Terms Of Target Lesion Revascularization Research Articles

Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry

BackgroundThe outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons.AimsTo evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India).MethodsWe conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2–5 bleedings.ResultsAmong 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91–2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95–3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92–1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09–4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status.ConclusionsIn the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

Comparison Among Ultra-Thin Coronary Stents: A Network Meta-Analysis

Ultrathin-strut drug-eluting stents (DES) have been related to potential improvement in stent-related outcomes compared with thicker-struts DES. However, comparisons among different ultrathin devices are lacking. All randomized controlled trials comparing ultrathin (struts thickness <70 µm) and thicker-struts DESs in an all-comers population were included. Target lesion failure (TLF), as defined by included trials, at 1-year follow-up was the primary end point. Overall mortality, myocardial infarction, target lesion revascularization (TLR), and stent thrombosis were the secondary end points. Arms of included trials were compared using network meta-analysis. Nine studies encompassing 20,081 patients were included, of which 9,509 patients had an ultrathin DES: Orsiro (evaluated in 7 arms with 8,086 patients), MiStent (1 arm with 703 patients), or Supraflex (1 arm with 720 patients). At 1-year follow-up, no significant differences were noted for TLF among these ultrathin DES. In particular, Orsiro was associated with a similar risk of TLF compared with Supraflex (risk rate 1.07, 95% confidence interval 0.59 to 1.78) and showed the highest probability of performing best in terms of TLF, myocardial infarction, and TLR. Ultrathin DES are all associated with a comparable risk of TLF compared with thicker-strut DES. In terms of TLR and TLF risk, Orsiro was the one with the highest probability of best performances, either compared with other ultrathin DES or to devices with thicker struts.

Different drugs in drug-eluting stents for peripheral artery disease: a systematic evaluation and Bayesian meta-analysis.

Drug-eluting stents (DESs) have become the first-line treatment for symptomatic peripheral arterial disease (PAD). Currently, there are many types of DESs on the market. The same type of DESs has different concentrations, and various drugs in them show uneven efficacy. The selection of DESs remains controversial. This study was aimed at comparing the long-term real-world outcomes of different DESs in the treatment of peripheral arterial occlusive disease (PAOD).The databases including Cochrane Library, Embase, and PubMed were searched with a time frame until March 25, 2023. The primary patency (PP) and target lesion revascularization (TLR) at 6 months were used as the primary endpoints.A total of 32 studies (5467 patients) were eligible. At the six-month follow-up, DES-Evero 1 ug/mm2 ranked first in terms of PP, with a significant difference from BMSs (RR [95% CI] = 1.6). DES-Siro 0.9 ug/mm2, DES-Siro 1.4 ug/mm2, DES-Siro 1.95 ug/mm2, DES-PTX 0.167 ug/mm2, DES-PTX 1 ug/mm2 and covered stents (CSs) showed significantly better PPs than BMSs. In terms of TLR, DES-Siro 0.9 ug/mm2 (0.31) ranked first, and DES-Evero 1 ug/mm2 ranked last.Among the treatment modalities for PAD, different DESs showed overall encouraging results in improving PP and TLR compared with BMSs. DES-Evero 1 ug/mm2 showed the best PP, but it had the highest reintervention rate at 6 months. Sirolimus-eluting stents were not always more effective with higher concentrations of sirolimus. Among various DESs, sirolimus-eluting stents and everolimus-eluting stents were superior to paclitaxel-eluting stents.

Efficacy and Safety of Atherectomy Combined With Balloon Angioplasty vs Balloon Angioplasty Alone in Patients With Femoro-Popliteal Lesions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Balloon angioplasty (BA), including drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA), has traditionally been used to treat femoral-popliteal lesions. However, in recent years, atherectomy (ATH) has been proposed as a complementary approach. To assess the effectiveness of ATH compared with BA alone in patients with femoral-popliteal artery lesions, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs). We included RCTs that focused on patients with femoral-popliteal artery lesions and reported data on the use of ATH and BA therapy. Two reviewers conducted a literature search, refined the data, and assessed the risk of bias. We included a total of 6 RCTs involving 399 patients with femoral-popliteal artery lesions. The use of ATH in combination with BA appeared to improve the patency rate at 12 months (odds ratio [OR]=2.04, 95% confidence interval [CI]=1.14-3.62). In addition, ATH with BA was associated with lower major amputation rates (MD=2.01, 95% CI=0.06-0.77, p=0.02) and a decreased likelihood of bailout stenting (OR=0.07, 95% CI=0.02-0.25, p=0.001). However, there were no statistically significant differences between the groups in terms of target lesion revascularization (TLR) at 12 months, major adverse cardiovascular events (MACEs), and distal embolization events. In addition, we performed subgroup analysis for different ATH devices and BA types. Based on this meta-analysis, it can be concluded that the use of ATH in combination with BA is a safe and effective method for treating femoral-popliteal artery lesions. In addition, the patency rate at 1 year is superior to treatment with BA alone. Atherectomy also reduces the likelihood of amputation and bailout stenting. Clinicians should consider these findings when designing future RCTs and developing clinical practice guidelines. This meta-analysis summarises a number of existing studies to advance understanding of the atherectomy devices and to reveal its potential. This new technique, when compared with drug coated balloon, shows the possibility of obtaining better clinical outcomes in femoro-popliteal lesions than drug-coated balloon alone, such as higher 12-month primary patency rates as shown in some studies. Currently, it is important to consider the appropriate technology applicable for individualised treatment. atherectomy devices seem to provide clinicians with additional options in clinical practice and to benefit patients in the future. This requires more high quality studies to explore the role and benefits of atherectomy devices in femoro-popliteal lesions.

Diabetes mellitus and femoropopliteal in-stent restenosis.

Background: The influence of diabetes mellitus (DM) on recurrent in-stent restenosis (ISR) of femoropopliteal arteries remains understudied. We investigated whether DM has an impact on recurrent restenosis after femoropopliteal stenting in patients included in the dRug-coatEd balloon angioPlasty for femoropopliteAl In-stent Restenosis (REPAIR) cooperation. Patients and methods: The REPAIR cooperation pooled the patient-level data from 3 randomized trials in which patients with ISR of femoropopliteal arteries received either drug-coated balloon (DCB) or plain balloon angioplasty. For this analysis, patients were divided in two groups based on whether they had or had not a DM diagnosis at the time of enrollment. The primary outcome was target lesion revascularization (TLR). The main secondary outcome was recurrent ISR. Other outcomes of interest were death, Rutherford class improvement and ankle-brachial index at follow-up. Results: 256 patients (DM, n=99 vs. non-DM, n=157) with 12-month follow-up were included in the analysis. Compared to non-DM patients, DM patients displayed no difference in terms of TLR [adjusted hazard ratio (95% Confidence intervals): 0.96 (0.55, 1.69), p=0.89] and recurrent ISR [1.04 (0.61, 1.77), p=0.88], whilst mortality was higher [9.38 (1.06, 83.11), p=0.044]. There were no differences between groups with respect to other secondary outcomes. The percutaneous treatment with DCB as compared to plain balloon angioplasty significantly reduced the risk of TLR and recurrent ISR without an excess risk of death irrespective of DM (p for interaction ≥0.70). Conclusions: In patients with femoropopliteal ISR, diabetes has a neutral effect on the risk of recurrence, but increases mortality at 12-month follow-up. DCB as compared to plain balloon angioplasty is associated with superior efficacy without trade-off in safety, regardless of diabetes.

Safety and Efficacy of Modern Stents in Patients with Metabolic Syndrome

The impact of metabolic syndrome (MS) on stent performance and outcomes of patients underwent percutaneous coronary intervention (PCI), including stent implantation, had not yet been fully established. The aim of the present study was to investigate long-term safety and efficacy of 2nd generation DES vs. other stent types in MS patients underwent successful PCI for an acute coronary event. Descriptive epidemiology, angiographic characteristics and one-year clinical outcomes, including major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) procedures were evaluated according to the stent type inserted for 204 patients. The occurrence of TLR (6.62% vs. 9.43%, p = 0.50) and the composite outcomes (20.52% vs. 24.52%, p = 0.54) did not differ significantly between patients having 2nd generation drug eluting stents (DES) or other stent types implanted at the index procedure. It seems that the PCI in acute coronary syndrome (ACS) is similarly efficient regardless of the stent type, suggesting that for the treatment of ACS in MS patients, all stent types show similar results, in terms of TLR or MACE.

Benefits with drug-coated balloon as compared to a conventional revascularization strategy for the treatment of coronary and non-coronary arterial disease: a comprehensive meta-analysis of 45 randomized trials

BackgroundDrug-coated balloons (DCB) have shown promising results for the percutaneous treatment of de novo and restenotic lesions, involving both the coronary and femoropopliteal district. However, clinical outcomes data associated with the use of this devices are still unclear, with potential warnings on increased mortality being raised from initial studies.We aimed at performing an updated and comprehensive meta-analysis comparing DCB with conventional percutaneous revascularization strategies for the treatment of coronary (CAD) or peripheral artery disease (PAD). MethodsLiterature and main scientific session abstracts were searched for studies comparing DCB vs a standard percutaneous revascularization strategy, with or without stenting, for the treatment of CAD and PAD. The primary efficacy endpoint was mortality. Secondary endpoints were recurrent acute ischemic events (myocardial infarction or amputation) or target lesion revascularization (TLR). ResultsWe included 45 randomized trials, (CAD: 27 studies, PAD: 18 studies) with an overall population of 7718 patients, (56.4%) randomized to a DCB strategy. At a mean follow-up of19.3 ± 15.2 months, death occurred in 5.8% of the patients, with no significant difference between DCB or conventionally treated patients (5.9% vs 5.7%, OR[95%CI] = 0.89[0.71,1.11], p = 0.31; phet = 0.43). We observed a non-significant reduction in recurrent acute ischemic events, whereas the use of DCB significantly reduced the rate of TLR, with larger benefits observed in patients with PAD and respect to balloon-only angioplasty, while being lower in comparison with stent implantation. No significant interaction was observed with de novo lesions or in-stent restenosis. ConclusionsBased on the current meta-analysis, the use of drug-coated balloons for the percutaneous treatment of CAD and PAD is associated to a comparable risk of mortality and recurrent acute ischemic events as compared to a conventional revascularization strategy, although offering larger benefits in terms of TLR, especially when compared with balloon-only angioplasty and in femoropopliteal disease.

10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction

BackgroundOutcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. ObjectivesThe aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial. MethodsThe EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis. ResultsComplete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years. ConclusionsAt 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315)

Comparison of coronary bifurcation lesions stenting techniques- a network meta-analysis

Abstract Background Coronary bifurcations lesions (CBL) are account for 15–20% of all percutaneous coronary interventions (PCI) and constitute a major challenge for interventionists in terms of procedural success rate and long-term cardiac events. Based on data from multiple randomized trials and registries, current guidelines advocate the use of provisional side branch (SB) stenting strategy for the majority of CBL's. However, for true or complex CBL's (long side branches lesions, difficult side branches access or high risk of side branches compromise), which account for up to 25% of CBL's, this strategy may by unsafe and ineffective due to a potential risk of intraprocedural or long-term occlusion of a significant side branch and a two-stenting technique may be needed in order to achieve optimal results. Up to date, the optimal two- stenting technic for CBL remains in debate. Accordingly, our aim was to compare different stenting techniques in coronary bifurcation lesions. Methods We performed a MEDLINE search for randomized controlled trials (RCT) and observational studies comparing stenting techniques in CBL's with reported clinical outcomes. Mixed treatment comparison model generation was performed to directly and indirectly compare culotte, T and protrusion (TAP), crush and provisional techniques Results A total of 13 RCT and 12 observational studies were identified including 6806 patients, among whom 1,201 were treated with cullotte, 2,731 with crush, 797 with TAP and 2077 with provisional stenting. The Bayesian hierarchical random-effects model demonstrated a significant reduction in target lesion revascularization (TLR) rate with crush techniques compared with provisional technique (OR 0.64 95% CI 0.42–0.97) along with a trend for reduction in major adverse cardiovascular (MACE) events (OR 0.75, 95% CI 0.55–1.02). TAP and culotte techniques did not show similar results. Equality of other endpoints, including mortality, myocardial infarction and re-stenosis was found between all CBL's techniques (Figure 1). Discussion Our findings suggest improved outcomes with crush technique compared to other double stenting techniques in terms of TLR with a trend towards MACE reduction. Further research is required to determine the optimal stenting technique for coronary bifurcations lesions along with the utility of imaging and physiology in this complex subset. Figure 1. Comparison of double stentin techniques Funding Acknowledgement Type of funding source: None

Comparative Effectiveness of Endovascular Treatment Modalities for De Novo Femoropopliteal Lesions: A Network Meta-analysis of Randomized Controlled Trials

Purpose: To report the results of a network meta-analysis of randomized controlled trials (RCTs) comparing multiple endovascular treatments for de novo femoropopliteal lesions. Materials and Methods: The MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases were systematically searched on June 1, 2019, for prospective RCTs comparing 14 treatments [ie, atherectomy, brachytherapy, cryoplasty, cutting balloons, drug-coated balloons, bare nitinol stents, drug-eluting stents (DES), covered stents (CS), and combinations] in the treatment of de novo femoropopliteal lesions. Outcomes were technical success; binary restenosis and target lesion revascularization (TLR) at 6, 12, and/or 24 months; and all-cause mortality at 12 months. Ultimately, 53 articles reporting on 45 studies (91 study arms; 5565 patients) were selected. For the technical success outcome, all types of stents, all balloons, and all atherectomy devices were aggregated in stent, balloon, and atherectomy technology groups, respectively. Results: In terms of technical success for aggregated treatment types, stent technology was the most effective treatment and was better than balloon and atherectomy technologies. In terms of binary restenosis, DES was the most effective single treatment at the 6- and 12-month follow-up and CS at the 24-month follow-up. Both DES and CS were better than the majority of other single treatments, including balloon angioplasty, cutting balloon, cryoplasty, directional atherectomy, and bare nitinol stent during all follow-up periods. In terms of TLR, DES was the second most effective single treatment and the most effective single treatment at the 6- and 12-month follow-up intervals; CS was the most effective single treatment at the 24-month follow-up. Both DES and CS were better than the majority of other single treatments. The 12-month all-cause mortality of both DES and CS were similar to other treatments, whereas cryoplasty seemed to be the least effective treatment with regard to binary restenosis and TLR. Conclusion: Both DES and CS had substantial advantages in terms of restenosis and TLR in femoropopliteal lesions and were similar to aggregate stent technology in terms of technical success. DES performed better within 12 months after operation and CS at ~24 months, but neither had much advantage in terms of mortality. In contrast, cryoplasty seemed to be a less effective treatment.

Outcomes of Drug-Coated Balloon Angioplasty vs. Conventional Balloon Angioplasty for Endovascular Treatment of Common Femoral Artery Atherosclerotic Disease

BackgroundAtherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment. MethodsIn this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up. ResultsThis real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46–3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36–2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26–1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09–18.85; p = .04). ConclusionsBoth DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease.

Turbo-Power™ Laser Atherectomy Combined with Drug-coated Balloon Angioplasty is Associated with Improved One-Year Outcomes for the Treatment of Tosaka II and III Femoropopliteal In-stent Restenosis

BackgroundFemoropopliteal (FP) artery in-stent restenosis (ISR) is associated with high rates of re-intervention and occlusion. The combined use of laser atherectomy (LA) with balloon angioplasty (BA) is superior to conventional balloon angioplasty (BA). Drug-coated balloons (DCBs) when combined with LA have provided additional efficacy for the treatment of FP-ISR. The aim of this study was to investigate the combination of DCB + LA with the recently approved Turbo-Power™ (Spectranetics Inc., Colorado Springs, CO, USA) LA device. MethodsThis was a dual-center retrospective study enrolling 78 consecutive patients with Tosaka type II (n = 18) or III (n = 60) FP-ISR. The lesions were treated with either Turbo-Power™ LA followed by DCB (n = 27) or with other LA devices followed by plain BA (LA + BA; n = 51) from 2015 to 2017. A Cox regression analysis was performed to examine the association between the two groups in terms of target lesion revascularization (TLR) and occlusion rates over a follow up period of 12 months. Kaplan-Meier survival curves were estimated and compared with the log-rank test. ResultsThe overall procedural success was 90%. Eight periprocedural complications occurred without any difference between the two groups (Turbo-Power™ + DCB: 7.4% vs LA + BA: 11.8%, p = .7). The 12-month KM estimates for freedom from TLR were 90.9% in the Turbo-Power™ + DCB group vs 55.7% in the LA + BA group (p = .005). Among Toasaka III lesions, the 12 m-KM survival estimates for freedom from TLR were 88.9% in the Turbo-Power™ + DCB group vs 54.2% in the LA + BA group (p = .009). The 12 m-KM estimates for freedom from re-occlusion were 89.0% in the Turbo-Power™ + DCB group vs 58.9% in the LA + BA group (p = .070). ConclusionsTurbo-Power™ laser atherectomy combined with DCB exerted synergistic mechanism of actions and improved 12-month TLR rates for the treatment of complex FP-ISR lesions.

Angioplasty or bare metal stent versus drug-eluting endovascular treatment in femoropopliteal artery disease: a systematic review and meta-analysis

Endovascular treatment represents nowadays the preferred therapeutic approach for disabling femoro-popliteal arterial occlusive disease in fit patients. In the latest years, in order to improve short- and long-term outcomes, drug eluting devices have been developed. Drug coated balloons (DCB) and drug eluting stents (DES) are today employed in clinical practice, and several studies has been completed to assess their performance in different clinical scenarios. Objective of the present review and meta-analysis is to compare clinical results of different endovascular treatment modalities in the published literature in the last 10 years. A systematic review and meta-analysis following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement on the literature regarding direct comparisons between DCB, DES, bare metal stents (BMS) and Plain Old Balloon Angioplasty (POBA) has been conducted. Primary outcomes were considered Primary Patency and Target Lesion Revascularization (TLR) at 12 months. Analysis of late survival in different treatment groups was outside the scope of the present study and was therefore not included as main end point. Meta analysis results confirm that DCB outperforms POBA in both primary patency (estimate OR=3.17, 95% CI: 2.10-4.76) and TLR (POBA estimate OR=3.59, 95% CI= 2.31-5.56). No clear evidences emerged comparing DES and BMS; however, DES were shown to fare better than BMS in terms of TLR when analyzing lesions <15 cm (OR 0.36, 95% CI: 0.35-0.36). Comparison of DCB and DES revealed higher rates of TLR for DES (OR 1.26 95% CI: 1.07-1.49), however no significant differences have been found regarding primary patency analyzing such long lesions (range 14-19.4 cm) as those included in the studies. While confirming that DCB outperforms POBA in terms of primary patency and TLR at 12 months, only TLR benefits are noted for DES vs. BMS and DCB vs. DES in limited clinical settings. Further RCTs are needed to strongly assess the compared performance of drug eluting devices in relation to lesion length and controlling possible confounders.

One-year clinical performance of ABSORB bioresorbable vascular scaffold in patients presenting with acute coronary syndromes: Results from the RAI registry.

To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.

Drug-Eluting Balloon versus New-Generation Drug-Eluting Stent for the Treatment of In-Stent Restenosis: An Updated Systematic Review and Meta-Analysis.

Background:Currently, drug-eluting balloon (DEB) appears to be an attractive alternative option for the treatment of in-stent restenosis (ISR). Nevertheless, the clinical outcomes of DEB have seldom been compared to those of new-generation drug-eluting stent (DES). Thus, this meta-analysis aimed to evaluate the safety and efficacy of DEB compared to those of new-generation DES in the treatment of ISR.Methods:A comprehensive search of electronic databases including PubMed, EMBASE, and Cochrane Library up to November 2, 2017 was performed to identify pertinent articles comparing DEB to new-generation DES for the treatment of ISR. In addition, conference proceedings for the scientific sessions of the American College of Cardiology, American Heart Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, and EuroPCR were also searched. The primary endpoint was target lesion revascularization (TLR) at the longest follow-up. Dichotomous variables were presented as risk ratios (RR s) with 95% confidence intervals (CIs), while the overall RRs were estimated using the Mantel-Haenszel random-effects model.Results:Five randomized controlled trials (RCTs) and eight observational studies involving 2743 patients were included in the present meta-analysis. Overall, DEB was comparable to new-generation DES in terms of TLR (RR = 1.24, 95% CI: 0.89–1.72, P = 0.21), cardiac death (RR = 1.55, 95% CI: 0.89–2.71, P = 0.12), major adverse cardiovascular event (RR = 1.21, 95% CI: 0.98–1.48, P = 0.07), myocardial infarction (RR = 1.12, 95% CI: 0.72–1.76, P = 0.62), and stent thrombosis (RR = 0.95, 95% CI: 0.38–2.42, P = 0.92). However, DEB was associated with higher risk of all-cause mortality than new-generation DES (RR = 1.65, 95% CI: 1.09–2.50, P = 0.02). This was especially true in the real-world observational studies (RR = 1.79, 95% CI: 1.12–2.88, P = 0.02). In RCTs, however, no significant difference was found between the two treatment strategies in the risk of all-cause mortality.Conclusions:The current meta-analysis showed that DEB and new-generation DES had comparable safety and efficacy for the treatment of ISR in RCTs. However, treatment with DEB was associated with higher risk of all-cause mortality in the real-world nonrandomized studies.

One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients: Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTre rEgistry)

BackgroundDespite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a “real-world” multicenter-independent cohort of patients. Methods1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. Results1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p<0.001) and dyslipidemia (p<0.001) and more frequently dialyzed (p=0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p=0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p=0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. ConclusionsThe results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.

Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries

Purpose: To report the 3-year safety and effectiveness outcomes from the prospective all-comers DEBATE-ISR study (ClinicalTrials.gov identifier NCT01558531) of symptomatic diabetic patients with femoropopliteal in-stent restenosis (ISR) undergoing treatment with paclitaxel-eluting balloons compared with historical diabetic controls. Methods: From January 2010 to December 2011, 44 consecutive diabetic patients (mean age 74±11 years; 32 men) were treated with drug-eluting balloons (DEBs) and enrolled in the study. The control group comprised 42 consecutive diabetic patients (age 76±7 years; 23 men) treated with conventional balloon angioplasty (BA) from 2008 to 2009. Results: No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Critical limb ischemia was present in the majority of patients. Tosaka class III ISR was observed in more than half of the patients. Mean lesion length was 132±86 and 137±82 mm in the DEB and BA groups, respectively (p=0.7). At 3-year follow-up, the rate of target lesion revascularization (TLR) was 40% in the DEB group vs 43% in the BA group (p=0.8); Kaplan-Meier analysis showed no significant differences in terms of freedom from TLR. The presence of a Tosaka class III occlusion was associated with a worse outcome in both study groups (odds ratio 3.96, 95% confidence interval 1.55 to 10.1, p=0.004). Conclusion: Using DEBs for femoropopliteal ISR yielded similar results to BA in terms of TLR at 3-year follow-up. The treatment of more complex ISR lesions was associated with an increased rate of TLR, irrespective of the technology used.

Comparison among drug-eluting balloon, drug-eluting stent, and plain balloon angioplasty for the treatment of in-stent restenosis: a network meta-analysis of 11 randomized, controlled trials.

A Bayesian network meta-analysis was performed comparing the efficacy and safety of drug-eluting balloons (DEB), drug-eluting stents (DES), or plain old balloon angioplasty (POBA) for treatment of in-stent restenosis (ISR). Optimal treatment options for ISR have not been well established. Randomized, controlled trials comparing DEB, DES, and POBA for the treatment of ISR after percutaneous coronary intervention with bare metal stent or DES were included. The primary outcome was target lesion revascularization (TLR). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR: 0.22, 95% CrI: 0.10 to 0.42) or DES (OR: 0.24, 95% CrI: 0.11 to 0.47) than in those treated with POBA in a random-effects model. In a comparison of DEB and DES, the risk of TLR (OR: 0.92, 95% CrI: 0.43 to 1.90) was similar. The risk of MI or all-cause mortality was lowest in the DEB group compared with the DES and POBA groups, which did not meet statistical significance. The risk of major adverse cardiac events, which was mainly driven by TLR, was also significantly lower in the DEB or and DES group (OR: 0.28, 95% CrI: 0.14 to 0.53) than in the POBA group, but it was similar between the DEB and DES groups (OR: 0.84, 95% CrI: 0.45 to 1.50). The probability of being ranked as the best treatment was 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas it was 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Local drug delivery by DEB or DES for ISR lesions was markedly better than POBA in preventing TLR, but not for MI or mortality. Among the 2 different strategies of drug delivery for ISR lesions, treatment with DEB showed a trend of less development of MI than did treatment with DES.

Abstract 11277: Comparison Among Drug-Eluting Balloon, Drug-Eluting Stent, and Plain Balloon Angioplasty for Treatment of In-Stent Restenosis: A Network Meta-Analysis of 11 Randomized Controlled Trials

Objective: The optimal treatment option for in-stent restenosis (ISR) is not established. We performed a Bayesian network meta-analysis comparing the efficacy and safety of drug-eluting balloon (DEB), drug-eluting stent (DES) or plain old balloon angioplasty (POBA) for treatment of ISR. Design: Systemic review and Bayesian network meta-analysis using random-effects model. The primary outcome was target lesion revascularization (TLR). The secondary outcomes were myocardial infarction (MI), all-cause mortality or major adverse cardiovascular events (MACE). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. Data Sources: PubMed, EMBASE, BioMed Central, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings through February 2014. Eligibility Criteria for Selecting Studies: Randomized controlled trials (RCTs) comparing DEB, DES, or POBA for treatment of ISR. Results: This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR 0.22, 95% CrI 0.10-0.42) or DES (OR 0.24, 95% CrI 0.11-0.47) than in those treated with POBA. The risk of TLR (OR 0.92, 95% CrI 0.43-1.90) was similar between DEB and DES. The risk of MI or all-cause mortality was lowest in the DEB group compared with DES or POBA, which did not meet statistical significance. The risk of MACE was significantly lower in DEB (OR 0.24, 95% CrI 0.12-0.39) or DES (OR 0.28, 95% CrI 0.14-0.53) than in POBA, but it was similar between DEB and DES group (OR 0.84, 95% CrI 0.45-1.50). The probability to be ranked as the best treatment were 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas, 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Conclusions: DEB or DES was markedly better than POBA in preventing TLR, but not for MI or mortality in treatment of ISR. DEB resulted in less MI than DES without statistical significance.

TCT-270 Comparison Among Drug-eluting Balloon, Drug-eluting Stent, and Plain Balloon Angioplasty for Treatment of In-Stent Restenosis: A Network Meta-analysis of 11 Randomized Controlled Trials

Objective: The optimal treatment option for in-stent restenosis (ISR) is not established. We performed a Bayesian network meta-analysis comparing the efficacy and safety of drug-eluting balloon (DEB), drug-eluting stent (DES) or plain old balloon angioplasty (POBA) for treatment of ISR. Design: Systemic review and Bayesian network meta-analysis using random-effects model. The primary outcome was target lesion revascularization (TLR). The secondary outcomes were myocardial infarction (MI), all-cause mortality or major adverse cardiovascular events (MACE). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. Data Sources: PubMed, EMBASE, BioMed Central, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings through February 2014. Eligibility Criteria for Selecting Studies: Randomized controlled trials (RCTs) comparing DEB, DES, or POBA for treatment of ISR. Results: This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR 0.22, 95% CrI 0.10-0.42) or DES (OR 0.24, 95% CrI 0.11-0.47) than in those treated with POBA. The risk of TLR (OR 0.92, 95% CrI 0.43-1.90) was similar between DEB and DES. The risk of MI or all-cause mortality was lowest in the DEB group compared with DES or POBA, which did not meet statistical significance. The risk of MACE was significantly lower in DEB (OR 0.24, 95% CrI 0.12-0.39) or DES (OR 0.28, 95% CrI 0.14-0.53) than in POBA, but it was similar between DEB and DES group (OR 0.84, 95% CrI 0.45-1.50). The probability to be ranked as the best treatment were 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas, 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Conclusions: DEB or DES was markedly better than POBA in preventing TLR, but not for MI or mortality in treatment of ISR. DEB resulted in less MI than DES without statistical significance.