Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5–1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. http://clinicaltrials.gov NCT02497014. Compared with a dual stent strategy, numerically (but not statistically) fewer major adverse cardiac events occurred with the stepwise provisional approach.

A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents. This prospective, multicenter, non-randomized, first-in-human study was conducted at 14 centers in Europe. Eligible patients had stable or unstable angina, documented silent ischemia, or non-ST-elevation myocardial infarction, and a maximum of two single de novo lesions in two separate coronary arteries with a reference vessel diameter between 2.5 mm and 4.2 mm. Clinical follow-up was scheduled at one, six and 12 months and annually thereafter until five years. Invasive imaging assessments were scheduled six and 12 months postoperatively. The primary endpoint was angiographic in-scaffold late lumen loss at six months. This trial was registered at ClinicalTrials.gov (NCT04157153). Between April 2020 and February 2022, 116 patients with 117 coronary artery lesions were enrolled. At six months, in-scaffold late lumen loss was 0.21 mm (SD 0.31). Intravascular ultrasound assessment showed preservation of the scaffold area (mean 7.59 mm² [SD 2.21] post-procedure vs 6.96 mm² [SD 2.48]) at six months) with a low mean neointimal area (0.02 mm² [SD 0.10]). Optical coherence tomography revealed that struts were embedded in the vessel wall and were already hardly discernible at six months. Target lesion failure occurred in one (0.9%) patient; a clinically driven target lesion revascularization was performed on post-procedure day 166. No definite or probable scaffold thrombosis or myocardial infarction was observed. These findings show that the implantation of DREAMS 3G in de novo coronary lesions is associated with favorable safety and performance outcomes, comparable to contemporary drug-eluting stents. This study was funded by BIOTRONIK AG.

Background: Whereas the efficacy and safety of intravascular lithotripsy (IVL) have been confirmed in de novo calcified coronary lesions, little is known about its utility in treating stent underexpansion. This study aimed to investigate the impact of IVL in treating stent underexpansion. Methods and Results: Consecutive patients with stent underexpansion treated with IVL entered the multicenter IVL-Dragon Registry. The procedural success (primary efficacy endpoint) was defined as a relative stent expansion >80%. Thirty days device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. A total of 62 patients were enrolled. The primary efficacy endpoint was achieved in 72.6% of patients. Both stent underexpansion 58.5% (47.5–69.7) vs. 11.4% (5.8–20.7), p < 0.001, and the stenotic area 82.6% (72.4–90.8) vs. 21.5% (11.1–37.2), p < 0.001, measured by quantitative coronary angiography improved significantly after IVL. Intravascular imaging confirmed increased stent expansion following IVL from 37.5% (16.0–66.0) to 86.0% (69.2–90.7), p < 0.001, by optical coherence tomography and from 57.0% (31.5–77.2) to 89.0% (85.0–92.0), p = 0.002, by intravascular ultrasound. Secondary endpoint occurred in one (1.6%) patient caused by cardiac death. There was no target lesion revascularization or target vessel myocardial infarction during the 30-day follow-up. Conclusions: In this real-life, largest-to-date analysis of IVL use to manage underexpanded stent, IVL proved to be an effective and safe method for facilitating stent expansion and increasing luminal gain.

Low-level laser therapy (LLLT) has become an important part of the therapeutic process in various diseases. However, despite the broad use of LLLT in everyday clinical practice, the full impact of LLLT on cell life processes has not been fully understood. This paper presents the current state of knowledge concerning the mechanisms of action of LLLT on cells. A better understanding of the molecular processes occurring within the cell after laser irradiation may result in introducing numerous novel clinical applications of LLLT and potentially increases the safety profile of this therapy.

Shock Waves (SW) are acoustic disturbances that propagate through a medium carrying the energy. These specific sonic pulses are composed of two phases—high positive pressure, a rise time < 10 ns, and a tensile wave. Originally Shock Waves were introduced to clinical practice as a part of the lithotripsy therapy focused on disrupting calcific deposits in the body. Since that time, shock wave therapy (SWT) has gone far beyond the original application related to the destruction of kidney stones. In this narrative Review, we present basic clinical applications of the SWT along with the potential therapeutic application in clinical practice.

BACKGROUND: The optimal coronary stenting technique for true left main bifurcation lesions is uncertain. EBC MAIN (European Bifurcation Club Left Main Trial) aimed to evaluate clinical outcomes of a stepwise provisional strategy compared with a systematic dual-stent approach. METHODS: EBC MAIN was a randomized, investigator-initiated, open-label, multicenter, parallel-group trial conducted across 35 hospitals in 11 European countries. A total of 467 participants undergoing percutaneous coronary intervention for unprotected true left main bifurcation lesions were randomly assigned to the stepwise provisional strategy (n=230) or an upfront dual-stent approach (n=237). The mean (SD) age was 71 (10) years and 23% of participants were women. The primary end point was a composite of major adverse cardiac events, defined as all-cause mortality, all myocardial infarction, or clinically driven target lesion revascularization. Events were adjudicated by an independent clinical events committee and all analyses were by the intention-to-treat principle. RESULTS: At 3 years, the primary end point occurred in 54 of 230 (23.5%) stepwise provisional and 70 of 237 (29.5%) dual-stent patients (hazard ratio, 0.75 [95% CI, 0.53–1.07]; P =0.11). There was no significant difference in all-cause mortality (10.0% versus 13.1%) or myocardial infarction (12.2% versus 11.0%). However, target lesion revascularization was significantly lower in the stepwise provisional group (8.3% versus 15.6%; hazard ratio, 0.50 [95% CI, 0.29–0.86]; P =0.013). In this population, the mean side vessel diameter by quantitative angiography was 2.9 mm, and median side vessel lesion length was 5 mm. Significant interactions were identified between the assigned bifurcation strategy and both side vessel diameter and lesion length with respect to the primary outcome ( P =0.009 and P =0.005, respectively), with smaller vessels (<3.25 mm diameter) and shorter lesions (<10 mm length) favoring the provisional approach. CONCLUSIONS: In a European population with true left main stem bifurcation coronary disease requiring intervention, there was no difference in major adverse cardiovascular events between stepwise provisional and systematic dual-stent strategies at 3 years. Target lesion revascularization was significantly less frequent with the stepwise provisional approach, which should be the default strategy for noncomplex left main bifurcation coronary intervention. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02497014.