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.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Warisawa ◽  
C.M Cook ◽  
J.P Howard ◽  
D Nour ◽  
S Doi ◽  
...  

Abstract Background Physiology-guided treatment strategy improves clinical outcomes of patients with coronary artery disease. However, it has not been fully evaluated whether such guideline-based strategy is useful for patients with diffuse coronary artery disease as well, which is known to be one of the major factors affecting morbidity and mortality. Purpose The aim of this study was to clarify clinical outcomes of patients with diffuse coronary artery disease whose treatment strategy was based on coronary physiology. Methods From an international multicentre registry of iFR-pullback, consecutive 1067 patients (1185 vessels) with stable angina were included in whom coronary lesions were deferred or revascularized according to the iFR cutoff: 0.89. The physiological pattern of disease was classified according to the iFR-pullback recording as predominantly physiologically diffuse (n=463) or predominantly physiologically focal (n=722). Major adverse cardiovascular events (MACEs), defined as a composite of cardiac death, non-fatal myocardial infarction, and ischemia-driven target lesion revascularization during follow-up period, were compared between diffuse and focal groups, in both deferred and revascularized groups, respectively. Results Mean age was 67.1±10.7 years and 75.8% of patients were men. Median iFR was 0.88 (interquartile range: 0.80 to 0.92). At a median follow-up period of 18 months, no significant differences in MACEs were found between diffuse and focal groups, in both iFR-based deferred and revascularized groups. In the deferred group (n=480), MACEs occurred in 6.9% patients (15/217) in the diffuse group and 8.0% patients (21/263) in the focal group (p=0.44). In the revascularized group (n=705), MACEs occurred in 8.9% patients (22/246) in the diffuse group and 7.2% patients (33/459) in the focal group (p=0.49). Conclusions Despite potentially higher risks in patients with diffuse coronary artery disease, clinical outcomes of those patients were comparable to those of patients without diffuse disease, as long as treatment strategy was based on the physiology guidance, which is globally recommended by international guidelines. Funding Acknowledgement Type of funding source: None


2019 ◽  
Vol 29 (2) ◽  
Author(s):  
Zahra Sharifi ◽  
Majid Jalal Yazdi ◽  
Ali Eshraghi ◽  
Vida Vakili ◽  
Javad Ramezani

Cardiovascular disease is one of the most important causes of morbidity and mortality in the world. Treatment in most patients is percutanseous coronary intervention. One of new generation drug-eluting stent (DES) is Sirolimus Eluting Stent. The current study was aimed to investigate the clinical outcomes and complications of treatment with supraflex stent during one year follow up in patients with coronary artery disease. This cross-sectional study was performed on patients with myocardial ischemia who were candidate for coronary angioplasty between 2017 -2018 in Imam Reza Hospital, Mashhad, Iran. Patients were followed for four primary end points including Target lesion revascularization (TLR), stent thrombosis (ST), myocardial infarction (MI) and cardiac death (CD) for one year. Descriptive data were analyzed by Freidman at a significance level of 0.05. A total of 287 patients were enrolled in the study. There was no TLR, MI, ST and CD records in the one month follow up. Six months follow up demonstrated three TLR patients and three MI patients, but no ST and death were reported. After one year follow up, three cases of CD and four ST cases were found in patients treated with supraflex stent. Based on the Freidman test, the highest rate of TLR was revealed in a six-month follow-up when comparing with one-month and twelve-month follow-up (p = 0.05). No significant relationship was found between the other cases. The most common complications associated with supraflex stent were TLR and MI in six-month follow-up. The most likely occurrence of CD and ST were found in one year follow up.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Hiromasa ◽  
S Kuramitsu ◽  
K Yamaji ◽  
T Domei ◽  
M Hyodo ◽  
...  

Abstract Background Impact of SYNTAX score II (SSII) on long-term clinical outcomes after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation remains unclear. Methods Between February 2010 and May 2011, 1064 consecutive patients with 1440 lesions were treated only with CoCr-EES implantation. Of these, the SSII was calculated in 1013 patients with 1345 lesions. Patients were divided into the tertile group: Tertiles for SSII (low SSII [12–28.9], n=334; intermediate SSII [29–39.1], n=339; and high SSII [39.2–80.8], n=340). We assessed the cumulative 7-year incidences of major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, definite stent thrombosis, and clinically driven target lesion revascularization (CDTLR) based on SSII groupings. Results Cumulative 7-year incidence of MACE was significantly higher in the high SSII group than in the other groups (34.1% vs. 18.6% vs. 17.2%, p&lt;0.001). The cumulative incidence of cardiac death, myocardial infarction and stent thrombosis were significantly higher in the high SSII group than in the other groups (22.1% vs. 2.0% vs. 5.3%, p&lt;0.001; 6.6% vs. 4.9% vs. 1.7%, p=0.01; 2.9% vs. 1.7% vs. 0.3%, p=0.03, respectively). The cumulative incidence of CDTLR was similar between the groups (15.2% vs. 12.8% vs. 15.7%, p=0.57). High SSII group (hazard ratio [HR] 2.18 [vs. low SS], 95% confidence intervals [CI]: 1.56–3.06, p&lt;0.001) and diabetes mellitus (HR 1.37, 95% CI: 1.04–1.81, p=0.03) were predictors of 7-year MACE. Conclusions SSII has significantly impact on 7 years clinical outcomes after CoCr-EES implantation. Cumulative incidence of MACE Funding Acknowledgement Type of funding source: None


Sign in / Sign up

Export Citation Format

Share Document