scholarly journals Clinical Outcomes Following Large Vessel Coronary Artery Perforation Treated with Covered Stent Implantation: Comparison between Polytetrafluoroethylene- and Polyurethane-Covered Stents (CRACK-II Registry)

2021 ◽  
Vol 10 (22) ◽  
pp. 5441
Author(s):  
Jerzy Bartuś ◽  
Rafał Januszek ◽  
Damian Hudziak ◽  
Michalina Kołodziejczak ◽  
Łukasz Kuźma ◽  
...  

Data on the clinical outcomes comparing synthetic fluorocarbon polymer polytetrafluoroethylene- (PTFE, GraftMaster) and polyurethane- (Papyrus) covered stents (CSs) to seal coronary artery perforations (CAPs) are limited. We aimed to evaluate 30-day and 1-year clinical outcomes after PCI complicated by CAP and treated with CS. We assessed 106 consecutive patients with successful CAP sealing (122 CSs): GraftMaster (51 patients, 57 CSs) or Papyrus CS (55 patients, 65 CSs). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac death, target lesion revascularisation (TLR), and myocardial infarction (MI). The mean age of subjects was 69 ± 9.6 years (53.8% males). No significant differences were identified between the GraftMaster and Papyrus groups at the 30-day follow-up for MACE, cardiac death, MI and stent thrombosis (ST), while significantly lower rate of TLR and TVR (p = 0.02) were confirmed in the Papyrus group. At one year, differences remained similar between stents for MACE, a trend towards a lower rate of TLR (p = 0.07), MI (p = 0.08), and ST (p = 0.08), and higher for cardiac death (p = 0.07) was observed in the Papyrus group. This real-life registry of CAP illustrated that the use of Papyrus CS is associated with lower rates of TLR and TVR at 30-day follow-up in comparison to the GraftMaster CSs and no significant differences between both assessed CS at one year of follow-up.

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiaoyue Song ◽  
Qing Qin ◽  
Shufu Chang ◽  
Rende Xu ◽  
Mingqiang Fu ◽  
...  

Objectives. The present study aimed to investigate the short- and long-term clinical outcomes of self-made polyurethane-covered stents (PU-CS) in patients for the management of coronary artery perforation (CAP) during percutaneous coronary intervention (PCI). Background. Coronary artery perforation is reckoned as a serious complication in PCI and associated with considerable morbidity and mortality. Covered stents have been used for treating the life-threatening CAP during PCI. But in some catheterization laboratories, no commercial CS is immediately available when there is an urgent need for CS to rescue the coronary rupture site. Methods. We retrospectively identified 24 patients who underwent 31 self-made PU-CS implantations due to CAP in Zhongshan Hospital, Fudan University, from June 2015 to January 2020. Results. The total procedural success rate of CS to seal the perforation was 79.2%. Nine patients (37.5%) developed cardiac tamponade, of which 8 patients (33.3%) underwent pericardiocentesis and 4 patients (16.7%) underwent cardiac surgeries. Except for 4 cardiac death cases (16.7%), none of myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis (ST) was reported during hospital stay. Data from 22 patients (91.7%) were available at 610.4 ± 420.9 days of follow-up. Major adverse cardiac events (MACE) occurred in 6 patients (27.3%), including 5 cases of cardiac death and one TLR case. Conclusions. Self-made PU-CS demonstrates high rates of successful delivery and sealing of severe CAP during PCI. Although the in-hospital mortality remains high after PU-CS implantation, the long-term follow-up shows favorable clinical outcomes, indicating the feasibility of PU-CS in treating CAP.


PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0249698
Author(s):  
Wojciech Wańha ◽  
Rafał Januszek ◽  
Michalina Kołodziejczak ◽  
Łukasz Kuźma ◽  
Mateusz Tajstra ◽  
...  

Background Data regarding the clinical outcomes of covered stents (CSs) used to seal coronary artery perforations (CAPs) in the all-comer population are scarce. The aim of the CRACK Registry was to evaluate the procedural, 30-days and 1-year outcomes after CAP treated by CS implantation. Methods This multicenter all-comer registry included data of consecutive patients with CAP treated by CS implantation. The primary endpoint was the composite of major adverse cardiac events (MACEs), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI). Results The registry included 119 patients (mean age: 68.9 ± 9.7 years, 55.5% men). Acute coronary syndrome, including: unstable angina 21 (17.6%), NSTEMI 26 (21.8%), and STEMI 26 (21.8%), was the presenting diagnosis in 61.3%, and chronic coronary syndromes in 38.7% of patients. The most common lesion type, according to ACC/AHA classification, was type C lesion in 47 (39.5%) of cases. A total of 52 patients (43.7%) had type 3 Ellis classification, 28 patients (23.5%) had type 2 followed by 39 patients (32.8%) with type 1 perforation. Complex PCI was performed in 73 (61.3%) of patients. Periprocedural death occurred in eight patients (6.7%), of which two patients had emergency cardiac surgery. Those patients were excluded from the one-year analysis. Successful sealing of the perforation was achieved in 99 (83.2%) patients. During the follow-up, 26 (26.2%) patients experienced MACE [7 (7.1%) cardiac deaths, 13 (13.1%) TLR, 11 (11.0%) MIs]. Stent thrombosis (ST) occurred in 6 (6.1%) patients [4(4.0%) acute ST, 1(1.0%) subacute ST and 1(1.0%) late ST]. Conclusions The use of covered stents is an effective treatment of CAP. The procedural and 1-year outcomes of CAP treated by CS implantation showed that such patients should remain under follow-up due to relatively high risk of MACE.


2019 ◽  
Author(s):  
Tilman Stephan ◽  
Nadine Goldberger ◽  
Mirjam Keßler ◽  
Dominik Felbel ◽  
Manuel Rattka ◽  
...  

Abstract Background: Percutaneous coronary intervention (PCI) of left main coronary artery disease (LMD) is associated with appropriate clinical and angiographic outcomes, resulting in a class I recommendation in patients with less complex coronary anatomy. Due to higher SYNTAX scores and worse clinical outcomes, PCI in distal LMD is accomplished with a lower strength of recommendations for revascularization compared to ostial LM lesions. We compare angiographic and clinical outcomes of ostial/midshaft lesions versus distal lesion in LMD after PCI. Methods: This retrospective study included 176 patients with LMD undergoing PCI with drug-eluting stents. The study population was divided into 34 patients with ostial/midshaft LMD and 142 patients with distal LMD. Patients were routinely scheduled for 9 months of angiographic and 12 months of clinical follow-up. Quantitative coronary analysis (QCA) was performed for all lesions, using an 11-segment model. Primary outcome was MACE (major adverse cardiac events) defined as a composite of cardiac death, myocardial infarction and target lesion revascularization (TLR). Results: The primary outcome measure was comparable in both cohorts after 12 months follow-up (20.6% in ostial/midshaft LMD vs. 17.6% in distal LMD, P=0.71). As expected, TLR rates were increased in distal LM lesions compared to ostial LM lesions, but without reaching statistical significance (14.1% vs. 5.9%, P=0.15). Late lumen loss (LLL) in ostial/midshaft LMD was 0.42±0.33mm. In distal LM lesions value for LLL in the main vessel was 0.42±0.97 mm, with the highest values observed in segments adjacent to the bifurcation (0.37±1.13mm and 0.37±0.73 mm). On cox proportional regression analysis LLL in a bifurcation segment (P=0.03, HR 1.68 [1.1-2.7]) and diabetes mellitus (P=0.046, HR 2.77 [1.0-7.5] were independent correlates for occurrence of MACE. Conclusion: PCI of distal LM lesions result in comparable angiographic and clinical outcomes compared to ostial LM lesions. Highest rates for binary restenosis were observed in segments nearest to the bifurcation.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G N Janssens ◽  
N W Van Der Hoeven ◽  
J S Lemkes ◽  
H Everaars ◽  
P Van De Ven ◽  
...  

Abstract Background Up to 24% of acute coronary syndrome patients present with ST-elevation but show complete resolution of ST-elevation and symptoms before revascularization. The current guidelines do not clearly state whether these transient ST-elevation myocardial infarction (TSTEMI) patients should be treated with a ST-elevation myocardial infarction (STEMI)-like or a non-STEMI-like invasive approach. Purpose The aim of the present study is to determine the effect of an immediate versus a delayed invasive strategy on infarct size measured by 4-month cardiac magnetic resonance imaging (CMR) and clinical outcome up to one year. Methods In this multicenter trial, 142 TSTEMI patients were randomized 1:1 to either an immediate or a delayed intervention. CMR was performed at four days and at 4-month follow-up to assess infarct size and myocardial function. Clinical follow-up was performed at four months and one year. Results Both in the immediate (0.4 h) and the delayed invasive group (22.7 h) CMR-derived infarct size at four months was very small and left ventricular function was good. In addition, major adverse cardiac events and all-cause mortality at one year were low and not different between both groups (table 1). CMR and clinical outcomes up to one year Outcome Immediate invasive group (n=70) Delayed invasive group (n=72) p-value Myocardial infarct size (% of LV), median (IQR) 0.4 (0.0–3.5) 0.4 (0.0–2.5) 0.79 LVEF (%), mean ± SD 59.9±5.4 59.3±6.5 0.63 LVEF recovery (%), mean ± SD 2.2±5.4 1.7±5.3 0.66 MVO present, No. (%) 0 (0.0) 1 (1.9) 0.50 MACE (death, reinfarction, target lesion revascularization), No. (%) 3 (4.4) 4 (5.7) 1.00 Death from any cause, No. (%) 0 (0.0) 3 (4.3) 0.24 Reinfarction, No. (%) 2 (3.0) 1 (1.4) 0.62 Target lesion revascularization, No. (%) 2 (3.0) 1 (1.4) 0.62 Definite stent thrombosis, No. (%) 1 (1.5) 1 (1.4) 1.00 Abbreviations: IQR, interquartile range; LV, left ventricle; LVEF, left ventricle ejection fraction; MACE, major adverse cardiac events; MVO, microvascular obstruction; NA, not applicable; SD, standard deviation. Conclusions We demonstrated that patients with TSTEMI have limited infarct size and preserved left ventricular function and that an immediate or delayed approach has no effect on clinical outcome up to one year. Therefore, patients with TSTEMI can be treated with both an immediate or a delayed invasive strategy with similar outcome. These findings extend our current knowledge about the optimal timing of coronary intervention in patients with TSTEMI and complement the guidelines. Acknowledgement/Funding AstraZeneca, Biotronik


Scientifica ◽  
2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Anurag Polavarapu ◽  
Raghava Sarma Polavarapu ◽  
Jayesh Prajapati ◽  
Kamlesh Thakkar ◽  
Asif Raheem ◽  
...  

Background. Long lesions being implanted with drug-eluting stents (DES) are associated with relatively high restenosis rates and higher incidences of adverse events.Objectives. We aimed to examine the safety and efficacy of the long (40 mm) biodegradable polymer coated Indolimus sirolimus-eluting stent (SES) in real-world patients with long coronary lesions.Methods. This study was observational, nonrandomized, retrospective, and carried out in real-world patients. A total of 258 patients were enrolled for the treatment of long coronary lesions, with 40 mm Indolimus. The primary endpoints in the study were incidence of major adverse cardiac events (MACE), a miscellany of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR), and stent thrombosis (ST) up to 6-month follow-up.Results. The study population included higher proportion of males (74.4%) and average age was 53.2 ± 11.0 years. A total of 278 lesions were intervened successfully with 280 stents. The observed MACE at 6-month follow-up was 2.0%, which included 0.8% cardiac death and 1.2% MI. There were no TLR or TVR and ST observed during 6-month follow-up.Conclusions. The long (40 mm) Indolimus stent demonstrated low MACE rate and was proven to be safe and effective treatment for long lesions in “real-world” patients.


2017 ◽  
Vol 46 (1) ◽  
pp. 457-463 ◽  
Author(s):  
Chor Cheung Tam ◽  
Kelvin Chan ◽  
Simon Lam ◽  
Arthur Yung ◽  
Yui Ming Lam ◽  
...  

Objective To evaluate the 1-year clinical outcomes of patients who received the Resolute Onyx™ stent. Methods This was a single-centre, retrospective registry analysis that reviewed the clinical data from all patients who were implanted with a Resolute Onyx™ stent between March 2015 and February 2016. Clinical follow-up was performed at 1 year post-implantation. Results A total of 252 patients received a Resolute Onyx™ stent and two patients were lost to follow-up. The mean age of the cohort was 66.9 years and 113 (45.2%) had diabetes mellitus. Thirty-eight patients (15.2%) had left main disease and 73 (29.2%) had three-vessel disease. A total of 175 patients (70.0%) had small vessel disease (<2.75 mm) and 210 (84.0%) had long lesions (>20 mm). The 1-year target lesion failure was 4.4% (11 of 250), cardiovascular death occurred in eight patients (3.2%), ischaemia-driven target lesion revascularization was undertaken in five patients (2.0%) and stent thrombosis occurred in one patient (0.4%). Conclusion The Resolute Onyx™ stent showed a favourable 1-year clinical performance in a real-world population.


2020 ◽  
Vol 43 (2) ◽  
pp. E35-46
Author(s):  
Xiao-Rui Chen, MD Chen ◽  
Di-Yu Cui ◽  
Yun-Qing Chen, MD, PhD Chen ◽  
Tie-Sheng Niu

Purpose: Crush and Culotte techniques have been used increasingly to treat patients with complex unprotected left main coronary artery bifurcation lesions. This article compares published data on these two techniques. Methods: Databases, including PubMed, Embase, Cochrane Library, Wanfang Data and China National Knowledge Infrastructure, were searched for articles published before Aug 21, 2019 to identify all relevant studies on left main coronary artery bifurcation lesions treated by Crush versus Culotte techniques. The pooled data were analyzed using either fixed- or random-effects model depending on heterogeneity (assessed via the I2 index). The endpoints were major adverse cardiac events, target lesion revascularization, cardiac death, stent thrombosis, myocardial infarction and target vessel revascularization. Results: Eight articles with a total of 1,283 patients were included, and 710 patients were treated with Crush, and 573 ones with Culotte. Crush group was trend to decreased major adverse cardiac event compared with Culotte group [Relative ratio (RR) 0.63,95% confidence interval(CI) 0.39-1.04, I2 =72.7%], mainly driven by decreased cardiac death [RR 0.49, 95% CI(0.25-0.99), I2 =0%], decreased myocardial infarction [RR 0.40, 95% CI(0.21-0.76), I2 =21.6%],and lower stent thrombosis [RR 0.39, 95% CI(0.16-0.98), I2 =39.4%]. There was no significant difference in target lesion revascularization and target vessel revascularization between Crush and Culotte [RR 0.77, 95% CI 0.46-1.28, I2=61.1%; RR 0.78, 95% CI (0.30-2.02), I2 =73.1%, respectively]. Conclusion: Crush was superior to Culotte for treatment of left main coronary artery bifurcation lesions with a trend of lower incidence of long-term major adverse cardiac events, mainly derived from decreased myocardial infarction, stent thrombosis and cardiac death.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Athulorala ◽  
B H Loku Waduge ◽  
H Kalkat ◽  
A Saif ◽  
A M Fawzy ◽  
...  

Abstract Introduction Provisional stenting is the preferred strategy even in true bifurcations, however, to minimise the need for repeat revascularization of side-branches, the use of drug coated balloons has been suggested. Most of the data available in the literature are on Paclitaxel coated balloons, a drug which is almost obsolete in stents due to its cytotoxic properties. There is limited data on Limus coated balloons (SCB), a drug which is the default for all the currently available drug eluting stents. In this study, we explore the clinical outcomes following use of SCB in side-branches during provisional stent technique in true bifurcations. Methods and results We evaluated all de novo lesions treated with DCB for true bifurcations between March 2018 and October 2020 at our centre. The results are reported as cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target vessel MI and TLR). During the study period 110 patients with de novo lesions were treated with SCB for bifurcation lesions. Of them; 66 were in true bifurcations. The mean age of patients were 66.3±10.7 years, 75% (n=50) were male, 40 (61%) were in the setting of acute coronary syndrome, 52% (n=34) had diabetes and 32% (n=21) had CKD. Pre-dilatation was performed in all cases and none of them needed bailout stenting. Small vessels (&lt;3.0 mm) accounted for 72% (n=48) of cases. Non-compliant balloons and scoring balloons to prepare the lesion was used in 51% (n=34) and 13% (n=9) of cases respectively. The mean diameter and length of SCBs were 2.6±0.4 mm and 23.2±7.3 mm respectively. During a median follow-up of 729 days (2-years); there were no cardiac deaths, TVMI occurred in one case (2%), TLR in 3% (n=2) and the overall MACE rate was 3% (n=2). There were no documented cases of acute vessel closure Conclusion The results from long term follow-up with this relatively new technology of DCB in treatment of side-branch in true bifurcation is encouraging. We have demonstrated low rates of hard endpoints, TLR and MACE rates despite complex group of patients (61% ACS, 52% diabetics and 32% CKD). These results are encouraging, but going forward, we need more data from larger patient trials. In the meanwhile our data should instil confidence to adopt this technology in clinical practice. FUNDunding Acknowledgement Type of funding sources: None.


2018 ◽  
Vol 11 (3) ◽  
pp. 1275-1289
Author(s):  
Bimal Chhajer ◽  
Vikram Singh ◽  
Girija Kumari ◽  
Mahendra Lohmor

This study was designed to evaluate the impact of yoga based lifestyle intervention on coronary artery disease (CAD) patients. This multi-centric prospective study was held in the Saaol heart center in different cities (Delhi, Kolkata, Bangalore, Chennai, and Mumbai) of India from 1995 to 2015. In this study, total 5,000 CAD patients having co-morbidity of obesity, hypertension, and diabetes were enrolled. A yoga-based lifestyle modification counseling (consist the essential components; cardiac education, plant-based balanced diet, regular walk, yoga, and meditation) was administrated to study subjects and clinical assessment was done using Saaol safety wheel as a holistic tool. In the beginning, lifestyle modification counseling was provided every month for one year and after one year the counseling was repeated for every six months with clinical assessment till the end of the study. The results of this study demonstrate a significant improvement in angina with reduction of New York Heart Association (NYHA) angina classification score from 3.08±0.56 (mean±SD) to 2.45±0.70 and also reduce the intake of anti-anginal drugs from 4.36±1.35 to 3.82±1.20. In this study, a significant improvement was also observed in heart attack protection score from 56.68±13.53 to 104.13±14.55. After the adherence to yoga-based lifestyle modification counseling components and Saaol safety wheel, 98% study subjects showed the significant improvements in clinical outcomes (BMI, blood pressure, and lipid parameters) and cardiac patients reduced the risk of heart attack and cardiac events. This study concludes that yoga-based lifestyle intervention is a non-invasive effective treatment method to control and prevent cardiac risk factors in CAD patients. This type of holistic approach may help to reduce the rate of cardiac events and heart attacks but there is further long-term multicentric randomized controlled trials are required for better clinical outcomes.


2017 ◽  
Vol 21 (1) ◽  
pp. 44 ◽  
Author(s):  
V. L. Vorobev ◽  
A. A. Semenihin ◽  
N. I. Grachev ◽  
V. V. Verin

<p><strong>Aim</strong>. To evaluate the effectiveness of the stent use Calypso Angiolain Russia with primary percutaneous transluminal coronary angioplasty (PTCA).<br /><strong>Methods.</strong> The study prospectively included 150 patients who underwent PTCA in acute coronary syndrome (ACS) for the period from January to December 2015. During the one-year follow-up period were evaluated indicators insolvency target lesion (cardiac death, myocardial infarction in the pool target artery, target lesion revascularization when clinically indicated), major adverse cardiac events (death from any cause, myocardial infarction, repeat revascularization as clinically indicated). <br /><strong>Results.</strong> In one year, the incidence of target lesion failure was 6.66% for cardiac death rate of 1.33%, myocardial infarction in the target artery 3.33% and target lesion revascularization at 5.3%. The frequency of cardiac major adverse cardiac events was 12% at mortality 2.66%, myocardial infarction 4% and revascularization when clinically indicated 8.66%. <br /><strong>Conclusion.</strong> The use of stents in primary PTCA Calypso is possible, the percentage of cardiovascular complications is comparable with the data of clinical trials.</p><p>Received 31 January 2017. Accepted 17 March 2017.</p><p><strong>Financing:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> The authors declare no conflict of interest.</p>


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