Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials.

BACKGROUND: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. METHODS: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. RESULTS: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ±â€¯10.8 and 62.7 ±â€¯10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. CONCLUSION: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials

Background The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. Methods Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. Results The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ±â€¯10.8 and 62.7 ±â€¯10.4 years in Magmaris and Orsiro groups, respectively ( p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups ( p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. Conclusion At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

First Report of Edge Vascular Response at 12 Months of Magmaris, A Second-Generation Drug-Eluting Resorbable Magnesium Scaffold, Assessed by Grayscale Intravascular Ultrasound, Virtual Histology, and Optical Coherence Tomography. A Biosolve-II Trial Sub-Study.

INTRODUCTION AND OBJECTIVE: The edge vascular response (EVR) remains unknown in second generation drug-eluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. METHODS: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. RESULTS: The segment-level grayscale IVUS (n = 10), virtual histology IVUS (n = 10), and OCT (n = 18) analysis did not show any significant changes after 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ±â€¯1.43 mm2 (p = 0.012) and 2.49 ±â€¯1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ±â€¯0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ±â€¯0.48 mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ±â€¯0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ±â€¯0.53 mm2 (p = 0.023) and 0.17 ±â€¯0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ±â€¯1.51 mm2 (p = 0.045) in a distal frame. CONCLUSION: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS. SUMMARY: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imaging modalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over time in the segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.

First report of edge vascular response at 12 months of Magmaris, a second-generation drug-eluting resorbable magnesium scaffold, assessed by grayscale intravascular ultrasound, virtual histology, and optical coherence tomography. A biosolve-II trial sub-study

Introduction and objective: The edge vascular response (EVR) remains unknown in second generation drugeluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. Methods: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. Results: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not showany significant changes after 12months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p=0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p = 0.045) in a distal frame. Conclusion: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process a the edges of the RMS. Summary: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imagingmodalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over timein the segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS. As a result, after 12months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.

Clinical outcomes of complete revascularization using either angiography-guided or fractional flow reserve-guided drug-eluting stent implantation in non-culprit vessels in ST elevation myocardial infarction patients: insights from a study based on a systematic review and meta-analysis.

Current guidelines recommend that percutaneous coronary intervention (PCI) should be restricted to the culprit vessel in ST elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD) and without cardiogenic shock. However, newer data suggests that performing complete revascularization (CR) in MVD patients may lead to better outcomes compared to intervention in the culprit vessel only. The aim of this meta-analysis is to examine the available data to determine if CR (using either angio- or fractional flow reserve guidance-FFR) following primary PCI in STEMI patients without cardiogenic shock impacts clinical outcomes. Meta-analysis was performed by conducting a literature search of PubMed from January 2004 to July 2017. Pooled estimates of outcomes, presented as odds ratios (OR) [95% confidence intervals], were generated using random-effect models. A total of 9 studies (3317 patients) were included. CR showed a significant MACE reduction (OR 0.49, 95% CI 0.36-0.66, p < 0.001); All-cause mortality (OR 0.69, 95% CI 0.48-0.98, p = 0.04) and repeat revascularization (OR 0.38, 95% CI 0.28-0.51, p < 0.001) at ≥ 12 months follow-up. The FFR-guiding CR group presented a MACE reduction (odds ratio 0.52, 95% CI 0.30-0.90, p = 0.02) due to a decrease of repeat revascularization (OR 0.41, 95% CI 0.21-0.80, p = 0.009). Overall, performing complete revascularization in STEMI patients showed a MACE reduction, all-cause death and repeat revascularization. Compared to culprit-only revascularization, treating multi-vessel disease in STEMI patients using FFR guidance is associated with decreased incidence of MACE, due to a decreased rate of revascularization.

Optical coherence tomography-guided percutaneous coronary intervention compared with other imaging guidance: a meta-analysis.

The use of optical coherence tomography (OCT) in PCI guidance is limited perhaps by the lack of adequately powered studies which compare its efficacy and outcomes to the other more popular imaging modalities. We therefore performed a meta-analysis to compare clinical outcomes following OCT-guided PCI with the other imaging modalities in two separate comparisons. We abstracted data from randomized control trials and observational comparative studies focusing on OCT versus either angiography- or IVUS-guided PCI outcomes identified following a systematic search (April 2006 and May 2017). This meta-analysis included a total of 2781 patients; OCT-guidance versus Angiography guidance (n = 1753) and OCT-guidance versus IVUS-guidance (n = 1028). Pooled estimates of outcomes, presented as odds ratios (OR) [95% confidence intervals], were generated with random-effect models. OCT guidance showed lower rates of MACE (OR 0.70 [0.49, 1.00] p = 0.05) and cardiac deaths (OR 0.40 [0.18, 0.90] p = 0.03) compared to Angiography-guidance alone but no statistical significant results for myocardial infarction (OR 0.70 [0.42, 1.16] p = 0.17), stent thrombosis (OR 1.17 [0.40, 3.43] p = 0.77) and target lesion revascularizations (OR 1.07 [0.48, 2.38] p = 0.86).No statistical significance was observed in the OCT versus IVUS comparison; MACE (OR 0.89 [0.46, 1.73] p = 0.73), cardiac deaths (OR 0.56 [0.12, 2.70] p = 0.47), MI (OR 0.56 [0.12, 2.70] p = 0.47), ST (OR 0.43 [0.06, 2.95] p = 0.39), and TLR(OR 0.99 [0.45, 2.18] p = 0.99). OCT-guided PCI in comparison with angiography-guided was associated with reduction in adverse events for the composite of cardiac deaths, myocardial infarction and repeat revascularizations. There was no statistically significant difference in clinical outcomes observed in the comparison between OCT- and IVUS-guidance.

Intravascular ultrasound assessment of the effect of laser energy on the arterial wall during the treatment of femoro-popliteal lesions: a CliRpath excimer laser system to enlarge lumen openings (CELLO) registry study.

The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) registry included patients treated with modified excimer laser catheters for the endovascular treatment of peripheral artery disease affecting the superficial femoral artery (SFA) and proximal popliteal artery. The aim of this study was to assess, via intravascular ultrasound (IVUS) the dissections in the vessel wall following treatment with the laser catheters. IVUS grayscale images from the CELLO registry were systematically reviewed for dissections in the treated vessel segments by two investigators. Images from 33 patients; 66 pullbacks (1867 IVUS frames in 2 phases), were successfully matched frame-to-frame to evaluate identical segments of the treated vessels in the two phases; post-2 mm Turbo-Elite laser pilot channel creation and post Turbo-Booster laser atherectomy. Dissections were categorized as; (1) intimal, (2) medial, (3) intramural hematoma, and (4) adventitial according to the ACC Clinical Expert Consensus Document classification of dissections. An average of 57 frames was evaluated per pullback, giving a total of 3734 frames (1867 matched for pre-ablation (post channel creation) and post-ablation phases). Treatments with the modified Excimer laser catheters resulted in a significant increase in lumen area of 5.5 ± 3.2-mm2 (95% CI 4.3-6.8, p < 0.0001) and reduction in plaque plus media volume of -10.6 ± 36.0 mm3 (95% CI -25.8 to 4.6, p = 0.1619) whilst giving rise to mainly intramural hematoma formations post Turbo-Booster laser treatment in 55% of frames assessed and 24% medial dissections with less than 1% adventitial disruption. The Excimer laser based Turbo-Booster treatment of peripheral artery lesions resulted in significant plaque debulking and increased lumen diameter with negligible degree of adventitial layer injury.