Cardiology

Vemmou, E., Quadros, A.S., Dens, J.A., Rafeh, N.A., Agostoni, P., Alaswad, K., Avran, A., Bellli, K.C., Carlino, M., Choi, J.W., El-Guindy, A., Jaffer, F.A., Karmpaliotis, D., Khatri, J.J., Khelimskii, D., Knaapen, P., La Manna, A., Krestyaninov, O., Lamelas, P., Ojeda, S., Padilla, L., Pan, M., Piccaro de Oliveira, P., Rinfret, S., Spratt, J.C., Tanabe, M., Walsh, S., Nikolakopoulos, I., Karacsonyi, J., Rangan, B.V., Brilakis, E.S. and Azzalini, L. (2021). “In-Stent CTO Percutaneous Coronary Intervention: Individual Patient Data Pooled Analysis of 4 Multicenter Registries.” JACC Cardiovasc Interv May 19;S1936-8798(21)00677-4. [Epub ahead of print].

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OBJECTIVES: The authors sought to examine the outcomes of percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) chronic total occlusions (CTOs). BACKGROUND: The outcomes of PCI for ISR CTOs have received limited study. METHODS: The authors examined the clinical and angiographic characteristics and procedural outcomes of 11,961 CTO PCIs performed in 11,728 patients at 107 centers in Europe, North America, Latin America, and Asia between 2012 and 2020, pooling patient-level data from 4 multicenter registries. In-hospital major adverse cardiovascular events (MACE) included death, myocardial infarction, stroke, and tamponade. Long-term MACE were defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization. RESULTS: ISR represented 15% of the CTOs (n = 1,755). Patients with ISR CTOs had higher prevalence of diabetes (44% vs. 38%; p < 0.0001) and prior coronary artery bypass graft surgery (27% vs. 24%; p = 0.03). Mean J-CTO (Multicenter CTO Registry in Japan) score was 2.32 ± 1.27 in the ISR group and 2.22 ± 1.27 in the de novo group (p = 0.01). Technical (85% vs. 85%; p = 0.75) and procedural (84% vs. 84%; p = 0.82) success was similar for ISR and de novo CTOs, as was the incidence of in-hospital MACE (1.7% vs. 2.2%; p = 0.25). Antegrade wiring was the most common successful strategy, in 70% of ISR and 60% of de novo CTOs, followed by retrograde crossing (16% vs. 23%) and antegrade dissection and re-entry (15% vs. 16%; p < 0.0001). At 12 months, patients with ISR CTOs had a higher incidence of MACE (hazard ratio: 1.31; 95% confidence intervals: 1.01 to 1.70; p = 0.04). CONCLUSIONS: ISR CTOs represent 15% of all CTO PCIs and can be recanalized with similar success and in-hospital MACE as de novo CTOs.

Karacsonyi, J., Alaswad, K., Choi, J.W., Vemmou, E., Nikolakopoulos, I., Poommipanit, P., Rafeh, N.A., ElGuindy, A., Ungi, I., Egred, M. and Brilakis, E.S. (2021). “Laser for balloon uncrossable and undilatable chronic total occlusion interventions.” Int J Cardiol May 19;S0167-5273(21)00827-5. [Epub ahead of print].

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BACKGROUND: There is limited information on use of laser in complex percutaneous coronary interventions (PCI). We examined the impact of laser on the outcomes of balloon uncrossable and balloon undilatable chronic total occlusions (CTO) PCI. METHODS: We reviewed baseline clinical and angiographic characteristics and procedural outcomes of 4845 CTO PCIs performed between 2012 and 2020 at 32 centers. RESULTS: Of the 4845 CTO lesions, 752 (15.5%) were balloon uncrossable (523 cases) or balloon undilatable (356 cases) and were included in this analysis. Mean patient age was 66.9 ± 10 years and 83% were men. Laser was used in 20.3% of the lesions. Compared with cases in which laser was not used, laser was more commonly used in longer length occlusions (33 [21, 50] vs. 25 [15, 40] mm, p = 0.0004) and in-stent restenotic lesions (41% vs. 20%, p < 0.0001). Laser use was associated with higher technical (91.5% vs. 83.1%, p = 0.010) and procedural (88.9% vs. 81.6%, p = 0.033) success rates and similar incidence of major adverse cardiac events (3.92% vs. 3.51%, p = 0.805). Laser use was associated with longer procedural (169 [109, 231] vs. 130 [87, 199], p < 0.0001) and fluoroscopy time (64 [40, 94] vs. 50 [31, 81], p = 0.003). CONCLUSIONS: In a contemporary, multicenter registry balloon uncrossable and balloon undilatable lesions represented 15.5% of all CTO PCIs. Laser was used in approximately one-fifth of these cases and was associated with high technical and procedural success and similar major complication rates.

Shahim, B., Malaisrie, S.C., George, I., Thourani, V.H., Biviano, A.B., Russo, M.J., Brown, D.L., Babaliaros, V., Guyton, R.A., Kodali, S.K., Nazif, T.M., McCabe, J.M., Williams, M.R., Généreux, P., Lu, M., Yu, X., Alu, M.C., Webb, J.G., Mack, M.J., Leon, M.B. and Kosmidou, I. (2021). “Atrial Fibrillation and Outcomes After Transcatheter or Surgical Aortic Valve Replacement (from the PARTNER 3 Trial).” Am J Cardiol 148: 116-123.

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The prognostic impact of preexisting atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis treated with transcatheter (TAVR) or surgical aortic valve replacement (SAVR) remains unknown. In this sub-analysis of the PARTNER 3 trial of patients with severe aortic stenosis at low surgical risk randomized 1:1 to TAVR versus SAVR, clinical outcomes were analyzed at 2 years according to AF status. Among 948 patients included in the analysis (452 [47.7%] in the SAVR vs 496 [52.3%] in the TAVR arm), 168 (17.6%) patients had AF [88/452 (19.5%) and 80/496 (16.1%) treated with SAVR and TAVR, respectively]. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke or rehospitalization (21.2% vs 12.9%, p = 0.007) and rehospitalization alone (15.3% vs 9.4%, p = 0.03) but not all cause death (3.8% vs 2.6%, p = 0.45) or stroke (4.8% vs 2.6%, p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke or rehospitalization (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.20-2.71, p = 0.0046) and rehospitalization alone (HR 1.8, 95% CI 0.12-2.9, p = 0.015), but not death or stroke. There was no interaction between treatment modality and AF on the composite outcome (Pinter = 0.83). In conclusion, preexisting AF in patients with severe AS at low surgical risk was associated with increased risk of the composite outcome of death, stroke or rehospitalization at 2 years, irrespective of treatment modality.

Lansky, A.J., Makkar, R., Nazif, T., Messé, S., Forrest, J., Sharma, R., Schofer, J., Linke, A., Brown, D., Dhoble, A., Horwitz, P., Zang, M., DeMarco, F., Rajagopal, V., Dwyer, M.G., Zivadinov, R., Stella, P., Rovin, J., Parise, H., Kodali, S., Baumbach, A. and Moses, J. (2021). “A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial.” Eur Heart J May 17;ehab213. [Epub ahead of print].

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AIMS : The REFLECT I trial investigated the safety and effectiveness of the TriGuard™ HDH (TG) cerebral embolic deflection device in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS : This prospective, multicentre, single-blind, 2:1 randomized (TG vs. no TG) study aimed to enrol up to 375 patients, including up to 90 roll-in patients. The primary combined safety endpoint (VARC-2 defined early safety) at 30 days was compared with a performance goal. The primary efficacy endpoint was a hierarchical composite of (i) all-cause mortality or any stroke at 30 days, (ii) National Institutes of Health Stroke Scale (NIHSS) worsening at 2-5 days or Montreal Cognitive Assessment worsening at 30 days, and (iii) total volume of cerebral ischaemic lesions detected by diffusion-weighted magnetic resonance imaging at 2-5 days. Cumulative scores were compared between treatment groups using the Finkelstein-Schoenfeld method. A total of 258 of the planned, 375 patients (68.8%) were enrolled (54 roll-in and 204 randomized). The primary safety outcome was met compared with the performance goal (21.8% vs. 35%, P < 0.0001). The primary hierarchical efficacy endpoint was not met (mean efficacy score, higher is better: -5.3 ± 99.8 TG vs. 11.8 ± 96.4 control, P = 0.31). Covert central nervous system injury was numerically lower with TG both in-hospital (46.1% vs. 60.3%, P = 0.0698) and at 5 days (61.7 vs. 76.2%, P = 0.054) compared with controls. CONCLUSION : REFLECT I demonstrated that TG cerebral protection during TAVR was safe in comparison with historical TAVR data but did not meet the predefined effectiveness endpoint compared with unprotected TAVR controls.

Agarwala, A., Quispe, R., Goldberg, A.C. and Michos, E.D. (2021). “Bempedoic Acid for Heterozygous Familial Hypercholesterolemia: From Bench to Bedside.” Drug Des Devel Ther 15: 1955-1963.

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Bempedoic acid is a first-in-class, oral, inhibitor of cholesterol biosynthesis that is approved for use in patients with atherosclerotic cardiovascular disease (ASCVD) and for primary prevention in individuals with heterozygous familial hypercholesterolemia (HeFH) by the United States Food and Drug Administration. Pooled data from the phase III clinical trials, CLEAR Harmony and CLEAR Wisdom, have demonstrated the safety and efficacy of bempedoic acid with regard to lowering of low-density lipoprotein cholesterol (LDL-C) in patients with HeFH as an adjunct or alternative to currently existing lipid-lowering therapies. CLEAR Outcomes is a cardiovascular outcomes trial that is currently underway that will provide additional insight as to where bempedoic acid will fit into treatment regimens among the non-statin lipid-lowering therapy options. Patients who might particularly benefit from bempedoic acid are those with HeFH and those unable to take adequate doses of statins or take any statin therapy altogether who need additional LDL-C lowering. In this review, we will discuss the profile of bempedoic acid from its design, development, and its place in therapy for the management of LDL-C for the purposes of ASCVD prevention