Effectiveness and safety of the ABSORB bioresorbable vascular scaffold for the treatment of coronary artery disease: Systematic review and meta-analysis of randomized clinical trials

Background: In the last years bioresorbable vascular scaffold (BVS) become a new therapeutic option for interventional cardiologists, with the advantage of a scaffold inducing a possible vessel wall restoration. Nevertheless, several trials tried to prove the safety and efficacy profile of scaffolds, but with conflicting results. Methods: A systematic review and meta-analysis was performed. The search was carried out in PubMed, Google Scholar, Biomed Central and Cochrane Library between January and March 2017. Inclusion criteria: randomized clinical trials (RCT) comparing the Absorb BVS versus durable polymer cobalt-chromium Everolimus Eluting Stent. The outcomes analysed were all-cause mortality, cardiac death, ischemia-driven target lesion revascularization, target vessel myocardial infarction (MI), target lesion failure (TLF)/device oriented composite endpoints (DOCE), and device thrombosis. Fixed-effect meta-analysis was performed. Data were expressed as odds ratio (OR). Results: Overall 5,674 patients were included (mean age 62.2±1.31 in drug eluting stents (DES) group vs. 62±1,47 in BVS group; P=0.942). DOCE (OR 1.16, 95% CI: 0.90-1.48; P=0.259, I2=0%), cardiac death (OR 0.86, 95% CI: 0.52-1.40; P=0.537, I2=0%) and all-cause death (OR 0.78, 95% CI: 0.53-1.15; P=0.205, I2=15%) did not differ between BVS and DES. Conversely, ischemia-driven target lesion revascularization was more frequent in the BVS group (OR 1.32, 95% CI: 1.01-1.73; P=0.039, I2=0%), as well as device thrombosis (2.2% vs. 0.6%, OR 2.94, 95% CI: 1.71-5.05, P=0.0001, I2=0%) and target-vessel MI (5.4% vs. 3%, OR 1.66, 95% CI: 1.25-2.21, P=0.001, I2=0%). Conclusions: The implantation of BVS is associated with an increased risk of device thrombosis, ischemiadriven target lesion revascularization and target vessel MI. If longer follow-up or different implantation technique may change these findings should be addressed in future trials

Three-year results of ST-segment elevation myocardial infarction patients treated with a prespecified bioresorbable vascular scaffold implantation strategy: bVS STEMI STRATEGY-IT long-term

Three-year results of ST-segment elevation myocardial infarction patients treated with a prespecified bioresorbable vascular scaffold implantation strategy: bVS STEMI STRATEGY-IT long-ter

A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction: The BVS STEMI STRATEGY-IT Study

Objectives The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI). Background Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention. Methods This was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days. Results During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported. Conclusions A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781

Contemporary antithrombotic strategies in patients with acute coronary syndromes managed without revascularization: Insights fromthe EYESHOT study

Aims Patients with acute coronary syndromes (ACSs) whoare managed without coronary revascularization represent a mixed and understudied population that seems to receive suboptimal pharmacological treatment. Methods and results We assessed patterns of antithrombotic therapies employed during the hospitalization and in-hospital clinical events of medically managed patients withACS enrolled in the prospective, multicentre, nationwideEYESHOT(EmploYEd antithrombotic therapies in patients with acute coronary Syndromes HOspitalized in Italian cardiac care units) registry.Among the 2585 consecutive ACS patients enrolled in EYESHOT, 783 (30.3%) did not receive any revascularization during hospital admission. Of these, 478 (61.0%) underwent coronary angiography (CA), whereas 305 (39.0%) did not. The median GRACE and CRUSADE risk scores were significantly higher among patients who did not undergo CA compared with those who did (180 vs. 145, P, 0.0001 and 50 vs. 33, P, 0.0001, respectively). Antithrombotic therapies employed during hospitalization significantly differ between patients who received CA and those who did not with unfractioned heparin and novel P2Y12 inhibitors more frequently used in the first group, and low-molecular-weight heparins and clopidogrel in the latter group. During the index hospitalization, patients who did not receive CA presented a higher incidence of ischaemic cerebrovascular events and of mortality compared with those who underwent CA (1.6 vs. 0.2%, P = 0.04 and 7.9 vs. 2.7%, P = 0.0009, respectively). Conclusion Almost one-third of ACS patients are managed without revascularization during the index hospitalization. In this population, a lower use of recommended antiplatelet therapy and worse clinical outcome were observed in those who did not undergo CA when compared with those who did

Antithrombotic strategies in the catheterization laboratory for patients with acute coronary syndromes undergoing percutaneous coronary interventions: Insights from the EmploYEd antithrombotic therapies in patients with acute coronary Syndromes HOspitalized in Italian cardiac care units Registry

Aims: In the last decades, several new therapies have emerged for the treatment of acute coronary syndromes (ACS). We sought to describe real-world patterns of use of antithrombotic treatments in the catheterization laboratory for ACS patients undergoing percutaneous coronary interventions (PCI). Methods: EmploYEd antithrombotic therapies in patients with acute coronary Syndromes HOspitalized in Italian cardiac care units was a nationwide, prospective registry aimed to evaluate antithrombotic strategies employed in ACS patients in Italy. Results: Over a 3-week period, a total of 2585 consecutive ACS patients have been enrolled in 203 cardiac care units across Italy. Among these patients, 1755 underwent PCI (923 with ST-elevation myocardial infarction and 832 with non-ST-elevation ACS). In the catheterization laboratory, unfractioned heparin was the most used antithrombotic drug in both ST-elevation myocardial infarction (64.7%) and non-ST-elevation ACS (77.5%) undergoing PCI and, as aspirin, bivalirudin and glycoprotein IIb/IIIa inhibitors (GPIs) more frequently employed before or during PCI compared with the postprocedural period. Any crossover of heparin therapy occurred in 36.0% of cases, whereas switching from one P2Y12 inhibitor to another occurred in 3.7% of patients. Multivariable analysis yielded several independent predictors of GPIs and of bivalirudin use in the catheterization laboratory, mainly related to clinical presentation, PCI complexity and presence of complications during the procedure. Conclusion: In our contemporary, nationwide, all-comers cohort of ACS patients undergoing PCI, antithrombotic therapies were commonly initiated before the catheterization laboratory. In the periprocedural period, the most frequently employed drugs were unfractioned heparin, leading to a high rate of crossover, followed by GPIs and bivalirudin, mainly used during complex PCI