Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: final 7-year results of the COMPARE-ABSORB trial.

The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS). The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group. In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.

The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; Pint=0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02-2.87] versus 3.23 [95% CI, 1.25-8.30]; Pint=0.056) compared with the 0- to 3-year time period. In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. URL: https://clinicaltrials.gov. Unique identifier: NCT01751906.

The Absorb bioresorbable vascular scaffold (BVS) completely resorbs within 3 years after coronary artery implantation. The safety and effectiveness of BVS through this critical 3-year period have not been characterized. We performed an individual-patient-data pooled meta-analysis of the 4 randomized ABSORB trials in which 3389 patients with coronary artery disease were randomly assigned to everolimus-eluting Absorb BVS (n=2164) or cobalt-chromium everolimus-eluting stents (n=1225). The primary efficacy outcome measure was target lesion failure (cardiac mortality, target vessel myocardial infarction, or ischemia-driven target lesion revascularization), and the primary safety outcome measure was device thrombosis. BVS compared with cobalt-chromium everolimus-eluting stents resulted in higher 3-year rates of target lesion failure (11.7% versus 8.1%; risk ratio [RR], 1.38; 95% confidence interval [CI], 1.10-1.73; P=0.006), driven by greater target vessel myocardial infarction (7.8% versus 4.2%; RR, 1.72; 95% CI, 1.26-2.35; P=0.0006) and ischemia-driven target lesion revascularization (6.6% versus 4.4%; RR, 1.44; 95% CI, 1.05-1.98; P=0.02), with comparable cardiac mortality (1.1% versus 1.1%; RR, 0.93; 95% CI, 0.47-1.88; P=0.85). Device thrombosis rates through 3 years were also higher with BVS (2.4% versus 0.6%; RR, 3.71; 95% CI, 1.70-8.11; P=0.001). Between 1 and 3 years, target lesion failure rates (6.1% versus 3.9%; P=0.02) and device thrombosis rates (1.1% versus 0.0%; P<0.0001) were higher with BVS than cobalt-chromium everolimus-eluting stents. In the present individual-patient-data pooled meta-analysis of the ABSORB trials, BVS was associated with increased rates of target lesion failure and device thrombosis between 1 and 3 years and cumulatively through 3 years of follow-up compared with everolimus-eluting stents. URL: https://clinicaltrials.gov. Unique identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial.

Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes. We searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ≥ 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Five studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n = 917; DES n = 841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P = .02) and stent/scaffold thrombosis (ST/ScT) (OR = 2.35, 95% CI: 1.13-4.89, P = .02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P = .22). The risk for all-cause death (OR = 1.32 95% CI: 0.61-2.88, P = .48), cardiac death (OR = 1.29, 95% CI: 0.58-2.86 P = .52), target vessel myocardial infarction (OR = 1.50, 95% CI: 0.86-2.61, P = .15), and target lesion failure (OR = 1.34, 95% CI: 0.76-2.35, P = .31) did not differ between BVS and DES groups. At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.

Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program.

Data regarding the long-term efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents are limited. This meta-analysis aimed to compare the long-term outcomes with both devices. Randomized trials reporting clinical outcomes beyond 1 year and comparing BVS with everolimus-eluting stents were included. Summary estimates risk ratios (RRs) were constructed. The primary efficacy outcome was target lesion failure, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, and the primary safety outcome was definite or probable stent/scaffold thrombosis. Six trials with 5392 patients were included (mean follow-up, 25 months). BVS had a higher rate of target lesion failure (RR, 1.33; 95% confidence interval [CI], 1.11-1.58) driven by the higher rates of target vessel myocardial infarction (RR, 1.65; 95% CI, 1.26-2.17) and target lesion revascularization (RR, 1.39; 95% CI, 1.08-1.78). The risk of definite or probable stent/scaffold thrombosis (RR, 3.22; 95% CI, 1.89-5.49) and very late stent/scaffold thrombosis (>1 year; RR, 4.78; 95% CI, 1.66-13.8) was higher with BVS. The risk of cardiac and all-cause mortality was similar in both groups. Compared with everolimus-eluting stents, BVS is associated with increased risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization in these studies (mean follow-up, 25 months). The risk of definite or probable stent/scaffold thrombosis and very late stent/scaffold thrombosis seems to be higher with BVS. Further information from randomized trials is critical to evaluate clinical outcomes with BVS on complete resolution of the scaffold.

Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials

Clinical data on the early and midterm outcomes of bioresorbable vascular scaffolds (BVS) in routine clinical practice are limited. To fill this gap, we report on the early and midterm clinical outcomes of PCI with everolimus-eluting BVS from the large multicentre GHOST-EU registry. Between November 2011 and January 2014, 1,189 patients underwent percutaneous coronary intervention with one or more BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) at 10 European centres. The primary outcome of interest was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR). A total of 1,731 Absorb BVS were implanted at a mean of 12.3±3.4 atm. Technical success was achieved in 99.7% of cases. TLF was recorded in 67 of 1,189 patients at a median of 109 (interquartile range 8-227) days after implantation. The cumulative incidence of TLF was 2.2% at 30 days and 4.4% at six months. The annualised rate of TLF was 10.1%. At six months, the rate of cardiac death was 1.0%, target vessel myocardial infarction was 2.0%, TLR was 2.5%, and target vessel revascularisation was 4.0%. Diabetes mellitus was the only independent predictor of TLF (hazard ratio 2.41, 95% confidence interval: 1.28-4.53; p=0.006). The cumulative incidence of definite/probable scaffold thrombosis was 1.5% at 30 days and 2.1% at six months, with 16 of 23 cases occurring within 30 days. "Real-world" outcomes of BVS showed acceptable rates of TLF at six months, although the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible.

To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

Bioresorbable coronary stents have been introduced into clinical practice to improve the outcomes of patients treated with percutaneous coronary intervention. The everolimus-eluting bioresorbable vascular scaffold (BVS) is the most studied of these stent platforms; however, recent trials comparing BVS with everolimus-eluting metallic stents (EES) raised concerns about BVS safety. We aimed to assess the efficacy and safety of BVS versus EES in patients undergoing percutaneous coronary intervention. We searched Medline, Embase, the Cochrane Central Register of Controlled Trials, scientific sessions abstracts, and relevant Web sites for randomized trials with a follow-up of ≥2 years investigating percutaneous coronary interventions with BVS versus EES. The primary outcomes of our analysis were definite/probable stent thrombosis (ST) and target lesion failure (TLF; device-oriented composite end point of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization [TLR]). Secondary outcomes were target vessel myocardial infarction, TLR, and cardiac death. We calculated the risk estimates for main outcomes according to a fixed-effect model. We included 7 trials comprising data for 5583 patients randomized to receive either a BVS (n=3261) or an EES (n=2322). Median follow-up was 24 months (range, 24-36 months). Patients treated with BVS had a higher risk of definite/probable ST compared with patients treated with EES (odds ratio, 3.33; 95% confidence interval, 1.97-5.62; P<0.00001). In particular, patients with BVS had a higher risk of subacute, late, and very late ST, whereas the risk of acute ST was similar. Patients treated with BVS compared with EES had a higher risk at 2 years of TLF (odds ratio, 1.47; 95% confidence interval, 1.14-1.90; P=0.003), driven mainly by an increased risk of target vessel myocardial infarction (odds ratio, 1.73; 95% confidence interval, 1.31-2.28; P=0.0001; I2=0%) and of TLR (odds ratio, 1.27; 95% confidence interval, 1.00-1.62; P=0.05). Of importance, the risk of TLF and TLR for patients with BVS was higher between 1 and 2 years, whereas there was no difference in the first year. Risk of cardiac death was similar between the 2 groups. Our meta-analysis of randomized trials with a follow-up of ≥2 years demonstrated a higher risk of ST and of TLF in patients treated with BVS compared with EES. Of note, BVS had a higher risk of subacute, late, and very late ST, whereas the risk of TLF and TLR was higher between 1 and 2 years.

Bioresorbable vascular scaffold failure – Post factum research to look for the reasons

Background: Bioresorbable vascular scaffolds (BVS) implantation in selected patients with stable angina has been demonstrated feasible and safe. However, limited data are currently available on long-term outcomes after BVS implantation for ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess the safety, efficacy and long-term results of BVS implantation in STEMI patients.Methods: Retrospective review of all STEMI patients treated with the Absorb® BVS (Abbott Vascular, Santa Clara, CA) or conventional drug eluting stent (DES) between 1 April 2013 and 30 March 2014. Primary outcomes were procedural success, device thrombosis and device-oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction and target lesion revascularization. The study included 54 BVS patients and 121 DES patients.Results: Patients were slightly younger in the BVS group (60 vs. 63 years old, p = .03). Other baseline characteristics were comparable between the two groups. Procedural success was achieved in all patients. Median follow-up was 901 days and 849 days for BVS and DES patients, respectively (p = .01). The cumulative incidence of DOCE was not significantly different between the BVS and DES groups (7.5% vs. 9.1%, hazard ratio [HR]: 0.74 [95% confidence interval (CI): 0.26–2.2], p = NS). Rate of probable/definite device thrombosis were not statistically different between both groups (3.7% vs. 3.3%, p = NS).Conclusions: The results of this single-centre retrospective study, one of the first assessing long-term safety and efficacy of BVS in STEMI, seems reassuring with similar long-term results as compared with patients treated with conventional DES.

Bioresorbable vascular scaffolds (BVS) completely resorb within 3 years after placement into the coronary artery. The safety and effectiveness of bioabsorbable scaffolds are of critical importance during this 3-year period. We performed a meta-analysis to compare the safety and efficacy of BVS and second-generation drug-eluting stents (DES) at 3 years after implantation. Published randomized trials comparing BVS to second-generation DES for the treatment of coronary artery disease were identified within PubMed, EMBASE, Cochrane Library, Web of Science, and relevant Web sites with publication dates through June 2019. The primary efficacy endpoint was target lesion failure. The primary safety endpoint was definite/probable stent/scaffold thrombosis. Secondary outcomes were cardiac death, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and a patient-oriented composite end point. Six randomized controlled trials, with a total of 5,412 patients (BVS n = 3,177; DES n = 2,235), were included. At 3 years, BVS was associated with higher rates of target lesion failure (OR = 1.33, 95%CI: 1.10-1.60, P = 0.003) and definite/probable stent/scaffold thrombosis (OR = 3.75, 95% CI: 2.22-6.35, P < .00001)compared with DES. The incidence of target vessel myocardial infarction (OR = 1.68, 95% CI: 1.30-2.17, P < .0001), ischemia-driven target lesion revascularization (OR = 1.46, 95% CI: 1.14-1.86, P = .003), and the patient-oriented composite end point(OR = 1.20, 95% CI: 1.04-1.39, P = .01) were higher for those treated with BVS compared with DES. However, there was no significant difference in risk of cardiac death (OR = 0.94, 95%CI: 0.61-1.45, P = .79) between treatment groups. At the 3-year follow-up, BVS was inferior to second-generation DES in both safety and efficacy.

Mid-term clinical outcomes of ABSORB bioresorbable vascular scaffold versus everolimus-eluting stent for coronary bifurcation lesions