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 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.

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.

scholarly journals Effect of smoking on clinical outcomes in patients receiving rotational atherectomy in calcified coronary lesions: from the ROCK Registry, South Korea

2021 ◽  
Vol 41 (4) ◽  
pp. 191-197
Author(s):  
Won Young Jang ◽  
Su Nam Lee ◽  
Sung-Ho Her ◽  
Donggyu Moon ◽  
Keon-Woong Moon ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
South Korea ◽  
Clinical Outcomes ◽  
Cardiac Death ◽  
Conflicts Of Interest ◽  
Smoking Status ◽  
Rotational Atherectomy ◽  
Target Vessel ◽  
The Impact ◽  
Multicenter Registry

BACKGROUND: Tobacco smoking and its harmful health effects also increase economic burdens globally. Surprisingly, despite the detrimental health consequences of smoking, some studies have shown better survival among smokers compared with non-smokers, a phenomenon called “smoker's paradox”. However, the impact of smoking status on clinical outcomes in severe calcified coronary artery disease (CAD) patients has yet to be reported. OBJECTIVES: Investigate the impact of smoking on clinical outcomes in calcified CAD receiving rotational atherectomy (RA). DESIGN: Retrospective review of medical records. SETTING: Multicenter registry in South Korea. PATIENTS AND METHODS: This multicenter registry included consecutive patients with calcified CAD who underwent RA at nine tertiary centers in Korea between January 2010 and October 2019. MAIN OUTCOME MEASURES: Target-vessel failure (TVF) which included the composite of cardiac death, target-vessel myocardial infarction (TVMI), and target-vessel revascularization (TVR). SAMPLE SIZE: 583 lesions in 540 patients followed for a median of 16.1 months. RESULTS: Lesions were divided into two groups: non-smokers (n=472, 81.0%) and smokers (n=111, 19.0%). TVF in the smoker group was significantly more frequent than in non-smoker group (log rank P =.016). The inverse probability of treatment weighting analysis also showed that smoking was significantly associated with a higher incidence of the primary outcome (HR: 1.617; 95% CI: 1.127–2.320; P =.009), cardiac death (HR 1.912; 95% CI: 1.105-3.311; P =.021), myocardial infarction (HR: 3.914; 95% CI: 1.884-8.132; P <.001), TVMI (HR: 3.234; 95% CI: 1.130-9.258; P =.029), and TVR (HR: 1.661; 95% CI: 1.043-2.643; P =.032). However, any bleeding was significantly observed less in the smokers. CONCLUSION: Smoking is significantly associated with adverse clinical outcomes in CAD patients requiring RA. LIMITATIONS: Retrospective design. CONFLICTS OF INTEREST: None.

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.

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 Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry)

2021 ◽  
Author(s):  
Wojciech Wańha ◽  
Jacek Bil ◽  
Rafał Januszek ◽  
Natasza Gilis-Malinowska ◽  
Tomasz Figatowski ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Death ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Target Vessel ◽  
End Point ◽  
Stent Restenosis ◽  
Drug Eluting ◽  
In Stent Restenosis

Background: Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis. Methods: Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%). Results: Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41–0.83], P =0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45–0.84], P =0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50–0.94], P =0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55–1.51], P =0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55–1.36], P =0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58–1.42], P =0.667) between the thin-DES and DEB group, respectively. Conclusions: This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04415216.

Sirolimus-Eluting Magnesium Resorbable Scaffold Implantation in Patients with Acute Myocardial Infarction

Cardiology ◽  
2019 ◽  
Vol 142 (2) ◽  
pp. 93-96 ◽  
Author(s):  
Alfonso Ielasi ◽  
Enrico Cerrato ◽  
Salvatore Geraci ◽  
Gianluca Campo ◽  
Nadia Garro ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cardiac Death ◽  
Cohort Analysis ◽  
Target Lesion ◽  
Target Vessel ◽  
Multicenter Cohort ◽  
Potential Benefits ◽  
Procedural Success

To date, very little is known about the performance of a sirolimus-eluting bioresorbable magnesium scaffold (Mg-BRS) in patients with acute myocardial infarction (AMI). A multicenter cohort analysis was performed on 69 consecutive AMI subjects treated with Mg-BRS. Procedural success was obtained in all cases, and no in-hospital events were reported. At 9-month follow-up, no cardiac death, target-vessel myocardial infarction, ischemia-driven target lesion revascularization, or Mg-BRS thrombosis was reported. Although our analysis showed encouraging results, larger studies and longer-term follow-up are needed to better understand the potential benefits associated with the use of a Mg-BRS in AMI patients.

Impact of SYNTAX score 2 on 7-year clinical outcomes in patients treated with cobalt-chromium everolimus-eluting stent

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Hiromasa ◽  
S Kuramitsu ◽  
K Yamaji ◽  
T Domei ◽  
M Hyodo ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Outcomes ◽  
Stent Thrombosis ◽  
Cumulative Incidence ◽  
Cardiac Death ◽  
Target Lesion ◽  
The Other ◽  
Syntax Score ◽  
Cobalt Chromium ◽  
Cardiac Events

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

scholarly journals Clinical outcomes following use of sirolimus coated balloon in side-branches during provisional stent technique in true bifurcations

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Athulorala ◽  
B H Loku Waduge ◽  
H Kalkat ◽  
A Saif ◽  
A M Fawzy ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cardiac Death ◽  
De Novo ◽  
New Technology ◽  
Target Lesion ◽  
Side Branch ◽  
Target Vessel ◽  
Coronary Syndrome ◽  
The Mean

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.

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