Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry.

OBJECTIVES: The aim of this study was to determine the 3-year outcomes of patients treated with Absorb bioresorbable vascular scaffold (BVS) implantation. BACKGROUND: Randomized trials and observational registries performed in patients undergoing percutaneous coronary intervention have demonstrated higher 1-year and midterm rates of device thrombosis and adverse events with BVS compared to contemporary drug eluting stent. Data on long-term follow-up of patients treated with BVS are scarce. METHODS: All patients treated with BVS were included in a large nationwide prospective multicenter registry (FRANCE ABSORB). The primary endpoint was a composite of cardiovascular death, myocardial infarction, and target lesion revascularization at 3 years. Secondary endpoints were 3-year scaffold thrombosis and target vessel revascularization (TVR). RESULTS: Between September 2014 and April 2016, 2070 patients were included (mean age 55 ± 11 years; 80% men). The indication was acute coronary syndrome (ACS) in 49% of patients. At 3 years, the primary endpoint occurred in 184 patients (8.9%) and 3-year mortality in 43 patients (2.1%). Scaffold thrombosis and TVR rates through 3 years were, respectively, 3 and 7.6%. In a multivariable analysis, independent predictors of primary endpoint occurrence were diabetes, oral anticoagulation, active smoking, absence of initial angiographic success and the association of a total BVS length ≥30 mm with the use of 2.5 mm diameter BVS. CONCLUSIONS: Although 3-year mortality was low in this ACS population, device-related events were significant beyond 1 year. Total BVS length and 2.5 mm BVS were associated with higher rates of MACE at long-term follow-up.

Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry.

BACKGROUND: Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. AIM: The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. METHODS: All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. RESULTS: Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. CONCLUSIONS: Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

EuroSCORE is a good global predictor of long-term outcomes in high-risk but not in low-risk patients after unprotected left main angioplasty.

BACKGROUND: Percutaneous coronary intervention is increasingly emerging as a valuable alternative to surgery for the treatment of patients with unprotected left main coronary artery (ULMCA) disease. In this study, we aimed to assess the ability of the EuroSCORE risk stratification model to predict long-term major adverse cardiac events after unprotected left main angioplasty according to the individual level of risk. METHODS: Two hundred forty-six consecutive patients who underwent ULMCA in a single high volume center over a 5-year period were included. Major adverse cardiac events were defined as a combined end point of cardiac death, nonfatal myocardial infarction, or target lesion revascularization. RESULTS: Areas under the receiver-operating characteristic curve of EuroSCORE in the entire cohort were 0.687 (P = 0.005; 95% CI: 0.575-0.846) and 0.589 (P = 0.038; 95% CI: 0.511-0.673) respectively for cardiac death and major adverse cardiac events (MACE). One hundred twenty-four patients had a EuroSCORE value > 6 and constituted the high surgical risk (HSR) group. Actuarial 4-year survivals free from cardiac death and free from MACE were significantly lower in this group respectively at 84% versus 93% (log rank P = 0.02) and 50% versus 74% (log rank P = 0.004). EuroSCORE was the only independent predictor of long-term cardiac mortality by the Cox analysis (HR = 3.95, P = 0.027, 95% CI: 1.16-13.39). It had a good discriminatory power for predicting both cardiac death and MACE with AUC respectively at was 0.705 (P = 0.01, 95% CI: 0.55-0.86) and 0.65 (P = 0.013, 95% CI: 0.54-0.78) in the HSR cohort but not in the lower risk (EuroSCORE ≤ 6) cohort. CONCLUSION: EuroSCORE is a good predictor not only of cardiac death but also of MACE after ULMCA angioplasty; however, the discriminatory ability of EuroSCORE appears to be limited to patients with high surgical risk as defined by EuroSCORE values > 6.

Percutaneous coronary interventions with the Absorb Bioresorbable vascular scaffold in real life: 1-year results from the FRANCE ABSORB registry.

BACKGROUND: Several randomized studies have shown that bioresorbable vascular scaffold (BVS) technology is associated with an increased risk of stent thrombosis. AIM: This study aimed to assess the rates of adverse outcomes at 1 year in patients treated with the Absorb BVS (Abbott Vascular, Santa Clara, CA, USA), using data from a large nationwide prospective multicentre registry (FRANCE ABSORB). METHODS: All patients receiving the Absorb BVS in France were included prospectively in the study. Predilatation, optimal sizing and postdilatation were recommended systematically. The primary endpoint was a composite of cardiovascular death, myocardial infarction and target lesion revascularization at 1 year. Secondary endpoints were scaffold thrombosis and target vessel revascularization at 1 year. RESULTS: A total of 2072 patients at 86 centres were included: mean age 55±11 years; 80% men. The indication was acute coronary syndrome (ACS) in 49% of cases. Predilatation and postdilatation were done in 93% and 83% of lesions, respectively. At 1 year, the primary endpoint occurred in 3.9% of patients, the rate of scaffold thrombosis was 1.5% and the rate of target vessel revascularization was 3.3%. In a multivariable analysis, diabetes and total Absorb BVS length>30mm were independently associated with the occurrence of the primary endpoint, whereas oral anticoagulation and total Absorb BVS length>30mm were independently associated with occurrence of scaffold thrombosis. CONCLUSIONS: The Absorb BVS was implanted in a relatively young population, half of whom had ACS. Predilatation and postdilatation rates were high, and 1-year outcomes were acceptable.

6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin: Final Results of the ITALIC Trial (Is There a Life for DES After Discontinuation of Clopidogrel).

OBJECTIVES: The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients. BACKGROUND: The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. METHODS: In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component. RESULTS: Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding. CONCLUSIONS: Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.

6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.

BACKGROUND: The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS). OBJECTIVES: This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. METHODS: A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting. RESULTS: A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]). CONCLUSIONS: Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020).

Percutaneous management of lower limb ischemia after the use of vascular closure devices.

BACKGROUND: Lower extremity ischemia after the use of vascular closure devices (VCDs) after transfemoral percutaneous coronary and peripheral interventions is an infrequent though relevant clinical entity. We aimed to assess immediate and midterm outcomes of a systematic endovascular approach for the treatment of VCD-related lower limb ischemia. METHODS: Between 2006 and 2008, all the patients who developed lower limb ischemia after the use of a VCD in a high volume French institution were systematically managed percutaneously and constituted the study population. Clinical characteristics, immediate, and midterm outcomes are reported. RESULTS: Of 2944 consecutive patients undergoing VCD placement after femoral access, 18 (3 men and 15 women) had VCD-related lower limb ischemia and were all managed percutaneously. Median age was 66.5 years. Devices were Angio-Seal (St Jude Medical) in 12 cases, StarClose (Abbott Vascular Devices) in 3 cases, and Perclose (Abbott Vascular Devices) in 3 cases. Limb ischemia occurred with a median delay of 2 days after device placement. Index procedures were coronary interventions in 14 cases and peripheral in 4 cases. The occlusion site was successfully crossed in all cases. Twelve patients were treated with balloon angioplasty and 6 with stent implantation. Angiographic success was obtained in all cases. After a median 32-month follow-up, only 2 patients initially treated using percutaneous transluminal angioplasty needed reintervention consisting of a balloon angioplasty in 1 case and stent implantation in the second case. At final follow-up, all the patients were asymptomatic. CONCLUSIONS: Endovascular treatment for VCD-related limb ischemia is a feasible and effective approach resulting in excellent immediate and midterm outcomes.

Unprotected left main angioplasty in nonagenarians: clinical characteristics, procedural features and outcome: a case series study.

UNLABELLED: Limited information is available on clinical characteristics and outcomes in very old patients with unprotected left main coronary artery disease (ULMCA) undergoing percutaneous coronary intervention (PCI). METHODS: From January 2004 and December 2008, 248 patients with ULMCA stenosis underwent coronary revascularization with stent implantation. Among those, 6 were older than 90 years at the time of the procedure and were included in this study. RESULTS: There were 5 males and 1 female; mean age was 91.5 years (range 91-93). All the patients presented with acute coronary syndromes. All of them had multivessel disease with a distal left main stenosis in 4 patients. All were deemed inoperable, with a mean EuroSCORE of 12.66 (range 10-20) and a predicted mortality at 34% (range15.8-86.6%). 5 patients received bare-metal stents and 1 patient a paclitaxel-eluting stent. Rotational atherectomy was required in 2 patients. Provisional side branch T-stenting with final kissing balloons was the technique used in all bifurcation lesions. Angiographic success was obtained in all patients. There were no in-hospital deaths or complications. After a 29.8-month (range 8-59) mean follow up period, a myocardial infarction caused by late stent thrombosis occurred in 1 patient and ischemia-driven target vessel revisualization was required in another; however, all patients were alive. CONCLUSION: In the very elderly patients at excessively high risk for surgery, PCI for ULMCA disease is a suitable alternative with excellent short-term results and acceptable long-term outcomes.

Assessment of the trackability, flexibility, and conformability of coronary stents: a comparative analysis.

The efficacy and safety of coronary stent implantation depend on the mechanical features of these devices when deployed in atheromatous lesions of various morphologies. We evaluated the trackability, flexibility, and conformability of 17 coronary stents using specific mechanical bench tests. The quantifications used a dynamometer for assessment of trackability (maximal strength) and flexibility (stiffness) and a 3D optical gauging machine for assessment of conformability (distance between stent and arterial wall in a curvature). The maximal strength (measuring the trackability) ranged respectively from 0.24 +/- 0.06 and 0.38 +/- 0.03 N (Seaquest) to 1.31 +/- 0.42 and 1.34 +/- 0.35 N (Carbostent), concerning respectively curvatures of 90 degrees (P < 0.0001) and 135 degrees (P < 0.0001). The stiffness (measuring the flexibility) ranged from 0.53 +/- 0.16 (Seaquest) to 1.28 +/- 0.10 N/mm (NIR Royal; P < 0.0001). The mean distance between stent and external curvature (external conformability) ranged from 0.15 +/- 0.06 mm (S7) to 0.57 +/- 0.4 mm (NIR Royal; P < 0.0001). The mean distance between stent and internal curve (internal conformability) ranged from 0.26 +/- 0.13 (S7) to 0.44 +/- 0.12 mm (S670; P < 0.0001). These results may influence the choice of a particular stent adapted to a specific coronary anatomy.