In-segment Restenosis Research Articles

Safety and efficacy of everolimus-eluting bioresorbable vascular scaffold for cardiac allograft vasculopathy (CART).

Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of failure. This study aimed to investigate the safety and efficacy of bioresorbable scaffolds (BRSs) as potential novel therapeutic tool for the treatment of coronary stenoses in CAV. This is a multicenter, single-arm, prospective, open-label study (CART, NCT02377648), that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS (Abbott Vascular). The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the incidence of major adverse cardiac events (MACEs) at 12- and 36-month follow-up and the incidence of ISSR at 36months. A paired intracoronary imaging analysis at baseline and follow-up was also performed. Between 2015 and 2017 35 HTx patients were enrolled and treated for 44 coronary lesions with 51 BRSs. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3years of 16.2% (6/37). Angiographic lumen loss was 0.40 ± 0.62mm at 12months and 0.53 ± 0.57mm at 36months. Overall survival rate was 91.4% and 74.3%, and MACEs incidence 14.2% and 31.4% at 12 and 36months, respectively. At the paired intracoronary imaging analysis, a significant increase of the vessel external elastic membrane area in the treated segment and some progression of CAV proximally to the BRS were detected. BRS-based PCI for the treatment of CAV is feasible and safe, with an ISSR incidence similar to what reported in retrospective studies with drug-eluting stents.

Clinical and angiographic outcomes following percutaneous treatment of non-occlusive vs. chronically total occluded coronary lesions

Abstract Background Recent advancements in recanalization techniques, introduction of dedicated equipment and elaboration of systematic algorithmic approaches have significantly improved procedural success of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures. However, despite their undisputable merits in terms of procedural success, direct comparisons of mid-term clinical and angiographic outcomes following CTO and non-CTO-PCI are missing. Purpose The aim of this study was to assess the clinical and angiographic outcomes of patients undergoing successful CTO-PCI as compared to a propensity matched cohort of patients undergoing PCI of non-occlusive coronary lesions. Methods All consecutive patients undergoing successful CTO recanalization procedures at our center between 2015 and 2018 were included (N=453; 472 lesions). For matching purposes, all patients undergoing non-CTO-PCI present in our database were included (N=14733; 23458 lesions). A 1-to-1 nearest neighbour matching using baseline clinical and angiographic variables was performed to identify one patient undergoing non-CTO-PCI (N=453; 472 vessels) for each patient undergoing CTO-PCI (N=453; 472 vessels). Surveillance angiography was scheduled at 6–9 months and clinical follow-up was performed up to 12 months. The primary clinical endpoint of interest was the incidence of major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). The secondary angiographic endpoint was in-segment binary restenosis. Results Patients undergoing CTO-PCI displayed a tendency towards higher degrees of binary restenosis at surveillance angiography as compared to those undergoing non-CTO-PCI (CTO vs. non-CTO: 30.5% vs. 24.0%; P=0.058), despite not meeting statistical significance. Of note, the incidence of occlusive restenosis was low and comparable between groups (2.2% vs. 1.4%; P=0.603). At 12 months follow-up, MACE occurred in 83 patients (19.7%) in the CTO-PCI and 59 patients (14.1%) in the non-CTO-PCI group (hazard ratio [HR] = 1.44; 95% confidence interval [CI]: 1.03–2.01; P=0.033). TLR rates were significantly higher following CTO- as compared to non-CTO-PCI (17.2% vs. 10.3%; HR=1.72 [1.18–2.51], P=0.005). The incidence of all-cause death (2.6% vs. 3.3%; P=0.548) and MI (0.5% vs. 1.4%; P=0.177) was not significantly different between the groups. Conclusion In this large, propensity-matched comparison of clinical and angiographic outcomes following CTO- vs. non-CTO-PCI, we found CTO-PCI to be associated with a higher MACE rate at 12 months, primarily driven by significantly higher TLR rates. The incidence of occlusive restenosis was low and comparable between groups. Funding Acknowledgement Type of funding sources: None.

Everolimus-eluting bioresorabable scaffold system in the treatment of cardiac allograft vasculopathy: the cardiac allograft reparative therapy (CART) prospective multicentre pilot study

Abstract Background Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of PCI failure. The bioresorbable scaffolds (BRS) could represent a potential novel therapeutic tool for the treatment of coronary obstructions in CAV. Purpose To investigates the effects of BRS implantation in CAV patients in a Nationwide prospective study. Methods Multicentre, single-arm, prospective, open-label study that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS. The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the composite of cardiac death, myocardial infarction, and target lesion revascularisation at 12-and 36-month follow-up and the incidence of ISSR at 36 months. A paired analysis of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at baseline and follow-up was also performed. Results Between 2015–2017 35 HTx patients were enrolled and treated on 44 coronary lesions with 51 BRS. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3 years of 16.2% (6/37).Angiographic lumen loss was 0.40±0.62mm at 12 months and 0.53±0.57mm at 36 months. Overall survival was 91.4% and 74.3%, and MACEs 14.2% and 31.4% at 12 and 36 months, respectively. At the paired intracoronary imaging analysis a significant increase of the vessel external elastic membrane area in the treated segment of the BRS was described at the OCT, while some progression of CAV was detected proximally at the IVUS assessment. Conclusions BRS in CAV was feasible and safe, with an ISSR incidence similar to drug-eluting stents. For the first time, a positive remodeling was observed in HTx patients after PCI. Vessel enlargement and the lack of metallic stents may allow repeated PCI avoiding the vessel shrinkage caused by the addition of multiple metal layers, being CAV a complex clinical scenario with a high incidence of MACEs, mainly driven by PCI failure. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Partial funding by Abbott Vascular Italy

Clinical and angiographic outcomes of crossing techniques for coronary chronic total occlusions: the ISAR-CTO registry.

Clinical and angiographic outcomes following recanalisation of coronary chronic total occlusions (CTO) through contemporary dissection and re-entry techniques (DART) as opposed to intraplaque techniques remain controversial. The aim of this study was to compare clinical and angiographic outcomes following subintimal and intraplaque CTO recanalisation. A total of 454 consecutive patients undergoing successful CTO recanalisation (473 vessels) were included. Intraplaque techniques were used in 403 (85.2%) and DART in 70 (14.8%) vessels. Surveillance angiography was scheduled at 6-9 months and clinical follow-up was performed up to 12 months. There were no significant differences in terms of the cumulative incidence of MACE (p=0.908) or binary restenosis (p=0.320) between the two groups. There was no independent correlation between recanalisation technique and MACE occurrence or in-segment binary restenosis. Target lesion revascularisation (TLR) was performed in 60 (17.5%) and 12 (18.1%) (p=0.719) lesions, respectively. The occurrence of occlusive restenosis was low (7 [2.3%] vs 1 [1.6%]; p=0.824) and comparable between groups. Contemporary DART are associated with similar midterm clinical and angiographic outcomes compared to intraplaque recanalisation. The rate of occlusive restenosis was low and comparable in both groups. Regardless of recanalisation technique, the overall incidences of binary restenosis and TLR following CTO recanalisation remain higher than those reported for non-CTO PCI.

Efficacy and safety of drug-eluting balloon-only strategy (DEB-only) for de novo coronary artery disease: a systematic review and meta-analysis

Abstract Background Many clinical trials have demonstrated the value of drug-eluting balloon (DEB) for in-stent restenosis. Recently, DEB for de novo lesions has also attracted more attention. There have been promising results of PCI using DEB alone in selected de novo coronary diseases (small vessels, bifurcating lesions, acute myocardial infarction). However, the application of DEB for patients with de novo coronary artery disease remains controversial due to relatively limited evidence. Purpose The purpose of this study was to evaluate the efficacy and safety DEB-only strategy (bail-out stents were allowed when required) compared with other modalities for the treatment of de novo coronary lesions. Methods We searched PubMed, Embase, Web of Science and Cochrane Library Central Register of Controlled Trials (CENTRAL) electronic databases for randomized controlled trials as well as observational studies published up to Jan 22, 2020. Studies which compared DEB-only approach with other PCI strategies for treatment of any type of de novo coronary lesions were identified. The primary outcome was late lumen loss (LLL) during angiographic follow up. The secondary outcomes were major adverse cardiac events (MACE), target lesion revascularisation (TLR) and binary in-segment restenosis. Results Nineteen studies (eleven randomised controlled trials and eight observational studies) with a total of 3,356 patients were included in this meta-analysis. Angiographic observations were obtained at 6 or 9 months and clinical follow-up duration ranged from 6 months to 36 months. Among the overall studies, the results indicated that DEB-only strategy was superior to the control groups for LLL (mean difference (MD) = −0.30mm; 95% confidence interval (CI), −0.41 to −0.19; P<0.001). DEBs were associated with a similar risk of MACE (risk ratio (RR): 0.84, 95% CI: 0.64, 1.11, P=0.22), TLR (RR: 0.79, 95% CI: 0.53, 1.16, P=0.23) and binary restenosis (RR: 0.68, 95% CI: 0.35, 1.31, P=0.25) compared with the control groups. In subgroup analysis, DEB-only strategy showed significantly better outcomes for most endpoints compared to POBA. Compared with DES, there were also significant favorable effects associated with treatment of DEB-only on LLL (MD: −0.14, 95% CI: −0.23, −0.04, P=0.005), while insignificant inter-strategy differences were observed in other endpoints. Vessel diameter did not have a significant influence on the result. Conclusion DEB-only intervention is an effective treatment associated with a significant reduction in late loss late lumen loss compared to other options. The efficacy and safety of DEB alone are comparable to those of DES and superior to POBA for treatment of selected de novo coronary lesions. Additional evidence is still warranted to confirm value of DEB before a widespread clinical utilization can be recommended. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Beijing Lab for Cardiovascular Precision Medicine

Drug-Coated balloons vs drug-eluting stents for the treatment of small coronary artery disease: A meta-analysis of randomized trials.

There is conflicting evidence about the effects of drug-coated balloons (DCB) compared with drug-eluting stents (DES) in patients with native small vessel coronary artery disease (CAD). The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases and main international conference proceedings were searched for randomized controlled trials (RCT) comparing DCB versus DES in patients with native small vessel CAD. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was target vessel revascularization (TVR). Secondary clinical endpoints were: myocardial infarction (MI), target lesion revascularization (TLR), all-cause death, cardiac death, and stent thrombosis or target vessel thrombosis. Secondary angiographic outcomes were: in-segment restenosis, in-segment percentage-diameter stenosis, in-segment late lumen loss, in-segment net luminal gain, and in-segment minimal lumen diameter. Five trials enrolling 1,459 patients were included. Mean clinical follow-up was 10.2months. The use of DCB, compared with DES, was associated with similar risk of TVR (odds ratio [OR]: 0.97; 95% confidence interval [CI] 0.56 to 1.68; p=.92), TLR (OR: 1.74; 95% CI: 0.57 to 5.28; p=.33), all-cause death (OR: 1.03; 95% CI: 0.14 to 7.48; p=.98), with a trend toward a lower risk of MI (OR: 0.49; 95% CI: 0.23 to 1.03; p=.06), and with significant lower risk of vessel thrombosis (OR: 0.12; 95% CI: 0.01 to 0.94; p=.04). DCB use was associated with similar risk of angiographic restenosis (OR: 1.12; 95% CI 0.69 to 1.84; p=.64), comparable late luminal loss (standardized mean difference (SMD): -0.18; 95% CI: -0.39 to 0.03; p=.09), while leading to significant higher percentage diameter stenosis (SMD: 0.27; 95% CI 0.12 to 0.41; p < .01) and smaller minimal luminal diameter (SMD: -0.52; 95% CI: -0.86 to -0.18; p=.003). Compared with DES, the use of DCB for the treatment of native small vessel CAD is associated with similar TVR and restenosis and reduces the risk of vessel thrombosis, although DES implantation yields slightly better angiographic surrogate endpoints.

Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year-Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS).

Aim Optimal revascularization strategy in multivessel (MV) coronary artery disease (CAD) eligible for percutaneous management (PCI) and surgery remains unresolved. We evaluated, in a randomized clinical trial, residual myocardial ischemia (RI) and clinical outcomes of MV-CAD revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR), or MV-PCI. Methods Consecutive MV-CAD patients (n = 155) were randomized (1 : 1 : 1) to conventional CABG (LIMA-LAD plus venous grafts) or HCR (MIDCAB LIMA-LAD followed by PCI for remaining vessels) or MV-PCI (everolimus-eluting CoCr stents) under Heart Team agreement on equal technical and clinical feasibility of each strategy. SPECT at 12 months (primary endpoint of RI that the trial was powered for; a measure of revascularization midterm efficacy and an independent predictor of long-term prognosis) preceded routine angiographic control. Results Data are given, respectively, for the CABG, HCR, and MV-PCI arms. Incomplete revascularization rate was 8.0% vs. 7.7% vs. 5.7% (p=0.71). Hospital stay was 13.8 vs. 13.5 vs. 4.5 days (p < 0.001), and sick-leave duration was 23 vs. 16 vs. 8 weeks (p < 0.001). At 12 months, RI was 5 (2, 9)% vs. 5 (3, 7)% vs. 6 (3, 10)% (median; Q1, Q3) with noninferiority p values of 0.0006 (HCR vs. CABG) and 0.016 (MV-PCI vs. CABG). Rates of angiographic graft stenosis/occlusion or in-segment restenosis were 20.4% vs. 8.2% vs. 5.9% (p=0.05). Clinical target vessel/graft failure occurred in 12.0% vs. 11.5% vs. 11.3% (p=0.62). Major adverse cardiac and cerebral event (MACCE) rate was similar (12% vs. 13.4% vs. 13.2%; p=0.83). Conclusion In this first randomized controlled study comparing CABG, HCR, and MV-PCI, residual myocardial ischemia and MACCE were similar at 12 months. There was no midterm indication of any added value of HCR. Hospital stay and sick-leave duration were shortest with MV-PCI. While longer-term follow-up is warranted, these findings may impact patient and physician choices and healthcare resources utilization. This trial is registered with NCT01699048.

Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold.

Background A novel bioresorbable scaffold, the sirolimus-eluting Fantom, incorporates a radiopaque polymer, struts with a thickness of 125 µm, and a crossing profile of 1.35 mm. The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the FANTOM scaffold in a larger patient population. Methods and Results The FANTOM II study (Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold - First Report on Initial 24 Month Outcomes) was a prospective, multicenter trial which enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length ≤20 mm. Major adverse cardiac events through 12-month follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n=117) and 9 months (n=123). Acute delivery success, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235/240), 95.8% (230/240), 99.1% (228/230), and 99.6% (227/228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25±0.40 mm and 0.33±0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Major adverse cardiac events and target lesion failure through 12 months occurred in 4.2% of 240 patients; scaffold thrombosis developed in only one patient (0.4%). Conclusions The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness performance at 12-month follow-up. Longer-term follow-up is ongoing to examine the late outcomes with this novel device. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02539966.

Comparison of Resolute zotarolimus-eluting and Xience everolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES VI trial.

Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions. This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.

Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.

We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

Mid-term Results of a Novel Dedicated Venous Stent for the Treatment of Chronic Thoracic Central Vein Obstruction of Benign Aetiology

Endovascular treatment is indicated for the treatment of symptomatic thoracic central vein obstruction (TCVO) but is limited by high rates of restenosis and the need for re-intervention. The aim was to assess the safety and mid-term patency of a novel dedicated venous stent for the treatment of TCVO of benign aetiology. This was a prospective single centre observational study of 20 patients (median age 65 years, 50% male) referred for the treatment of symptomatic chronic (>three months duration) TCVO between May 2016 and January 2018. Balloon angioplasty with implantation of a self expanding nitinol stent (Vici, Boston Scientific, Marlborough, MA, USA) was performed in all patients. Clinical records including demographics, aetiologies and types of TCVO, and procedural details were recorded. Patients were followed up clinically at one, six, and 12 months. Primary and assisted primary patency were reported. All 20 lesions were total occlusions, of which 55% (n=11) were de novo, 10% (n=2) peri-stent restenosis, and 35% (n=7) in-stent re-occlusion. The aetiology of TCVO was predominantly (95%) because of multiple or prolonged central venous line insertion. The procedural success rate was 90% (18/20) with no procedural complications. The median follow up was 13.5 months. Primary patency was 100% at 6 months. One patient required re-intervention for stent in segment restenosis at 7 months. The assisted primary patency rate was 100% at 12 months. Endovascular treatment of benign TCVO with the novel dedicated venous stent was safe and effective in relieving obstructive symptoms with excellent one year patency rates.

Effects of Cilostazol-Based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy After Coronary Drug-Eluting Stent Implantation: An Updated Meta-Analysis of the Randomized Controlled Trials.

The results of studies on cilostazol-based triple antiplatelet therapy (TAT) after drug-eluting stent (DES) implantation were inconsistent. To assess the effects of TAT compared with dual antiplatelet therapy (DAT) after DES/second-generation DES implantation, we performed a meta-analysis of randomized controlled trials (RCTs). All relevant studies evaluated were identified by searching thePubMed, EMBASE, Cochrane Library, and ISI Web of Sciencedatabases without time and language limitation. Subgroup analyses were performed to evaluate the efficacy and safety of TAT after second-generation DES implantation. Eleven RCTs involving a total of 4684 patients were included. The meta-analysis showed TAT was associated with significant beneficial effects on angiographic findings of in-stent restenosis [risk ratio (RR) 0.645, 95% confidence interval (CI) 0.470-0.885; P = 0.007], in-segment restenosis (RR 0.606, 95% CI 0.450-0.817; P = 0.001), in-stent late loss (RR - 0.095, 95% CI - 0.136 to - 0.054; P < 0.0001), in-segment late loss (RR - 0.100, 95% CI - 0.139 to - 0.061; P < 0.0001), target lesion revascularization (TLR) (RR 0.570, 95% CI 0.430-0.755; P < 0.0001), and target vessel revascularization (TVR) (RR 0.523, 95% CI 0.380-0.719; P < 0.0001). No significant difference was found in outcomes of all-cause death, cardiac death, definite/probable stent thrombosis (ST), non-fatal myocardial infarction (MI), overall bleeding, and major bleeding between the two groups, as well as some minor adverse effects including palpitations, thrombocytopenia, neutropenia, and hepatic dysfunction. However, the incidence rate of rash, gastrointestinal disorders, and headache was significantly higher in TAT. The second-generation DES subgroup showed similar results, except for the indicators of all-cause death (RR 2.161, 95% CI 1.007-4.635; P = 0.048) and hepatic dysfunction (RR 0.176, 95% CI 0.031-0.995; P = 0.049). Compared with DAT, cilostazol-based TAT can significantly improve the angiographic findings of in-stent and in-segment late loss, in-stent and in-segment restenosis, TLR, and TVR after DES/second-generation DES implantation. However, no benefits were observed in outcomes of all-cause death, cardiac death, ST, and MI.

A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study

BackgroundThe comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner.ObjectivesThe SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DP-SES) in women undergoing percutaneous coronary intervention (PCI).MethodsA total of 455 female patients with stable CAD were randomly assigned to receive DP-EES (n = 304) or DP-SES (n = 151). The powered angiographic outcome of the trial was in-stent late lumen loss (LLL) at 9 months after the index procedure. Secondary angiographic end points included in-segment LLL, in-stent and in-segment binary restenosis and percent diameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR).ResultsAt 9-month follow-up, in-stent LLL was 0.19±0.38 mm and 0.11±0.37 mm in patients assigned to DP-EES and DP-SES, respectively. The one-sided upper 95% CI of the difference in in-stent LLL between the groups of 0.08 mm was 0.15 and therefore within the pre-specified non-inferiority margin of 0.17 mm (p for non-inferiority = 0.013). However, the test for superiority showed a borderline significant difference in terms of LLL between DP-EES and DP-SES (p for superiority = 0.044). There were no significant differences in binary restenosis (2.0% vs. 0.72%, p = 0.44) and percent diameter stenosis (14.97±12.17 vs. 13.36±10.82, p = 0.19). The rate of definite stent thrombosis at 12 months was lower in patients treated with DP-EES (0% vs. 2.0%, p = 0.036).ConclusionsAmong women undergoing PCI, DP-EES was associated with a small but probably clinically relevant increase in in-stent LLL at 9 months as compared to DP-SES and with a lower risk of definite stent thrombosis at 12 months.Trial registrationClinicalTrials.gov NCT01182428.https://clinicaltrials.gov/

Angiographic and clinical outcome after crush of everolimus-eluting stent for distal unprotected left main disease.

Few data exist about crushing of EES for distal ULMD. From the Florence ULMD Percutaneous Coronary Interevention Registry consecutive patients with distal ULMD treated with EES were included in the analysis. Patients treated with provisional stenting were compared with patients treated with crush stenting. angiographic in-segment restenosis rate, and 1-year clinical outcome. From 2008 to 2015, 405 patients with distal ULMD were treated with EES: 278 (69%) were treated with provisional stenting while 127 (31%) with crush stenting. Provisional stenting group compared to crush stenting group had higher incidence of acute coronary syndrome on admission (63% vs. 52%; P = 0.033) and of left ventricular ejection fraction ≤ 40% (36% vs. 23%; p= 0.008), while patients treated with crush stenting had more frequently diabetes mellitus (35% vs. 21%; P = 0.003) and 3-vessel coronary artery disease (46% vs. 29%; P < 0.001). Angiographic follow rate was 95%. Restenosis rates were similar: 7.1% in the crush stenting group and 5.8% in the provisional stenting group. There were no differences in 1-year clinical outcome between crush stenting group and provisional stenting group: major adverse cardiac events 11.1% and 11.2%, stent thrombosis 0.8% and 1.4%, respectively. Crush stenting using EES in patients with complex distal ULMD is associated with low rates of restenosis and adverse clinical events and could be considered as a valid double stenting technique in all patients with complex ULMD bifurcation lesions. © 2017 Wiley Periodicals, Inc.

Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial

ObjectivesThe aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). BackgroundThe introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. MethodsIn this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. ResultsOverall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: −0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. ConclusionsThis randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.

Impact of stent implantation on endothelial shear stress.

Endothelial shear stress (ESS) may play akey role in the pathobiology of stent restenosis (SR). Nevertheless, limited data are available about ESS and its relation to SR. We enrolled 14patients who underwent successful percutaneous coronary intervention (PCI) in this study. Three-dimensional (3D) reconstruction of 14coronary arteries before and after stent implantation was performed. Using computational fluid dynamics, mean ESS was calculated proximally, in tertiles within and distal to the stent, both before and after stent implantation. Stent implantation resulted in asignificant ESS decrease in the entire atherosclerotic lesion (1.83vs. 1.26Pa, p= 0.02). Regarding the fiveterritories in which the entire lesion was divided, ESS decrease was marginally significant in the area of the second in-stent tertile, and in the area 5mm distal to the stent, whereas ESS decrease was not significant in the area 5mm proximal to the stent, and in the area of the first and third in-stent tertile. At 12months, two patients had SR, but restenosis was not related to ESS decrease. ESS decreases after stent implantation but not uniformly, with the major reduction being in the middle tertile of the stent, and distal to the stent. In-stent ESS decrease may create local hemodynamic conditions leading to in-stent and in-segment restenosis.

Clinical and Imaging Outcomes up to 1 Year Following Balloon Angioplasty for Isolated Penile Artery Stenoses in Patients With Erectile Dysfunction

Purpose: To assess the angiographic and clinical outcomes in patients with erectile dysfunction and isolated penile artery stenoses treated by balloon angioplasty. Methods: In this prospective study, 22 patients (mean age 61.0±7.6 years, range 50–79) with erectile dysfunction and 34 isolated penile artery stenoses (mean 74.9%±9.1%) were enrolled and underwent balloon angioplasty. The mean International Index for Erectile Function–5 (IIEF-5) score at baseline was 10.3±4.5. The mean lesion length was 11.1±9.0 mm (mean reference vessel diameter 1.7±0.4 mm). The primary endpoint was in-segment restenosis ≥50% by pelvic computed tomography angiography (CTA) at 8 months. The 1-year sustained clinical success (IIEF-5 score ≥22 or a ≥4-point change in the IIEF-5 score and no later decline by ≥4) was the secondary outcome measure. Results: Procedural success was achieved in 31 (91%) of 34 stenotic lesions; there was 1 flow-limiting dissection and 2 arteries with >30% residual stenosis. At 8 months, 14 of 34 lesions in 13 of 22 patients had CTA-documented binary restenosis. At 1 year, sustained clinical success was achieved in 11 of 22 patients. Of the 9 patients not developing binary restenosis, 8 achieved sustained clinical success. Conclusion: Our findings establish the safety and efficacy of penile artery angioplasty for patients with erectile dysfunction and isolated penile artery stenoses. They also highlight the unmet need for a more enduring treatment strategy for penile artery stenotic disease.

A Pilot Study on Culottes versus Crossover Single Stenting for True Coronary Bifurcation Lesions.

The purpose of our study was to compare clinical and angiographic outcomes of planned culottes technique with that of provisional crossover single stenting in the treatment of true coronary bifurcation lesions (CBL) with drug-eluting stent (DES). True CBL patients (n = 104) were randomly assigned to either the provisional stenting of the side branch (crossover group) or the culottes group. Additional side branch (SB) stenting in the crossover group was required if there was thrombolysis in myocardial infarction flow ≤ 1 flow). The primary end point was the occurrence of major adverse cardiac events (MACE) at nine months, including cardiac death, myocardial infarction, target lesion/vessel revascularization and in-stent thrombosis. The secondary end point was angiographic in-segment restenosis at nine months. The rate of MACE at nine months was similar between the crossover and culottes groups (7.7% vs. 7.7%, p = 1.000). Additional SB stenting in the crossover group was required in 3.8% of patients. There was one procedural occlusion of SB in the crossover group. At nine months, the rate of in-segment restenosis was similar in the parent main vessel (0% vs. 1.9%, p = 1.000), main branch (1.9% vs. 7.7%, p = 0.363) and SB (17.3% vs. 9.6%, p = 0.250) between the crossover and culottes groups, respectively. This study demonstrated that there is no significant difference in cumulative MACE or in-segment restenosis between crossover and culottes groups. Larger randomized clinical trials are warranted to re-evaluate the outcomes of the provisional crossover stenting versus the culottes stenting techniques utilizing DES for true CBL.

Relationship between left coronary artery bifurcation angle and restenosis after stenting of the proximal left anterior descending artery.

Restenosis after a percutaneous coronary intervention for proximal left anterior descending (pLAD) coronary artery disease remains a clinical challenge. However, the relationship between the left main trunk (LMT)/LAD bifurcation angle and the pLAD artery restenosis is unclear. This study examined the relationship between the LMT-LAD bifurcation angle and restenosis after stent implantation for pLAD disease. We analysed the data of 177 consecutive patients who underwent stent implantation for pLAD disease, followed by coronary angiography between December 2008 and September 2013. The LMT-LAD bifurcation angle was measured in the left or the right anterior oblique caudal (CAU) angiographic view. Out of 177 patients, 12 developed in-stent restenosis and 21 developed in-segment restenosis. The mean angle in patients with in-stent restenosis (52.2°±14.5°) in the left anterior oblique CAU view was significantly larger than that in patients without restenosis (32.0°±18.1°; P<0.001). The LMT-LAD angle in the right anterior oblique CAU view was significantly larger in patients with in-segment restenosis (27.3°±14.3°) than in patients without restenosis (17.5°±10.1°; P<0.001). Moreover, by multivariate analysis, the LMT-LAD angle was an independent predictor of in-stent and in-segment restenosis, after adjustment for significant confounders such as diabetes, hypertension, dyslipidaemia, final minimum lesion diameter and lesion length. This study suggests that a wide LMT-LAD angle is a predictor of restenosis after stent implantation for pLAD artery disease.

The SSTARS (STeroids and Stents Against Re-Stenosis) Trial: Different stent alloys and the use of peri-procedural oral corticosteroids to prevent in-segment restenosis after percutaneous coronary intervention

BackgroundStent design and technological modifications to allow for anti-proliferative drug elution influence restenosis rates following percutaneous coronary intervention (PCI). We aimed to investigate whether peri-procedural administration of corticosteroids or the use of thinner strut cobalt alloy stents would reduce rates of binary angiographic restenosis (BAR) after PCI. MethodsThis was a two centre, mixed single and double blinded, randomised controlled trial using a factorial design. We compared (a) the use of prednisolone to placebo, starting at least six hours pre-PCI and continued for 28days post-PCI, and (b) cobalt chromium (CoCr) to stainless steel (SS) alloy stents, in patients admitted for PCI. The primary end-point was BAR at six months. Results315 patients (359 lesions) were randomly assigned to either placebo (n=145) or prednisolone (n=170) and SS (n=160) or CoCr (n=160). The majority (58%) presented with an ACS, 11% had diabetes and 287 (91%) completed angiographic follow up. BAR occurred in 26 cases in the placebo group (19.7%) versus 31 cases in the prednisolone group (20.0%) respectively, p=1.00. For the comparison between SS and CoCr stents, BAR occurred in 32 patients (21.6%) versus 25 patients (18.0%) respectively, p=0.46. ConclusionOur study showed that treating patients with a moderately high dose of prednisolone for 28days following PCI with BMS did not reduce the incidence of BAR. In addition, we showed no significant reduction in 6month restenosis rates with stents composed of CoCr alloy compared to SS (http://www.isrctn.com/ISRCTN05886349).