Background: Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare‐metal and first‐generation drug‐eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer‐generation drug‐eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable‐polymer sirolimus‐eluting stent or a durable‐polymer everolimus‐eluting stent. Methods and Results: Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target‐lesion failure (TLF) (cardiac death, target‐vessel myocardial infarction, or target‐lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P =0.003) and stent thrombosis rates (2.1% versus 0.2%; P <0.0001), whereas target‐lesion revascularization was not different between the groups (5.0% versus 3.9%; P =0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89–2.08; P =0.148) but did for target‐vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03–2.68; P =0.037). TLF rates were similar between bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent (12.6% versus 15.4%, P =0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable‐polymer sirolimus‐eluting stent showed lower TLF (7.5% versus 10.3%, P =0.045). Conclusions: With newer‐generation drug‐eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target‐vessel myocardial infarction was higher. The bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent were equally effective and safe in calcified lesions. Registration: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Objectives: To evaluate the safety and efficacy of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota‐Cut).Background: Whether the Rota‐Cut combination improves stent performance in severely calcified coronary lesions is unknown.Methods: PREPARE‐CALC‐COMBO is a single‐arm prospective trial in which 110 patients were treated with a Rota‐Cut strategy before implantation of sirolimus‐eluting stents and compared with patients treated with modified balloon (MB, scoring or cutting) or RA from a historical cohort (the randomized PREPARE‐CALC trial). The study had two primary endpoints: in‐stent acute lumen gain (ALG) by quantitative angiographic analysis and stent expansion (SE) on optical coherence tomography.Results: In‐stent ALG was significantly higher with Rota‐Cut compared to RA or MB alone (1.92 ± 0.45 mm vs. 1.74 ± 0.45 mm with MB vs. 1.70 ± 0.42 mm with RA; p = 0.001 and p < 0.001, respectively). SE was comparable between groups (75.1 ± 13.8% vs. 73.5 ± 13.3 with MB vs. 73.1 ± 12.2 with RA; p = 0.19 and p = 0.39, respectively). The Rota‐Cut combination resulted in higher minimal stent area (MSA) (7.1 ± 2.2mm² vs. 6.1 ± 1.7mm² with MB vs. 6.2 ± 1.9mm² with RA; p = 0.003 and p = 0.004, respectively). In‐hospital death occurred in one patient. Target vessel failure at 9 months was low and comparable between groups (8.2% vs. 8% with MB vs. 6% with RA; p = 1 and p = 0.79, respectively).Conclusion: Rota‐Cut combination resulted in higher ALG and larger MSA compared with historical control of RA or MB alone, but was not associated with higher SE. Despite extensive lesion preparation, this strategy is safe, feasible, and associated with favorable clinical outcome at 9 months.

Background: Percutaneous intervention of calcified coronary lesions often requires lesion preparation with either balloon dilatation or atherectomy. We sought to evaluate the impact of lesion preparation strategy on stent expansion following preparation of severely calcified coronary lesions with modified (cutting/scoring) balloons (MB) versus rotational atherectomy (RA) and to evaluate the impact of calcium burden as assessed by optical coherence tomography (OCT) on acute stent performance. Methods: In the PREPARE-CALC trial (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions), 200 patients with severely calcified coronary lesions were randomly assigned to receive either lesion preparation with MB or RA. In 122 patients, OCT was performed before lesion preparation and at the end of the procedure. The principal end point of this OCT sub-analysis was stent expansion as assessed by OCT. The key secondary end points included stent asymmetry and eccentricity. Results: The maximal calcific arc (257.5±96.7° versus 248.7±82.1°, P =0.59), thickness (1.34±0.29 versus 1.32±0.27 mm, P =0.76), and length of calcification (21.1±9.7 versus 24.0±10.9 mm, P =0.12) did not differ between the MB versus RA group. Lesion preparation with MB versus RA lead to comparable stent expansion (73.5±13.3% versus 73.1±12.2%, respectively, P =0.85). The use of RA did not have a significant impact on stent asymmetry or eccentricity compared with the use of MB. Length of calcified plaque appeared to be increased in patients with stent underexpansion, while thickness of calcified plaque was increased in patients with stent asymmetry. Target lesion revascularization at 9 months was 3.3% when MB was used and 1.6% when RA was performed ( P =0.62). Conclusions: In this OCT sub-analysis from the PREPARE-CALC trial, calcified plaque length was increased in patients with stent underexpansion, while its thickness was higher in patients with stent asymmetry, with no impact of the lesion preparation strategy. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02502851.

BACKGROUND: Severe functional mitral regurgitation (fMR) is a heterogenous disease that exhibits different underlying pathophysiological mechanisms and represents independent entities. The aim of this study was to characterize remodeling patterns defined by the left atrial (LA) to left ventricular (LV) volume ratio in patients with severe fMR and heart failure, and to examine its prognostic implications. METHODS: A total of 13 052 patients with fMR were included. Based on the LA/LV volume ratio, patients with severe fMR were divided into 2 distinct groups: predominant LV remodeling (PLVR [ratio ≤0.56, n=581]) and predominant LA remodeling (PLAR [ratio >0.56, n=582]). RESULTS: Patients with PLAR were more often female, with the peak age a decade later. PLAR was associated with lower leaflet tethering indices, as indicated by the leaflet tenting area (PLVR versus PLAR: 227 mm ² versus 181 mm ² , P <0.001) and angles (PLVR versus PLAR: posterior leaflet: 42° versus 36°, P <0.001; anterior leaflet: 28° versus 23°, P <0.001). PLAR was the predominant subtype in heart failure with preserved (76%) and heart failure with mildly reduced ejection fraction (61%), but a significant proportion could be observed in heart failure with reduced ejection fraction (32%). The median follow-up time for severe fMR was 66 months (interquartile range, 60–85). After 4 years, 42.1% with PLAR and 34.1% with PLVR had died. At 8 years, 57.3% of patients with PLAR, and 49.6% of patients with PLVR had died. Compared with PLVR, PLAR showed excess mortality, with a hazard ratio of 1.37 ([95% CI, 1.13–1.65]; P =0.001) in the univariate analysis. This effect remained after multivariable adjustment. CONCLUSIONS: The LA/LV volume ratio indicates the prevailing remodeling pattern in severe fMR. It is associated with morphological features of valve apparatus distortion resulting from differential remodeling. A strong correlation is observed between the LA/LV volume ratio and mortality.