Five-Year Outcomes With Biodegradable-Polymer Sirolimus-Eluting Stents Versus Durable-Polymer Everolimus-Eluting Stents in Patients With Acute Coronary Syndrome: A Subgroup Analysis of the BIOSCIENCE Trial

BackgroundThin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) have been shown to reduce target lesion failure (TLF) at one-year follow-up compared with durable polymer everolimus-eluting stents (DP-EES) among patients with acute coronary syndrome (ACS). The long-term clinical benefits of thin-strut BP-SES over DP-EES in ACS patients after complete degradation of the polymer coating remain uncertain.MethodsWe performed a post-hoc subgroup analysis of ACS patients included into the BIOSCIENCE randomized trial (NCT01443104). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction or clinically indicated target lesion revascularization, at 5 years.ResultsAmong 2119 patients enrolled between March 2012 and May 2013, 1131 (53%) presented with ACS. The 5-year cumulative incidence of TLF was significantly lower in patients with ACS compared to chronic coronary syndrome [16.5% vs. 22.9%; rate ratio (RR), 0.69; 95% confidence interval (CI), 0.57–0.85; p < 0.001]. At 5 years, TLF occurred similarly in ACS patients treated with BP-SES and DP-EES (16.9% vs. 16.0%; RR, 1.04; 95% CI, 0.78–1.41; p = 0.78). The individual components of the primary endpoint did not differ between ACS patients treated with BP-SES or DP-EES at 5 years. Overall, there was no interaction between clinical presentation and treatment effect.ConclusionsIn a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term outcomes between ACS patients treated with BP-SES or DP-EES at 5 years.     

Randomized Comparison of Everolimus-Eluting Stents and Sirolimus-Eluting Stents in Patients With ST Elevation Myocardial Infarction: RACES-MI Trial

ObjectivesThe aim of the current study was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing primary angioplasty.BackgroundDrug-eluting stents may offer benefits in terms of repeat revascularization. However, as shown for first-generation drug-eluting stents, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with ST-segment elevation myocardial infarction (STEMI). No data have been reported so far on the long-term benefits and safety of the new generation of drug-eluting stents in STEMI.MethodsConsecutive STEMI patients admitted within 12 h of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary percutaneous coronary intervention capability were randomly assigned to SES or EES. The primary endpoint was a major adverse cardiac event at 3-year follow-up. The secondary endpoints were death, reinfarction, definite or probable stent thrombosis, and target vessel revascularization at 3-year follow-up. No patient was lost to follow-up.ResultsFrom April 2007 to May 2009, 500 patients with STEMI were randomized to EES (n = 250) or SES (n = 250). No difference was observed in terms of baseline demographic and clinical characteristics between the groups. No difference was observed between the groups in terms of number of implanted stents per patient or total stent length. However, a larger reference diameter was observed with SES (3.35 ± 0.51 mm vs. 3.25 ± 0.51 mm, p = 0.001), whereas patients randomized to EES more often received glycoprotein IIb/IIIa inhibitors (54.4% vs. 42.4%, p = 0.006). Follow-up data were available in all patients (1,095 ± 159 days). No significant difference was observed between EES and SES in major adverse cardiac events (16% vs. 20.8%, adjusted hazard ratio [HR]: 0.75 [95% confidence interval (CI): 0.5 to 1.13], p = 0.17), cardiac death (4.4% vs. 5.6%, adjusted HR: 0.77 [95% CI: 0.35 to 1.71], p = 0.53), recurrent MI (6.4% vs. 10%, adjusted HR: 0.62 [95% CI: 0.33 to 1.16], p = 0.13), and target vessel revascularization (4.8% vs. 4.8%, adjusted HR: 1.00 [95% CI: 0.45 to 2.32], p = 0.99). However, EES was associated with a significant reduction in stent thrombosis (1.6% vs. 5.2%, adjusted HR: 0.3 [95% CI: 0.1 to 0.92], p = 0.035).ConclusionsThis study shows that among STEMI patients undergoing primary angioplasty, EES has similar efficacy as SES, but is associated with a significant reduction in stent thrombosis. (Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction [RACES-MI]; NCT01684982)     

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)     

Impact of Acute Coronary Syndrome Classification and Procedural Technique on Clinical Outcomes in Patients With Coronary Bifurcation Lesions Treated With Drug‐Eluting Stents

Background:

We examined the impact of non–ST‐segment elevation acute coronary syndrome (NSTE‐ACS) on clinical outcomes in patients with bifurcation lesions treated with drug‐eluting stents.

Hypothesis:

We hypothesized that NSTE‐ACS would be attributable to the increased risk of major adverse cardiac events (MACE) in bifurcation percutaneous coronary intervention.

Methods:

We enrolled 1668 patients, using data from a multicenter real‐world bifurcation registry. The primary objective was to compare the 2‐year cumulative risk of MACE in patients with NSTE‐ACS to those with stable angina. Major adverse cardiac events were defined as the composite endpoint of cardiac death, myocardial infarction (MI), and target‐lesion revascularization.

Results:

Non–ST‐segment elevation acute coronary syndrome was seen in 969 (58.1%) patients and stable angina in 699. Major adverse cardiac events occurred in 7.3% of NSTE‐ACS patients and in 5.2% with stable angina (P = 0.042). However, cardiac death, MI, and target‐lesion revascularization were similar between the 2 groups. We stratified patients with NSTE‐ACS into those with non–ST‐segment elevation MI and those with unstable angina. Cumulative risks of 2‐year MACEs were 7.0% in non–ST‐segment elevation MI patients and 7.5% in unstable angina patients (P = 0.87). In the NSTE‐ACS cohort, the baseline lesion length in the side branch (adjusted hazard ratio [HR]: 1.04, 95% confidence interval [CI]: 1.01‐1.07, P = 0.022), paclitaxel‐eluting stents in the main vessel (adjusted HR: 2.02, 95% CI: 1.21‐3.40, P = 0.008), and final kissing ballooning (adjusted HR: 1.88, 95% CI: 1.10‐3.21, P = 0.021) were independent predictors of MACE.

Conclusions:

Compared with stable angina patients, the NSTE‐ACS patients who underwent bifurcation percutaneous coronary intervention had an increased risk of MACE during the 2‐year follow‐up. Clin. Cardiol. 2012 doi: 10.1002/clc.22020 Drs Pil Sang Song and Dong Ryeol Ryu contributed equally to this work. Coronary Bifurcation Stenting (COBIS) Registry in South Korea, US Department of Health and Human Services, US National Institutes of Health, ClinicalTrials.gov no. NCT00851526. This work was supported by the Korean Society of Interventional Cardiology, Seoul, South Korea. The authors have no other funding, financial relationships, or conflicts of interest to disclose.     

Five-Year Outcomes in Patients With Chronic Total Coronary Occlusion Treated With Drug-Eluting vs Bare-Metal Stents: A Case-Control Study

Background

Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS).

Methods

We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years.

Results

After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively.

Conclusions

After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.     

Annual Incidence of Confirmed Stent Thrombosis and Clinical Predictors in Patients With ACS Treated With Ticagrelor or Prasugrel

Introduction and objectives

There is little evidence on rates of stent thrombosis (ST) in patients receiving dual antiplatelet therapy (DAPT) with ticagrelor or prasugrel. The aim of this study was to analyze the incidence and predictors of ST after an acute coronary syndrome among patients receiving DAPT with ticagrelor vs prasugrel.

Clinical Outcomes and OCT Analysis After Culotte Stenting With 2nd- and 3rd-Generation Everolimus-Eluting Stents: Two-Year Follow-Up of the CELTIC Bifurcation Study

PurposeThe aim of this study was to provide 2-year clinical outcomes for patients with Medina 1,1,1 bifurcation lesions treated with a culotte technique, comparing Synergy and Xience drug eluting stent (DES) platforms. A sub-group analysis of 9-month Optical Coherence Tomography (OCT) was performed to assess stent healing.MethodsA total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurcations were carried out on OCT images taken at 9-month follow-up.ResultsAfter 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all patients by 2 years.OCT analysis found smaller stent and lumen areas in patients treated with Synergy stents. There was a higher proportion of malapposed struts in patients treated with Xience stents.ConclusionsThe first report of the CELTIC bifurcation study demonstrated a low MACCE rate after 9 months. There was little accrual of events after this timepoint. There was no difference in clinical outcomes between the platforms tested. OCT analysis demonstrated excellent healing of both platforms.     

Amphilimus- Versus Everolimus-Eluting Stents in Patients With Diabetes Mellitus: 5-Year Follow-Up of the RESERVOIR Trial

The amphilimus-eluting stent (AES) is a thin-strut polymer-free stent that releases sirolimus formulated with a carrier from abluminal grooves. The RESERVOIR trial compared AES vs everolimus-eluting stents (EES) in patients with diabetes mellitus (DM) and showed non-inferior neointimal hyperplasia suppression at 9 months follow-up. The aim of this study was to assess comparative clinical outcomes at 5 years. The endpoints analyzed for this extended follow-up were target-vessel failure (TVF), target-vessel revascularization (TVR) and target-lesion revascularization (TLR). At 5-years, AES vs EES had similar risk of TVF (HR 0.54, 95% CI 0.20–1.47, p = 0.23), TVR (HR 0.36, 95% CI 0.12–1.14, p = 0.08) and TLR (HR 0.43, 95%CI 0.11–1.67, p = 0.22). Landmark analyses between 1 and 5 years also showed no significant differences between groups.     

Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents: BIOFLOW V Final 5-Year Outcomes

BackgroundRandomized trials have demonstrated the superiority of ultrathin strut drug-eluting stents compared with alternative stent designs. Whether these differences persist over late-term follow-up is uncertain.ObjectivesThis study sought to compare late-term (5-year) clinical outcomes among patients treated with ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81 µm) durable polymer everolimus-eluting stents (DP EES).MethodsBIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international, 2:1 randomized trial comparing percutaneous coronary intervention with ultrathin strut BP SES versus thin strut DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Prespecified outcomes through 5 years were assessed.ResultsAmong 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 5-year rates of TLF were 12.3% for BP SES and 15.3% for DP EES (P = 0.108). Revascularization with BP SES was associated with a significantly lower target vessel–related myocardial infarction (6.6% vs 10.3%, P = 0.015) and late/very late definite/probable stent thrombosis (0.3% vs 1.6%, P = 0.021). Ischemia-driven target lesion revascularization was numerically but not significantly lower with BP SES (5.9% vs 7.7%, P = 0.202). Cardiac death rates were 2.6% versus 1.9% (P = 0.495) for BP SES and DP EES, respectively.ConclusionsIn a large, randomized trial, TLF and the individual outcomes of cardiac death and target lesion revascularization at 5 years were similar among patients treated with BP SES versus DP EES. Both target vessel–related myocardial infarction and late/very late definite/probable stent thrombosis were significantly lower with BP SES. These results confirm the durability of safety and the effectiveness of percutaneous coronary intervention with ultrathin BP SES.