Ischemia-driven Target Lesion Revascularization Research Articles

Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program.

The risk-benefit ratio of the Absorb bioresorbable vascular scaffold (BVS) may vary before and after 3years, the time point of complete bioresorption of the poly-L-lactic acid scaffold. The aim of this study was to determine the time-varying outcomes of the Absorb BVS compared with cobalt-chromium everolimus-eluting stents (EES) from a large individual-patient-data pooled analysis of randomized trials. The individual patient data from 5 trials that randomized 5,988 patients undergoing percutaneous coronary intervention to the Absorb BVS vs EES with 5-year follow-up were pooled. The primary effectiveness and safety endpoints were target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis (DT). Between 0 and 5 years, TLF occurred in 15.9% BVS patients vs 13.1% EES patients (HR: 1.25; 95%CI: 1.08-1.43; P=0.002), and DT occurred in 2.2% vs 1.0%, respectively (HR: 2.38; 95%CI: 1.49-3.79; P=0.0002). Between 0 and 3 years, TLF occurred in 12.4% BVS patients vs 9.3% EES patients (HR: 1.35; 95%CI: 1.15-1.59; P=0.0002), and DT occurred in 2.0% vs 0.6%, respectively (HR: 3.58; 95%CI: 2.01-6.36; P< 0.0001). Between 3 and 5 years, TLF occurred in 4.5% BVS patients vs 4.7% EES patients (HR: 0.99; 95%CI: 0.76-1.27; P=0.91), and DT occurred in 0.2% vs 0.4%, respectively (HR: 0.49; 95%CI: 0.18-1.38; P=0.17). By spline analysis, the TLF hazard by 5years was lower with BVS than EES. Compared with EES treatment, BVS increased TLF and DT rates through 5-year follow-up. However, the period of excess risk for the first-generation Absorb BVS ended at 3 years, when poly-L-lactic acid bioresorption is complete. Thereafter event rates were comparable or lower with BVS. (ABSORB II Randomized Controlled Trial, NCT01425281; A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold [Absorb™ BVS] System in Chinese Population - ABSORB CHINA Randomized Controlled Trial [ABSORB CHINA], NCT01923740; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN], NCT01844284; ABSORB III Randomized Controlled Trial [ABSORB III], NCT01751906; Absorb IV Randomized Controlled Trial, NCT02173379).

Impact of coronary artery tortuosity on outcomes following stenting with newer-generation drug-eluting stents. An analysis of the randomized BIOFLOW trials.

Patients undergoing percutaneous coronary intervention in vessels with moderate-to-severe tortuosity are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation stents. We compared outcomes following percutaneous coronary intervention in vessels with moderate-to-severe tortuosity using a bioresorbable-polymer sirolimus-eluting stent (BP-SES) vs a durable-polymer everolimus-eluting stent (DP-EES). A total of 2350 patients from the BIOFLOW II, IV, and V randomized trials were stratified into 2 groups based on target-vessel tortuosity: none-to-mild and moderate-to-severe. The primary endpoints included target lesion failure (TLF)-a composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (TLR)-and probable/definite stent thrombosis at 3 years. Patients with moderate-to-severe tortuosity (n=903) had more comorbidities than those with none-to-mild tortuosity (n=1447). Rates of TLF (P=.354), cardiac death (P=.690), TLR (P=.447), and stent thrombosis (P=.084) were similar between the 2 groups, whereas TV-MI occurred more frequently in the moderate-to-severe tortuosity group (P=.031). However, on multivariate analysis, moderate-to-severe tortuosity was not an independent predictor of TV-MI (adjusted HR, 1.06; 95% CI, 0.72-1.55; P=.772). Among patients with moderate-to-severe tortuosity, the use of BP-SES was associated with significantly lower rates of TLF compared with the durable-polymer everolimus-eluting stent (7.8% vs 13.4%; HR, 0.57; 95% CI, 0.37-0.87; P=.009), driven by reductions in TV-MI (5.0% vs 9.2%; HR, 0.54; 95% CI, 0.32-0.90; P=.018) and TLR (2.7% vs 6.1%; HR, 0.45; 95% CI, 0.23-0.90; P=.021). This pooled analysis of the randomized BIOFLOW trials demonstrates that patients with none-to-mild and moderate-to-severe tortuosity have comparable long-term adverse event rates. However, the use of BP-SES in patients with moderate-to-severe tortuosity may help mitigate potential ischemic risks. Clinicaltrials.gov NCT01356888, NCT01939249, NCT02389946.

Outcomes of coronary intravascular lithotripsy for the treatment of calcified nodules: a pooled analysis of the Disrupt CAD studies.

Coronary intravascular lithotripsy (IVL) safely facilitates stent implantation in severely calcified lesions. This analysis sought to determine the relative impact of IVL on acute and long-term outcomes specifically in calcified nodules (CNs). Individual patient-level data (N=155) were pooled from the Disrupt CAD optical coherence tomography (OCT) substudies. Severely calcified lesions with and without CNs were compared by OCT for acute procedural results and for target lesion failure (TLF) at 2 years - a composite of cardiac death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation. A CN was identified in 18.7% (29/155) of lesions. When comparing lesions with and without CNs, there were no significant differences in preprocedure minimal lumen area or diameter stenosis; however, the mean calcium angle and calcium volume were greater in CN lesions. Despite a higher calcium burden, the final minimal stent area (CN: 5.7 mm2 [interquartile range [IQR] 4.4, 8.3] vs non-CN: 5.7 mm2 [IQR 4.7, 7.2]; p=0.80) and stent expansion (CN: 79.3% [IQR 64.3, 87.0] vs 80.2% [IQR 68.9, 92.4]; p=0.30) were comparable between the two groups. In the CN group, the final stent area and expansion at CN sites were 7.6 mm2 (IQR 5.5, 8.5) and 89.7% (IQR 79.8, 102.5), respectively. The cumulative incidence of TLF at 2 years was 13.9% and 8.0% in the CN and non-CN groups, respectively (p=0.32). Despite a greater calcium volume in CNs, IVL use was associated with comparable stent expansion and luminal gain in both CN and non-CN lesions. Further studies powered for clinical outcomes comparing different plaque modification techniques in this lesion subset are warranted.

Five-year clinical outcomes of STEMI patients treated with a pre-specified bioresorbable vascular scaffold implantation technique: Final results of the BVS STEMI STRATEGY-IT

BackgroundData on Absorb bioresorbable vascular scaffold (BVS) use in patients presenting with ST-segment elevation myocardial infarction (STEMI) are limited. Furthermore, Absorb studies including STEMI patients lacked a prespecified implantation technique to optimize BVS deployment. This study examines the 5-year outcomes of BVS in STEMI patients using an optimized implantation strategy and the impact of prolonged dual antiplatelet therapy (DAPT). MethodsThe BVS STEMI STRATEGY-IT study is a prospective, non-randomized, single-arm multicenter trial (NCT02601781). It involved 505 STEMI patients undergoing primary percutaneous coronary intervention with a predefined BVS implantation protocol. Key endpoints were a 5-year device-oriented composite endpoint (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). The study also compared outcomes based on DAPT duration (36 months vs. shorter). Results502 (99.4 %) patients completed the 5-year follow-up. DOCE rate was 2.4 %. ID-TLR, TV-MI, and cardiac death rates were 1.6 %, 0.8 %, and 0.6 %, respectively. No DOCE occurred between three and five years. Scaffold thrombosis (ScT) was 1 %, all occurring within 24 months. Longer-term DAPT significantly reduced DOCE (1.3 % vs. 4.3 %; HR: 0.29; 95 % CI: 0.1–0.9; p = 0.03) driven by a lower rate of TV-MI (0 % vs. 2.2 %; p = 0.018) compared to shorter-term DAPT, as well as ScT (0 % vs 2.7 %, p = 0.007). ConclusionsThis study shows favorable 5-year outcomes for BVS in selected STEMI patients with an optimized implantation strategy. Prolonged DAPT further improved outcomes, emphasizing its role in reducing adverse events during scaffold resorption. Further research is needed to assess newer-generation bioresorbable devices.

Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study

BackgroundCoronary artery disease (CAD) is the leading cause of death for women, yet they remain underrepresented in interventional CAD studies. Women have been shown to be at increased risk of mortality and major adverse events after percutaneous coronary intervention (PCI). The poorer outcomes are likely because women are typically diagnosed with CAD late, at an older age, with more comorbidities, and with more challenging anatomy including smaller vessels and higher prevalence of coronary artery calcification. MethodsThe EMPOWER CAD study (NCT05755711) is a postmarket, prospective, multicenter, single-arm observational study of the Shockwave Coronary intravascular lithotripsy (IVL) system for the treatment of women with calcified coronary artery disease. The study will enroll 400 female patients referred for PCI with coronary IVL and stenting. The primary safety end point is target lesion failure (TLF) at 30 days, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The primary effectiveness end point is procedural success, defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions and without in-hospital TLF as assessed by an independent core laboratory and clinical events committee. Patients will be followed up for 3 years. ConclusionsThe EMPOWER CAD study will enroll real-world female patients. Adjunctive use of IVL with other calcium modification technologies will be assessed, as well as a subcohort analysis of patients with optical coherence tomography imaging. The EMPOWER CAD study therefore directly addresses the underrepresentation of women in interventional cardiology clinical trials.

The long-term clinical impact of high-intensity statin therapy in older patients with acute myocardial infarction

Abstract Introduction Despite substantial clinical evidence supporting the benefits of high-intensity statins for acute myocardial infarction, the clinical implications of their use in elderly populations have yet to be fully elucidated. Purpose This study aims to clarify the importance of high-intensity statin therapy at discharge for patients aged over 65 with acute myocardial infarction (AMI). Methods In this retrospective cohort analysis conducted with data from the Korean Acute Myocardial Infarction Registry (KAMIR), we evaluated 4,147 patients aged 65 and above who experienced acute myocardial infarction (AMI), underwent coronary interventions utilizing second-generation drug-eluting stents, and were prescribed statins at the time of discharge. The primary outcome was major adverse cardiovascular events (MACE) at 3 years, defined as the composite of all-cause deaths, any myocardial infarction, and any coronary revascularization. The secondary outcome was target-lesion failure (TLF), defined as the composite endpoint of all cardiac deaths, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 3 years. Results In this study, 1,268 patients (30.5%) were treated with high-intensity statins at discharge. The patients were stratified into two groups using an age threshold of 78 years. In the propensity-matched cohort aged 65 to 78, the use of high-intensity statins was associated with a significant reduction in MACE (19.1% versus 14.5%, p=0.011). In the propensity score-matched cohort aged over 78, however, treatment with high-intensity statins did not lead to a reduction in MACE (24.8% versus 24.5%, p&amp;gt;0.99). Additionally, multivariate analysis revealed that high-intensity statin therapy was associated with a reduced risk of MACE (HR 0.69, 95% CI [0.57-0.85], p&amp;lt;0.001) in patients aged 65 to 78. However, the effects of high-intensity statins on TLF were not significant in matched patients aged 65 to 78 (7.9% versus 6.5%, p=0.269) and in those aged over 78 (13.7% versus 12.1%, p=0.638). Conclusion This extensive, nationwide cohort study suggests that treatment with high-intensity statins upon discharge may not offer clinical benefits in reducing MACE and TLF in patients with AMI aged over 78, compared to those aged 65 to 78.

Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial

Persistent non-plateauing adverse event rates in patients who underwent percutaneous coronary intervention (PCI) remain a challenge. A bioadaptor is a novel implant that addresses this issue by restoring the haemodynamic modulation of the artery, allowing cyclic pulsatility, vasomotion, and adaptative remodelling, by unlocking and providing dynamic support to the artery. We aimed to assess outcomes with the device versus a contemporary drug-eluting stent (DES) in a representative PCI population. INFINITY-SWEDEHEART is a single-blind, non-inferiority, registry-based, randomised controlled study conducted in 20 hospitals in Sweden. Patients aged 18-85 years, with chronic or acute coronary syndrome ischaemic heart disease, with an indication for PCI, with up to three de novo lesions suitable for implantation with one single device per lesion, and successful pre-dilatation were identified via the Swedish Coronary Angiography and Angioplasty Registry and eligible for enrolment. Participants were randomly assigned (1:1), using block randomisation with random variation in block size and stratified by site, to either the DynamX bioadaptor (Elixir Medical, Milpitas, CA, USA) or a zotarolimus-eluting DES (Resolute Onyx and Onyx Trustar, Medtronic, Minneapolis, MN, USA). The primary endpoint was the device-oriented clinical endpoint of target lesion failure at 12 months (a composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation), assessed in the intention-to-treat (ITT) population (ie, all patients randomly assigned to treatment, regardless of treatment received) who had either experienced an event up to 12 months or completed the trial up to 12 months. Non-inferiority was established if the upper limit of the two-sided 95% CI for the absolute risk difference was less than 4·2%. Powered secondary endpoints were landmark analyses from 6 months onwards for target lesion failure, target vessel failure (composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target vessel revascularisation), and target lesion failure for patients with acute coronary syndrome assessed in the ITT population). This study is registered with ClinicalTrials.gov, NCT04562805, and follow-up to 5 years is ongoing. Between Sept 30, 2020, and July 11, 2023, 2399 patients were randomly assigned to receive the bioadaptor (n=1201) or DES (n=1198; ITT population). Median age was 69·5 years (IQR 61·2-75·6), 575 (24·0%) of 2399 patients were female, and 1824 (76·0%) were male (data on race and ethnicity were not collected), and 1838 (76·6%) patients presented with acute coronary syndrome. The primary endpoint of 12-month target lesion failure occurred in 28 (2·4%) of 1189 assessable patients in the bioadaptor group versus 33 (2·8%) of 1192 assessable patients in the DES group, with a risk difference of -0·41% (95% CI -1·94 to 1·11; pnon-inferiority<0·0001). In the prespecified landmark analysis from 6 months to 12 months, the Kaplan-Meier estimates of target lesion failure were 0·3% (with events in three of 1170 patients) in the bioadaptor group versus 1·7% (with events in 16 of 1176 patients) in the DES group (hazard ratio 0·19 [95% CI 0·06 to 0·65]; p=0·0079), of target vessel failure were 0·8% (events in eight of 1167) versus 2·5% (events in 23 of 1174; 0·35 [0·16 to 0·79]; p=0·011), and of target lesion failure in patients with acute coronary syndrome were 0·3% (events in two of 906) versus 1·8% (events in 12 of 895; 0·17 [0·04 to 0·74]; p=0·018). The rate of definite or probable device thrombosis, which was recorded as a safety outcome, was low and did not differ between groups (eight [0·7%] of 1201 in the bioadaptor group vs six [0·5%] of 1198 in the DES group; difference in event rates of 0·16% [95% CI -0·50 to 0·83]). Among patients with coronary artery disease, including those with acute coronary syndrome, treatment with the bioadaptor was non-inferior to contemporary DES, showing potential to mitigate non-plateauing device-related events and improving outcomes in patients undergoing PCI. The additional planned follow-up will help to reinforce the clinical significance of the 1-year findings. Elixir Medical.

Long-term clinical outcomes of acute myocardial infarction based on a center's experience with IVUS in the contemporary drug-eluting stent era

Abstract Introduction Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) is recognized for improving patient prognosis. However, how a center's experience with IVUS affects clinical outcomes remains unclear. Purpose This study aims to elucidate the impact of a center's expertise in IVUS on clinical outcomes, emphasizing the value of institutional experience. Methods In this retrospective cohort study from the Korean AMI Registry (KAMIR), we analyzed 9,752 patients diagnosed with acute myocardial infarction (AMI) who underwent intervention with second-generation drug-eluting stents. The primary outcome was major adverse cardiovascular events (MACE) at 3 years, defined as the composite of all-cause deaths, any myocardial infarction, and any coronary revascularization. The secondary outcome was target-lesion failure (TLF), defined as the composite endpoint of all cardiac deaths, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 3 years. Results In this study, the median frequency of IVUS usage across 20 institutions was 10.3%. Hospitals were categorized as centers with extensive experience in IVUS or those with limited experience, based on the median frequency of IVUS usage. In centers with extensive experience in IVUS, IVUS-guided PCI consistently showed a reduction in MACE (18.5% vs. 15.3%, p=0.016) and TLF (8.3% vs. 6.3%, p=0.039) within propensity-score matched populations. Furthermore, multivariate Cox regression analysis revealed that IVUS-guided PCI was associated with decreased risks of MACE (HR 0.80, 95% CI [0.69-0.93], p=0.003) and TLF (HR 0.75, 95% CI [0.59-0.95], p=0.01). However, from propensity matched population in centers with limited experience in IVUS, there were no significant reductions in the incidences of MACE (18.6% versus 15.7%, p=0.422) and TLF (10.4% versus 8.9%, p=0.644). Conclusion This comprehensive, nationwide cohort study shows that outcomes of IVUS-guided PCI are more favorable in centers with extensive IVUS experience compared to those with limited experience. These results indicate that the clinical advantages of IVUS-guided PCI are more pronounced in centers with extensive experience than in those with limited experience.

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

Significant stenosis without thrombus may be the third most common etiology of acute coronary syndrome

Abstract Background Plaque rupture (PR), plaque erosion (PE) and calcified nodule (CN) are known as major etiologies of acute coronary syndrome (ACS). On the other hand, significant stenosis without thrombus (SSWT) can be sometimes observed in culprit plaque of ACS. However, incidence and clinical feature of SSWT in ACS patients are not well known in Japanese. Method This is a sub study of TACTICS registry which include ACS patients (n=702) undergoing primary percutaneous coronary intervention (PCI) under optical coherence tomography (OCT) in Japan. Using this registry data, we compared the clinical features and OCT findings of SSWT in ACS patients in comparison with PR, PE and CN. Major adverse cardiac event (MACE) was defined as death, non-fatal myocardial infarction, heart failure, or ischemia-driven revascularization at 1-year. Results Plaque rupture (PR: n=411, 61%) and plaque erosion (PE: n=178, 26%) were 2 major etiologies, which was followed by SSWT (n=59, 9%) and calcified nodule (CN: n=28, 4%). Clinical characteristics are shown in table 1. Patients with SSWT was slightly older than PR and PE but younger than CN. Proportion of male was fewer than PR and PE but greater than CN. In terms of traditional coronary risk factors, there were significant differences in prevalences of diabetes, active smoking, and hemodialysis among different etiologies. In SSWT, non-ST elevation myocardial infarction was the main type of ACS followed by unstable angina and ST elevation myocardial infarction (51%, 39% and 10%, respectively), which may be associated with the least CK level and greater TIMI flow. Lesion was less complex with lower proportion of type B2 or C, shorter procedure time, lower proportion of multivessel disease and lower syntax score. OCT findings are shown in table 2. Regarding lipid component and calcification, SSWT showed similar finding as PE. Cholesterol crystal was relatively less as compared to PR and PE. Kaplan-Meier survival curve showing MACE and ischemia driven-TLR are shown in figure 1 and 2. MACE and TLR was the least in SSWT. Conclusion SSWT was the third most common etiology of ACS with different feature from PR, PE and CN.

Randomized Comparison of NovelLow-Dose Sirolimus-Eluting Biodegradable Polymer Stent vsSecond-Generation DES: TARGET-IV NA Trial.

Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs. We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs. The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12months (composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss). A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). Atotal of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5%CI: 2.03, Pnoninferiority< 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263mm for BP-SES and 0.327 ± 0.463mm for control (least squares mean difference:-0.178; 90%CI:-0.2943 to-0.0632; Pnoninferiority< 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13months (Pnoninferiority=0.01). The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (Firehawk® Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532).

Practices and outcomes of rotational atherectomy in China: The Rota China registry.

Rotational atherectomy (RA) remains an integral tool for the treatment of severe coronary calcified lesions despite emergence of newer techniques. We aimed to evaluate the contemporary clinical practices and outcomes of RA in China. The Rota China Registry (NCT03806621) was an investigator-initiated, prospective, multicenter registry based on China Rota Elite Group. Consecutive patients treated with RA were recruited. A pre-designed, standardized protocol was recommended for the RA procedure. The primary safety endpoint was major adverse cardiovascular events (MACE: composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) at 30 days. The primary efficacy endpoint was procedural success. Between July 2018 and December 2020, 980 patients were enrolled at 19 sites in China. Mean patient age was 68.4 years, and 61.4% were men. Radial access was used in 79.1% patients, and 32.7% procedures were guided by intravascular imaging. A total of 22.6% procedures used more than 1 burr, and the maximal burr size was ≥1.75 mm in 24.4% cases, with burr upsizing in 19.3% cases, achieving a final burr-to-artery ratio of 0.52. Procedural success was achieved in 91.1% of patients, and the rate of 30-day and 1-year MACE was 4.9% and 8.2%, respectively. Multivariable analysis identified the total lesion length (HR 1.014, 95% CI: 1.002-1.027; p = 0.021) as predictor of 30-day MACE, and renal insufficiency (HR 1.916, 95% CI: 1.073-3.420; p = 0.028) as predictor of 1-year MACE. In this contemporary prospective registry in China, the use of RA was effective in achieving high procedural success rate with good short- and long-term outcomes in patients with severely calcified lesions.

Safety, efficacy, and optical coherence tomography insights into intravascular lithotripsy for the modification of non-eruptive calcified nodules: A prospective observational study.

Non-eruptive calcium nodules (CNs) are commonly seen in heavily calcified coronary artery disease. They are the most difficult subset for modification, and may result in stent damage, malapposition and under-expansion. There are only limited options available for non-eruptive CN modification. Intravascular lithotripsy (IVL) is being explored as a potentially safe and effective modality in these lesions. This study aimed to investigate the safety and efficacy of the use of IVL for the modification of non-eruptive CNs. The study also explored the OCT features of calcium nodule modification by IVL. This is a single-center, prospective, observational study in which patients with angiographic heavy calcification and non-eruptive CN on OCT and undergoing PCI were enrolled. The primary safety endpoint was freedom from perforation, no-reflow/slow flow, flow-limiting dissection after IVL therapy, and major adverse cardiac events (MACE) during hospitalization and at 30 days. MACE was defined as a composite of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR). The primary efficacy endpoint was procedural success, defined as residual diameter stenosis of <30% on angiography and stent expansion of more than 80% as assessed by OCT. A total of 21 patients with 54 non-eruptive CNs undergoing PCI were prospectively enrolled in the study. Before IVL, OCT revealed a mean calcium score of 3.7 ± 0.5 and a mean MLA at CN of 3.9 ± 2.1 mm2. Following IVL, OCT revealed calcium fractures in 40 out of 54 (74.1%) CNs with an average of 1.05 ± 0.72 fractures per CN. Fractures were predominantly observed at the base of the CN (80%). Post IVL, the mean MLA at CN increased to 4.9 ± 2.3 mm2. After PCI, the mean MSA at the CN was 7.9 ± 2.5 mm2. Optimal stent expansion (stent expansion >80%) at the CN was achieved in 85.71% of patients. All patients remained free from MACE during hospitalization and at the 30-day follow-up. At 1-year follow-up, all-cause death had occurred in 3 (14.3%) patients. This single-arm study demonstrated the safety, efficacy, and utility of the IVL in a subset of patients with non-eruptive calcified nodules. In this study, minimal procedural complications, excellent lesion modifications, and favorable 30-day and 1-year outcomes were observed.

Hybrid strategy of drug-eluting stent and drug-coated balloon in the treatment of de novo coronary artery disease: 1-year clinical outcomes.

The hybrid strategy of drug-eluting stent (DES) and drug-coated balloon (DCB) has been increasingly accepted for the treatment of de novo coronary artery disease. However, data regarding the clinical outcome of this practice in a Southeast Asian population are limited. We aimed to investigate the safety and clinical outcome of this hybrid strategy (DES and DCB) in the treatment of de novo coronary artery disease. The primary endpoint was target lesion failure (TLF) in the DES/DCB-treated segment at 12 months. TLF is defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR) in the DES- and/or DCB-treated segment. A total of 401 patients with 458 lesions were treated with the hybrid strategy at the National Heart Institute (IJN), Kuala Lumpur, Malaysia, from 1 July 2021 to 30 June 2022, were retrospectively enrolled in the study. A total of 38 patients (9.5%) were lost to subsequent follow-up, and the remaining 363 patients (90.5%) were included in the outcome analysis. Clinical outcomes at 1 year were analysed. In all, 219 lesions (47.8%) involved the left anterior descending artery, 146 lesions (31.9%) involved the right coronary artery, and 57 lesions (12.4%) involved the left circumflex artery. In all, 87 lesions (19%) were bifurcation lesions. A total of 8 patients (2.2%) had TLF, of whom 3 patients (0.83%) had TVMI, 3 patients (0.83%) had ID-TLR, and 2 patients (0.6%) experienced cardiac death. Four patients died of a non-cardiac cause at 1-year follow-up. A hybrid strategy of DES and DCB for the treatment of de novo coronary artery lesions appears to be feasible and clinically safe according to the 1-year outcomes.

Optical coherence tomography predictors of clinical outcomes after stent implantation: the ILUMIEN IV trial.

Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial. ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions. A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P < .0001) and proximal edge dissection (hazard ratio 1.77, 95% confidence interval 1.20-2.62, P = .004). The independent predictors of cardiac death or TV-MI were smaller minimal stent area and longer stent length; of ID-TLR were smaller intra-stent flow area and proximal edge dissection; and of stent thrombosis was smaller minimal stent expansion. In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length.

Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent

Modern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI). The INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients. The INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.

Long-term clinical outcomes of image-guided percutaneous coronary intervention in acute myocardial infarction from the Korea Acute Myocardial Infarction Registry.

Imaging modalities for percutaneous coronary intervention (PCI), such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT), have increased in the current PCI era. However, their clinical benefits in acute myocardial infarction (AMI) have not been fully elucidated. This study investigated the long-term outcomes of image-guided PCI in patients with AMI using data from the Korean Acute Myocardial Infarction Registry. A total of 9,271 patients with AMI, who underwent PCI with second-generation drug-eluting stents between November 2011 and December 2015, were retrospectively examined, and target lesion failure (TLF) at 3 years (defined as the composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was evaluated. From the registry, 2,134 patients (23.0%) underwent image-guided PCI (IVUS-guided: n = 1,919 [20.6%]; OCT-guided: n = 215 patients [2.3%]). Based on propensity score matching, image-guided PCI was associated with a significant reduction in TLF (hazard ratio: 0.76; 95% confidence interval: 0.59-0.98, p = 0.035). In addition, the TLF incidence in the OCT-guided PCI group was comparable to that in the IVUS-guided PCI group (5.3% vs 4.7%, p = 0.903). Image-guided PCI, including IVUS and OCT, is associated with favorable clinical outcomes in patients with AMI at 3 years post-intervention. Additionally, OCT-guided PCI is not inferior to IVUS-guided PCI in patients with AMI.

Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions.

The use of multiple overlapping stents for long lesions in tapered coronary arteries has been associated with poor outcomes. This study was conducted to evaluate the 3-year safety and performance of the BioMime™ Morph sirolimus-eluting stent (SES) in very long (length 30 to ≤ 56 mm) coronary lesions in native coronary arteries with a reference vessel diameter of 2.25 to 3.50 mm. This was a prospective, single-center, observational, real-world, post-marketing surveillance study. Eligible patients were implanted with BioMime™ Morph SES. Patients were followed up at 6, 12, 24, and 36 months. A total of 88 patients were enrolled in the study. The mean age was 58.72 ± 10.10 years and 82.95% were male. Most patients had angina (81.82%) and ischemic heart disease (78.41%), and there was a high prevalence of comorbidities like diabetes mellitus (59.09%), and hypertension (54.55%). A total of 92 long coronary de novo lesions were treated with BioMime™ Morph SES with an average stent length of 45.54 ± 10.20 mm. Device and procedural success rates were 100%. One patient died at 30 days and one case of myocardial infarction was recorded. The cumulative rates of major adverse cardiovascular events (MACEs) at 6, 12, 24, and 36 months were 3.41%, 6.82%, 7.95%, and 7.95%, respectively. There were no cases of stent thrombosis (ST), ischemia-driven target vessel revascularization, or ischemia-driven target lesion revascularization until 36 months of follow-up. BioMime™ Morph SES showed favorable outcomes up to 3 years in treating very long coronary lesions in native coronary arteries, as demonstrated by an acceptable rate of MACEs and absence of ST, based on clinical outcomes up to 3 years.

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.

Physiological Assessment with iFR prior to FFR Measurement in Left Main Disease

Despite guideline-based recommendation of the interchangeable use of instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) to guide revascularization decision-making, iFR/FFR could demonstrate different physiological or clinical outcomes in some specific patient or lesion subsets. Therefore, we sought to investigate the impact of difference between iFR and FFR-guided revascularization decision-making on clinical outcomes in patients with left main disease (LMD). In this international multicenter registry of LMD with physiological interrogation, we identified 275 patients in whom physiological assessment was performed with both iFR/FFR. Major adverse cardiovascular event (MACE) was defined as a composite of death, non-fatal myocardial infarction, and ischemia-driven target lesion revascularization. The receiver-operating characteristic analysis was performed for both iFR/FFR to predict MACE in respective patients in whom revascularization was deferred and performed. In 153 patients of revascularization deferral, MACE occurred in 17.0% patients. The optimal cut-off values of iFR and FFR to predict MACE were 0.88 (specificity:0.74; sensitivity:0.65) and 0.76 (specificity:0.81; sensitivity:0.46), respectively. The area under the curve (AUC) was significantly higher for iFR than FFR (0.74; 95%CI 0.62–0.85 vs. 0.62; 95%CI 0.48–0.75; p = 0.012). In 122 patients of coronary revascularization, MACE occurred in 13.1% patients. The optimal cut-off values of iFR and FFR were 0.92 (specificity:0.93; sensitivity:0.25) and 0.81 (specificity:0.047; sensitivity:1.00), respectively. The AUCs were not significantly different between iFR and FFR (0.57; 95%CI 0.40–0.73 vs. 0.46; 95%CI 0.31–0.61; p = 0.43). While neither baseline iFR nor FFR was predictive of MACE in patients in whom revascularization was performed, iFR-guided deferral seemed to be safer than FFR-guided deferral.Graphical abstractImpact of Physiological Assessment with iFR and FFR on Clinical Outcomes of Patients with LMD. In the present study, physiological assessment, both with iFR and FFR, provided a high predictability of adverse cardiovascular event in LMD patients with revascularization deferral. Furthermore, the iFR-guided deferral strategy was safer as compared to FFR. Conversely, in patients in whom revascularization was performed for LMD, neither iFR nor FFR was predictive of cardiovascular event. AUC: area under the curve; FFR: fractional flow reserve; iFR: instantaneous wave-free ratio; LMD: left main coronary artery disease.