Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

BACKGROUND AND AIMS: Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. METHODS: This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. RESULTS: Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). CONCLUSIONS: Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Long-term outcomes after paclitaxel-coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study.

OBJECTIVES: The long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study. METHODS: The IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events. RESULTS: In this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years. CONCLUSIONS: This subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.

Comparative Outcome Analysis of N-Butyl Cyanoacrylate Embolization of the False Lumen Versus Thoracic Endovascular Aortic Repair in Aortic Dissection.

PURPOSE: To evaluate the feasibility, safety, and effectiveness of N-butyl cyanoacrylate (NBCA) embolization for the treatment of aortic dissection. MATERIALS AND METHODS: In this single-center retrospective study conducted from February 2003 to June 2019, NBCA embolization of an aortic false lumen was attempted in 12 patients (median age, 59 y; range, 41-68 y) and thoracic endovascular aortic repair (TEVAR) was performed in 53 patients (median age, 59 y; range, 37-70 y) for aortic dissection with one or more indications of persisting pain, malperfusion, rupture or impending rupture, maximal aortic diameter ≥ 55 mm, and/or rapid aortic enlargement. The main exclusion criterion for embolization was the presence of fast blood flow in the aortic false lumen on aortography. The efficacy of NBCA embolization and TEVAR was compared by evaluating technical and clinical outcomes, repeat intervention-free survival (RFS), and overall survival (OS). RESULTS: Technical success was achieved in 11 of the 12 patients treated with NBCA embolization (91.7%), and clinical success was achieved in 9 of these 11 (81.8%). No significant difference was found between embolization and TEVAR in clinical success rates (embolization, 81.8%; TEVAR, 84.9%; P = .409) or procedure-related complications (embolization, 1 patient [8.3%]; TEVAR, 4 patients [7.5%]; P = .701). In addition, embolization showed comparable 5-y RFS (embolization, 82.5% ± 9.3; TEVAR, 85.5% ± 4.8; P = .641) and 5-y OS (embolization, 100%; TEVAR, 95.4% ± 3.2; P = .744) rates to TEVAR. CONCLUSIONS: NBCA embolization of the false lumen in aortic dissection seems to be a safe and effective treatment modality for the closure of false lumen in selected patients.

Outcomes of Adjunctive Drug-Coated Versus Uncoated Balloon after Atherectomy in Femoropopliteal Artery Disease.

BACKGROUND: The purpose of this study is to evaluate outcomes using drug-coated balloon (DCB) in comparison with uncoated balloon as adjunctive treatment after atherectomy for femoropopliteal artery lesions. METHODS: This single-center retrospective and prospective study included 115 patients with 126 femoropopliteal artery lesions treated with endovascular treatment using atherectomy. Of these, 58 patients received adjunctive DCB after atherectomy (group A) and 57 patients were managed with uncoated balloon after atherectomy (group B). Immediate and late clinical outcomes were compared. RESULTS: Baseline clinical and lesion data were comparable between the 2 groups. However, group A included more uses of rotational atherectomy (43.9% vs. 1.7%, P < 0.001) or embolization protection filter (53.0% vs. 6.7%, P = 0.001), and fewer cases requiring provisional stenting (4.5% vs. 18.3%, P = 0.014). Clinical primary patency at 1 year was significantly higher in group A than in group B (76.3% vs. 61.1%, P = 0.039). There was a trend toward higher 1-year target lesion revascularization (TLR)-free survival in group A (89.8% vs. 77.9% at 1 year, P = 0.275) without statistical significance. Proportional hazards regression analysis indicated that age (hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.90-0.99, P = 0.016) and provisional stenting (HR 9.78, 95% CI 2.20-43.46, P = 0.003) were independent factors associated with restenosis after combined treatment with atherectomy and DCB. CONCLUSIONS: In femoropopliteal artery disease, the combination of atherectomy with adjunctive DCB achieved better clinical outcomes in terms of clinical primary patency compared to atherectomy plus uncoated balloon while TLR-free survival may also be improved.

Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis.

Drug-coated balloon (DCB) angioplasty has been shown to be a promising option for the treatment of coronary in-stent restenosis (ISR). We compared the clinical outcomes of patients with ISR who were treated with two commonly used paclitaxel-containing DCBs, the Pantera Lux (PL) and SeQuent Please (SP). A total of 491 patients with 507 ISR lesions [PL-DCB in 127 (26%) patients and SP-DCB in 364 (74%) patients] underwent DCB angioplasty for ISR lesions. The major adverse cardiac events (MACEs), including cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, were assessed. There were no significant differences in each occurrence of MACE and cardiac death: 16 MACEs (61 per 1000 person-years) in the PL-DCB group and 55 (60 per 1000 person-years) MACEs in the SP-DCB group, log-rank p = 0.895, and three cardiac deaths (11 per 1000 person-years) in the PL-DCB group and ten cardiac deaths (11 per 1000 person-years) in the SP-DCB group, log-rank p = 0.849. Diabetes mellitus under insulin treatment [hazard ratio (HR) 2.71; 95% confidence interval (CI) 1.31-5.60; p = 0.007], chronic kidney disease (HR 1.99; 95% CI 1.01-3.92; p = 0.045), early-onset ISR (HR 1.99; 95% CI 1.18-3.36; p = 0.010), and recurrent ISR (HR 1.89; 95% CI 1.08-3.32; p = 0.026) were associated with the occurrence of MACE after DCB angioplasty. There was no significant difference of MACE between PL-DCB and SP-DCB treatment in patients with ISR. Patients with insulin-treated diabetes, chronic kidney disease, early-onset ISR, and recurrent ISR were at a higher risk of MACE after DCB angioplasty.

Two-year clinical outcomes of zotarolimus- and everolimus-eluting durable-polymer-coated stents versus biolimus-eluting biodegradable-polymer-coated stent in patients with acute myocardial infarction with dyslipidemia after percutaneous coronary intervention: data from the KAMIR.

There are limited data comparing the clinical outcomes among new-generation drug-eluting stents (DES) in acute myocardial infarction (AMI) patients with dyslipidemia after percutaneous coronary intervention (PCI). We thought to investigate 2-year clinical outcomes among durable-polymer (DP)-coated stents [zotarolimus eluting (ZES) and everolimus eluting (EES)] and biodegradable-polymer (BP)-coated biolimus-eluting stent (BES) in dyslipidemic AMI patients after PCI. Finally, a total 2403 enrolled patients were divided into ZES (n = 953), EES (n = 1145) or BES (n = 305) group. The primary endpoint was major adverse cardiac events (MACE) defined as total death (TD), cardiac death (CD), myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and non-TVR. The secondary endpoint was the incidence of definite or probable stent thrombosis (ST). The 2-year adjusted hazard ratio (HR) of MACE for ZES vs. EES [HR, 1.066; 95% confidence interval (CI) 0.752-1.511; p = 0.720], ZES vs. BES (HR 0.933; 95% CI 0.565-1.541; p = 0.786), EES vs. BES (HR 1.876; 95% CI 0.535-1.436; p = 0.600) and ZES/EES vs. BES (HR 0.929; 95% CI 0.591-1.462; p = 0.751) was similar. The cumulative incidences of ST were comparable (ZES vs. EES vs. BES = 1.1% vs. 0.9% vs. 1.1%, p = 0.675) and adjusted HR was not different. In addition, the 2-year adjusted HR of TD, CD, MI, TLR, TVR, and non-TVR was similar. The AMI patients with dyslipidemia receiving ZES, EES, or BES after PCI showed comparable safety and efficacy during 2-year follow-up periods. Therefore, DP-DES or BP-DES is equally acceptable in dyslipidemic AMI patients during PCI.

Risk Factors for Restenosis after Drug-coated Balloon Angioplasty for Complex Femoropopliteal Arterial Occlusive Disease.

BACKGROUND: Currently, there exist limited data on patient outcomes following the use of drug-coated balloons (DCBs) to treat complex femoropopliteal arterial occlusive lesions. The aim of the this study is to investigate the outcomes of patient treated with DCBs and to identify the predictors of restenosis. METHODS: We retrospectively investigated medical records from 120 patients (137 limbs) treated with DCBs for femoropopliteal lesions at a single center between 2013 and 2016. Primary patency, target lesion revascularization (TLR), and risk factors of restenosis were analyzed. RESULTS: There were 80 de novo and 57 in-stent restenosis lesions. Mean lesion length was 22.2 ± 11.6 cm. The clinical primary patency was 85.2% at 1 year and 65.3% after 2 years. The TLR-free survival rate was 93.0% at 1 year and 87.1% after 2 years. Critical limb ischemia (CLI; hazard ratio [HR] 5.80, 95% confidence interval [CI] 1.26-26.68, P = 0.024) and hypercholesterolemia (HR 4.66, 95% CI 1.30-16.76, P = 0.018) were identified as independent predictors of restenosis. In addition, nonuse of cilostazol and popliteal artery involvement showed trends toward an increased risk of restenosis. CONCLUSIONS: Treatment with DCBs showed excellent primary patency and TLR-free survival at 1 year after the procedure. However, the primary patency continuously deteriorated beyond 1 year, suggesting a late catch-up phenomenon. The risk of restenosis after treatment with DCBs was significantly associated with CLI and hypercholesterolemia.

Comparison of Spot versus Long Stenting for Femoropopliteal Artery Disease.

BACKGROUND: Optimal stenting strategy for long femoropopliteal artery lesions still remains undefined. Longer stent length has been shown to be associated with increased risk of restenosis. We sought to compare the efficacy of spot versus long stenting in the treatment of femoropopliteal artery disease. METHODS: This study was designed as a multicenter randomized controlled trial to compare immediate and mid-term outcomes of spot versus long primary stenting for femoropopliteal arterial lesions. A total of 125 patients were randomized 1:1 to spot stenting group (n = 59) or long stenting group (n = 66). RESULTS: All lesions were treated with self-expanding bare nitinol stents. Baseline clinical and lesion characteristics were similar between the 2 groups except for male gender and current smoker. The mean lesion length was 24.1 ± 8.8 cm. Technical success was achieved in all patients. The 1-year primary patency and TLR-free (target lesion revascularization) survival did not differ significantly between the 2 groups. However, the spot stenting group showed a trend toward higher primary patency (86.1% vs. 72.7%, P = 0.158) and TLR-free survival (94.2% vs. 82.5%, P = 0.120). The total stented length (hazard ratio [HR] 1.01, 95% confidence interval [CI] 1.00-1.01, P = 0.011) and age (HR 0.94, 95% CI 0.90-1.00, P = 0.035) were independent predictors of restenosis. CONCLUSIONS: The spot stenting appears to be more favorable than the long stenting in terms of primary patency and TLR-free survival, although the difference was not statistically significant. The stented length was an independent predictor of restenosis.

Long-Term Clinical Outcomes of a Biodegradable Polymer-Based Biolimus-Eluting Stent.

OBJECTIVES: To investigate the long-term clinical outcomes of biolimus-eluting stents with biodegradable polymers in real-world clinical practice. BACKGROUND: Long-term clinical outcomes of biolimus-eluting stents have not been clearly established. METHODS: A total of 824 all-comer patients (971 lesions) treated with unrestricted implantation of a biolimus-eluting stent with a biodegradable polymer were prospectively enrolled. Patients were divided into complex (413 patients) versus noncomplex (411 patients) groups according to the complexity of coronary lesions. Long-term clinical outcomes for stent efficacy (target lesion revascularization) and safety (composite of cardiac death, target lesion-related myocardial infarction, and definite or probable stent thrombosis) were compared between the two groups during 5 years of follow-up. RESULTS: The complex group showed higher rates of decreased left ventricular ejection fraction, impaired renal function, previous history of myocardial infarction, and diabetes mellitus compared to the noncomplex group. In the overall population, the 5-year cumulative rate of target lesion revascularization was 4.8% (8.3% in the complex group vs 1.6% in the noncomplex group, P < 0.001). For stent safety, the 5-year cumulative rate for a composite of cardiac death, target lesion-related myocardial infarction, and stent thrombosis was 2.5% overall (3.9% in the complex group vs 1.1% in the noncomplex group, P = 0.010). Overall 5-year cumulative rate of stent thrombosis was 0.4% (0.5% in the complex vs 0.2% in the noncomplex group, P = 0.561) with no very late stent thrombosis (VLST). CONCLUSIONS: Biodegradable polymer-based biolimus-eluting stents showed favorable efficacy and safety in all-comer patients during 5 years of follow-up.

Comparison between drug-coated balloon angioplasty and second-generation drug-eluting stent placement for the treatment of in-stent restenosis after drug-eluting stent implantation.

Even though drug-coated balloon (DCB) angioplasty has emerged as a treatment option for drug-eluting stent in-stent restenosis (DES-ISR), the most effective treatment strategy for DES-ISR is still under debate. Therefore, we compared long-term clinical outcomes following DCB treatment of DES-ISR with those following 2nd-generation drug-eluting stent (DES) treatment. We identified 248 DES-ISR lesions in 238 patients that were treated with either 2nd-generation DES implantation (n = 56) or DCB angioplasty (n = 192). We compared the incidences of major adverse cardiac events (MACEs) in the two groups during the 2-year period following treatment. MACE was defined as cardiac death, non-fatal myocardial infarction, or target-vessel revascularization. The percentage of patients with diabetes and the mean age of patients in the DCB group were greater than in the DES group. The DCB group also had a smaller reference vessel diameter. The DES group had a larger post-intervention minimal luminal diameter. We found no significant difference in the MACE rate between the two groups during the 2 years following treatment (11.0 % in the DCB group vs. 8.9 % in the DES group, p = 0.660). Reference segment diameter was the only independent predictive factor for MACE in the post-treatment period (hazard ratio 0.35, 95 % confidence interval: 0.15-0.82, p = 0.016). Clinical efficacy of DCB angioplasty for treatment of DES-ISR was comparable to that of 2nd-generation DES implantation as measured by the rate of MACEs in the two groups. Reference segment diameter was the only statistically significant independent predictor for MACE in the 2-year period following treatment.

Treatment of type I endoleaks after endovascular aneurysm repair of infrarenal abdominal aortic aneurysm: usefulness of N-butyl cyanoacrylate embolization in cases of failed secondary endovascular intervention.

PURPOSE: To evaluate the technical feasibility and effectiveness of N-butyl cyanoacrylate (NBCA) embolization using a percutaneous transabdominal or a transarterial approach in the failed secondary endovascular treatment of type I endoleaks after endovascular aneurysm repair (EVAR) of infrarenal abdominal aortic aneurysms. MATERIALS AND METHODS: From 2000-2007, seven patients with failed secondary endovascular treatment of type I endoleaks (five patients with type Ia endoleak, one patient with type Ib endoleak, and one patient with type Ia and Ib endoleaks) were treated with embolization using NBCA with or without a coil. Embolizations were performed using either a percutaneous transabdominal (n = 5) or a transarterial (n = 5) approach. Four patients underwent a single session of embolization, and three underwent two sessions of embolization. The duration between EVAR and endoleak treatment was 9.6 months ± 15.3 (mean ± standard deviation; range 0-42 months). Follow-up computed tomography (CT) scans were evaluated for changes in size and shape of the aneurysm sac and presence or resolution of endoleaks. The follow-up period after endoleak treatment was 18.0 months ± 20.4 (mean ± standard deviation; range 0-53 months). RESULTS: Technical success was achieved in six patients with complete resolution of the endoleak confirmed by follow-up CT scans. One technical failure was observed in a patient who eventually underwent surgical conversion. There were no procedure-related complications. CONCLUSIONS: Embolization with NBCA by a percutaneous transabdominal or a transarterial approach for the treatment of type I endoleaks after EVAR was technically feasible and clinically effective, with no major complications.

1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial.

OBJECTIVES: The aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation. BACKGROUND: It is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI). METHODS: In this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%). RESULTS: The primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference -0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842). CONCLUSIONS: Among patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy. (A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-Eluting Stent Implantation; NCT02513810).

One-year clinical outcomes between biodegradable-polymer-coated biolimus-eluting stent and durable-polymer-coated drug-eluting stents in STEMI patients with multivessel coronary artery disease undergoing culprit-only or multivessel PCI.

BACKGROUND AND AIMS: There are limited data comparing clinical outcomes among new-generation drug-eluting stents (DES) in ST-segment elevation myocardial infarction (STEMI) patients with multivessel coronary artery disease (MVD) who underwent primary percutaneous coronary intervention (PCI) with culprit-only or multivessel PCI. We investigated 1-year clinical outcomes between biodegradable-polymer (BP)-coated biolimus-eluting stent (BES) and durable-polymer (DP)-coated DES in STEMI patients with MVD who underwent two different reperfusion strategies. METHODS: A total of 4255 patients were enrolled and divided into two groups, a culprit-only (n = 2571, BP- [n = 264] or DP-DES [n = 2307]) or a multivessel PCI group (n = 1684, BP- [n = 145] or DP-DES [n = 1539]). The primary endpoint was major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), and total repeat revascularization. The secondary endpoint was the incidence of definite or probable stent thrombosis (ST). RESULTS: BP-BES and DP-DES showed a similar 1-year adjusted hazard ratio (HR) for MACE (culprit-only, adjusted hazard ratio [HR], 1.114; p = 0.740; multivessel, HR, 0.564; p = 0.167) and ST (culprit-only, HR, 1.110, p = 0.891; multivessel, HR, 0.375; p = 0.402). The adjusted HR for all-cause death, re-MI, and repeat revascularization were similar between the two groups. In the total population, the culprit-only PCI group showed a higher incidence of total repeat revascularization than the multivessel PCI group. CONCLUSIONS: BP-BES and DP-DES showed comparable safety and efficacy in STEMI patients with MVD who underwent primary PCI with two different reperfusion strategies during a 1-year follow-up period.

Impact of current smoking on 2-year clinical outcomes between durable-polymer-coated stents and biodegradable-polymer-coated stents in acute myocardial infarction after successful percutaneous coronary intervention: Data from the KAMIR.

OBJECTIVE: Data concerning the effect of current smoking on solely new-generation drug-eluting stents (DES) are limited. We investigated the impact of current smoking on 2-year clinical outcomes between durable-polymer (DP)-coated DES (zotarolimus-eluting [ZES] and everolimus eluting [EES]) and biodegradable-polymer (BP)-coated biolimus-eluting stent (BES) in acute myocardial infarction (AMI) patients after successful percutaneous coronary intervention (PCI). METHODS: Finally, a total of 8357 AMI patients with current smoking underwent successful PCI with new-generation DES (ZES, EES, and BES) were enrolled and divided into three groups as ZES (n = 3199), EES (n = 3987), and BES group (n = 1171). The primary endpoint was the occurrence of major adverse cardiac events (MACE) defined as all-cause death (cardiac death [CD] or non-cardiac death), recurrent AMI (re-MI), any revascularization (target lesion revascularization [TLR], target vessel revascularization [TVR], and non-TVR). The secondary endpoint was the incidence of definite or probable stent thrombosis (ST). RESULTS: The 2-year adjusted hazard ratio (HR) of MACE for ZES vs. EES (1.055; 95% confidence interval [CI], 0.843-1.321; p = 0.638), ZES vs. BES (HR, 0.885; 95% CI, 0.626-1.251; p = 0.488), EES vs. BES (HR, 0.889; 95% CI, 0.633-1.250; p = 0.499), and ZES/EES vs. BES (HR, 0.891; 95% CI, 0.648-1.126; p = 0.480) were similar. The occurrence of ST after adjustment were also comparable. In addition, the 2-year adjusted HR for all-cause death, CD, re-MI, TLR, TVR, and non-TVR were not different. CONCLUSIONS: In this study, DP-DES and BP-DES showed comparable safety and efficacy during 2-year follow-up periods. Therefore, DP-DES or BP-DES are equally acceptable in AMI patients with current smoking undergoing PCI.

Nobori-Biolimus-Eluting Stents versus Resolute Zotarolimus-Eluting Stents in Patients Undergoing Coronary Intervention: A Propensity Score Matching.

PURPOSE: To compare the 1-year outcomes of a durable polymer Zotarolimus-eluting stent (ZES) versus a biodegradable polymer Biolimus-eluting stent (BES) in patients undergoing percutaneous coronary intervention. MATERIALS AND METHODS: A total of 2083 patients from 2 different registries, 1125 treated with BES in NOBORI registry and 858 received ZES in CONSTANT registry were included in this study. Clinical outcomes were compared with the use of propensity score matching (PSM). The primary endpoint was a composite of major adverse cardiovascular and cerebrovascular events (MACCEs) including cardiac death, myocardial infarction, clinically driven target lesion revascularization and stroke. Secondary end points were individual components of MACCEs as well as the incidence of stent thrombosis at 1-year follow-up. RESULTS: After PSM, 699 matched pairs of patients (n=1398) showed no significant difference between BES and ZES in the risk of composite MACCEs at 1 year (2.6% vs. 1.7%; p=0.36). Cardiac death was not statistically different between groups (0.7% vs. 0.4%, p=0.73). Target lesion revascularization rate was also similar between BES and ZES (1.1% vs. 0.7%, p=0.579). Non-Q wave myocardial infarction, as well as target-vessel revascularization rate, was similar between the two groups (0.14% for BES and 0.72% for ZES). Both stent types were excellent with no cases of stent thrombosis and rate of Q wave myocardial infarction reported during the follow-up period. CONCLUSION: In this cohort of patients treated with BES or ZES, the rate of MACCEs at 1 year was low and significantly not different between both groups.

Development of a New Hybrid Biodegradable Drug-Eluting Stent for the Treatment of Peripheral Artery Disease.

This study aimed to develop a new biodegradable stent for peripheral artery disease (PAD) that could provide sufficient radial force to maintain long-term patency and flexibility. All self-expandable hybrid biodegradable stents were designed by using a knitting structure composed of poly-L-lactic acid (PLLA) and nitinol. Four different types of stents were implanted in 20 iliac arteries in 10 mini pigs as follows: a bare-metal stent (BMS) (group 1, n = 5), a drug-free hybrid stent (group 2, n = 5), a 50% (50 : 100, w/w) paclitaxel (PTX)/poly-lactide-co-glycolic acid (PLGA; fast PTX-releasing form) hybrid stent (group 3, n = 5), and a 30% (30 : 100, w/w) PTX/PLGA (slow PTX-releasing form) hybrid stent (group 4, n = 5). We performed follow-up angiography and intravascular ultrasonography (IVUS) at 4 and 8 weeks. In a comparison of groups 1, 2, 3, and 4, less diameter stenosis was observed in the angiographic analysis for group 4 at the 4-week follow-up (19.0% ± 12.7% versus 39.3% ± 18.1% versus 46.8% ± 38.0% versus 4.8% ± 4.2%, resp.; p = 0.032). IVUS findings further suggested that the neointima of the patients in group 4 tended to be lesser than those of the others. Our new biodegradable 30% PTX/PLGA (slow-releasing form) stent showed more favorable results for patency than the other stent types.

Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

BACKGROUND: The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease. METHODS/DESIGN: The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound. DISCUSSION: The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions. TRIAL REGISTRATION: National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

Comparison of effects of drug-eluting stents versus bare metal stents on plasma C-reactive protein levels.

After coronary stenting, inflammatory mechanisms play a crucial role in the pathogenesis of neointimal proliferation and in-stent restenosis. Drug-eluting stents (DESs) have been shown to decrease in-stent restenosis in different studies. We compared plasma C-reactive protein (CRP) levels after DES implantation with levels after bare metal stent (BMS) implantation. We performed percutaneous coronary intervention with a single stent in 67 patients (54 men; 59 +/- 9 years of age; n = 21 in the BMS group, n = 46 in the DES group) who had stable angina. Plasma CRP levels were determined before intervention and at 48 hours, 72 hours, and 2 weeks after coronary stenting. There was no difference in clinical and angiographic baseline characteristics except that the DES group had more patients with diabetes (34.8% vs 9.5%, p = 0.04), smaller reference vessels (2.95 +/- 0.53 vs 3.29 +/- 0.53 mm, p = 0.02), and smaller stent diameters (3.0 +/- 0.4 mm vs 3.4 +/- 0.5 mm, p <0.01). Plasma CRP levels at 48 hours (13.4 +/- 14.7 vs 5.9 +/- 4.9 mg/L, p <0.01) and 72 hours (16.7 +/- 19.8 vs 5.4 +/- 3.9 mg/L, p <0.01) after stent implantation were significantly higher in the BMS than in the DES group. In conclusion, DESs showed significantly lower plasma CRP levels after coronary stenting compared with BMSs. This may reflect the potent effects of DESs on acute inflammatory reactions induced by coronary intervention.

Randomized comparison of acute stent malapposition between platinum-chromium versus cobalt-chromium everolimus-eluting stents.

No randomized data exist regarding optical coherence tomography (OCT) evaluation immediately post-procedure and at the 3-month follow-up for platinum-chromium everolimus-eluting stents (PtCr-EES) versus cobalt-chromium everolimus-eluting stents (CoCr-EES). A total of 100 patients were randomly assigned to undergo PtCr-EES (n = 51) or CoCr-EES (n = 49) implantation. OCT was serially evaluated after stent deployment with nominal pressure and immediately post-procedure, and 3-month follow-up. The primary endpoint was the percentage of malapposed strut after nominal pressure and immediately post-procedure. Compared to the CoCr-EES, the PtCr-EES showed a lower tendency of percent malapposed strut at nominal pressure [median value (interquartile range); 4.1 % (0.5-11.7) vs. 7.6 % (2.9-13.7), p = 0.082] and immediately post-procedure [1.2 % (0-3.4) vs. 2.5 % (0.7-5.3), p = 0.051]. The percentage of cross sections with any malapposed struts was significantly lower with PtCr-EES at nominal pressure [15.0 % (5.6-39.0) vs. 23.8 % (18.2-44.4), p = 0.036] and immediately post-procedure [6.5 % (0-15.3) vs. 10.5 % (7.1-20.0), p = 0.026]. At the 3-month follow-up, both PtCr-EES and CoCr-EES showed comparable percentages of malapposed struts (0 vs. 0 %, respectively, p = 0.332) and uncovered struts (5.3 vs. 4.7 %, respectively, p = 0.829). We found a significant correlation between the immediate post-procedural percentage of malapposed struts versus the percentage of uncovered struts (r = 0.430, p < 0.001) at the 3-month follow-up. Compared to the CoCr-EES, the PtCr-EES shows a lower tendency toward a lower percentage of malapposed struts but no significant difference in strut coverage at the 3-month follow-up. The percentage of malapposed struts immediately post-procedure was correlated with strut coverage at the 3-month follow-up.

A new stent design with multiple radio-opaque markers for protection of side-branch vessels in bifurcation lesions: HJ stents.

BACKGROUND: Loss of side-branch vessels is a serious complication following stent implantation in parent vessels of bifurcation lesions. The purpose of this study was to introduce and test a new stent design for the protection of side-branch vessels in the management of bifurcation lesions. METHODS AND MATERIALS: This stent has multiple radio-opaque markers in its central portion, whose presence is useful in avoiding stent-strut placement across the side-branch orifice and in correctly directing the insertion of a second guide wire through the struts into the side branch to minimize jailing of side branches during stent deployment in the parent vessel. In vitro tests of the acrylic resin bifurcation phantom model were performed under fluoroscopic guidance in the catheterization laboratory with 10 stents with multiple radio-opaque markers and 10 stents without. Kissing balloon angioplasty was performed across the side branch after stent implantation in the parent vessel in both groups. Side-branch jailing by the stent (presence of any stent struts crossing the side-branch orifice) was determined visually and compared between the two groups. RESULTS: The jailed side branch with the stent struts was observed in one of 10 new stents and in five of 10 conventional stents without them. CONCLUSIONS: The in vitro tests demonstrated the superiority of a new stent design for the reduction of side-branch jailing in bifurcation lesions.