Treatment Of Coronary Lesions Research Articles

Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.

There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions. Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated. From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed. Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.

Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions

BackgroundNon stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. MethodsThis was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. ResultsA total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. ConclusionThe novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.

Functional assessment of coronary blood flow as contemporary method for optimizing results of percutaneous coronary interventions in patients with ischemic heart disease

Coronary angiography is still the ‘gold standard’ in assessing the severity of stenotic lesions of the coronary arteries in the catheter laboratory. However, it is often difficult to identify the hemodynamic significance of one or another coronary artery stenosis, which is especially difficult in the case of borderline lesions with a coronary artery stenosis of 40–70 % according to angiography. It is important to note that the results of performed PCI are still largely assessed only on the basis of control angiographic data. This is due to the fact that the largest difference between angiography and FFR is in the intermediate range, and in general there is much less variation between angiography and fractional blood flow reserve (FFR) in the severe and mild lesions. However, the results of studies evaluating FFR after PCI showed a wide range of FFR values after satisfactory results of stenting according to angiography data. This additionally confirms the thesis that only one angiography is limited in determining the ischemic boundaries after PCI, and the level of FFR values after PCI is directly related to the results in the long-term period. Percutaneous coronary interventions under the control of FFR allows the operator to improve the results of endovascular treatment of coronary lesions in patients with coronary heart disease. The use of FFR in a catheter laboratory contributes to an increase in the clinical and economic efficiency of procedures, which is achieved due to the fact that the determination of FFR before PCI can significantly reduce the number of stents implanted during PCI, as well as to avoid unnecessary PCI stages in the treatment of patients with lesions of the LMCA. In addition, FFR allows to timely optimize the results of suboptimal PCI, as well as to reduce the frequency of main adverse cardiovascular events in the long-term period.

Operator-Controlled Comparison Between 5 French and 6 French Guiding Catheters for Percutaneous Intervention Using Transradial Approach.

ObjectiveTo compare 5 French (Fr) and 6 Fr guiding catheters regarding the volume of contrast administered, fluoroscopy time, and total procedure time during transradial percutaneous coronary intervention (PCI).BackgroundPrevious studies had compared 5 Fr and 6 Fr catheters and deemed 5 Fr catheters safe and effective. In this study, we retrospectively compared the 5 Fr catheter to 6 Fr catheter with an attempt to eliminate the effect of inter-operator skill level variability.MethodsIn a single-center, retrospective cohort study, we randomly selected patients who had received PCI through transradial access using 5 Fr or 6 Fr catheters. The study involved two groups of 100 patients each. These groups were comprised of an equal number of cases from each operator. The primary endpoint was contrast medium volume. Secondary endpoints were fluoroscopy time and procedure time.ResultsLess contrast was used in the 5 Fr group vs. 6 Fr catheter group (140.2 ± 45.7 mL vs. 158.2 ± 66.7 mL, p=0.004). PCI using 5 Fr catheters was associated with shorter fluoroscopy time (13.7 ± 7.3 mins vs. 15.2 ± 8.2 mins, p=0.584) and shorter procedure time (43.7 ± 22.2 mins vs. 46.5 ± 19.7 mins, p=0.890), but this was not statistically significant.ConclusionTransradial PCI using 5 Fr guiding catheters was associated with less contrast medium usage, but there was no advantage regarding procedure time or fluoroscopy time when compared to 6 Fr catheters. Similar to 6 Fr catheters, 5 Fr catheters achieved high PCI success rates through radial access when compared in the treatment of coronary lesions with the same level of complexity.

Utility of Imaging Modalities in Coronary Lesions With Borderline Fractional Flow Reserve

BackgroundCoronary intervention is routinely deferred in intermediate lesions with fractional flow reserve (FFR) ≥ 0.80. Patients with borderline FFR (0.80–0.85) who were initially deferred, have been shown to have higher risk of future interventions; however, the data is limited, and the long term prognosis in these patients remains unknown. We assessed the utility of adjunctive imaging modalities to determine the need for intervention in lesions with borderline FFR. MethodsWe retrospectively evaluated consecutive patients who underwent coronary angiography at Einstein Medical Center from January 2013 to April 2016. All patients with borderline FFR (0.80–0.85) were included. Patients were divided into Defer or Perform intervention groups based on additional available or procured clinical data. The Perform group was further stratified into intervention With or Without adjunctive imaging guidance (including intravascular ultrasound, optical coherence tomography, echocardiography, and exercise or pharmacologic stress test). Follow-up data was collected for all patients, which included future target lesion revascularization (TLR) and major adverse cardiac events (MACE; all-cause and cardiovascular mortality and acute coronary syndromes). ResultsA total of 196 patients were eligible. Median (IQR) FFR in Perform and Defer groups was 0.81 (0.8–0.83) and 0.84 (0.82–0.85) respectively. Median (IQR) follow up was 21 (13–29) and 25 (15–36) months respectively. Overall MACE rate in Perform group (n = 101) was 20.8% (n = 21) and Defer group (n = 95) was 15.8% (n = 15). The stratified MACE rate in Perform group With imaging guidance (n = 57) was 17.5% (n = 10) and Without imaging guidance (n = 44) was 25% (n = 11). Overall, the FFR only guided management (n = 196) led to MACE rate of 18.4% (n = 36); whereas, FFR With imaging guidance (n = 136) led to MACE rate of 16.2% (n = 22). The p values were non-significant in each of the above group comparisons due to relatively low numbers with trends as noted. ConclusionsOur study suggests that intervention of coronary lesions with borderline FFR under imaging guidance, although not significant, trends towards improved cardiovascular outcomes compared with intervention in this group without adjunctive imaging. These findings are merely speculative without achieving statistical significance in a small subset and need to be further validated in a large scale prospective study.

Bioresorbable scaffolds for complex coronary interventions.

Bioresorbable scaffolds (BRS) have been introduced to clinical practice to avoid some limitations associated with the presence of permanent metal prostheses in coronary arteries. Due to elimination of the natural vasomotion of the vessel and flow disturbance, stents impair endothelial function, increasing the risk of adverse events such as late and very late thrombosis or accelerated neoatherosclerosis. Additionally, the presence of metallic stents hinders non-invasive imaging of coronaries and may exclude the possibility of bypass graft anastomosis within the stented segment. The use of fully bioresorbable scaffolds would allow for an effective treatment of coronary lesions while overcoming the limitations related to the prolonged presence of metal prostheses in coronary vessels. After early positive clinical results of BRS implanted in simple lesions in small number of patients, large randomised trials revealed numerous limitations of this technology, with unacceptably high incidence of scaffold thrombosis and myocardial infarction. Nevertheless, the negative results of the studies render the learning curve of interventional cardiologists introducing into clinical practice this novel technology. Optimal stenting technique combined with extensive use of intravascular imaging may contribute to obtaining promising results also in patients with complex stenosis, like thrombotic lesions, bifurcations, chronic total occlusions, long and calcified lesions.

Мультидисциплинарный подход в формате Heart Team – вектор оптимизации лечения пациентов с поражениями коронарного русла.

Мультидисциплинарный подход в формате Heart Team – вектор оптимизации лечения пациентов с поражениями коронарного русла.

TCT-643 Safety and efficacy of Sirolimus coated balloon for the treatment of coronary lesions in small vessels: a subgroup analysis from the Nanolute registry

We sought to investigate the clinical outcomes after the treatment of Magic Touch Sirolimus Coated Balloon (SCB, Concept Medical Research Pvt Ltd, Surat, India) in patients with lesions located in small coronary arteries. The all comers, multicentre Nanolute registry enrolled patients with lesions

Impact of the learning curve on procedural results and acute outcome after percutaneous coronary interventions with everolimus-eluting bioresorbable scaffolds in an all-comers population.

The implantation of bioresorbable scaffolds (BVSs) is an emerging technique in the treatment of coronary lesions and implantation of BVSs is different than that of metallic drug-eluting stents, however, due to different mechanical properties. This investigation focused on procedural and mid-term results and was designed to evaluate whether there is evidence of a learning curve with BVSs and how it might influence the clinical outcome. In an all-comers registry, the first 100 consecutive patients were compared with the second 100 patients. Target parameters were major adverse cardiac events (MACEs), including cardiac death, any myocardial infarction, and percutaneous or surgical target lesion revascularization (TLR). Target vessel failure (TVF) comprised cardiac death, target vessel myocardial infarction, and percutaneous or surgical target vessel revascularization (TVR). Baseline characteristics were not significantly different. Post-dilatation was used significantly more often in the second group (23.8% vs. 50.5%, p<0.05) as was intravascular imaging (9% vs. 19%, p<0.05). In-hospital MACEs (2.0% for both groups) and median duration of hospital stay (4 (2-6)days) did not differ significantly. During a follow-up of 210 (155-369) or 200 (176-286)days (p=n.s.) for the first and second groups, respectively, MACE (11.2% vs. 1.1%, p<0.01), TVF (10.1% vs. 1.1%, p<0.01), and TVR (9.9% vs. 1.1%, p<0.05) rates were significantly lower in the second group. There is evidence of a learning curve. Post-dilatation is most probably associated with an improved clinical result and intravascular imaging might be useful for further improvement.

INT-002 The Evolution of Devices in Haemodynamic Unit: The Experience of ‘San Paolo’ Hospital in Bari (Italy)

BackgroundThe percutaneous transluminal coronary angioplasty (PTCA) is a therapeutic technique based on the use of devices (balloon catheters (POBA), bare-metal stents (BMS) and drug-eluting stents (DES)) which permit the treatment...

Amsterdam Investigator–initiateD Absorb strategy all-comers trial (AIDA trial): A clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: Rationale and study design

The Absorb everolimus-eluting bioresorbable vascular scaffold (AbsorbBVS) is a completely resorbable device engineered to overcome the limitations of permanent metallic stents, providing temporary scaffolding and antiproliferative drug delivery for the treatment of obstructive coronary artery disease. The objective of the AIDA trial is to evaluate the efficacy and performance in an contemporary all-comer population of the AbsorbBVS strategy vs the XIENCE family everolimus-eluting metallic coronary stent system in the treatment of coronary lesions. The AIDA trial is a prospective, randomized (1:1), active-control, single-blinded, all-comer, noninferiority trial. A total of 2,690 subjects will be enrolled with broad inclusion and limited exclusion criteria according to the "Instructions for Use" of the AbsorbBVS strategy. The study population includes both simple and complex lesions, in patients with stable and acute coronary syndrome. The follow-up continues for 5years. The primary end point of the trial is target vessel failure, defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization, at 2years. This study is registered on ClinicalTrials.gov with number NCT01858077. The AIDA trial will provide the first randomized direct comparison between the everolimus-eluting bioresorbable vascular scaffold and the everolimus-eluting metallic stent in contemporary percutaneous coronary intervention practice.

Automatic determination of optimal view for the visualization of coronary lesions by rotational X-ray angiography

Treatment of coronary lesions by percutaneous transluminal angioplasty is performed from 2D observations acquired according to an optimal view, i.e. a point of view showing the segment including the stenosis in its most extended and unobstructed dimension over a given perimeter around the lesion. In clinical routine, the research of this view generally involves a large number of acquisitions with repeated injections of contrast agent. In this paper, we present an automatic method to determine this optimal view. We consider that a dynamic sequence of 3D coronary tree is available either from pre-segmented CT data or by reconstruction of the 3D coronary tree from the projections acquired at each phase of the cardiac cycle. We proceed by volume projection into the detector plane in all possible gantry orientations. The optimal viewing angle is the one that minimizes the degree of segment foreshortening and overlap with adjacent segments in projection space.

Upon the Developments of Drug-Eluting Stents in the Treatment of Coronary Lesions

The review is devoted to the recent publications and patents focusing on drug-eluting stents (DESs), which due to their ability in reducing restenosis are becoming the lead player for the treatment of coronary artery disease (CAD). Various approaches have been used in development of these medical devices. Most DES architecture includes three components: a stent platform, a drug delivery vehicle and therapeutic agent; each part has significant impact on the biological performance of DES. The paper outlines the new developments on drug-eluting stents sustained by patents literature.

A Comparative Study of Risk Factors and the Occurrence Rate of Coronary Atherosclerosis in Extra- and Intracranial Atherosclerotic Lesions

The risk factors and epidemiology of extracranial and intracranial atherosclerotic lesions may be different. We evaluated the importance of perioperative management of coronary atherosclerotic lesions in carotid endarterectomy (CEA) or carotid artery stenting (CAS) for extracranial cervical carotid artery stenosis and superior temporal artery (STA)-middle cerebral artery (MCA) bypass for intracranial severe MCA stenosis/occlusion. The medical records of patients who underwent cerebrovascular surgery at Aizu Chuo Hospital between January 2000 and September 2010 were retrospectively analyzed. Preoperative cardiovascular screening was performed for all patients to prevent perioperative ischemic heart disease-related complications. The number of patients requiring preoperative treatment of the coronary artery was compared. A total of 320 patients underwent surgery for cervical carotid stenosis (IC group; 259 patients with CEA and 61 patients with CAS), and 92 patients underwent STA-MCA bypass for MCA stenosis/occlusion (MC group). Treatment for coronary lesions was required in 35 of 320 patients (10.9%) in the IC group and 14 of 92 patients (15.2%) in the MC group. Surgery was safely performed in both groups without any ischemic heart disease-related complications during the perioperative period. This study shows the importance of perioperative management of coronary atherosclerotic lesions for STA-MCA bypass, similar to that for CEA/CAS.

Comparison of zotarolimus‐ versus everolimus‐eluting stents in the treatment of coronary bifurcation lesions

To compare zotarolimus-eluting stent (Endeavor Sprint®; ZES-S) and the everolimus-eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions. Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated. In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES-S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in-hospital and at 12 months of follow-up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow-up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia. There were no significant differences in in-hospital MACE between the groups (ZES-S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES-S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES-S vs. one in EES; P = 0.14). The treatment of coronary bifurcation lesions using everolimus-eluting stents results in better outcomes at 12 months of follow-up than zotarolimus-eluting stents.

The Unrestricted Use of Sirolimus- and Paclitaxel-Eluting Stents Results in Better Clinical Outcomes During 6-Year Follow-Up Than Bare-Metal Stents: An Analysis of the RESEARCH (Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital) and T-SEARCH (Taxus–Stent Evaluated At Rotterdam Cardiology Hospital) Registries

The aim of this study was to assess the 6-year clinical outcome after unrestricted use of sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in consecutive de novo patients undergoing percutaneous coronary intervention (PCI). SES and PES have been shown to significantly decrease target vessel revascularization (TVR) rates compared with BMS in "real-world" registries. However, possible higher rates of very-late stent thrombosis and a restenosis "catch-up" trend might jeopardize the benefit. Three PCI cohorts, each with exclusive use of 1 stent type (BMS = 450; SES = 508; PES = 576), were systematically followed for the occurrence of major adverse cardiac events (MACE). Very-late stent thrombosis was more common in SES and PES patients than BMS patients (2.4% vs. 0.9% vs. 0.4%, respectively; p = 0.02); however, there were no significant differences between the stent types for all-cause mortality and all-cause mortality/myocardial infarction at 6-year follow-up. Sixty-nine SES patients (Kaplan-Meier estimate 14%) and 72 PES patients (14%) had a TVR, as compared with 79 BMS patients (18%; log-rank p = 0.02), which maintained significance after adjustment for (potential) confounders. Multivariate analysis showed that DES implantation is associated with lower incidence of TVR and MACE than BMS implantation (hazard ratio: 0.65, 95% confidence interval: 0.49 to 0.86; p = 0.003; hazard ratio: 0.79, 95% confidence interval: 0.65 to 0.97; p = 0.02, respectively). Incidence of MACE was also lower in SES and PES patients (30% and 30%, respectively) than in BMS patients (34%); however, significance was borderline. The unrestricted use of both DES resulted in a sustained advantage in decreasing TVR and, to a lesser extent, MACE compared with BMS at 6 years. The SES and PES are equally safe and effective in the treatment of coronary lesions.

Tacrolimus-eluting stents are more effective than bare metal stents in the treatment of coronary lesions,

Tacrolimus-eluting stents are more effective than bare metal stents in the treatment of coronary lesions,

A randomized comparison of balloon angioplasty and stent implantation in the percutaneous treatment of coronary bifurcations

Objective — A prospective randomized multicentre pilot trial, comparing stenting with balloon angioplasty as a treatment for coronary lesions, located in a bifurcation was performed.Methods and results — After balloon dilatation, with a < 30% residual stenosis in the main vessel and < 50% residual stenosis in the side branch, patients were randomized to stay in a “balloononly” group or to stenting. The stents used were the AVE S 670 for the main vessel and the Bestent, if needed, for the side branch. The primary end point was the incidence of major adverse cardiac events (MACE) at 6 months, secondary end points were in-hospital MACE, acute angiographic results, use of materials and duration of the procedure. One hundred eleven patients were randomized: 55 in the balloon group, 56 in the stent group. No differences in MACE-rates were found at 6 months (22% versus 20%, p = 0.78).The target vessel revascularization rate was 16% in the balloon group and 12.5% in the stent group (p = 0.56). The acute angiographic results were significantly better in the stent group (residual stenosis 8% versus 26% [p < 0.05]). More materials were used, with a near doubling of the duration of the procedure in the stent group (p < 0.05).Conclusions — Although stenting resulted in better immediate angiographic results during percutaneous treatment of lesions located in a bifurcation, as compared to balloon angioplasty alone, clinical events were comparable in the two treatment arms.

Interventional Cardiology. Where Are We and Where Are We Going From Here?

This article summarizes 20 years of percutaneous interventional cardiology for coronary angioplasty. During this period, interventional cardiology has evolved faster than any other type of treatment in the field of cardiovascular diseases. We describe the early results of interventional cardiology, the increase in primary success rates and the reduction in complication rates for percutaneous techniques during this period, which coincided with the introduction of technological advances. In the early 1990s, primary success rates for the treatment of coronary lesions stood at 86%-88%, with a restenosis rate of 30%-40% at 6-month follow-up. Current primary success rates have risen to over 95% with a restenosis rate of under 10%, even for many types of lesions classically considered complex. Currently the main limitations in interventional cardiology remain coronary segments that cannot be accessed due to chronic total occlusion, or severe proximal tortuosity or calcification. Rapid improvements have led to broader clinical indications for percutaneous revascularization procedures, and have made frequent updates of clinical practice guidelines necessary. Meanwhile, comparative studies involving other modes of surgical revascularization have become extremely difficult because percutaneous methods used in long-term studies begun 5 to 10 years have become obsolete.

Impact trial: Angiographic and intravascular ultrasound observations of the first human experience with mycophenolic acid-eluting polymer stent system

The purpose of the study was to examine the safety and efficacy of two different formulations of mycophenolic acid (MPA)-eluting Duraflex stents on coronary de novo lesions. Recent data indicate that local delivery of MPA in the porcine overstretch coronary model significantly reduces neointimal hyperplasia (NIH). Patients were divided into three consecutive groups. The first (n=50) and second (n=55) groups received moderate- and slow-release MPA-eluting Duraflex stent, respectively. The last group (n=50) received the bare metal Duraflex stent. Clinical, angiographic, and intravascular ultrasound analysis were performed at 6-month follow-up. All stents were successfully deployed and patients were discharged home without clinical events. Compared to controls, 6-month in-lesion and in-stent minimum luminal diameter as well as late lumen loss were not significantly different in the moderate- and slow-release treatment groups. At follow-up, percentage obstruction and NIH volume were also similar between the three groups. At 30 days and 6 and 12 months, there were no differences noted between the three groups with respect to major adverse cardiac events as well as the individual rates of mortality, myocardial infarction, or repeat revascularization. There were no cases of subacute or late thrombosis. In this feasibility trial, the MPA-eluting Duraflex stents in either slow- or moderate-release formulations were well tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. Further testing with different drug dosing or delivery rate might improve these results.