primary endpoint was the 1-year rate of target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. ResultsA total of 535 (10.2%) and 4725 (89.8%) patients were treated under OCT and IVUS guidance, respectively. The 1-year target lesion failure rates were comparable between the OCT and IVUS groups before and after propensity score matching (hazard ratio, 0.92; 95%CI, 0.42-2.05, P=.84). The OCT utilization rate did not exceed 5% of total patients treated with second-generation DES implantation during the study period. The primary factors for the selection of OCT over IVUS were the absence of chronic kidney disease, non-left main vessel disease, single-vessel disease, stent diameter <3mm, and stent length ≤ 25mm. ConclusionsOCT-guided PCI in patients with AMI treated with a second-generation DES provided comparable clinical outcomes for 1-year target lesion failure compared with IVUS-guided PCI.