To Örebro University

BACKGROUND: Intravascular ultrasound (IVUS) guides deferral decision-making regarding the left main coronary artery (LMCA) and improves outcomes. Further studies regarding coronary physiology to guide revascularization in the LMCA are needed. Our aim was to evaluate the outcome of LMCA deferral using IVUS or coronary physiology via instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR).

METHODS: Between January 2014 and February 2022, patients undergoing evaluation with either IVUS or coronary physiology in the LMCA were included from the SWEDEHEART registry. Exclusion criteria were a minimum luminal area < 6 mm2, iFR ≤ 0.89, FFR ≤ 0.80, ad hoc percutaneous coronary intervention of lesions in the LMCA, proximal left anterior descending artery, and proximal circumflex artery, planned elective revascularization, and planned valvular surgery. The primary outcome was major adverse cardiac events (MACE), defined as a composite of all-cause death, myocardial infarction, and unplanned revascularization. Kaplan-Meier event rates and multivariable Poisson regression were used for the statistical analyses.

RESULTS: Deferral of revascularization in the LMCA was performed in 1552 patients, 33.6 % with IVUS and 66.4 % with coronary physiology (iFR 11.3 % vs. FFR 55.0 %). The median follow-up time was 2.7 years. No significant difference was seen in MACE (IVUS 40.2 % vs. coronary physiology 35.5 %; adjusted RR: 1.18; 95 %CI: 0.97-1.44; p = 0.09). The results were consistent across all investigated subgroups. The rate of all-cause death was higher in the IVUS group (adjusted RR: 1.38; 95 %CI: 1.03-1.83; p = 0.03).

CONCLUSIONS: Deferral of coronary revascularization in LMCA lesions using IVUS or coronary physiology did not differ in our combined endpoint. We observed a higher risk of all-cause death using IVUS.

BACKGROUND: While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking.

AIMS: We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI.

METHODS: In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months.

RESULTS: Selective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53).

CONCLUSIONS: Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI. (ClinicalTrials.gov: NCT03447834).

BACKGROUND: 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.

METHODS: 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.

FINDINGS: 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]).

INTERPRETATION: 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.

FUNDING: Elixir Medical.

BACKGROUND: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years.

METHODS: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here.

RESULTS: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85-1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96-1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups.

CONCLUSIONS: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin.

REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02311231.

In high-bleeding risk (HBR) patients, non-inferiority of 1-month dual antiplatelet therapy (APT) to treatment continuation for ≥2 additional months for the occurrence of net and major adverse clinical events after drug-eluting stent implantation was showed in the MASTER DAPT trial.1 A significant reduction in bleeding was also noted. However, whether these treatment effects of APT are consistent across geographical regions remains uncertain. In the present analyses, the effects of abbreviated or standard APT on the 1-year occurrence of net and major adverse clinical events and bleeding were consistent across geographical regions (Europe, East Asia, and others) [NCT03023020].

BACKGROUND: Lipid content in untreated nonobstructive coronary artery lesions is associated with adverse clinical outcomes, and residual in-stent or stent edge lipid may worsen outcomes after percutaneous coronary intervention (PCI).

METHODS: Near-infrared spectroscopy-intravascular ultrasound was performed before and after PCI in patients with myocardial infarction. We evaluated the impact of lipid assessed by near-infrared spectroscopy (maximal lipid core burden index over 4 mm [maxLCBI4mm]) along with intravascular ultrasound information including residual plaque burden on in-stent or edge-related major adverse cardiac events (MACE) in de novo PCI-treated culprit coronary artery lesions. The primary end point was culprit lesion-related MACE (CL-MACE), defined as cardiac death, myocardial infarction, or unstable or progressive angina either requiring revascularization or with rapid lesion progression and classified as in-stent or stent edge-related.

RESULTS: During a median follow-up of 3.8 years, 25 CL-MACE (11 stent edge-related, 13 in-stent, and 1 in-lesion without a stent) occurred in 1041 PCI-treated lesions in 768 patients. Pre-PCI or post-PCI measures of lipid content were not related to in-stent CL-MACE. However, stent edge-related CL-MACE was increased if both the post-PCI stent edge maxLCBI4mm was greater than the upper quartile (108.7) and the stent edge plaque burden was >50% (adjusted odds ratio, 4.11 [95% CI, 1.12-15.2]; P=0.03).

CONCLUSIONS: In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), CL stent implantation leaving behind greater stent edge-related lipid and uncovered plaque burden was associated with an increased risk of stent edge-related CL-MACE during follow-up. In contrast, CL lipid content was not related to in-stent CL-MACE.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02171065.

Background: Coronary bifurcation stenting is a debated topic in percutaneous coronary intervention (PCI). We explored the outcomes of PCI in proximal left anterior descending (LAD) coronary bifurcation lesions involving the first diagonal branch (D1).

Methods: The Swedish Coronary Angiography and Angioplasty Registry (SCAAR) was used to include all patients undergoing LAD-D1 bifurcation PCI from 2010 to 2020 in Sweden. Two groups were defined: simple PCI and complex PCI. The simple PCI group comprised patients with stent implantation involving only the proximal LAD, and complex PCI was defined as kissing balloon technique or a 2-stent approach of proximal LAD and D1. A multivariable Cox regression model was used to assess major adverse clinical events (MACE) after 1 year, defined as all-cause mortality or myocardial infarction (MI).

Results: A total of 2,007 patients underwent complex PCI and 4,789 simple PCI. The complex PCI group was slightly younger, more often male, and more often taking statins. At 1 year, MACE rates were lower in the complex PCI group (6.2% vs 7.9%; adjusted HR: 0.74; 95% CI: 0.59-0.93). The result was driven by lower rates of all-cause mortality (3.6% vs 5.0%; adjusted HR: 0.73; 95% CI: 0.54-0.98). No difference was observed in MI, target segment revascularization or coronary artery bypass graft surgery, definite stent thrombosis, bleeding and stroke.

Conclusions: Over a 5-year period, complex PCI of LAD/D1 bifurcation lesions was associated with better outcome than simple PCI in a routine clinical setting.

Categories: CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP).

BACKGROUND: Percutaneous coronary intervention (PCI) is frequently used for patients with chronic coronary syndrome (CCS). However, the role of PCI beyond symptom relief in CCS remains controversial. The objective of this study was to determine whether PCI is associated with better outcomes, compared with medical therapy (MT) alone.

METHODS: We conducted a retrospective cohort study. Using the Swedish Coronary Angiography and Angioplasty Registry, we included all patients with CCS undergoing coronary angiography in Sweden between 2010 and 2020. Two groups were formed based on treatment strategy: PCI+MT versus MT alone. One-to-one propensity score (PS) matching was used to address confounding. Outcome was assessed using matched win ratio analysis, a statistical method that ranks the components of the composite by clinical importance. The primary outcome was net adverse clinical event (NACE) within 5 years. In the win ratio analysis, the components of NACE were ranked as follows: (1) all-cause mortality, (2) myocardial infarction (MI), (3) bleeding and (4) urgent revascularisation. Secondary outcomes were the individual components of NACE, major adverse cardiovascular events (MACE) and cardiovascular mortality.

RESULTS: After PS matching, two groups of 7220 patients each were formed. The hierarchical outcome analysis of NACE and MACE showed that PCI was associated with improved outcome (matched win ratio: 1.28 (95% CI 1.20 to 1.36, p<0.001) and matched win ratio: 1.38 (95% CI 1.29 to 1.48, p<0.001), respectively). The use of PCI was associated with higher win ratio of MI (matched win ratio: 1.15, 95% CI 1.04 to 1.28, p=0.008), urgent revascularisation (matched win ratio: 1.85, 95% CI 1.69 to 2.03, p<0.001) and cardiovascular mortality (matched win ratio: 1.15, 95% CI 1.00 to 1.34, p=0.044). No difference in win ratio was observed for all-cause mortality or bleeding.

CONCLUSIONS: In this study, which sought to evaluate the outcomes of patients with CCS using a hierarchical approach, patients selected for revascularisation with PCI experienced better outcome compared with MT alone.

BACKGROUND AND AIMS: The long-term outcomes of percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel disease remain debated.

METHODS: The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry was used to analyse 57 097 revascularized patients with NSTEMI with multivessel disease in Sweden from January 2005 to June 2022. The primary endpoint was all-cause mortality, encompassing both in-hospital and long-term mortality; the secondary endpoints included myocardial infarction (MI), stroke, new revascularization, and heart failure. Multilevel logistic regression with follow-up time as a log-transformed offset variable and double-robust adjustment with the instrumental variable method were applied to control for known and unknown confounders.

RESULTS: Percutaneous coronary intervention was the primary therapy in 42 190 (73.9%) patients, while 14 907 (26.1%) received CABG. Percutaneous coronary intervention patients were generally older with more prior cardiovascular events, whereas CABG patients had higher incidences of diabetes, hypertension, left main and three-vessel disease, and reduced ejection fraction. Over a median follow-up of 7.1 years, PCI was associated with higher risks of death [adjusted odds ratio (aOR) 1.67; 95% confidence interval (CI) 1.54-1.81] and MI (aOR 1.51; 95% CI 1.41-1.62) but there was no significant difference in stroke. Repeat revascularization was three times more likely to PCI (aOR 3.01; 95% CI 2.57-3.51), while heart failure risk was 15% higher (aOR 1.15; 95% CI 1.07-1.25). Coronary artery bypass grafting provided longer survival within 15 years, especially in patients under 70 years of age, with left main disease or left ventricular dysfunction, though this benefit diminished over shorter time horizons. C

CONCLUSIONS: Coronary artery bypass grafting is associated with lower risks of mortality, MI, repeat revascularization, and heart failure in patients with NSTEMI, particularly in high-risk subgroups. However, its survival benefit lessens with shorter life expectancy.

BACKGROUND: 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).

METHODS: 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.

SUMMARY: 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.