Background:The appropriate balloon-to-artery ratio (BAR) for cutting balloons (CBs), to expand calcified lesions without increasing the risk of coronary artery perforation is unknown. This study investigated the effects of BAR on stress levels in the calcification and at the borders of the coronary artery adjacent to the calcification to determine an appropriate BAR.

Methods and Results:A custom-designed folding process of the CB model was developed. The CB models were deployed in a coronary artery model with a reference diameter of 3.0 mm, length of 24 mm, and wall thickness of 0.8 mm equipped with a 50% diameter stenotic, 360° concentric, 400-µm, and 5-mm-long calcification. Finite element analysis of the expansion of CBs with diameters increasing from 2.0 to 3.0 mm in 0.25-mm increments, corresponding to BARs from 0.67 : 1 to 1 : 1, was conducted with pressures up to 12 atm. Decreasing the CB by 0.25 and 0.5 mm (relative to the reference diameter of 3 mm) preserved maximum principal tensile stress levels comparable to that of a CB with a BAR of 1 : 1 while distinctly reducing the stress at the border of the artery adjacent and calcification.

Conclusions:Selecting a CB that is 0.25 or 0.5 mm lower than the 3-mm reference diameter may be the first choice to effectively fracture calcifications without increasing the risk of severe artery dissection and perforation.

Background:SYNERGY is a thin-strut, platinum-chromium metal alloy stent with an ultrathin abluminal everolimus-eluting bioabsorbable polymer. EVOLVE II was a global randomized controlled trial that enrolled 1,684 patients treated with either a SYNERGY or durable polymer PROMUS Element Plus (PE+) everolimus-eluting stent, including 155 patients from Japanese sites. This substudy analyzed 5-year clinical outcomes in the Japanese and non-Japanese cohorts.

Methods and Results:Patients aged ≥18 years with ≤3 native coronary artery lesions (reference vessel diameter ≥2.25–≤4.00 mm; length ≤34 mm) in ≤2 major vessels were randomized 1 : 1 to receive either SYNERGY (n=74 patients in Japan) or PE+ (n=81 patients in Japan). Five-year target lesion failure (TLF) was observed in 8.3% SYNERGY- and 11.2% PE+-treated patients (P=0.54). There were no cardiac deaths, and rates of target lesion revascularization and myocardial infarction were comparable between treatment arms. One patient in the SYNERGY arm experienced a very late definite stent thrombosis (ST); no ST occurred in the PE+ arm (P=0.30). Despite differences in baseline clinical and lesion characteristics, the 5-year TLF rates were not significantly different in SYNERGY-treated patients either in (8.3%) or outside (14.8%) Japan (P=0.14).

Conclusions:In Japanese patients with coronary artery disease, SYNERGY showed comparable efficacy to PE+, with low rates of adverse events over 5 years. Similarly, 5-year clinical outcomes were favorable in Japanese vs. non-Japanese patients implanted with SYNERGY.

Background:There are limited data comparing clinical outcomes between biodegradable polymer and durable polymer drug-eluting stents (BP-DES and DP-DES, respectively) in patients with end-stage renal disease (ESRD).

Methods and Results:This study enrolled 229 ESRD patients who underwent successful percutaneous coronary intervention (PCI) for 400 lesions with 472 DES, with 2-year clinical outcomes compared between the BP-DES and DP-DES groups. The primary outcome measure was the incidence of target lesion revascularization (TLR), whereas secondary outcome measures were the occurrence of cardiac death (CD), myocardial infraction (MI), stent thrombosis (ST), target vessel revascularization (TVR), non-TVR, and major adverse cardiac events (MACE), defined as a composite of CD, MI, and TVR. Multivariate analysis was used to identify predictors of TLR occurrence. The 2-year incidence of TLR did not differ significantly between the BP-DES and DP-DES groups (P=0.274). In addition, there were no significant differences in the 2-year incidence of CD (P=0.144), MI (P=0.812), ST (P=0.241), TVR (P=0.434), non-TVR (P=0.375), or MACE (P=0.841) between the 2 groups. Multivariate analysis showed that diabetes (P=0.021) was independently associated with TLR occurrence.

Conclusions:BP-DES and DP-DES had comparable safety and efficacy profiles over a 2-year follow-up period after PCI in ESRD patients.

Background:Vonoprazan is a potassium-competitive acid blocker increasingly used in Japan to prevent upper gastrointestinal bleeding in patients undergoing dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). Cytochrome P450 (CYP) 3A4 is involved in the primary metabolism of both vonoprazan and prasugrel. This raises concern about the possibility of a CYP3A4-mediated drug-drug interaction between vonoprazan and prasugrel that may lead to attenuation of prasugrel’s antiplatelet effect.

Methods and Results:We evaluated 88 PCI patients who were taking either vonoprazan (n=45) or proton pump inhibitors (PPIs; n=43) in combination with DAPT (aspirin and prasugrel). Platelet reactivity on prasugrel was assessed using the VerifyNow P2Y₁₂assay. The primary endpoint was comparison of P2Y₁₂reaction units (PRU) between patients on vonoprazan and PPIs. PRU >208 and <85 were defined as high (HPR) and low (LPR) on-treatment platelet reactivity for prasugrel. PRU was comparable between patients receiving vonoprazan and PPIs (169±52 vs. 179±61, respectively; P=0.75). There were no significant differences between the vonoprazan and PPI groups in the prevalence of HPR (22% vs. 37%, respectively; P=0.16) and LPR (4 vs. 7%, respectively; P=0.48). The results were consistent regardless of the type of clinical presentation and DAPT duration.

Conclusions:PRU under DAPT with aspirin plus prasugrel in patients receiving vonoprazan was not significantly different from that in patients receiving PPIs after PCI in routine clinical practice.

Background:The aim of the prospective post-marketing AF-CHF Landiolol Survey was to evaluate the safety and effectiveness of landiolol for the treatment of atrial fibrillation or atrial flutter in patients with cardiac dysfunction in clinical practice in Japan. This analysis reports mid-term prognoses with a focus on switching from landiolol to oral β-blockers.

Methods and Results:The AF-CHF Landiolol Survey took place between June 2014 and May 2016 and involved 1,121 patients with cardiac dysfunction and atrial fibrillation/atrial flutter. Data collected about switching from landiolol to oral β-blockers were analyzed in relation to all-cause mortality within 180 days after landiolol initiation. Among 1,002 patients with available follow-up data, the 6-month all-cause mortality rate was 14. 6% (n=146 patients), of whom 39.7% had died from heart failure (HF). Kaplan-Meier survival curves showed significantly longer survival in patients who had switched to oral β-blockers vs. those who had not, with hazard ratios of 0.39 (95% confidence interval [CI] 0.28–0.55) for all-cause mortality and 0.40 (95% CI: 0.23–0.70) for death from HF. Only male sex and advanced age were independently associated with all-cause mortality and death from HF.

Conclusions:This large-scale routine practice survey of landiolol in HF patients with atrial fibrillation/flutter showed high mid-term all-cause mortality. Switching from landiolol to oral β-blockers was apparently, although not independently, associated with lower all-cause mortality and death from HF.

Background:Serum calcium (Ca) concentrations in the acute phase of acute heart failure (AHF) have not been not sufficiently investigated.

Methods and Results:This study enrolled 1,291 AHF patients and divided them into 3 groups based on original and corrected Ca concentrations: (1) hypocalcemia (both original and corrected Ca ≤8.7 mg/dL; n=651); (2) pseudo-hypocalcemia (original and corrected Ca ≤8.7 and >8.7 mg/dL, respectively; n=300); and (3) normal/hypercalcemia (both original and corrected Ca >8.7 mg/dL; n=340). AHF patients were also divided into 2 groups based on corrected Ca concentrations: (1) corrected hypocalcemia (corrected Ca ≤8.7 mg/dL; n=651); and (2) corrected normal/hypercalcemia (corrected Ca >8.7 mg/dL; n=640). Of the 951 patients with original hypocalcemia (≤8.7 mg/dL), 300 (31.5%) were classified as corrected normal/hypercalcemia after correction of Ca concentrations by serum albumin. The prognoses in the pseudo-hypocalcemia, low albumin, and corrected normal/hypercalcemia groups, including all-cause death within 730 days, were significantly poorer than in the other groups. Multivariate Cox regression analysis showed that classification into the pseudo-hypocalcemia, hypoalbumin, and corrected normal/hypercalcemia groups independently predicted 730-day all-cause death (hazard ratios [95% confidence intervals] of 1.497 [1.153–1.943], 2.392 [1.664–3.437], and 1.294 [1.009–1.659], respectively).

Conclusions:Corrected normal/hypercalcemia was an independent predictor of prognosis because this group included patients with pseudo-hypocalcemia, which was affected by the serum albumin concentration.

Background:In this study we investigated the efficacy and safety of very short duration (1-month) dual antiplatelet therapy (DAPT) followed by prasugrel monotherapy. In particular, we compared intrastent conditions using optical coherence tomography (OCT) after second-generation drug-eluting stent implantation between standard-duration and 1-month DAPT followed by prasugrel monotherapy.

Methods and Results:Between May 2015 and February 2018, 120 consecutive patients who underwent elective Resolute zotarolimus-eluting stent implantation were enrolled and divided into those receiving standard-duration or 1-month (1M) DAPT followed by prasugrel monotherapy; 47 patients (n=55 stents) and 46 patients (n=54 stents) in the standard and 1M groups, respectively, completed the protocol. The primary endpoint was the prevalence of abnormal intrastent tissue at the 9-month examination, as observed by OCT. The secondary endpoint was the presence of composite adverse events, including all-cause death, myocardial infarction, stent thrombosis, target lesion and vessel revascularization, and major and minor bleeding. The prevalence of abnormal intrastent tissue was similar between the standard and 1M groups (1.6% vs. 1.5%, respectively; non-inferiority P<0.01). There was a tendency for fewer composite events in the 1M than standard group at the 30-month follow-up examination (28.3% vs. 44.7%, respectively; P=0.41).

Conclusions:In conclusion, 1M DAPT followed by prasugrel monotherapy after second-generation drug-eluting stent implantation was not inferior to standard-duration DAPT in terms of intrastent thrombus formation and composite adverse events.