scholarly journals Impact of diabetes on outcome with drug-coated balloons versus drug-eluting stents: the BASKET-SMALL 2 trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J Wohrle ◽  
B Scheller ◽  
J Seeger ◽  
A Farah ◽  
A Ohlow ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Outcome ◽  
Cardiac Death ◽  
De Novo ◽  
Small Vessel Disease ◽  
Drug Eluting Stent ◽  
Diabetic Patients ◽  
Cardiovascular Research ◽  
Drug Eluting ◽  
The Impact

Abstract Objectives To evaluate the impact of diabetes mellitus on 3 year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de-novo lesions. Background For the treatment of de-novo coronary small vessel disease DCB are non-inferior to DES regarding clinical outcome up to 3 years. Methods In this prespecified analysis of a multicenter, randomized, non-inferiority trial, including 758 patients with de-novo lesions in coronary vessels <3mm who were randomized 1:1 to DCB (n=382) or DES (n=376) and followed over 3 years for major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction [MI], and target-vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus. Results In non-diabetic patients (n=506) rates of MACE (13.0% vs. 11.5%, hazard ratio [HR] 1.24, 95% confidence interval [CI] 0.73–2.09, p=0.43), cardiac death (2.8% vs. 2.9%, HR 0.97, 95% CI 0.32–2.92, p=0.96), non-fatal MI (5.1% vs. 4.8%, HR 1.00, 95% CI 0.44–2.28, p=0.99), and TVR (8.8% vs. 6.1%, HR 1.64, 95% CI 0.83–3.25, p=0.16) were similar in DCB and DES. In diabetic patients (n=252) rates of MACE (19.3% vs. 22.2%, HR 0.82, 95% CI 0.45–1.48, p=0.51), cardiac death (8.8% vs. 5.9%, HR 2.01, 95% CI 0.76–5.31, p=0.16), non-fatal MI (7.1% vs. 9.8%, HR 0.55, 95% CI 0.21–1.49, p=0.24) were similar in DCB and DES, whereas TVR was significantly lower with DCB compared to DES (9.1% vs. 15.0%, HR 0.40, 95% CI 0.17–0.94, p=0.036). In addition, need for TVR was highest in diabetic patients treated with DES (Picture 1). Conclusions The rates of MACE are similar in DCB and DES in de-novo coronary lesions of diabetic and non-diabetic patients. In diabetic patients the need for TVR was significantly lower with DCB compared to DES. FUNDunding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG. Picture 1

125Incidence and outcomes of bailout stenting following use of drug coated balloon

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Basavarajaiah ◽  
S Handi ◽  
L Foley ◽  
R Watkin ◽  
B Freestone ◽  
...  
Keyword(s):  
Synergistic Effect ◽  
Stent Thrombosis ◽  
Cardiac Death ◽  
De Novo ◽  
Target Lesion ◽  
Drug Eluting Stent ◽  
Target Vessel ◽  
Current Recommendation ◽  
Drug Eluting ◽  
Drug Coated Balloon

Abstract Background The incidence of bailout stenting post-drug coated balloon use (DCB) in the literature has been more than 10%; ranging up-to 21% in Bello trial and this variation could be due to the different criteria used to consider bailout stenting and may also reflect aggressive pre-dilatation. Our eyes are trained to expect stent like result and anything less is considered sub-optimal and this could be one of the reasons for high incidence of bailout stenting. The current recommendation is to use drug eluting stent (DES) for bailout stenting and hence raising in the possibility of drug toxicity or maybe even synergistic effect from combination of Paclitaxel (DCB) and limus (DES). Aim We have evaluated the incidence and outcomes of patients needing bailout stenting in our centre. Methods and results We evaluated all patients who were treated with DCB between January 2016-August 2017. Bailout stenting per lesion were identified and studied for endpoints which included cardiac death, target vessel MI, stent thrombosis, target lesion revascularization and target vessel revascularisation. Between the study period; 468 lesions (in 364 patients) were treated with paclitaxel DCB (Sequent Please, B Braun, Germany). Bailout stenting was required in 23 lesions (4.9%) and of which 12 (52%) was for flow limiting dissections (type C or more) and the remaining 11 was for recoil of more than 50%. Majority of the lesions were de novo (18; 78%). All bailout stenting was performed with third generation limus eluting stents. During a median follow-up of 18.14 months; range; 7–33 months, there was no cardiac death and target vessel MI occurred in 1 patient (4.3%), TLR and TVR were in 3 lesions (13%). MACE rate (combination of cardiac death, target vessel MI and TVR) was 13%. There were no cases of stent thrombosis as per the ARC definition. Conclusion One of the highlighting features of our study is very low-rates of bailout stenting. This may be due to our criteria of not stenting mild dissections (unless they are flow limiting) and also to accepting recoil of up-to 50% post-DCB use. The outcome in bailout stenting group is acceptable especially with hard endpoints (cardiac death, target vessel MI and stent thrombosis) although TLR and TVR rates were higher indicating synergistic effect of paclitaxel and limus may not offer additional benefits.

scholarly journals Impact of diabetes mellitus on the early-phase arterial healing after drug-eluting stent implantation

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Takayuki Ishihara ◽  
Yohei Sotomi ◽  
Takuya Tsujimura ◽  
Osamu Iida ◽  
Tomoaki Kobayashi ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Early Phase ◽  
Drug Eluting Stent ◽  
Color Grade ◽  
Light Yellow ◽  
Yellow Color ◽  
Coronary Angioscopy ◽  
Drug Eluting ◽  
Grade 3 ◽  
The Impact

Abstract Background Early arterial healing after drug-eluting stent (DES) implantation may enable short dual-antiplatelet therapy (DAPT) strategy. The impact of diabetes mellitus (DM) on this healing has not been elucidated. We used coronary angioscopy (CAS) to compare intravascular status of DM and non-DM patients in the early phase after DES implantation. Methods This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients evaluated 3–5 months after DES implantation. We divided the lesion into two groups: DM (n = 149) and non-DM (n = 188). We assessed neointimal coverage (NIC) grades (dominant, maximum and minimum), thrombus adhesion and maximum yellow color grade. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow. Results Minimum NIC grade was significantly lower in DM than in non-DM groups (p = 0.002), whereas dominant and maximum NIC grades were similar between them (p = 0.59 and p = 0.94, respectively), as were thrombus adhesion (44.3% vs. 38.8%, p = 0.32) and maximum yellow color grade (p = 0.78). A multivariate analysis demonstrated that DM was an independent predictor of minimum NIC of grade 0 (odds ratio: 2.14, 95% confidence interval: 1.19–3.86, p = 0.011). Conclusions DM patients showed more uncovered struts than non-DM patients 3–5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applied to DM patients.

One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients

2016 ◽  
Vol 214 ◽  
pp. 113-120 ◽  
Author(s):  
Antonio Colombo ◽  
Cosmo Godino ◽  
Michael Donahue ◽  
Luca Testa ◽  
Mauro Chiarito ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Outcome ◽  
Free Drug ◽  
Drug Eluting Stent ◽  
Drug Eluting ◽  
One Year

scholarly journals Impact of Diabetes Mellitus on the Early-Phase Arterial Healing After Drug-Eluting Stent Implantation

2020 ◽  
Author(s):  
Takayuki Ishihara ◽  
Yohei Sotomi ◽  
Takuya Tsujimura ◽  
Osamu Iida ◽  
Tomoaki Kobayashi ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Early Phase ◽  
Drug Eluting Stent ◽  
Color Grade ◽  
Light Yellow ◽  
Yellow Color ◽  
Coronary Angioscopy ◽  
Drug Eluting ◽  
Grade 3 ◽  
The Impact

Abstract Background: Early arterial healing after drug-eluting stent (DES) implantation may enable short dual-antiplatelet therapy (DAPT) strategy. The impact of diabetes mellitus (DM) on this healing has not been elucidated. We used coronary angioscopy (CAS) to compare intravascular status of DM and non-DM patients in the early phase after DES implantation.Methods: This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients evaluated 3-5 months after DES implantation. We divided the lesion into two groups: DM (n=149) and non-DM (n=188). We assessed neointimal coverage (NIC) grades (dominant, maximum and minimum), thrombus adhesion and maximum yellow color grade. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow.Results: Minimum NIC grade was significantly lower in DM than in non-DM groups (p=0.002), whereas dominant and maximum NIC grades were similar between them (p=0.59 and p=0.94, respectively), as were thrombus adhesion (44.3% vs. 38.8%, p=0.32) and maximum yellow color grade (p=0.78). A multivariate analysis demonstrated that DM was an independent predictor of minimum NIC of grade 0 (odds ratio: 2.14, 95% confidence interval: 1.19-3.86, p=0.011).Conclusion: DM patients showed more uncovered struts than non-DM patients 3-5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applied to DM patients.

scholarly journals Impact of diabetes mellitus on 2-year outcomes of Absorb BVS compared to Xience EES: a pooled analysis of the COMPARE-ABSORB and AIDA trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Gao ◽  
L Kerkmeijer ◽  
R.Y.G Tijssen ◽  
R Kraak ◽  
J Tijssen ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Cardiac Death ◽  
Target Lesion ◽  
Diabetic Patients ◽  
Funding Source ◽  
2Nd Generation ◽  
Significant Difference ◽  
Absorb Bvs ◽  
Target Lesion Failure ◽  
The Impact

Abstract Background and purpose Diabetes mellitus (DM) is associated with increased risk of cardiovascular events after percutaneous coronary intervention (PCI). To evaluate the impact of Absorb bioresorbable vascular scaffold (BVS) in patients with DM, we aimed to compare the 2-year outcomes of Absorb BVS versus 2nd generation drug eluting stents Xience (EES) by pooling diabetic patients treated with BVS or EES from two large, randomized controlled trial. Methods Patients with medically-treated DM and treated by Absorb BVS in the COMPARE-ABSORB and AIDA trial were pooled for analysis. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results Out of a total 3515 enrolled subjects in the two trials, 913 were diabetics. Compared with the non-diabetic patients, those with DM were older, more often to have a history of hypercholesterolemia, chronic renal failure, stroke, hypertension, heart failure, peripheral vascular disease and previous PCI. At 2-years, target lesion failure occurred in 10.8% of BVS DM patients and 7.6% of EES DM patients (adjusted HR 1.43, 95% CI: 0.87–2.34, P=0.115). The 2-year rates of cardiac death (2.4% vs 1.6%, P=0.385), TV-MI (5% vs 1.6%, P=0.123) and TLR (7.8% vs 5.8%, P=0.416) showed not significant difference. The 2-year incidence of definite device thrombosis was 3.2% in Absorb BVS versus 0.7% in Xience EES (adjusted HR 4.77, 95% CI: 1.01–22.43, P=0.048). Conclusion This pooling of the diabetic patients from two large scale RCTs compared BVS versus 2nd generation DES, showed an increased rate of device thrombosis in BVS-treated patients at 2 years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

Impact of atherosclerotic disease progression on mid-term clinical outcome in diabetic patients in the drug-eluting stent era

2009 ◽  
Vol 4 (5) ◽  
pp. 588-592 ◽  
Author(s):  
Petr Tousek ◽  
Andrea Pavei ◽  
Jacopo Oreglia ◽  
Guillaume Martin ◽  
Faisal Sharif ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Disease Progression ◽  
Atherosclerotic Disease ◽  
Drug Eluting Stent ◽  
Diabetic Patients ◽  
Drug Eluting
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