A review of therapeutic approaches for post-infarction left ventricular remodeling.

Left ventricular remodeling is an adaptive process initially developed in response to acute myocardial infarction (AMI), but it ends up with negative adverse outcomes such as infarcted wall thinning, ventricular dilation, and cardiac dysfunction. A prolonged excessive inflammatory reaction to cardiomyocytes death and necrosis plays the crucial role in the pathophysiological mechanisms. The pharmacological treatment includes nitroglycerine, ß-blockers, ACEi/ARBs, SGLT2i, mineralocorticoid receptor antagonists, and some miscellaneous aspects. Stem cells therapy, CD34+ cells transplantation and gene therapy constitute the promissing therapeutic approaches for post AMI cardiac remodeling, thereby enhancing angiogenesis, cardiomyocytes differenciation and left ventricular function on top of inhibiting apoptosis, inflammation, and collagen deposition. All these lead to reduce infarct size, scar formation and myocardial fibrosis.

Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction: The PiCSO-AMI-I Trial.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) has improved clinical outcomes in patients with ST-segment-elevation myocardial infarction. However, as many as 50% of patients still have suboptimal myocardial reperfusion and experience extensive myocardial necrosis. The PiCSO-AMI-I trial (Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I) evaluated whether PiCSO therapy can further reduce myocardial infarct size (IS) in patients undergoing pPCI. METHODS: Patients with anterior ST-segment-elevation myocardial infarction and Thrombolysis in Myocardial Infarction flow 0-1 were randomized at 16 European centers to PiCSO-assisted pPCI or conventional pPCI. The PiCSO Impulse Catheter (8Fr balloon-tipped catheter) was inserted via femoral venous access after antegrade flow restoration of the culprit vessel and before proceeding with stenting. The primary end point was the difference in IS (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance. Secondary end points were the extent of microvascular obstruction and intramyocardial hemorrhage at 5 days and IS at 6 months. RESULTS: Among 145 randomized patients, 72 received PiCSO-assisted pPCI and 73 conventional pPCI. No differences were observed in IS at 5 days (27.2%±12.4% versus 28.3%±11.45%; P=0.59) and 6 months (19.2%±10.1% versus 18.8%±7.7%; P=0.83), nor were differences between PiCSO-treated and control patients noted in terms of the occurrence of microvascular obstruction (67.2% versus 64.6%; P=0.85) or intramyocardial hemorrhage (55.7% versus 60%; P=0.72). The study was prematurely discontinued by the sponsor with no further clinical follow-up beyond 6 months. However, up to 6 months of PiCSO use appeared safe with no device-related adverse events. CONCLUSIONS: In this prematurely discontinued randomized trial, PiCSO therapy as an adjunct to pPCI did not reduce IS when compared with conventional pPCI in patients with anterior ST-segment-elevation myocardial infarction. PiCSO use was associated with increased procedural time and contrast but no increase in adverse events up to 6 months. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03625869.

Snare technique failure in extracting an embolized coronary sinus reducer to the pulmonary artery.

We report the case of a 79-year-old male patient who benefited from the implantation of a coronary sinus reducer (CSR) (Reducer; Neovasc, Inc.) in the management of typical angina with mild exertion with optimal medical treatment.

Survival outcomes of TAVR and self-expanding versus balloon-expandable valves in patients with advanced cardiac dysfunction.

AIMS: There is a growing body of literature on long-term outcomes post-transcatheter aortic valve replacement (TAVR), but to our knowledge, few research have focused on patients with advanced cardiac dysfunction. This challenging category of patients was excluded from the Partner 3 clinical trial. There are no data to guide the choice of valve type in patients with severely depressed ejection fraction. This study evaluates the safety, efficacy, and outcomes of TAVR in patients with severe aortic stenosis and left ventricular ejection fraction (LVEF) ≤ 35%. It compares post-TAVR survival outcomes with self-expanding (SEV) versus balloon-expandable (BEV) valves in the context of cardiac dysfunction. METHODS AND RESULTS: A retrospective cohort was conducted on 977 patients who underwent TAVR at Toulouse University Hospital between January 2016 and December 2020. The study population included two groups: LVEF ≤ 35% (N = 157) and LVEF ≥ 50% (N = 820). The group of LVEF ≤ 35% was divided into two subgroups according to the type of implanted device: self-expanding (N = 66) versus balloon-expandable (N = 91). The living status of each of study's participants was observed in December 2022. Patients with low ejection fraction were younger (82 vs. 84.6 years) and commonly males (71.3% vs. 45.6%). Procedural success was almost 98% in both study groups (97.5% vs. 97.9%). The prevalence of all in-hospital post-TAVR complications [acute kidney injury (3.8% vs. 2.2%), major bleeding events (2.5% vs. 3.2%), stroke (1.3% vs. 1.6%), pacemaker implantation (10.2% vs. 10.7%), major vascular complication (4.5% vs. 4.5%), new onset atrial fibrillation (3.2% vs. 3.4%), and in-hospital death (3.2% vs. 2.8%)] were similar between groups (LVEF ≤ 35% vs. LVEF ≥ 50%). No difference in long-term survival has been revealed over 3.4 years (P = 0.268). In patients with LVEF ≤ 35%, except for post-TAVR mean aortic gradient (7.8 ± 4.2 vs. 10.2 ± 3.6), baseline and procedural characteristics were comparable between SEV versus BEV subgroups. An early improvement in LVEF (from 29.2 ± 5.5 to 37.4 ± 10.8) was observed. In patients with LVEF ≤ 35%, the all-cause mortality rate was significantly higher in BEV than that in SEV subgroups, respectively (40.7% vs. 22.7%, P = 0.018). Kaplan-Meier curve showed better survival outcomes after SEV implantation (P = 0.032). A Cox regression identified BEV as independent predictor of mortality [HR = 3.276, 95% CI (1.520-7.060), P = 0.002]. CONCLUSIONS: In the setting of low LVEF, TAVR remains a safe and effective procedure not associated with an increased risk of complications and mortality. SEV implantation may likely result in superior survival outcomes in patients with advanced cardiac dysfunction.

A review of the conservative versus invasive management of ischemic heart failure with reduced ejection fraction.

Heart failure is increasing in terms of prevalence, morbidity, and mortality rates. Clinical trials and studies are focusing on heart failure as it is the destiny end-stage for several cardiovascular disorders. Recently, medical therapy has dramatically progressed with novel classes of medicines providing better quality of life and survival outcomes. However, heart failure remains a heavy impactful factor on societies and populations. Current guidelines from the American and European cardiac societies are not uniform with respect to the class and level of treatment recommendations for coronary artery disease patients with heart failure and reduced ejection fraction. The discrepancy among international recommendations, stemming from the lack of evidence from adequately powered randomized trials, challenges physicians in choosing the optimal strategy. Hybrid therapy including optimal medical therapy with revascularization strategies are commonly used for the management of ischemic heart failure. Coronary artery bypass graft (CABG) has proved its efficacy on improving long term outcome and prognosis while no large randomized clinical trials for percutaneous coronary intervention (PCI) are still available. Regardless of the lack of data and recommendations, the trends of performing PCI in ischemic heart failure prevailed over CABG whereas lesion complexity, chronic total occlusion and complete revascularization achievement are limiting factors. Lastly, regenerative medicine seems a promising approach for advanced heart failure enhancing cardiomyocytes proliferation, reverse remodeling, scar size reduction and cardiac function restoration.

Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial.

BACKGROUND: The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in non-left main true bifurcations. AIMS: This study aimed to investigate the 5-year clinical results of the EBC TWO Trial. METHODS: A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. Inclusion criteria required a side branch diameter ≥2.5 mm and side branch lesion length >5 mm. Five-year follow-up was completed for 197 patients. The primary endpoint was the composite of all-cause mortality, myocardial infarction, or target vessel revascularisation. RESULTS: The mean side branch stent diameter was 2.7±0.3 mm and mean side branch lesion length was 10.3±7.2 mm. At 5-year follow-up, the primary endpoint occurred in 18.4% of provisional and 23.7% of systematic culotte patients (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.41-1.38). No significant differences were identified individually for all-cause mortality (7.8% vs 7.2%, HR 1.11, 95% CI: 0.40-3.05), myocardial infarction (8.7% vs 13.4%, HR 0.64, 95% CI: 0.27-1.50) or target vessel revascularisation (6.8% vs 9.3%, HR 1.12, 95% CI: 0.37-3.34). Stent thrombosis rates were also similar (1.9% vs 3.1%, HR 0.63, 95% CI: 0.11-3.75). There was no significant interaction between the extent of side branch disease and the primary outcome (p=0.34). CONCLUSIONS: In large non-left main true bifurcation lesions, the use of a systematic culotte strategy showed no benefit over provisional stenting for the composite outcome of all-cause mortality, myocardial infarction, or target vessel revascularisation at 5 years. The stepwise provisional approach may be considered preferable for the majority of true coronary bifurcation lesions. CLINICALTRIALS: gov: NCT01560455.

Outcomes of Provisional Stenting With Versus Without Side Branch Intervention in Patients With Bifurcation Lesion-Related ST-Segment Elevation Myocardial Infarction.

To date, the best approach to coronary bifurcation lesion remains unsettled, and the parameters to guide side branch ballooning or stenting are not yet defined. This study aimed to compare the survival outcomes after provisional stenting with versus without side branch intervention. A cohort was conducted on 132 patients who underwent coronary angiography at Toulouse University Hospital for ST-segment elevation myocardial infarction with large culprit nonleft main coronary bifurcation lesion. Study participants were divided into 2 groups depending on the performance or not of a side branch intervention. We observed the living status at 1-year after hospital discharge. Side branch intervention by balloon inflation or final balloon kissing technique was performed in 34.1% of study participants. At 1-year follow-up, the incidence of all-cause mortality was 7.8 per 100 person-years (95% confidence interval [CI] 4.1 to 15), and although it seemed higher in the side branch intervention group (10 per 100 person-years [95% CI 3.8 to 26.7] vs 6.6 per 100 persons-years [95% CI 2.8 to 15.9]), the survival analyses showed no differences in survival outcomes (hazard ratio side branch intervention 1.55 [0.42 to 5.78], p = 0.513). In conclusion, in the setting of a coronary bifurcation causing ST-segment elevation myocardial infarction, simple provisional stenting without side branch intervention showed a low mortality rate and no differences in the 1-year survival outcomes.

Comparison of Paravalvular Leak in SAPIEN 3 and EVOLUT PRO Valves in Transcatheter Aortic Valve Replacement: A Multicenter Registry.

Paravalvular leak (PVL), conduction disturbances, and vascular complications remain the most common complications after TAVR. To address these adverse outcomes, the third generation of transcatheter heart valves has been developed. The last generation prosthesis provides an outer pericardial wrap for enhanced sealing and PVL prevention. This study aimed to compare the incidence and severity of PVL and 1-year survival after TAVR using SAPIEN 3 with those using EVOLUT PRO. An observational retrospective analysis was conducted in 1,481 patients who underwent TAVR for symptomatic severe aortic stenosis in 6 different European centers. The primary end point was to assess the frequency and severity of PVL at 30 days after TAVR. The secondary end point was to compare 1-year survival using EVOLUT PRO with that using SAPIEN 3. SAPIEN 3 transcatheter heart valve was implanted in 78.3% of study participants (n = 1,160) whereas EVOLUT PRO was implanted in 21.7% (n = 321). PVL is more commonly observed in patients treated with EVOLUT PRO at prehospital discharge (55.1% vs 37.3%) and at 1-month (51% vs 41.4%) and 1-year (51.3% vs 39.3%) follow-up. This difference mainly concerns low-grade (mild/trace) PVL. The frequency of high-degree (moderate/severe) PVL was almost similar in both groups throughout the study period (5.3% vs 5.8% before hospital discharge, 4% vs 3.1% at 1 month, and 3.2% vs 4.9% at 1 year). No significant difference in survival over 1 year has been observed (hazard ratio 0.73 [0.33 to 1.63], p = 0.442) (Graphical abstract). In conclusion, the detection rate of PVL after TAVR with third-generation heart valves remains high, and there are no major differences between the devices regarding the frequency of significant (moderate/severe) PVL and survival.

Effect of causative genetic variants on atherosclerotic cardiovascular disease in heterozygous familial hypercholesterolemia patients.

Background: Heterozygous familial hypercholesterolemia (HFH) is an autosomal dominant genetic disorder leading to a lifetime exposure to high low-density lipoprotein cholesterol (LDL-c) level and an increased risk of premature atherosclerotic cardiovascular disease (ASCVD). We evaluate the effect of a causative genetic variant to predict ASCVD in HFH patients undergoing treatment. Materials and methods: A retrospective cohort was conducted on 289 patients with possible, probable, and definite diagnosis of HFH according to Dutch Lipid Clinic Network Score and in whom DNA analyses were performed and mean LDL-c level was above 155 mg/dl. The study population was divided into groups based on the presence or not of a causative variant (pathogenic or likely pathogenic). We observed each of the study's participants for the occurrence of ASCVD. Results: A causative variant was detected in 42.2% of study participants, and ASCVD has occurred in 21.5% of HFH patients. The incidence of ASCVD (27% vs. 17.4%, p = 0.048) and the mean of LDL-c under an optimal medical treatment (226 ± 59 mg/dl vs. 203 ± 37 mg/dl, p = 0.001) were higher in HFH-causative variant carriers than others. After adjusting on confounders, ASCVD was positively associated with LDL-c level [OR = 2.347; 95% (1.305-4.221), p = 0.004] and tends toward a negative association with HDL-c level [OR = 0.140; 95% (0.017-1.166), p = 0.059]. There is no more association between the detection of a causative variant and the occurrence of ASCVD [OR = 1.708; 95% (0.899-3.242), p = 0.102]. Kaplan Meier and log rank test showed no significant differences in event-free survival analysis between study groups (p = 0.523). Conclusion: In this study population under medical care, it seems that the presence of a causative variant did not represent an independent predictor of adverse cardiovascular outcomes in HFH patients, and LDL-c level played an undisputable causal role.

Mortality rate after coronary revascularization in heart failure patients with coronary artery disease.

AIMS: Coronary artery disease (CAD) is a common cause of heart failure (HF). It remains unclear who, when and why to direct towards coronary revascularization. The outcomes of coronary revascularization in HF patients are still a matter of debate nowadays. This study aims to evaluate the effect of revascularization strategy on all-cause of death in the context of ischaemic HF. METHODS AND RESULTS: An observational cohort was conducted on 692 consecutive patients who underwent coronary angiography at the University Hospital of Toulouse between January 2018 and December 2021 for either a recent diagnosis of HF or a decompensated chronic HF, and in whom coronary angiograms showed at least 50% obstructive coronary lesion. The study population was divided into two groups according to the performance or not of a coronary revascularization procedure. The living status (alive or dead) of each of the study's participants was observed by April 2022. Seventy-three per cent of the study population underwent coronary revascularization either by percutaneous coronary intervention (66.6%) or coronary artery bypass grafting (6.2%). Baseline characteristics including age, sex and cardiovascular risk factors did not differ between the invasive and conservative groups, respectively. Death occurred in 162 study participants resulting in an all-cause mortality rate of 23.5%; 26.7% of observed deaths have occurred in the conservative group versus 22.2% in the invasive group (P = 0.208). No difference in survival outcomes has been observed over a mean follow-up period of 2.5 years (P = 0.140) even after stratification by HF categories (P = 0.132) or revascularization modalities (P = 0.366). CONCLUSIONS: Findings from the present study showed comparable all-cause mortality rates between groups. Coronary revascularization does not modify short-term survival outcomes in HF patients compared with optimal medical therapy alone outside the setting of acute coronary syndrome.

Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group.

Since the publication of the 2015 EAPCI consensus on rotational atherectomy, the number of percutaneous coronary interventions (PCI) performed in patients with severely calcified coronary artery disease has grown substantially. This has been prompted on one side by the clinical demand for the continuous increase in life expectancy, the sustained expansion of the primary PCI networks worldwide, and the routine performance of revascularization procedures in elderly patients; on the other side, the availability of new and dedicated technologies such as orbital atherectomy and intravascular lithotripsy, as well as the optimization of the rotational atherectomy system, has increased operators' confidence in attempting more challenging PCI. This current EAPCI clinical consensus statement prepared in collaboration with the EURO4C-PCR group describes the comprehensive management of patients with heavily calcified coronary stenoses, starting with how to use non-invasive and invasive imaging to assess calcium burden and inform procedural planning. Objective and practical guidance is provided on the selection of the optimal interventional tool and technique based on the specific calcium morphology and anatomic location. Finally, the specific clinical implications of treating these patients are considered, including the prevention and management of complications and the importance of adequate training and education.

Epidemiology, Pathophysiology, Diagnosis, and Principles of Management of Takotsubo Cardiomyopathy: A Review.

Takotsubo cardiomyopathy, also known as stress-induced cardiomyopathy, is a reversible syndrome commonly found among patients presenting for acute coronary syndromes, especially women. With the COVID-19 pandemic, the incidence of takotsubo cardiomyopathy was dramatically increased. However, this clinical cardiac entity remains underdiagnosed, largely due to the interplay with acute coronary syndrome. The pathophysiology of takotsubo cardiomyopathy is miscellaneous, including coronary vasospasm, microcirculatory dysfunction, catecholamine surge, and sympathetic overdrive. Diagnosing takotsubo cardiomyopathy requires a high index of clinical suspicion and multimodality tests. To date, there are no guidelines for the management of takotsubo cardiomyopathy. Thus, available data are derived from case series, retrospective analyses, and experts' opinions. Heart failure medicines were investigated in takotsubo cardiomyopathy patients. Evidence supports the benefits of angiotensin-converting enzyme inhibitors and angiotensin receptors blockers use on mortality and recurrence rates, while results from use of beta-blockers are controversial. In complicated cases, inotropes are preferred over vasopressors, except in the presence of left ventricular outflow tract obstruction, in which medical therapy is limited to fluids administration and beta-blockers. Use of oral vitamin K antagonist can benefit patients at high thrombo-embolic risk for up to 3 months. Mechanical supports are reserved for refractory hemodynamically unstable cases. This review aims to provide an update on the epidemiology, diagnosis, and outcomes of takotsubo cardiomyopathy, and an extended discussion on the management of complicated and non-complicated cases.

Spontaneous Coronary Artery Dissection: A Review of Epidemiology, Pathophysiology and Principles of Management.

Spontaneous coronary artery dissection (SCAD) is a sudden rupture of coronary artery wall leading to false lumen and intramural hematoma formation. It commonly occurs in young and middle-aged women lacking typical cardiovascular risk factors. Fibromuscular dysplasia and pregnancy are strongly associated with SCAD. To date, the "inside-out" and "outside-in" are the 2 proposed hypothesis for the pathogenesis of SCAD. Coronary angiography is the gold standard and first line diagnostic test. Three types of SCAD have been described according to coronary angiogram. Intracoronary imaging modalities are reserved for patients with ambiguous diagnosis or to guide percutaneous coronary intervention view the increased risk of secondary iatrogenic dissection. The management of SCAD includes conservative approach, coronary revascularization strategies accounting for percutaneous coronary intervention and coronary artery bypass graft, and long-term follow-up. The overall prognosis of patients with SCAD is favorable marked by a spontaneous healing in a large proportion of cases.

TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: The TIRATROP Study, A Randomized Controlled Trial.

BACKGROUND: Because rotational atherectomy (RA) is associated with arterial trauma and platelet activation, patients treated with RA may benefit from more potent antiplatelet drugs. The aim of this trial was to assess the superiority of ticagrelor over clopidogrel in reducing post procedure troponin release. METHODS: TIRATROP (TIcagrelor in Rotational Atherectomy to reduce TROPonin enhancement) is a multicenter double-blind randomized controlled trial that included 180 patients with severe calcified lesions requiring RA who received either clopidogrel (300 mg loading dose, then 75 mg/d) or ticagrelor (loading dose 180 mg then 90 mg twice daily). Blood samples were collected at the beginning (T0), and 6, 12, 18, 24 and 36 h after the procedure. Primary end point was troponin release within the first 24 h using area under the curve analysis (troponin level as a function of time). RESULTS: The mean age of patients was 76 ± 10 years, 35% had diabetes. RA was used to treat 1, 2 or 3 calcified lesions in 72%, 23% and 5% of patients, respectively. Troponin release within the first 24 h was similar in both the ticagrelor (adjusted mean ±SD of ln AUC 8.85 ± 0.33) and the clopidogrel (8.77 ± 0.34, p = 0.60) arms. Independent predictors for troponin enhancement were acute coronary syndrome presentation, renal failure, elevated C-Reactive protein and multiple lesions treated with RA. CONCLUSION: Troponin release did not differ among treatment arms. Our results suggest that greater platelet inhibition does not affect periprocedural myocardial necrosis in the setting of RA.

Comparison of in-hospital outcomes and long-term survival for valve-in-valve transcatheter aortic valve replacement versus the benchmark native valve transcatheter aortic valve replacement procedure.

Background: In recent years, the number of patients with failed surgically implanted aortic bioprostheses and the number of candidates for valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) have been increasing. Objectives: The purpose of this study is to evaluate the efficacy, safety, and long-term survival outcomes of VIV-TAVR compared with the benchmark native valve transcatheter aortic valve replacement (NV-TAVR). Methods: A cohort study was conducted on patients who underwent TAVR in the department of cardiology at Toulouse University Hospital, Rangueil, France between January 2016 and January 2020. The study population was divided into two groups: NV-TAVR (N = 1589) and VIV-TAVR (N = 69). Baseline characteristics, procedural data, in-hospital outcomes, and long-term survival outcomes were observed. Results: In comparison with NV-TAVR, there are no differences in TAVR success rate (98.6 vs. 98.8%, p = 1), per-TAVR complications (p = 0.473), and length of hospital stay (7.5 ± 50.7 vs. 4.4 ± 2.8, p = 0.612). The prevalence of in-hospital adverse outcomes did not differ among study groups, including acute heart failure (1.4 vs. 1.1%), acute kidney injury (2.6, 1.4%), stroke (0 vs. 1.8%, p = 0.630), vascular complications (p = 0.307), bleeding events (0.617), and death (1.4 vs. 2.6%). VIV-TAVR was associated with a higher residual aortic gradient [OR = 1.139, 95%CI (1.097-1.182), p = 0.001] and a lower requirement for permanent pacemaker implantation [OR = 0.235 95%CI (0.056-0.990), p = 0.048]. Over a mean follow-up period of 3.44 ± 1.67 years, no significant difference in survival outcomes has been observed (p = 0.074). Conclusion: VIV-TAVR shares the safety and efficacy profile of NV-TAVR. It also represents a better early outcome but a higher non-significant long-term mortality rate.

Comparison of outcomes in patients with or without ARC-HBR criteria undergoing PCI with polymer-free biolimus coated stents: The BioFreedom France study.

BACKGROUND: The polymer-free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all-comers' population. METHODS: We conducted a prospective single-arm study of patients undergoing percutaneous coronary intervention with the polymer-free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target-vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci-TLR) at 1-year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC-HBR definition. RESULTS: Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci-TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non-HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non-HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non-HBR group (relative risk 1.62 [95% confidence interval: 1.10-2.41], p = 0015). Compared to the non-HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci-TLR. BARC 3-5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non-HBR group (p < 0.0001). CONCLUSION: In this multicenter all-comers study, HBR patients treated with a polymer-free biolimus coated stent had, compared to non-HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3-5 bleeding.

Clinical Outcomes of Left Main Coronary Artery PCI With Rotational Atherectomy.

Data regarding rotational atherectomy percutaneous coronary intervention (RA PCI) angioplasty in the left main (LM) coronary artery are scarce, and mostly outdated. We aimed to describe clinical outcomes of RA PCI in LM. Patients requiring RA in 8 European countries and 19 centers were prospectively and consecutively included in the European registry of Cardiac Care of Calcified and Complex patients registry. In-hospital data collection and 1-year follow-up were performed for each patient. Between October 2016 and July 2018, 966 patients with complete data were included. Among them, 241 presented with an LM lesion, and 171 required an LM lesion preparation by RA. The latter, allocated to the LM-RA group, were compared with the 725 patients in the non-LM-RA group. Clinical success of the RA procedure was comparable in both groups, but in-hospital major adverse cardiac events were higher in the RA-LM group (7.6% vs 3.2%, adjusted p = 0.04), mainly driven by a higher in-hospital mortality rate (5.3 vs 0.3%, adjusted p = 0.005). At 1-year follow-up, mortality and major adverse cardiac event rates were comparable in both groups (12.9% vs 8.0%, adjusted p value: 0.821, and 15.8% vs 10.9%, adjusted p value: 0.329, respectively), but the rate of target vessel revascularization remained higher in the RA-LM group (5.3% vs 3.2%, adjusted p = 0.021). In conclusion, RA PCI is an efficient option for calcified LM lesions, providing acceptable outcomes regarding this population with high risk at 1 year, and yields comparable outcomes with RA PCI performed on non-LM lesions.