Need For Target Lesion Revascularization Research Articles

High- Versus Low-Dose Paclitaxel-Coated Balloons for Femoropopliteal Disease: A systematic review and meta-analysis.

To evaluate the comparative effectiveness of high- and low doses of paclitaxel in endovascular revascularization procedures for patients with femoropopliteal disease. The databases (Embase, PubMed, Scopus, and Web of Science) were searched for studies that had compared outcomes of high-dose and low-dose paclitaxel-coated balloons (PCBs) in the treatment of patients with femoropopliteal disease. Randomized controlled trials and nonrandomized comparative studies (eg, cohort studies and case-control studies) were eligible for inclusion. The primary outcomes of interest were patency rates, risk of restenosis, and clinically-driven target lesion revascularization (CD-TLR). Pooled effect sizes were reported as relative risk (RR) with 95% confidence intervals (CI). The analysis included 7 studies. High-dose PCB use was associated with higher patency (RR, 1.10; 95% CI, 1.00-1.21), reduced risk of restenosis (RR, 0.60; 95% CI, 0.46-0.79), and reduced need for CT-TLR (RR, 0.57; 95% CI, 0.41-0.79) compared to low-dose PCB. Rates of limb salvage (RR, 1.01; 95% CI, 0.99-1.04), freedom from major adverse limb events (RR, 1.39; 95% CI, 0.79-2.42), and overall survival (RR, 1.02; 95% CI, 0.99-1.05) were comparable in the 2 groups. There was no evidence of publication bias. High-dose PCB correlates with superior outcomes in patients with femoropopliteal disease, particularly in terms of better vascular patency, reduced restenosis risk, and lower need for target lesion revascularization, compared to low-dose PCB.

Comparisons of Drug-Eluting Balloon versus Drug-Eluting Stent in the Treatment of Young Patients with Acute Myocardial Infarction.

The incidence of acute myocardial infarction (AMI) in the younger population has been increasing gradually in recent years. The objective of the present study is to investigate the safety and effectiveness of drug-eluting balloons (DEBs) in young patients with AMI. All consecutive patients with AMI aged ≤ 45 years were retrospectively enrolled. The primary endpoint was a device-oriented composite endpoint (DOCE) of cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR). The secondary study endpoints included heart failure and major bleeding events. A total of 276 young patients presenting with AMI were finally included. The median follow-up period was 1155 days. Patients treated with DEBs had a trend toward a lower incidence of DOCEs (3.0% vs. 11.0%, p = 0.12) mainly driven by the need for TLR (3.0% vs. 9.1%, p = 0.19) than those treated with DESs. No significant differences between the two groups were detected in the occurrence of cardiac death (0.0% vs. 0.5%, p = 0.69), MI (0.0% vs. 1.4%, p = 0.40), heart failure (0.0% vs. 1.9%, p = 0.39), or major bleeding events (1.5% vs 4.8%, p = 0.30). Multivariate regression analysis showed that DEBs were associated with a trend toward a lower risk of DOCEs (HR 0.13, 95% CI [0.02, 1.05], p = 0.06). The findings of the present study suggested that DEBs might be a potential treatment option in young patients with AMI. A larger scale, randomized, multicenter study is required to investigate the safety and effectiveness of DEBs in this setting.

773 CONTRAST-ENHANCED EXCIMER LASER CORONARY ANGIOPLASTY IN THE TREATMENT OF HEAVILY CALCIFIED LESIONS: A STEPWISE APPROACH

Abstract Introduction The treatment of heavily calcified lesions is a challenge for the interventional cardiologist. The Excimer laser coronary atherectomy (ELCA) is a plaque modification tool and the main mechanism of action seems to be the photomechanical delivering acoustic pressure with a mechanical disruption of the plaque in front of the catheter tip. Objective To evaluate the effectiveness of the contrast-enhanced ELCA by a stepwise approach, with incremental frequency/fluency in the treatment of calcified lesions in different contexts. Methods We retrospectively enrolled consecutively all patients undergoing contrast-enhanced ELCA-assisted PCIs between 2018 and 2021 at the Cardiology Unit of “Umberto I” Hospital of Syracuse (Italy). The frequency/fluency ELCA profile used with a stepwise approach were 50/50, 60/60, 70/70 and 80/80. ELCA technical success was defined as the laser catheter crossing the entire length of the target lesion established by angiographic evidence of the catheter tip in the artery distal to the stenosis. Procedural success was defined as <30% residual stenosis after laser and adjunctive therapy. Clinical success requested procedural success with absence of major adverse cardiac events at hospital discharge. Major adverse cardiac events included death of all causes, myocardial infarction, need for target lesion revascularization, tamponade, and life-threatening arrhythmias. Results We enrolled 114 patients who underwent contrast-enhanced ELCA-assisted PCI. 58% of the patients had acute coronary syndrome and 42% had chronic coronary syndrome. The left anterior descending artery was the target vessel in 42.1% of cases, the right coronary artery in 26.3%, the circumflex in 10.5%, and the left main artery in 2.3%. The main indication for ELCA was intrastent restenosis (56.2%). The median stenosis was 90% (80% – 90%). The ELCA catheter tip was 0.9 mm and 1.4 mm was employed in the 89.5% and 10.5% of cases respectively. The most used frequency/fluency profile was 70/70 (39.5%) followed by 60/60 (31.6%), 50/50 (15.8%) and 80/80 (13.2%). Use of contrast-enhanced ELCA was associated with high technical success rate (97.4%), procedural success rate (93.7%), and clinical success rate (97.1%). Conclusions In Conclusion, the contrast-enhanced ELCA seems to be a safe and effective treatment for management of calcified lesions.

Feasibility and clinical outcomes of 48 mm drug eluting stents in management of patients with coronary artery disease

Abstract Background Long Coronary lesions represent a formidable challenge during percutaneous coronary intervention (PCI). Implantation of multiple contiguous stents may result in sections of overlapping stents or gaps of unstented segments and is an independent predictor of restenosis and major adverse cardiovascular events (MACEs). Objectives To assess the feasibility, and short-term clinical outcomes of implanting 48mm drug eluting stents (DES) in treatment of long lesions in patients with coronary artery disease (CAD). Methods A prospective study enrolling 300 patients, with a single CAD planned to undergo PCI with 48mm DES. Clinical data, procedural outcomes and follow-up to 6 months were obtained. MACEs were considered the combined study end point defined as cardiac death, non-fatal myocardial infarction, unstable angina and the need for target lesion revascularization (TLR). Results Among the 300 subjects enrolled, 80% were males, mean age was 60.8±8.6 years. Procedural success rate was 97.3%. Failure of crossing was encountered in 4 patients due to severe tortuosity. Six-month clinical outcome was compared between diabetic (DM) (n=90) and non-DM patients; 6-month cumulative MACEs were significantly lower in the non-DM than in DM group (2.9% in non-DM vs. 13.3% in DM, p=0.013). Clinically driven TLR was 4% and two cardiac deaths were reported. The independent predictors of repeat revascularization were insulin treated type 2 DM, and reference vessel diameter (RVD) ≤2.75 mm. Conclusion The use of 48mm DES is feasible, safe and cost effective in treatment of long coronary lesions. Independent predictors of repeat revascularization are type 2 diabetes mellitus, and RVD ≤2.75mm. Funding Acknowledgement Type of funding sources: None.

Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the \u201cSirPAD\u201d randomized controlled trial

BackgroundPeripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for “hard” clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability.MethodsIn this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective “hard” outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes.DiscussionBy focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative (“all-comer”) population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected.Trial registrationClinicalTrials.govNCT04238546

Safety and efficacy of the polymer-free and polymer-coated drug-eluting stents in patients undergoing percutaneous coronary intervention.

The relative safety and efficacy of polymer-free (PF) versus polymer-coated (PC) drug-eluting stents (DES) in patients with angina or acute coronary syndrome (ACS) undergoing percutaneous coronary intervention has received limited study. Digital databases were queried to identify relevant studies. Major adverse cardiovascular events (MACE) and secondary outcomes were compared using a random effect model to calculate unadjusted odds ratios (OR). A total of 28 studies consisting of 23,198 patients were included in the final analysis. On pooled analysis, there was no significant difference in the odds of MACE (OR 0.98, 95% CI 0.91-1.08) and major bleeding (OR 0.87, 95% CI 0.61-1.24) between patients undergoing PF-DES versus PC-DES. Similarly, the odds of myocardial infarction, stroke, stent thrombosis, cardiovascular mortality and need for target vessel revascularization was similar between the two groups. PF-DES was favored due to significantly lower odds of non-cardiac death (OR 0.78, 95% CI 0.68-89) and all-cause mortality (OR 0.87, 95% CI 0.80-0.95), but had a higher need for target lesion revascularization (OR 1.2, 95% CI 1.02-1.42). A subgroup analysis based on follow up duration, clinical presentation, presence of diabetes and class of eluting drugs mirrored the net estimates for all outcomes with a few exceptions. A sensitivity and meta-regression analysis showed no influence of single-study and duration of antiplatelet therapy on pooled outcomes. In patients presenting with angina or ACS, PF-DES might be favored due to lower all-cause mortality and equal risk of ischemic adverse cardiovascular and major bleeding events compared with PC-DES.

The CTGF gene -945 G/C polymorphism is associated with target lesion revascularization for in-stent restenosis

Background and aimsPrevious studies have shown that transforming growth factor β (TGF-β) and vascular endothelial growth factor A (VEGF-A) pathways are involved in the in-stent restenosis (ISR) process. The present study aimed to assess the relationship between single-nucleotide polymorphisms (SNPs) in genes encoding downstream proteins of TGF-β and VEGF-A pathways and the risk of target lesion revascularization (TLR) for in-stent restenosis. MethodsA total of 657 patients (with 781 treated lesions) who underwent percutaneous coronary intervention (PCI) with stent implantation at our center between 2007 and 2012 and completed a 4-year follow-up for clinically-driven TLR, were included. SNPs in CTGF (rs6918698), TGFBR2 (rs2228048), SMAD3 (rs17293632), KDR (rs2071559), CCL2 (rs1024610) were genotyped using TaqMan assay. ResultsMajor allele carriers of CTGF gene -945 G/C polymorphism (rs6918698) were significantly less likely to underwent clinically-driven TLR during follow-up than minor allele carriers. After adjustment for clinical, angiographic, and procedural covariates, CTGF polymorphism was significantly associated with TLR, and minor allele (C) carriers had nearly two times higher risk of developing ISR requiring TLR (HR of 1.93, 95%CI 1.15–3.24) compared to patients with major (GG) genotype. No significant relationship was found between other analyzed polymorphisms and cumulative incidence of TLR at 4-years. ConclusionsOur results suggest that functional -945 G/C polymorphism in the gene encoding connective tissue growth factor is associated with the need for TLR in patients who underwent PCI for stable coronary artery disease.

Meta-Analysis Comparing Endovascular Treatment Modalities for Femoropopliteal Peripheral Artery Disease

Endovascular interventions are commonly utilized for treatment of femoropopliteal peripheral artery disease. The relative efficacy of these interventions remains unclear. A Bayesian network meta-analysis was performed comparing 5 endovascular treatment modalities: balloon angioplasty (BA), bare metal stent (BMS), covered stent (CS), drug-coated balloon (DCB), drug-eluting stent (DES) for femoropopliteal peripheral artery disease. The primary efficacy end points were freedom from target lesion revascularization (TLR) and primary patency at 12 months. BA was the reference treatment. Twenty-two trials including 4,381 participants provided data on TLR. Sixteen trials including 3,691 participants provided data on primary patency. Point estimates for DCB suggested that it was the most efficacious treatment for freedom from TLR (odds ratio [OR] 4.23; 95% credible intervals [CrI] 2.43 to 7.66) followed by CS (OR 3.65; 95% CrI 1.11 to 12.55), DES (OR 2.64; 95% CrI 0.72 to 9.77), and BMS (OR 2.3; 95% CrI 1.11 to 4.76). Similarly, point estimates for primary patency were highest with DES (OR 8.93; 95% CrI 3.04, 27.14) followed by CS (OR 3.91; 95% CrI 1.18, 13.84), DCB (OR 3.32; 95% CrI 1.8, 6.25), and BMS (OR 3.5; 95% CrI 1.58, 7.99). In conclusion, DCB has the lowest need for TLR whereas DES has the highest primary patency rate. DCB, CS, and BMS were associated with significant reductions in TLR compared with BA, whereas DCB, DES, CS, and BMS were associated with significantly improved primary patency compared with BA.

Clinical Prognosis Associated With the Use of Overlapping Stents With Homogenous Versus Heterogeneous Pharmacological Characteristics for the Treatment of Diffuse Coronary Artery Disease

BackgroundThe clinical impact of percutaneous coronary intervention (PCI) and implantation of overlapping stents (OS) using platforms with the same versus different pharmacological characteristics is unknown. Our objective was to compare the outcomes of PCI with OS according to their pharmacological characteristics. MethodsIn this observational single-center registry, we included all PCI performed from April 2014 to December 2018 in which overlapping drug-eluting stents were implanted. Two groups were created according to whether the stents release the same drug [homogeneous: (HO)] or different [heterogeneous: (HE)]. The primary endpoint was the need for target lesion revascularization (TLR). Clinical assessment was performed after the procedure, bianually and at the end of follow-up (June 2019). Results381 lesions with OS (HO: 209; HE: 172) were included (75.1% male, 66.7 ± 11.6 years). Clinical presentation was stable coronary artery disease in 49.9%. Syntax score was 23.7 ± 13.3. The number of OS implanted was 2.2 ± 0.5 and the total stent length was 59.5 ± 20.1 mm (HE: 61.5 ± 21.6 vs. HO: 57.8 ± 18.8 mm; p < 0.01). After a median follow-up of 21 months, the HE group showed a lower TLR rate than the HO group (HE:2.3% vs HO:7.2%; p = 0.03). The rates of cardiac death (p = 0.44), myocardial infarction (p = 0.36) and stent thrombosis (p = 0.85) were similar between groups. In the multivariate analysis, the OS with homogeneous-drug devices was an independent predictor of a higher rate of TLR. ConclusionsPCI using OS with homogeneous pharmacological characteristics was associated with a higher rate of TLR in comparison with the implantation of OS with heterogeneous pharmacological characteristics.

Intravascular Ultrasound Imaging-Guided Versus Coronary Angiography-Guided Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.

BackgroundIntravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) offers tomographic images of the coronary vessels, allowing optimization of stent implantation at the time of PCI. However, the long‐term beneficial effect of IVUS over PCI guided by coronary angiography (CA) alone remains under question. We sought to investigate the outcomes of IVUS‐guided compared with CA‐guided PCI.Methods and ResultsWe performed a comprehensive search of PubMed, Medline, and Cochrane Central Register, looking for randomized controlled trials and observational studies that compared PCI outcomes of IVUS with CA. Data were aggregated for the primary outcome measure using the random‐effects model as pooled risk ratio (RR). The primary outcomes were the rate of cardiovascular death, need for target lesion revascularization, occurrence of myocardial infarction, and rate of stent thrombosis. A total of 19 studies met the inclusion criteria, comprising 27 610 patients divided into IVUS (n=11 513) and CA (n=16 097). Compared with standard CA‐guided PCI, we found that the risks of cardiovascular death (RR, 0.63; 95% CI, 0.54–0.73), myocardial infarction (RR, 0.71; 95% CI, 0.58–0.86), target lesion revascularization (RR, 0.81; 95% CI, 0.70–0.94), and stent thrombosis (RR, 0.57; 95% CI, 0.41–0.79) were all significantly lower using IVUS guidance.ConclusionsCompared with standard CA‐guided PCI, the use of IVUS imaging guidance to optimize stent implantation is associated with a reduced risk of cardiovascular death and major adverse events, such as myocardial infarction, target lesion revascularization, and stent thrombosis.

Endovascular treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery using the sinus-SuperFlex-635 stent: twelve-month results from the HERO Registry.

The aim of this study was to evaluate the safety and performance of the sinus-SuperFlex-635 self-expandable nitinol stent (Optimed GmbH) for the treatment of steno-occlusive lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The prospective, multicenter, observational HERO study recruited 117 eligible patients (83 men; mean age 69.4±9.7y) from 7 centers in Belgium. A total of 129 stents were successfully deployed in 121 lesions in 117 patients (100%). The patients presented with symptomatic ≥50% stenosis or chronic total occlusion (CTO) (30.6%). Mean lesion length was 71.4±56.3 mm. Moderate to severe calcification was present in 82.6% of the lesions. Acute lesion success (<30% residual stenosis) was achieved in 96.0%. There were no in-hospital serious adverse events. Duplex ultrasound-driven primary patency at 12 months was recorded in 84 of 107 (78.5%) lesions. The overall target lesion revascularization (TLR) rate was 8.4% at 12 months; the target extremity revascularization (TER) rate was 4.7%. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford class, without the need for TLR (i.e. primary sustained clinical improvement) in 83.9% of patients and with the need for TLR in 90.6% of patients (i.e. secondary sustained clinical improvement). Based on the high primary patency, low stent fracture rate and significant clinical improvement, combined with refined stent design and long stent availability, the sinus-SuperFlex-635 self-expandable nitinol stent proves its value in the treatment of complex femoropopliteal lesions.

Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study).

Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited. The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02-1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58-1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71-1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53-1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80-2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments. In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.

Comparison of Clinical Outcomes Between Very Long Stents and Overlapping Stents for the Treatment of Diffuse Coronary Disease in Real Clinical Practice

The stent length as well as the stent overlap for the percutaneous treatment of diffuse coronary disease have been considered predictors of adverse events. However, there are no comparative data on the use of very long stents or overlapping stents in this scenario. To compare the clinical results of very long stents (≥40 mm) or overlapping stents in real clinical practice. We included 643 lesions in 628 consecutive patients treated with a single very long stent (≥40 mm) (251 lesions) or ≥2 overlapped stents (392 lesions). We analyzed the procedural characteristics and the presentation of the combined endpoint [cardiovascular death, non-fatal myocardial infarction, need for target lesion revascularization or stent thrombosis] after a follow-up of 20 months. Total stent length was 54 ± 18 mm and minimum diameter was 2.9 ± 1.2 mm. At the end of follow-up, the rate of adverse events was 8.3% (cardiac death: 4.9%, myocardial infarction: 1.7%, target lesion revascularization: 3.1%, stent thrombosis: 0.7%). There were no significant differences between both groups in the presentation of the combined endpoint. Procedures with overlapping stents had more contrast volume (309 ± 115 vs 273 ± 127 ml; p = 0.002), longer duration (47 ± 22 vs 39 ± 18 min; p < 0.0001), higher fluoroscopy time (20 ± 13 vs 16 ± 9 min; p < 0.0001) and higher number of stents to treat the index lesion (2.2 ± 0.5 vs 1; p < 0.0001). New designs of very long stents allow not only treating increasingly complex lesions, but also simplifying the procedure and decreasing the number of stents with very favorable results similar to those obtained with stent overlap.

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents

ObjectivesThis study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). BackgroundTreatment of patients with DES-ISR remains a challenge. MethodsThe RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. ResultsA total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for “late” (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. ConclusionsThe 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940)

Sex differences in left main coronary artery stenting: Different characteristics but similar outcomes for women compared with men

BackgroundThe clinical outcomes for women compared with men undergoing left main PCI were sparse. We compared the characteristics and long-term outcomes in women versus men after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main CAD. MethodsWe identified 2328 patients (545 women; 1783 men) with unprotected left main CAD who received PCI with DES between January 2007 and December 2013 in the Interventional Cardiology Research In-cooperation Society-left MAIN revascularization (IRIS-MAIN) registry. The primary outcome was a composite of death from any cause, myocardial infarction, or stroke. ResultsThe median follow-up time was 2.9years (interquartile range: 1.0–4.1years). Women were older, had a higher incidence of insulin-requiring diabetes mellitus and hypertension, and more commonly presented with acute coronary syndrome than men. Left main ostial lesion was more common in women, whereas left main bifurcation lesion with more extensive CAD was more common in men. The incidence of primary outcome was similar between the two groups (10.8% vs. 10.8%, respectively, log-rank p=0.587). The results were similar after adjustment for baseline variables and consistent across major subgroups. The need for target lesion revascularization was significantly higher in women than in men (8.8% vs. 5.7%, respectively, p<0.05) but the sex bias was not confirmed after adjusting for confounders. ConclusionsWomen, as compared to men, had different clinical and lesion characteristics but similar long-term outcomes after PCI with DES for left main CAD.

Clinical Outcomes and Cost-Effectiveness Analysis of FFR Compared with Angiography in Multivessel Disease Patient.

BackgroundIn multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS).ObjectivesTo evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS.MethodsMultivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE.ResultsWe studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%.ConclusionFFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.

Results of endovascular treatment of iliac and femoral symptomatic lesions. Identification of re-intervention risk factors

Introduction. The aim of the study was to assess a presence of peripheral arterial disease risk factors in patients with symptomatic femoral and iliac lesions treated with use of Jaguar and Supera nitinol stents and to estimate potential relation between these factors and reintervention rate. Material and methods. The study group consisted of 60 patients between 46 and 85 years of age who presented with typical symptoms of intermittent claudication or critical limb ischemia and underwent percuta­neous transluminal angioplasty with stenting. We examined and divided group into two subgroups — patients who experienced or did not experience need of reintervention in treated lesion. Results. During the follow-up 24 (40%) of patients underwent reintervention in treated artery due to re­current symptoms of disease. Need of target lesion revascularization occurred more frequent in patients with hypertension (OR = 2.5), patient older than 68 (OR = 1.75) and smokers (OR = 1.75). Patency of all three arteries below knee protected from reintervention. Conclusions. Jaguar and Supera self-expanding nitinol stents has several advantages and its use were char­acterized by high procedural success and moderate frequency of reintervention correlated to some clinical findings like hypertension. Further studies are necessary to estimate factors disturbing and interfering with long-term patency.

The SYNERGY II Everolimus elutiNg stent In patients Older than 75 years undergoing coronary Revascularisation associated with a short dual antiplatelet therapy (SENIOR) trial: rationale and design of a large-scale randomised multicentre study.

In the elderly population, bare metal stents (BMS) are often preferred over drug-eluting stents (DES) because of the longer duration of dual antiplatelet therapy (DAPT) associated with the latter. The SENIOR trial is designed to determine whether one of the latest generation of DES can reduce major cardiovascular events compared to BMS, despite a similar short DAPT duration. The SENIOR trial is a multicentre, single-blind, prospective, randomised trial comparing the latest generation DES (SYNERGY™ II; Boston Scientific, Marlborough, MA, USA) to BMS (Rebel™; Boston Scientific) in 1,200 patients ≥75 years old. DAPT will be given for one or six months according to clinical presentation, irrespective of stent type. The primary outcome is the composite of all-cause mortality, non-fatal myocardial infarction, stroke or ischaemia-driven target lesion revascularisation at one year. Secondary endpoints include the rate of major bleedings and the rate of stent thrombosis at one year. This trial is designed to evaluate a new revascularisation strategy combining DES and short duration DAPT in elderly patients. It has the potential to decrease the need for target lesion revascularisation without a significant DAPT-related increase in bleeding compared to BMS.

Gene Delivery from Stents for Prevention of In-Stent Restenosis

The increasing sophistication of vascular stent design, especially devices that combine mechanical support with local drug delivery to the vascular wall, has resulted in major progress in the management of coronary and peripheral artery disease. This progress is reflected in expanded anatomical and clinical indications for stent angioplasty, with complementary reduction in bypass surgery rates and decreased need for target-lesion revascularisation. Nevertheless, even with second-generation drug-eluting stents (DES), the most common cause of stent failure, in-stent restenosis, while &lt;10%, generates high numbers of cases due to the large scale of stent use (there are &gt;1 million stent angioplasty procedures yearly in the USA alone). Gene-eluting stents (GES), the next generation of stent devices now in the preclinical phase of development, have evolved over the past two decades around the concept of localised vessel wall delivery of gene vectors attached to the stent struts. GES potentially provide several important advantages over DES, such as prolonged or even permanent anti-restenotic effect, capacity to deliver dissimilar impact on smooth muscle cells and endothelium, and fine-tuning of transgene expression and pharmacological effect with systemically administered therapeutics. Furthermore, GES can be used for treating non-occlusive lesions with the aim of slowing the underlying atherosclerotic process in the vessel wall. GES research at this time is concerned with achieving effective and safe transgene overexpression in the stented arteries, optimal vector choice, and proper techniques for vector immobilisation on the stent struts.

Long-term risks for patency loss in patients with hemodialysis after bare self-expandable nitinol stent implantation to femoropopliteal artery occlusive lesions

BackgroundAlthough patients receiving hemodialysis (HD+) have significantly different backgrounds, including a history of progressive atherosclerotic disease, compared with those not receiving hemodialysis (HD−), there are no studies evaluating the risks for loss of primary patency (PP) and need for target lesion revascularization (TLR) in HD+ patients following bare self-expandable nitinol stent (BSNS) implantation to femoropopliteal (FP) artery occlusive lesions, after adjusting for differences using propensity score (PS) analysis in observed characteristics between groups. MethodsWe studied 531 limbs of 432 Japanese patients (HD+, n=107; HD−, n=325) who received BSNS implantation to FP lesions between 2004 and 2014. Patients were followed-up for an average of 44.3±33.6months. We compared the long-term results between HD+ and HD− patients using the Cox-proportional hazard model with adjustment for inverse probability treatment weight (IPTW) of PS, which was calculated for covariates with HD as a dependent variable. ResultsPP rate in HD+ vs. HD− patients at 9years after the procedure was 19.1% vs. 47.9%, with a freedom from TLR rate of 47.6% vs. 62.9%, respectively. Adjusted HRs in HD+ patients with 95% confidence intervals (CIs) were as follows: loss of PP: HR 1.64, 95% CI 1.052–2.557, P=0.03; TLR: HR 1.862, 95% CI 1.104–3.139, P=0.02. ConclusionsThe present study suggests that HD+ patients have an increased risk for loss of PP and need for TLR after BSNS implantation to FP lesions.