Cardiology

Packer, M. (2021). “Pitfalls in Using Estimated Glomerular Filtration Rate Slope as a Surrogate for the Effect of Drugs on the Risk of Serious Adverse Renal Outcomes in Clinical Trials of Patients With Heart Failure.” Circ Heart Fail 14(6): e008537.

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The rate of decline in eGFR is commonly assessed by the measurement of eGFR slope, but this calculation is fraught with methodological difficulties. Estimation of slope relies in statistical models that make assumptions about linearity and are typically skewed by values measured late in the course of follow-up. [No abstract; excerpt from article].

Agarwala, A. and Goldberg, A. (2021). “Special Considerations for Lipid-Lowering Therapy in Women Reflecting Recent Randomized Trials.” Curr Atheroscler Rep 23(8): 42.

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PURPOSE OF REVIEW: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in women across all racial and ethnic groups within the USA. Despite robust evidence from randomized controlled trials demonstrating that treatment of hypercholesterolemia in women reduces cardiovascular events, women who are eligible for lipid-lowering therapy are less likely than men to be prescribed guideline-recommended therapy or to have therapy prescribed at the appropriate intensity. RECENT FINDINGS: Historically, women have been underrepresented in clinical trials. Recent randomized clinical trials have shown that women derive similar benefits as men when treated with lipid-lowering therapy, and recent studies demonstrate potential uses for lipid-lowering therapies that extend beyond their previously well-established indications. In this review, we will discuss lipid-lowering therapies in the context of recent clinical trials with a focus on special considerations in women.

Szerlip, M., Spargias, K.S., Makkar, R., Kar, S., Kipperman, R.M., O’Neill, W.W., Ng, M.K.C., Smith, R.L., Fam, N.P., Rinaldi, M.J., Raffel, O.C., Walters, D.L., Levisay, J., Montorfano, M., Latib, A., Carroll, J.D., Nickenig, G., Windecker, S., Marcoff, L., Cohen, G.N., Schäfer, U., Webb, J.G. and Lim, D.S. (2021). “2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.” JACC Cardiovasc Interv May 7;S1936-8798(21)00675-0. [Epub ahead of print].

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OBJECTIVES: The study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis. BACKGROUND: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established. METHODS: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. RESULTS: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001). CONCLUSIONS: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.

Karmpaliotis, D., Stoler, R., Walsh, S., El-Jack, S., Potluri, S., Moses, J., Oldroyd, K., Banning, A., Webster, M., Zaman, A., Wu, W., Ahmed, M., Underwood, P. and Allocco, D. (2021). “Safety and efficacy of Everolimus-Eluting bioabsorbable Polymer-Coated stent in patients with long coronary lesions: The EVOLVE 48 study.” Catheter Cardiovasc Interv May 29. [Epub ahead of print].

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OBJECTIVES: The EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions. BACKGROUND: Clinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long-term data in a broad population of patients undergoing PCI. METHODS: Patients with lesion length >34- ≤44 mm and reference vessel diameter (RVD) ≥2.5- ≤ 4.0 mm were enrolled in this prospective, multicenter, single-arm study. The primary endpoint was 12-month target lesion failure (TLF; composite of target lesion revascularization [TLR], target-vessel myocardial infarction [TV-MI], or cardiac death) compared to a prespecified performance goal (PG). RESULTS: A total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre-TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One-year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV-MI in two patients treated with SYNERGY 48 mm stent. Between the 1-2-year timeframe, TV-MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years. CONCLUSIONS: PCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.

Lim, D.S., Smith, R.L., Zahr, F., Dhoble, A., Laham, R., Lazkani, M., Kodali, S., Kliger, C., Hermiller, J., Vora, A., Sarembock, I.J., Gray, W., Kapadia, S., Greenbaum, A., Rassi, A., Lee, D., Chhatriwalla, A., Shah, P., Rodés-Cabau, J., Ibrahim, H., Satler, L., Herrmann, H.C., Mahoney, P., Davidson, C., Petrossian, G., Guerrero, M., Koulogiannis, K., Marcoff, L. and Gillam, L. (2021). “Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.” Catheter Cardiovasc Interv May 18. [Epub ahead of print].

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OBJECTIVES: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001). CONCLUSIONS: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.