scholarly journals Clinical outcomes of an ultrathin-strut sirolimus-eluting stent in all-comers population: Thailand Orsiro registry

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pannipa Suwannasom ◽  
Siriporn Athiksakul ◽  
Tasalak Thonghong ◽  
Vorarit Lertsuwunseri ◽  
Jarkarpun Chaipromprasit ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Cardiac Death ◽  
Target Lesion ◽  
Target Vessel ◽  
Chronic Total Occlusions ◽  
Small Vessels ◽  
Sirolimus Eluting Stent

Abstract Background Despite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro SES, Biotronik AG), the generalizability of the study results remains unclear in the Asian population. We sought to evaluate the clinical outcomes of the Orsiro SES in unselected Thai population. Methods The Thailand Orsiro registry was a prospective, open-label clinical study evaluating all patients with obstructive coronary artery disease implanted with Orsiro SES. The primary endpoint was target lesion failure (TLF) at 12 months. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), emergent coronary artery bypass graft (CABG), and clinically driven target lesion revascularization (CD-TLR). Patients with diabetes, small vessels (≤ 2.75 mm), chronic total occlusions (CTOs), and acute myocardial infarction (AMI) were pre-specified subgroups for statistical analysis. Result A total of 150 patients with 235 lesions were included in the analysis. Half of the patients (53.3%) presented with AMI, and 24% had diabetes. Among 235 lesions, 93(39.4%) were small vessels, and 24(10.2%) were chronic total occlusions. The primary endpoint, TLF at 12 months, occurred in eight patients (5.3%), predominately caused by cardiac death. By contrast, the incidences of TVMI and CD-TLR were null. The outcomes in pre-specified subgroup were not different from the overall population (all p > 0.05). One definite late stent thrombosis(0.7%) was incidentally observed during primary percutaneous coronary intervention to the non-target vessel. Conclusion The safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in the Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population. Trial Registration TCTR20190325001.

scholarly journals Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yi Dai ◽  
Rutao Wang ◽  
Fengying Chen ◽  
Yaojun Zhang ◽  
Yi Liu ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Outcomes ◽  
Real World ◽  
Cardiac Death ◽  
Target Lesion ◽  
Nonfatal Myocardial Infarction ◽  
Left Ventricular Ejection ◽  
Target Vessel ◽  
Safety And Efficacy ◽  
Multicenter Registry

Abstract Objectives To evaluate the 3-year clinical outcomes of a polymer-free sirolimus-eluting, Nano plus stent for the treatment of coronary artery disease in the NANO multicenter Registry. Background The long-term clinical data evaluating the safety and efficacy of the novel polymer-free sirolimus-eluting Nano plus stent (Lepu Medical, Beijing, China) is limited. Methods The NANO all-comers Registry trial was a prospective, multicenter clinical registry conducted in 26 centers in China between August 2016 and January 2017. A total of 2481 consecutive patients were exclusively treated with the Nano plus stent. The primary clinical endpoint, target lesion failure (TLF, defined as cardiac death, target vessel nonfatal myocardial infarction, and clinically driven target lesion revascularization [CD-TLR]), was analyzed at 3 years. Results At 3 years, 2295 patients (92.5%) were followed. The incidence of TLF was 6.8% (168/2481). The rate of cardiac death was 3.8% (94/2481), target vessel nonfatal myocardial infarction 0.7% (18/2481), and CD-TLR 2.9% (68/2481). The rate of definite/probable stent thrombosis was 0.5% (13/2481). The risk factors of diabetes mellitus, acute myocardial infarction, age, chronic renal failure, in-stent restenosis, chronic total occlusion, and left ventricular ejection fraction < 40% were the independent predictors of 3-year TLF. Conclusions At three years, the rate of TLF was relatively low in patients treated with the polymer-free Nano plus stent. The polymer-free Nano plus stent showed a favorable safety and efficacy profile in real-world patients. Clinical trial registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.

scholarly journals Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e026578 ◽  
Author(s):  
Anirban Choudhury ◽  
Scot Garg ◽  
Jamie Smith ◽  
Andrew Sharp ◽  
Sergio Nabais de Araujo ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Target Lesion ◽  
Performance Outcomes ◽  
Target Vessel ◽  
Cardiac Events ◽  
All Cause Mortality ◽  
Secondary Endpoints ◽  
Sirolimus Eluting Stent

ObjectiveTo prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in ‘real world’ patient population requiring percutaneous coronary intervention (PCI).MethodsNational, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months—overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE—composite of cardiac death, MI, emergent or repeat revascularisation).ResultsAt 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%).ConclusionsThe S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI.

P2808Absorb bioresorbable scaffold vs. Xience metallic stent: outcomes in the AIDA trial stratified by SYNTAX score

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Y G Tijssen ◽  
R P Kraak ◽  
I M Van Dongen ◽  
J Elias ◽  
S H Hofma ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Metallic Stent ◽  
Target Vessel ◽  
Increased Risk ◽  
Significant Difference ◽  
Absorb Bvs ◽  
The Impact

Abstract Aims Extent of coronary artery disease (CAD) may affect outcomes after percutaneous coronary intervention (PCI). In this pre-specified subgroup analysis of the AIDA trial we evaluated the impact of SXscore on clinical outcomes Methods and results AIDA was a multicenter trial comparing Absorb with Xience. SX score was assessed using the baseline diagnostic angiograms. Each coronary lesion with diameter stenosis ≥50% in vessels ≥1.5 mm was scored. All lesion scores were combined to provide the overall SXscore. The angiographic SXscore calculations were performed by core laboratory analysts who were blinded for clinical events (Cardialysis B.V., Rotterdam, The Netherlands). Clinical outcomes were subsequently stratified according to SXscore tertiles: SXlow (SXcore ≤8), SXmid (SXscore >8 and ≤15) and SXhigh (>15). The primary endpoint of this AIDA-trial substudy was target vessel failure (TVF), defined as a composite of cardiac death, target vessel myocardial infarction and target vessel revascularization. The SXscore was prospectively calculated in 1661 of the 1845 patients (90%). The SXscore ranged from 1 to 57, with a mean±SD of 12.9±8.5 and a median of 11 (Q1-Q3 7–17). In this analysis the SXscore tertiles were defined as SXlow (SXcore ≤8) (n=589), SXmid (SXscore >8 and ≤15) (n=538), and SXhigh (>15) (n=534). Patients in the SXhigh group were older, had a more extensive medical history for previous revascularizations (both PCI and coronary artery bypass grafting), and were more likely to present with a ST-elevation myocardial infarction. At 2 follow-up the Kaplan-Meier estimates of TVF for the overall AIDA study population was 15.5% in the SXhigh tertile, 10.4% in the SXmid tertile and 4.7% in the SXlow tertile (hazard ratio (HR) 3.53 95% CI 2.28–5.45; P<0.001). The event rate of the primary endpoint of TVF was numerically lower in Absorb when compared to Xience (3.7% versus 5.6%; HR 0.64; 95% CI 0.29 - 1.40; p=0.257) in the SXlow tertile. Patients treated with Absorb and a SXscore >8 had significantly higher event rates as compared to patients with a SXscore ≤8. The rates of TVF in the Absorb BVS population are 15.5% (SXhigh), 11.4% (SXmid), and 3.7% (SXlow), with a significant difference between the SXlow versus SXmid (HR 3.27; 95% CI 1.61–6.68; p=0.001) and SXlow versus SXhigh (HR 4.57; 95% CI 2.29–9.10; p<0.001). Target Vessel Failure in Absorb BVS Conclusions This study demonstrates that implantation of the Absorb in patients with a SXscore ≤8 is associated with numerically lower TVF rates as compared to the Xience drug-eluting stent. The rate of scaffold thrombosis in this SXlow tertile, while still higher for Absorb, is more acceptable than in SXmid and SXhigh score tertiles. Higher SXscore (i.e. >8), both Sxmid and SXhigh, however, appears to be associated with markedly increased risk of device thrombosis, revascularization and myocardial infarction in patients treated with the Absorb. Acknowledgement/Funding The AIDA trial was financially supported by an unrestricted research grant from Abbott Vascular

scholarly journals Clinical Outcomes in 2481 Unselected Real-World Patients Treated With a Polymer-Free Sirolimus-Eluting Stent: 3 Years Results From the NANO Multicenter Registry

2021 ◽  
Author(s):  
Yi Dai ◽  
Rutao Wang ◽  
Fengying Chen ◽  
Yaojun Zhang ◽  
Yi Liu ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Outcomes ◽  
Real World ◽  
Cardiac Death ◽  
Target Lesion ◽  
Nonfatal Myocardial Infarction ◽  
Left Ventricular Ejection ◽  
Target Vessel ◽  
Safety And Efficacy ◽  
Multicenter Registry

Abstract The long-term clinical data evaluating the safety and efficacy of the novel polymer-free sirolimus-eluting Nano plus stent (Lepu Medical, Beijing, China) is limited. We evaluated the 3-year clinical outcomes of a polymer-free sirolimus-eluting, Nano plus stent for the treatment of coronary artery disease in the NANO multicenter Registry. The NANO all-comers Registry trial was a prospective, multicenter clinical registry conducted in 26 centers between August 2016 and January 2017. A total of 2481 consecutive patients were exclusively treated with the Nano plus stent. The main clinical endpoint, target lesion failure (TLF, defined as cardiac death, target vessel nonfatal myocardial infarction, and clinically driven target lesion revascularization [CD-TLR]), was analyzed at 3 years. The incidence of TLF was 6.8% (168/2481). The rates of its individual components were as follows: cardiac death 3.8% (94/2481), target vessel nonfatal myocardial infarction 0.7% (18/2481), and CD-TLR 2.9% (68/2481). The rate of definite/probable stent thrombosis was 0.5% (13/2481). Diabetes mellitus, acute myocardial infarction, age, chronic renal failure, in-stent restenosis, chronic total occlusion and left ventricular ejection fraction <40% were the independent predictors of 3-year TLF. The TLF was relatively low in patients treated with polymer-free Nano plus stent at 3 years. The polymer-free Nano plus stent showed a favorable safety and efficacy profile in the real-world patients.Clinical trial registrationURL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.

P256 Clinical outcomes following coronary artery bifurcation intervention after acute myocardial infarction

2020 ◽  
Vol 41 (Supplement_1) ◽  
Author(s):  
KAREEM Abdelshafi ◽  
SEUNG Woon Rha ◽  
BYOUNG Geol Choi ◽  
S E Yeon Choi ◽  
DONG Kyeong Byun ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Coronary Artery ◽  
Clinical Outcomes ◽  
Stent Thrombosis ◽  
Cardiac Death ◽  
Chronic Stable Angina ◽  
Target Vessel ◽  
Total Death

Abstract Background Bifurcation coronary artery disease (CAD) represents 15-20% in PCI patients, however, limited data concerning the short and long term clinical outcome in AMI.  Methods A total of 1402 patients underwent bifurcation lesions PCI were enrolled. Patients were divided into two groups: 1) chronic stable angina group (CSA, N = 954) and 2) acute myocardial infarction group (AMI, N = 448) (241 NSTEMI and 207 STEMI). Major adverse cardiac events (MACE), the composite of death, myocardial infarction (MI), stroke and revascularization and stent thrombosis were compared between the two groups at up to 5 years. Results At 30 days follow up, the AMI group had significantly higher incidence of total death  (HR: 5.901, 95% CI : 1.879 to 18.532; p = 0.002), cardiac death (HR: 6.438, 95% CI 1.743 to 23.781; p = 0.005), MI (HR: 4.736  , 95% CI :1.646 to 13.632; p = 0.004), TLR (HR: 4.300  , 95% CI :1.295 to 14.279; p = 0.017), Stroke (HR: 5.901  , 95% CI :1.879 to 18.532; p = 0.002)  and MACE (HR: 4.318, 95% CI : 1.940 to 9.611; p = 0.000)  than the CSA group moreover, at 5 years follow up the AMI group had significantly higher incidence of  MI , TLR , Stent Thrombosis and MACE than the CSA group.Using Multivariate logistic regression, and after adjusting for potential confounding factors, the AMI  patients had higher incidence of total MACE at 30 days (HR: 3.668, 95% CI 1.572 to 8.558 ; p = 0.003) and at 5 years MACE (HR: 1.693, 95% CI 1.206 to 2.377 ; p = 0.002) Conclusion In this study, bifurcation lesion PCI in AMI setting was associated with a higher incidence of adverse clinical outcomes at 30 days and up to 5 years. Clinical Outcomes at 5 Years The incidence of Event (%) at 5 years Outcomes CSA (n = 954) AMI(n = 448) Log Rank Hazard ratio (95% Confidence interval ) P value Total death 21 (2.2) 14 (3.1) 0.285 1.443 (0.734-2838) 0.288 Cardiac death 10 (1.0) 10 (2.2) 0.078 2.160 (0.899-5.190) 0.085 Myocardial infarction 22 (2.3) 23 (5.1) 0.004 2.302 (1.283-4.130) 0.005 Revascularization 65 (6.8) 50 (11.2) 0.003 1.749 (1.210-2.529) 0.003 Target lesion 36 (3.7) 45 (6.4) 0.000 2.854 (1.831-4.448) 0.000 Target vessel 42 (4.4) 47 (10.5) 0.000 2.548 (1.680-3.863) 0.000 Non-target vessel 26 (2.7) 8 (1.8) 0.320 0.671 (0.304-1.482) 0.324 Stroke 131 (13.7) 66 (14.7) 0.555 1.093 (0.813-1.469) 0.556 Stent thrombosis 8 (0.8) 11 (2.5) 0.013 2.997 (1.205-7.451) 0.018 Total MACE 87 (9.1) 60 (13.4) 0.006 1.579 (1.135-2.196) 0.007

5-year outcomes in patients with acute coronary syndrome treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
O Muller ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Cardiac Death ◽  
Target Lesion ◽  
Funding Source ◽  
Target Vessel ◽  
Coronary Syndrome ◽  
Durable Polymer ◽  
Stable Cad

Abstract Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland

P833Two-year clinical outcomes between statin with ACE inhibitor or ARB in patients with ST-segment elevation myocardial infarction after successful PCI with DES

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Y H Kim ◽  
A.-Y Her ◽  
M.-H Jeong ◽  
B.-K Kim ◽  
S.-Y Lee ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Propensity Score ◽  
Clinical Outcomes ◽  
Cardiac Death ◽  
Hazard Ratio ◽  
P Value ◽  
Target Vessel ◽  
Cardiac Events ◽  
St Segment Elevation ◽  
Repeat Revascularization

Abstract Background Limited comparative data are available. Purpose We decided to compare 2-year major clinical outcomes between statin with ACEI and statin ARB therapy in patients with STEMI after PCI with drug-eluting stents (DES). Methods A total 11706 STEMI patients who underwent PCI with DES and who prescribed statin were enrolled and they were divided into two groups, the statin with ACEI group (n=8705) and the statin with ARB group (n=3001). The primary endpoint was the major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-TVR. The secondary endpoints were the cumulative incidences of individual components of MACE and target vessel failure (TVF), a composite of death related to the target vessel, re-MI, or clinically driven TVR. Results Two PSM groups (2835 pairs, n=5670, C-statistic = 0.680) were generated. The relative risk of MACE was higher in the statin with ARB group compared to statin with ACEI groups after propensity score-matched (PSM) analysis (hazard ratio [HR]: 1.323, 95% confidence interval [CI]: 1.085–1.613, p=0.006). The relative risks of cardiac death (HR: 1.831, 95% CI: 1.199–2.740, p=0.005), total repeat revascularization (HR: 1.487, 95% CI: 1.133–1.950, p=0.004), and non-TVR (HR: 1.696, 95% CI: 1.122–2.564, p=0.012) were also higher in the statin with ARB group after PSM. Outcomes Cumulative Events at 2-year (%) Hazard Ratio (95% CI) p value Statin + ACEI Statin + ARB Log-rank Propensity score matched Patients MACE 173 (6.5) 225 (8.5) 0.006 1.323 (1.085–1.613) 0.006 All-cause death 58 (2.2) 80 (3.0) 0.054 1.391 (0.992–1.950) 0.056 Cardiac death 35 (1.3) 63 (2.3) 0.004 1.831 (1.199–2.740) 0.005 Re-MI 39 (1.5) 44 (1.7) 0.548 1.141 (0.742–1.756) 0.548 Total repeat revascularization 88 (3.4) 128 (4.9) 0.004 1.487 (1.133–1.950) 0.004 TLR 26 (1.0) 40 (1.5) 0.075 1.561 (0.953–2.558) 0.077 TVR 53 (2.0) 71 (2.8) 0.086 1.364 (0.955–1.946) 0.088 Non-TVR 36 (1.4) 60 (2.3) 0.011 1.696 (1.122–2.564) 0.012 TVF 140 (5.3) 173 (6.6) 0.050 1.249 (1.000–1.561) 0.050 Conclusions In this study, we suggest that the combination of statin with ACEI may be beneficial for reducing the cumulative incidences of MACE, total repeat revascularization rate, and non-TVR rather than the statin with ARB after PCI with DES in STEMI patients.

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 ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Clinical Outcomes ◽  
Cardiac Death ◽  
Real Life ◽  
Target Lesion ◽  
Covered Stents ◽  
Cardiac Events ◽  
Coronary Artery Perforation ◽  
One Year

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.

scholarly journals Two-year safety and efficacy of Indigenous Abluminus Sirolimus Eluting Stent. Does it differ amongst diabetics? – Data from en-ABLe- REGISTRY

2021 ◽  
Vol 13 (2) ◽  
pp. 162-168
Author(s):  
Kamal Sharma ◽  
Sameer Dani ◽  
Devang Desai ◽  
Prathap Kumar ◽  
Nirav Bhalani ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Real World ◽  
Safety Profile ◽  
Target Lesion ◽  
Target Vessel ◽  
Open Label ◽  
Safety And Efficacy ◽  
Target Vessel Revascularization ◽  
Sirolimus Eluting Stent

Introduction: To evaluate the efficacy/safety profile of the Abluminus DES+ over 2-years follow-up in the "real-world" scenario in diabetics as compared to non-diabetics. Methods: In prospective, all-comers, open-label registry conducted at 31 sites, patients were analyzed for 1 & 2-year outcomes with the primary endpoint defined as 3P-MACE of CV death, target vessel related myocardial infarction (TV-MI), ischemia-driven target lesion revascularization (TLR)/target vessel revascularization (TVR) apart from Stent thrombosis (ST). Results: Of 2500 patients of PCI with 3286 Abluminus-DES+, 1641 (65.64%) were non-diabetics while859 (34.36%) were diabetics. The 3-P MACE for the cohort at 1 & 2 years were 2.9%, and 3.16%; TLR/TVR - 1.4% at both the intervals for 2493 patients at 2 yrs. follow-up. TV-MI & ST were 0.36% and0.56% at 1st and 2nd year respectively. The 3P-MACE was lower in non-diabetics at 1 & 2 years (2.3%vs 4.2%; 2.4% vs 4.7% respectively). For components of MACE, CV mortality (0.9 vs 1.9% at 1 yr ; 1.0vs 2.1% at 2 years) was significant (P < 0.05) while TLR (1.1 vs 1.9% at 1 yr. & 1.1 vs 2.1% at 2 yrs.) and TV-MI (0.9 vs 1.9% at 1 yr. & 1 vs 2.1% at 2 years) were similar for diabetics and non-diabetics so was ST (P > 0.05). Conclusion: Abluminus-DES+ showed excellent 2-year safety and efficacy with low 3-P MACE which was higher in diabetics driven by higher CV death but similar TLR, TV-MI and ST.

Quantitative flow ratio to predict non-target-vessel-related events at 5 years in STEMI patients undergoing angiography-guided revascularization

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Baer ◽  
R Kavaliauskaite ◽  
Y Ueki ◽  
T Otsuka ◽  
T Engstrom ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Primary Endpoint ◽  
Cardiac Death ◽  
Complete Revascularization ◽  
Primary Pci ◽  
Target Vessel ◽  
Flow Ratio ◽  
Incremental Value ◽  
Quantitative Flow Ratio ◽  
Quantitative Flow

Abstract Background In patients with ST-segment-elevation myocardial infarction (STEMI), angiography-based complete revascularization is associated with superior outcomes compared with culprit-lesion-only percutaneous coronary intervention (PCI). Quantitative Flow Ratio (QFR) is a novel, non-invasive, vasodilator-free method to assess the hemodynamic significance of coronary stenoses. Purpose To investigate the incremental value of QFR over angiography alone in the assessment of non-culprit lesions (NCL) in STEMI patients undergoing primary PCI. Methods In the randomized, multicenter COMFORTABLE AMI trial, STEMI patients underwent angiography-guided complete revascularization. QFR was determined in untreated non-target vessels by assessors blinded for clinical outcomes. Results Out of 1161 STEMI patients, 946 vessels in 617 patients could be analyzed by QFR. At 5-year follow-up, the rate of the primary endpoint cardiac death, non-target vessel myocardial infarction (non-TV-MI) and clinically indicated, non-target vessel revascularization (non-TVR) was significantly higher in patients with QFR ≤0.80 compared with QFR &gt;0.80 (62.9% vs. 12.7%, HR 7.20, 95% CI 4.46–11.62, p&lt;0.001), driven by higher rates of non-TV-MI (15.4% vs. 3.6%, HR 4.59, 95% CI 1.72–12.23, p=0.002) and non-TVR (58.6% vs. 7.7%, HR 10.99, 95% CI 6.39–18.91, p&lt;0.001). No significant differences for cardiac death were observed. Multivariate analysis identified QFR ≤0.80, MI SYNTAX score and left ventricular function as independent predictors of the primary endpoint. QFR ≤0.80 showed an accuracy of 86.1%, sensitivity of 23.2%, specificity of 97.5%, positive predictive value of 62.9% and negative predictive value of 87.5% for the prediction of the primary endpoint. Conclusions Our study results suggest incremental value of QFR over angiography-guided PCI for NCL among STEMI patients undergoing primary PCI. Kaplan-Meier curves of primary endpoint Funding Acknowledgement Type of funding source: None

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