scholarly journals Treatment of Infrainguinal Arterial Occlusive Disease by Acotec Drug-coated Balloon in 435 Patients

2020 ◽  
Author(s):  
rui ling ◽  
Fengqiang Cui ◽  
Jianghao Chen ◽  
Hui Wang ◽  
Wenlong Shi ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Clinical Data ◽  
Target Lesion ◽  
Major Amputation ◽  
Ischemic Disease ◽  
Late Lumen Loss ◽  
Clinical Events ◽  
Arterial Occlusive Diseases ◽  
Drug Coated Balloon

Abstract Background: At present, there are many clinical trials of drug coated balloon in the treatment of lower extremity arterial occlusive diseases, but there are not many clinical data in the real world study. Here we aimed to evaluate the efficacy and safety ofAcotec drug-coated balloon (DCB) for chronic ischemic disease in lower extremity.Methods: Clinical data of 435 patientswith 564occlusive/stenotic lesions in 492lower extremities treated by DCB from April 2016 toApril2019 were retrospectively analyzed.The mean age was 63years.Rutherford stage 2, 3, 4, 5, and 6 were classified in 11, 167, 182, 109, and 23 limbs, respectively.The mean length of the targeted lesions was 179.6mm. Of all the lesions, 436 located at femoraland/or popliteal arteries, and 128 at infra-popliteal arteries. All the patients were followed up at 6-month intervals. The major evaluation endpoints included late lumen loss (LLL), target lesion restenosis, target lesion revascularization (TLR), and severe clinical events including mortality and major amputation.Results: The technique success rate was 96.1%.Stents were placed in 57 (13.1%) cases for flow-limited dissections or remnant stenosisgreater than 50% after DCB angioplasty.The mean follow-up time was 28.5 ± 12.1 months (12-48 months). The meanLLLwas 1.1 mm, 1.8mm, and 2.8 mm, respectively, 1, 2, and 3 years after operation. The rate ofrestenosis and TLRwas 17.3%and8.2%, respectively, 1 year after operation; 20.6% and 11.6%, respectively, 2 years after operation; 29.4% and 18.3%, respectively, 3 years after operation.Fourteenpatientsdiedand 25received amputation.Conclusion: AcotecDCBwas safe and effective in treating chronic ischemic diseases of lower extremities.A better clinical outcome was achieved in femoro-popliteal arteries, compared toinfrapopliteal arteries.

Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial

2020 ◽  
Vol 27 (2) ◽  
pp. 276-286
Author(s):  
Gunnar Tepe ◽  
Henrik Schroeder ◽  
Thomas Albrecht ◽  
Peter Reimer ◽  
Nicolas Diehm ◽  
...  
Keyword(s):  
Single Dose ◽  
Randomized Study ◽  
Target Lesion ◽  
Lesion Length ◽  
Double Dose ◽  
Stent Restenosis ◽  
Late Lumen Loss ◽  
Drug Coated Balloon ◽  
In Stent Restenosis

Purpose: To investigate the efficacy and sustainability of drug-coated balloon (DCB) treatment of femoropopliteal in-stent restenosis (ISR). Materials and Methods: An investigator-initiated, prospective, multicenter, 1:1 randomized study enrolled 88 patients for treatment of ISR with DCB (n=47; mean age 68.3±9.6 years; 26 men) or uncoated balloon (n=41; mean age 67.6±10.2 years; 26 men) angioplasty ( ClinicalTrials.gov identifier NCT01594684). Additionally, the protocol provided for an observational arm composed of patients from either randomized arm who experienced recurrent ISR ≥30 days after the index treatment. Redo treatment consisted of 2 DCBs sequentially inflated at the same location (double dose therapy). The majority of patients (66, 78%) had Rutherford category 3 ischemia. The mean lesion length was 140 mm; a third (27, 31%) were total occlusions. The primary endpoint was angiographic late lumen loss (LLL) at 6 months evaluated by an independent core laboratory. Results: Twenty-two patients (7 DCB +15 uncoated) were treated for recurrence with fully overlapping double DCB angioplasty. Six-month LLL was lower after DCB (0.34±1.12 mm) treatment than after angioplasty with an uncoated balloon (1.58±1.10 mm, p<0.001). At the 12-month follow-up, target lesion revascularization (TLR) was performed in 18 (49%) of 37 patients in the uncoated group, 6 (14%) of 43 patients in the single-dose DCB group (p=0.001), and no patients from the recurrent ISR group. At ~2 years after treatment, a remarkable number (14/27, 52%) of TLRs were recorded in the single-dose DCB group. Conclusion: Treatment with DCBs resulted in significantly less 6-month LLL and fewer TLRs up to 24 months than treatment with uncoated balloons. The double dose for treating recurrent ISR did not cause recognizable adverse events or require TLR up to 24 months.

scholarly journals Efficacy of Low-Pressure Inflation of Oversized Drug-Coated Balloon for Coronary Artery Disease

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Katsumi Ueno ◽  
Norihiko Morita ◽  
Yoshinobu Kojima ◽  
Hiroki Kondo ◽  
Hiroshi Takahashi ◽  
...  
Keyword(s):  
Propensity Score Analysis ◽  
Standard Technique ◽  
Low Pressure ◽  
Target Lesion ◽  
Late Lumen Loss ◽  
Frequent Use ◽  
Significant Difference ◽  
Artery Disease ◽  
Late Restenosis ◽  
Drug Coated Balloon

Objectives. This study sought to assess the efficacy of oversized drug-coated balloon (DCB) inflation at low pressure for the prevention of acute dissections and late restenosis. Background. The major limitation of DCB coronary angioplasty is the occurrence of severe dissection after inflation of DCB. Methods. Between 2014 and 2018, 273 consecutive patients were retrospectively studied. 191 lesions (154 patients) treated by oversized DCB inflation at low pressure (<4 atm, 2.4 ± 1.2 atm, DCB/artery ratio 1.14 ± 0.22; LP group) were compared with 135 lesions (119 patients) treated by the standard DCB technique (7.1 ± 2.2 atm, DCB/artery ratio 1.03 ± 0.16; SP group). Results. Although the lesions in the LP group were more complex than those in the SP group (smaller reference diameter (2.38 mm vs. 2.57 mm, P = 0.011 ), longer lesions (11.7 mm vs. 10.5 mm, P = 0.10 ), and more frequent use of rotational atherectomy (45.0% vs. 28.1%, P = 0.003 ), there was no significant difference in the NHLBI type of dissections between the two groups (11.5%, 12.0%, 5.2% vs. 12.6%, 12.6%, 2.2% in type A, B, and C, P = 0.61 ), and no bailout stenting was required. In 125 well-matched lesion pairs after propensity score analysis, the cumulative incidence of target lesion revascularization at 3 years was 4.5% vs. 7.0%, respectively ( P = 0.60 ). Late lumen loss (−0.00 mm vs. −0.01 mm, P = 0.94 ) and restenosis rates (7.4% vs. 7.1%, P = 1.0 ) were similar in both of the groups. Conclusion. The application of oversized DCB at low pressure is effective and feasible for preventing late restenosis comparative to the standard technique of DCB.

scholarly journals Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

2019 ◽  
Vol 26 (3) ◽  
pp. 305-315 ◽  
Author(s):  
Michel M. P. J. Reijnen ◽  
Iris van Wijck ◽  
Thomas Zeller ◽  
Antonio Micari ◽  
Pierfrancesco Veroux ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Limb Amputation ◽  
Post Hoc Analysis ◽  
Kaplan Meier ◽  
Global Study ◽  
Post Hoc ◽  
Drug Coated Balloon

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 27 (4) ◽  
pp. 647-657
Author(s):  
Stefanos Giannopoulos ◽  
Sheila Ghanian ◽  
Sahil A. Parikh ◽  
Eric A. Secemsky ◽  
Peter A. Schneider ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Target Lesion ◽  
Major Amputation ◽  
Primary Patency ◽  
Safety And Efficacy ◽  
All Cause Mortality ◽  
Procedural Success ◽  
Random Effects Modeling ◽  
Drug Coated Balloon

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

Major lower extremity amputations in a developing country: 10-Year experience at a tertiary medical center

Vascular ◽  
2020 ◽  
pp. 170853812096508
Author(s):  
Mohamad A Chahrour ◽  
Mouafak Homsi ◽  
Mohammad R Wehbe ◽  
Caroline Hmedeh ◽  
Jamal J Hoballah ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Developing Country ◽  
Positive Impact ◽  
Medical Center ◽  
Perioperative Complications ◽  
Care Center ◽  
Major Amputation ◽  
Ambulatory Status ◽  
Rehabilitation Centers

Background Lower extremity amputation (LEA) is a major surgical procedure with a high risk of significant morbidity and mortality. The objective of this study was to describe mortality and functionality outcomes following this procedure in a developing country. Methods This is a retrospective study of all patients undergoing LEA for non-traumatic etiology between 2007 and 2017. Medical records were used to retrieve demographics, comorbidities, and perioperative complications of identified patients. Patients were contacted to follow-up on their medical, postoperative care, and ambulatory status. Mortality and postoperative functionality rates were analyzed. Results The study included 78 patients. Median follow-up duration was 24 months. Hypertension (81%) and diabetes (79%) were the most common comorbidities. Mortality rates at 30 days, 1, and 5 years were 10.3, 29.2, and 65.5%, respectively. Mortality was significantly associated with age > 70 at amputation ( p = 0.042), hypertension ( p = 0.003), chronic kidney disease ( p = 0.031), and perioperative sepsis ( p = 0.01). Only 1.6% of patients were discharged into a specialized care center, and only 27% of patients were ambulatory postoperatively, although 90.5% were fitted with a prosthesis. Conclusions Survival following major amputation in a developing country is currently comparable to more developed regions of the world. Major discrepancy seems to exist in ambulatory status following the procedure. Discharge placement policies should be properly set, and rehabilitation centers funding should be increased. Awareness may also be warranted to educate patients and families about the value and positive impact of rehabilitation centers.

Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study

Vascular ◽  
2020 ◽  
pp. 170853812095366
Author(s):  
Guoyi Sun ◽  
Jie Liu ◽  
Senhao Jia ◽  
Jiwei Zhang ◽  
Baixi Zhuang ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Chronic Total Occlusion ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Total Occlusion ◽  
Chronic Total Occlusions ◽  
Late Lumen Loss ◽  
Drug Coated Balloon

Objectives Femoropopliteal chronic total occlusions are challenging to treat, and evidence of the effectiveness of drug-coated balloon angioplasty for long femoropopliteal chronic total occlusion lesions is limited. We compared the midterm outcomes of drug-coated balloon angioplasty versus plain old balloon angioplasty (POBA) for femoropopliteal chronic total occlusions. Methods In total, 95 patients from the AcoArt I trial (ClinicalTrials.gov identifier NCT01850056) with ≥5-cm femoropopliteal chronic total occlusion lesions were enrolled in this post-hoc subset analysis (drug-coated balloon, n = 50; POBA, n = 45). The primary endpoints were primary patency and clinically driven target lesion revascularization (CD-TLR) at 24 months. The secondary endpoints were late lumen loss at six months and binary restenosis, major adverse events (composite of death and target limb amputation), change in the Rutherford class, and the ankle-brachial index at 24 months. Results Demographic, clinical, and lesion characteristics were matched (mean lesion length, 20 cm). The six-month late-lumen loss rate was lower in the drug-coated balloon than POBA group (0.18 ± 0.81 vs. 1.34 ± 0.94 mm, respectively; P < 0.001). The 24-month primary patency rate was significantly higher in the drug-coated balloon than POBA group (53.85% vs. 17.50%, respectively; P < 0.001). The CD-TLR rate in the drug-coated balloon and POBA groups was 12.77 and 45.24%, respectively ( P = 0.002). The 24-month overall mortality rate in the drug-coated balloon and POBA groups was 12.77% and 6.98%, respectively ( P = 0.360), with no device- or procedure-related deaths. One major amputation had occurred in each group by the 24-month follow-up. Conclusion The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24 months after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.

scholarly journals Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial

2017 ◽  
Vol 25 (1) ◽  
pp. 109-117 ◽  
Author(s):  
Osamu Iida ◽  
Yoshimitsu Soga ◽  
Kazushi Urasawa ◽  
Shigeru Saito ◽  
Michael R. Jaff ◽  
...  
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
De Novo ◽  
Target Lesion ◽  
Major Amputation ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Lesion Length ◽  
Japanese Cohort ◽  
Percutaneous Transluminal ◽  
Drug Coated Balloon

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.

Predictors of Favorable Angiographic Outcomes After Drug-Coated Balloon Use for de novo Small Vessel Coronary Disease (DCB-ONLY)

Angiology ◽  
2021 ◽  
pp. 000331972110155
Author(s):  
Woong Chol Kang ◽  
Sang Min Park ◽  
Albert Youngwoo Jang ◽  
Pyung Chun Oh ◽  
Eun-Seok Shin ◽  
...  
Keyword(s):  
De Novo ◽  
Small Vessel Disease ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Small Vessel ◽  
Luminal Diameter ◽  
Minimal Luminal Diameter ◽  
Late Luminal Loss ◽  
Drug Coated Balloon

We evaluated the angiographic parameter and clinical outcomes of drug-coated balloon (DCB) to assess the optimal angiographic criteria in de novo small vessel disease (SVD). Patients (n = 424, mean age: 64.4 ± 11.2 years, men: 69.8%) at 20 sites in Korea were prospectively enrolled. The primary end point was late luminal loss (LLL) at 9-month follow-up angiography. Secondary end points included restenosis rates, target lesion failure (TLF), and DCB-related thrombosis during the 12-month follow-up period. We included 403 patients for analysis excluding 21 patients who required bailout stenting. Baseline mean reference vessel .diameter was 2.52 ± 0.39 mm and mean minimal luminal diameter (MLD) was 0.71 ± 0.40 mm. The mean MLD was 1.54 ± 0.37 mm after DCB. Late luminal loss was −0.01 ± 0.43 mm and restenosis was noted in 26 patients (12.2%). Minimal luminal diameter >1.6 mm and % diameter stenosis (DS ) <45% after DCB was associated maintenance of MLD without LLL at 9-months. Multivariate analysis demonstrated that %DS at baseline and post-MLD was associated with the restenosis. During 12-month follow-up, TLF was 2.6% including 1 cardiac death, 1 myocardial infarction, and 10 ischemia-driven target lesion revascularizations. Drug-coated balloon showed a low restenosis and lower LLL despite high in-segment DS. Post-MLD and % DS may be helpful to get optimal results in de novo SVD after DCB.

scholarly journals Effect of Drug-Coated Balloon in Side Branch Protection for de novo Coronary Bifurcation Lesions: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Yawei Zheng ◽  
Jie Li ◽  
Lingzhun Wang ◽  
Peng Yu ◽  
Haibo Shi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Outcomes ◽  
De Novo ◽  
Meta Analysis ◽  
Treatment Strategies ◽  
Target Lesion ◽  
Side Branch ◽  
Significant Difference ◽  
Drug Coated Balloon

Background: At present, there are a variety of treatment strategies for percutaneous coronary intervention. The role of drug-coated balloon (DCB) in the treatment of side branch for de novo coronary bifurcated lesions (CBL) is unclear.Objective: To examine the effect of DCB in side branch protection for de novo CBL.Methods: Electronic databases, including Pubmed, Embase, the Web of science, Cochrance library, CNKI, CBM, WanFang Data and VIP were searched for studies that compared DCB with non-drug-coated balloon (NDCB) in side branch protection for de novo CBL from inception through July 7th, 2021. The primary outcome was target lesion revascularization (TLR). Secondary clinical outcomes included myocardial infarction (MI), cardiac death (CD). The angiographic outcomes included side branch late lumen loss (LLL), minimum lumen diameter (MLD), diameter stenosis (DS) and binary restenosis (BR). The target lesion failure (TLF) was also analyzed.Results: A total of 10 studies, including 5 randomized controlled trials and 5 non-randomized observational studies, with 934 patients were included. Meta-analysis results of angiographic outcomes suggested that DCB group had the less LLL, DS and BR and the higher MLD compared with NDCB group at follow-up (P &lt; 0.05). Meta-analysis results of clinical outcomes suggested that the significant difference in the TLR, MI and CD between DCB group and NDCB group has not been found yet (P &gt; 0.05). However, the MACE of DCB group was significantly less than that of NDCB group at 9-month follow-up [OR = 0.21, 95%CI (0.05, 0.84), P = 0.03] and 12-month follow-up [OR = 0.45, 95%CI (0.22, 0.90), P = 0.02]. In addition, there was no significant difference in TLF between DCB group and NDCB group (P &gt; 0.05).Conclusions: DCB had great effect in side branch protection for de novo CBL at short and medium-term follow-up with no reduction in the procedural success rate.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=267426, PROSPERO [Identifier: CRD42021267426].

scholarly journals Clinical outcome of biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with diabetes

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Ryota Kakizaki ◽  
Yoshiyasu Minami ◽  
Masahiro Katamine ◽  
Aritomo Katsura ◽  
Yusuke Muramatsu ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Biodegradable Polymer ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Clinical Events ◽  
Stent Type ◽  
Durable Polymer ◽  
Significant Difference ◽  
Patients With Diabetes

Abstract Background Diabetes mellitus is a risk for increased incidence of adverse clinical events after percutaneous coronary intervention. However, the difference in the incidence of adverse clinical events according to stent type in patients with diabetes remains to be elucidated. In the present study, we aimed to compare the clinical outcomes between patients treated with the biodegradable polymer sirolimus-eluting stents (BP-SES) and the durable polymer everolimus-eluting stents (DP-EES) among patients with diabetes. Methods Among 631 lesions in 510 consecutive patients treated with either BP-SES or DP-EES, 165 lesions in 141 patients with diabetes mellitus and stable angina pectoris were identified and classified into the BP-SES group (48 lesions in 44 patients) and the DP-EES group (117 lesions in 100 patients). The incidence of adverse clinical events after stent implantation was compared between the 2 groups. Results There was no significant difference in the prevalence of conventional risk factors, lesion characteristics, and procedural characteristics between the 2 groups. During median 386 [334–472] days follow-up, the incidence of target lesion revascularization (11.4 vs. 2.0%, p = 0.003) and device-oriented clinical endpoint (13.6 vs. 6.0%, p = 0.035) in the BP-SES group was significantly greater than that in the DP-EES group. A univariate model demonstrated that the BP-SES usage was significantly associated with the higher incidence of target lesion revascularization (odds ratio, 6.686; 95% confidence interval, 1.234–36.217; p = 0.028). Conclusion BP-SES was associated with the greater incidence of TLR than the DP-EES in patients with diabetes mellitus. Further studies with larger cohorts and longer follow-up are required to confirm the present results.

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