Two-Year Outcomes for Patients with Non-ST-Elevation Acute Coronary Syndrome Treated with Magmaris and Absorb Bioresorbable Scaffolds in Large-Vessel Lesions.

BACKGROUND: The acute coronary syndrome (ACS) continues to be a fundamental indication for revascularization by percutaneous coronary intervention (PCI). Drug-eluting stent (DES) implantation remains a part of contemporary practice but permanent caging of the vascular structure with the metallic stent structure may increase the rate of device-related adverse clinical events. As an alternative to classic metallic DESs, the bioresorbable scaffolds (BRSs) have emerged as a temporary vascular support technology. We evaluated the mid-term outcomes of two generations of bioresorbable scaffolds-Absorb (Abbott-Vascular, Chicago, IL, USA) and Magmaris (Biotronik, Germany)-in patients with non-ST-elevation ACS. METHODS: The study cohort consisted of 193 subjects after Magmaris implantation and 160 patients following Absorb implantation in large-vessel lesions. RESULTS: At 2 years, a significantly lower rate of a primary outcome (cardiac death, myocardial infarction, stent thrombosis) was observed with Magmaris (5.2% vs. 15%; p = 0.002). In addition, we observed a significantly lower rate of MI in the target vessel (2.6% vs. 9.4%; p = 0.009) and a lower rate of scaffold thrombosis (0% vs. 3.7%; p = 0.008). The TLF rate between the two groups was not significantly different. CONCLUSION: Magmaris demonstrated a good safety profile and more favorable clinical outcomes when compared to Absorb in patients with non-ST-elevation ACS.

Magnesium bioresorbable scaffold (Magmaris) versus polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in acute coronary syndrome. Mid-term outcomes (2 years).

Introduction: Acute coronary syndrome (ACS) is a well-known risk factor for adverse clinical outcomes in percutaneous coronary intervention (PCI). Therefore, evaluation of coronary stents in this challenging clinical scenario can provide unique information on device safety and efficacy. Bioresorbable scaffolds (BRS) were designed to overcome long-term complications related to permanent vessel caging with a permanent metallic drug-eluting stent (DES). Aim: We designed this study to evaluate the mid-term safety and efficiency of the Magmaris BRS in comparison to the leading new-generation ultrathin DES Ultimaster in the ACS population. Material and methods: We present a retrospective analysis of 2-year follow-up data. The primary outcomes consisted of death from cardiac causes, myocardial infarction, and in-stent thrombosis. The second main study endpoint was defined as target-lesion failure (TLF). Results: The study population consisted of two cohorts, the first of 193 patients treated with Magmaris implantation and the second of 169 patients treated with Ultimaster implantation. At the 2-year follow-up, there were no significant differences in both study cohorts in terms of primary outcome (5.1% vs. 11%; p = 0.051), and TLF (5.6% vs. 8%, p = 0.41). Conclusions: Treatment with a second-generation BRS (Magmaris) versus a novel second-generation DES (Ultimaster) in non-ST-elevation acute coronary syndrome (NSTE-ACS) was associated with similar rates of target lesion failure at 2-year follow-up.

Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR).

BACKGROUND: Coronary calcifications represent a challenging subset for the interventional cardiologist performing percutaneous coronary intervention (PCI) and are well-established risk factors for adverse outcomes. Adequate plaque modification prior to stent implantation is critical to achieve an optimal outcome following PCI. Recently, a novel orbital atherectomy device has been introduced into clinical practice to modify calcified plaques. We evaluated the mid-term safety and efficacy of OA in a high-risk "all-comers" population. METHODS: We evaluated 96 consecutive patients with severely calcified coronary lesions who underwent PCI facilitated by the orbital atherectomy device. RESULTS: In-hospital MACCE was 5.2% without target lesion revascularization. At 6-month follow-up, the MACCE rate was 10.4% with a concomitant TLR rate of 1%. CONCLUSIONS: Our mid-term data showed good safety and efficacy of orbital atherectomy as a plaque-modifying tool in an all-comers cohort with severely calcified coronary lesions.

Mid-term safety and efficacy of magnesium bioresorbable vascular scaffolds - magmaris in diabetic population. 2-Years outcome in acute coronary syndrome cohort.

BACKGROUND: Diabetes type 2 is one of the strongest risk factors affecting coronary artery disease (CAD) and is also a marker of poor short and long-term prognosis in subjects with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) with subsequent drug-eluting stent (DES) implantation. Chronic local vascular inflammation along with endothelial dysfunction is postulated to be the pathophysiological background of unfavorable results. The second generation of metallic magnesium BRS -Magmaris (Biotronik, Berlin, Germany) had been introduced to clinical practice to overcome these limitations. METHODS: We evaluated 2-years clinical outcomes after Magmaris BRS implantation in NSTE-ACS diabetic (n-72) and non-diabetic (n-121) cohorts. RESULTS: No significant differences between diabetic and non-diabetes cohorts were noticed in terms of Primary Outcome (cardiac death, myocardial infarction, stent thrombosis) (8.1% vs 3.3% p = 0.182) and Principal secondary outcome - TLF- target lesion failure (9.5% vs 3.3% p = 0.106) at 2-years follow-up. CONCLUSIONS: 2-years outcome suggests good safety and efficacy of the magnesium BRS (Magmaris) in NSTE- ACS and concomitant DM. Nevertheless, there is a strong need for large multicenter, randomized, prospective studies for a full assessment of this novel device in diabetic patients with ACS.

Safety and efficacy of a novel calcified plaque modification technique - Shockwave Intravascular Lithotripsy - in patients with coronary artery disease: Mid-term outcomes.

BACKGROUND: Coronary interventions in calcified lesions are associated with a higher rate of adverse clinical events. Initial aggressive plaque modification along with post-implantation optimization is pivotal for achieving a favorable outcome of percutaneous coronary intervention (PCI). Recently, the Shockwave C2 Intravascular Lithotripsy (S-IVL) System, a novel acoustic wave-based device designed to modify calcified plaque, has been introduced into clinical practice. AIMS: We evaluated the mid-term safety and efficiency of S-IVL in a cohort of 131 consecutive patients with severely calcified coronary lesions. METHODS: We retrospectively analyzed a total of 131 consecutive S-IVL PCI procedures. The study had two main inclusion criteria - the presence of a calcified resistant lesion (defined by inadequate non-compliant balloon catheter inflation) or a significantly underexpanded stent (more than 20% of reference diameter). The study had two primary endpoints - successful clinical outcome and safety concerns. Clinical success was defined as effective stent deployment or optimization of a previously underexpanded stent (with less than <20% in-stent residual stenosis). Safety outcomes were defined as periprocedural complications, such as device failure and major adverse cardiac and cerebrovascular events (MACCE). Clinical follow-up was performed at the end of hospitalization and 6 months after the index procedure. RESULTS: In-hospital MACCE was 4.6% with 1.5% target lesion revascularization (TLR) and one case of subacute fatal stent thrombosis. At 6-month follow-up, the MACCE rate was 7.9% with a concomitant TLR rate of 3.8%. CONCLUSION: Our mid-term data confirm acceptable safety and efficacy of intravascular lithotripsy as a valuable strategy for lesion preparation and stent optimization in a cohort of 131 consecutive patients with severely calcified coronary lesions.

Comparison of Orbital Atherectomy and Rotational Atherectomy in Calcified Left Main Disease: Short-Term Outcomes.

BACKGROUND: Coronary calcifications, particularly in left main disease (LMD), are independently associated with adverse outcomes of percutaneous coronary intervention (PCI). Adequate lesion preparation is pivotal to achieve favorable short- and long-term outcomes. Rotational atherectomy devices have been used in contemporary practice to obtain adequate preparation of the calcified lesions. Recently, novel orbital atherectomy (OA) devices have been introduced to clinical practice to facilitate the preparation of the lesion. The objective of this study is to compare the short-term safety and efficacy of orbital and rotational atherectomy for LMD. METHODS: we retrospectively evaluated a total of 55 consecutive patients who underwent the LM PCI supported by either OA or RA. RESULTS: The OA group consisted of 25 patients with a median SYNTAX Score of 28 (26-36). The Rota group consisted of 30 patients with a median SYNTAX Score of 28 (26-33.1) There were no statistical differences in MACCE between the RA and OA subpopulations when recorded in-hospital (6.7% vs. 10.3% p = 0.619) as well as in a 1-month follow-up after the procedure (12% vs. 16.6% p = 0.261). CONCLUSION: OA and RA seem to be similarly safe and effective strategies for preparating the lesion in the high-risk population with calcified LMD.

Shockwave intravascular lithotripsy as a novel strategy for balloon undilatable heavily calcified chronic total occlusion lesions.

BACKGROUND: The successful percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) improves the long-term outcome in patients with coronary artery disease (CAD). Heavy calcification remains one of the strongest predictors of an unfavorable outcome of PCI. In this case series study, shockwave intravascular lithotripsy (S-IVL)-a novel balloon-based coronary system facilitating modification of calcified coronary lesions was evaluated. METHODS: The study population consisted of five heavily calcified, undilatable-CTOs lesions treated with S-IVL selected out of all consecutive CTO-PCI patients performed at two high-volume cardiac centers. RESULTS: The registry included 5 patients successful CTO - S-IVL procedures with an average J-CTO of 2.6 points. In the short-term follow-up period, including the first 30 days, no cases of acute in-stent thrombosis, target lesion failure, or major adverse cardiac and cerebrovascular events were noted. CONCLUSIONS: The present data suggest that this approach can be safe and useful in the treatment of complex calcified CTO lesions.

Rota-Lithotripsy as a Novel Bail-Out Strategy for Highly Calcified Coronary Lesions in Acute Coronary Syndrome.

BACKGROUND: Heavily calcified lesions in acute coronary syndrome (ACS) still represent a challenging subset for percutaneous coronary intervention (PCI). Rota-lithotripsy-a marriage of rotational atherectomy and intravascular lithotripsy-has recently been introduced to clinical practice as a novel therapeutic option. METHODS: This study is among the to present the 6-month clinical outcomes of rota-lithotripsy when performed in the ACS setting. The study cohort consisted of 15 consecutive ACS patients who underwent a rota-lithotripsy-PCI due to the presence of a highly calcified, undilatable lesion. RESULTS: The procedural success ratio reached 100%. During the 6-month follow-up, in two of the patients, instances of MACE (major adverse cardiac events) occurred, including one fatal event. Additionally, during the observation period, one target lesion failure, due to subacute stent thrombosis, was identified. CONCLUSIONS: Rotational atherectomy with the subsequent use of shockwave intravascular lithotripsy appears to be a safe and effective therapeutic bail-out option for the management of highly calcified coronary artery lesions. Despite, these initial favorable outcomes, carrying out a large number of studies with long-term observations is still necessary in order to establish the potential benefits and shortcomings of rota-lithotripsy.

Intravascular Lithotripsy as a Novel Treatment Method for Calcified Unprotected Left Main Diseases-Comparison to Rotational Atherectomy-Short-Term Outcomes.

BACKGROUND: The unprotected calcified Left Main disease represents a high-risk subset for percutaneous coronary intervention (PCI), and it is associated with a higher number of periprocedural complications and an increased rate of in-stent thrombosis and restenosis. Adequate lesion preparation plays a crucial role in achieving a favorable PCI outcome. Rotational Atherectomy (RA) is a well-established plaque-modifying method; nevertheless, the data regarding the effectiveness of RA in LM diseases is scarce. Recently, the novel ShockWave-Intravascular-Lithotripsy(S-IVL) device has been introduced to the PCI armamentarium in order to modify the calcified plaque. METHODS: We performed a retrospective evaluation of 44 consecutive subjects who underwent the LM-PCI, and who were supported by either the RA or S-IVL. RESULTS: The Rota group consisted of 29 patients with a mean syntax score of 28.0 ± 7.5. The S-IVL group was composed of 15 subjects with a syntax score of 23.3 ± 13.0 There were no statistical differences regarding MACE between the RA and Shockwave arms of the in-hospital group (10.3% vs. 6.7%), or in the six month (17.2% vs. 13.3%) follow-up group. CONCLUSIONS: RA and S-IVL could be safe and effective therapeutic strategies for calcified LM disease. Further studies with a higher number of participants and longer follow-up times are warranted to establish the potential benefits of RA and S-IVL for the management of LM stenosis.

Magnesium Bioresorbable Scaffold (BRS) Magmaris vs Biodegradable Polymer DES Ultimaster in NSTE-ACS Population-12-Month Clinical Outcome.

Background: Percutaneous coronary intervention (PCI) in the acute coronary syndrome (ACS) setting is associated with a greater probability of device failure. The currently ongoing development of new scaffold technologies has concentrated an effort on improving the PCI outcomes, including the use of new biodegradable materials. This pilot study evaluates the performance of a magnesium bioresorbable scaffold (Magmaris, Biotronik, Germany) in comparison to the sirolimus-eluting bioresorbable polymer stents (BP-SES) (Ultimaster, Terumo, Japan) in the NSTE-ACS setting. Methods: The population of this pilot comprised 362 patients assigned to one of two arms (193-Magmaris vs 169-Ultimaster). The data regarding the primary outcome comprised of death from cardiac causes, myocardial infarction, and stent thrombosis, along with target-lesion failure (TLF) and other clinical events was collected in the 1-yearfollow-up. Results: There were no statistically significant differences in clinical outcomes in the short term (30 days) or in the 1-yearfollow-up between both groups. Conclusion: At 12 months, there were no statistically significant differences between the Magmaris and Ultimaster for composed endpoints or the TLF.

Long-term clinical follow-up of the resorbable magnesium scaffolds in acute coronary syndrome patients.

BACKGROUND: Research on the resorbable magnesium scaffolds (RMSs) has shown their safety and effectiveness in stable clinical conditions. It seems that this new therapeutic option could be promising for selected acute coronary syndrome (ACS) patients. AIMS: Our analysis aims to analyse the long-term performance of RMSs among ACS patients. METHODS: The study population consisted of consecutive ACS patients treated with the implantation of at least one RMS. The Magmaris ACS Registry was designed as a single-arm observational registry in the 'real-world' treatment practice setting. RESULTS: The study population consisted of 193 patients, predominantly male (78%), at a mean (SD) age of 64 (9) years and with the typical risk factors of ACS. Unstable angina (UA) was the indication for revascularisation in 32.1%, non-ST-segment myocardial infarction (NSTEMI) in 65.8% and ST-segment elevation myocardial infarction (STEMI) only in 2.1%. During the mean 24 months of follow-up, ten cases (5.2%) of target lesion failure (TLF) were diagnosed, of which five cases (2.6%) were clinically driven target lesion failure (CD-TLR), four cases (2.1%) of asymptomatic scaffold restenosis and one case (0.5%) of target vessel myocardial infarction (TV-MI). No cardiac deaths and 2 non-cardiac deaths (2.2%, both fatal strokes) were observed. No cases of scaffold thrombosis were observed during the median 24-month follow-up. CONCLUSIONS: The use of the RMSs in selected ACS patients is associated with procedural safety and promising early and long-term clinical efficacy and safety outcomes. Proper lesion selection is key to the long-term success of bioresorbable technology in this patient population.

Feasibility of intravascular lithotripsy for calcific coronary lesions: A multi-institutional experience.

OBJECTIVE: We sought to determine the safety and performance of intravascular lithotripsy in the treatment of severe calcified atherosclerotic lesions. BACKGROUND: The modification of severe calcified atherosclerotic lesions with noncompliant or specialty balloons, as well as orbital or rotational atherectomy has limitations and may be ineffective, increasing the risk of periprocedural complications and worsening long-term results. Intravascular lithotripsy has recently been shown to be a safe and feasible alternative to the above methods. METHODS: All consecutive patients treated with Shockwave Medical Intravascular Lithotripsy (S-IVL) between May 2019 and June 2020 were included in current analysis. Device safety and efficacy were the critical endpoints of the study. The primary safety endpoint was 30-day major adverse cardiac events (MACE). In turn, device and clinical success were the primary performance endpoints. RESULTS: In total, 46 patients undergoing percutaneous coronary intervention were treated with S-IVL before stent deployment (65% male; age, 71 ± 7 years). Device success was achieved in 45 (97.8%) patients with reduction of diameter stenosis from 80% to 5.2% with an acute gain of 2.5 mm. Clinical success was demonstrated in 95.6% of cases. During the 30-day follow-up, one sudden death was recorded, regarded as probable subacute stent thrombosis. During 6-month follow up one target lesion and target vessel revascularizations occurred. The rate of MACE after 6 month was 6.2%. CONCLUSIONS: S-IVL appears to be a safe and effective treatment modality in coronary calcium modification to optimize stent expansion. In selected cases this device obviates the need for more complex lesion preparation strategies such as atherectomy.