TIOMAX: A Spanish Multicenter Registry of the real-world use of the TItanium OptiMAX® biostent: TIOMAX: Registro Español Multicéntrico Del Biostent De Titanio OptiMAX® En La Vida Real.

OBJECTIVES: To compare the safety and efficacy of the new cobalt-chromium bioactive stent Titan Optimax® (Hexacath, France) with its predecessor, Titan-2® . BACKGROUND: The TIOMAX registry includes 784 patients who underwent percutaneous coronary intervention with these stents in 21 Spanish hospitals. METHODS: Analysis of all patients in the registry without exclusion criteria, candidates for revascularization (March-2013/July-2014). Initially 273 patients received Titan-2® , and the next 511 received the Optimax® after its launch. RESULTS: Mean age was 65.8 ± 13.0 (78.1% men); 49.2% were STEACS patients (n = 322), 29.8% NSTEACS, and 27.3% had stable angina or silent ischemia. Most STEACS patients (76.4% of n = 322) were treated <24 hr after developing symptoms. All-cause death (D), cardiac death (CD), acute myocardial infarction (AMI), and stent thrombosis (ST) at 1 month were 1.1, 0.8, 0.1, and 0.5%, respectively, with no significant differences between groups. At 1 year, the death rate was 5.5% for Titan-2 vs. 4.1% for Optimax® , CD was 1.8% for both groups, ST 1.1 vs. 0.6%, new AMI 3.3 vs. 2.5% and target lesion revascularization (TLR) 3.7 vs. 2.9%. The primary endpoint of the composite event (CE) of D/AMI/TLR/ST occurred in 10.3% vs. 7.6% (p = 0.211). Patients with STEACS (N = 322: Titan-2/Optimax: 103/209) had better outcomes for secondary events, device-oriented failure CD/AMI/TLR (7.8% vs. 5.0%; p = 0.330), and non-fatal CE of AMI/ST/TLR (7.8% vs. 2.7%, p = 0.039). CONCLUSIONS: The Titan Optimax retains the efficacy and safety of Titan 2. It appears to perform better in the subgroup of STEACS patients, by reducing the non-fatal CE of AMI/ST/TLR.

Impact of Calcified Target Lesions on the Outcome of Percutaneous Coronary Intervention for Acute Coronary Syndrome: Insights From the BASE ACS Trial.

OBJECTIVES: We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial. BACKGROUND: The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown. METHODS: The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium-nitride-oxide-coated stents or everolimus-eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months, and yearly thereafter for up to 7 years. RESULTS: Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non-fatal myocardial infarction events (P < 0.05, both). The rates of ischemia-driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity-score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions. CONCLUSIONS: Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long-term clinical outcome, compared with those treated for non-calcified lesions, mainly due to more frequent safety events. In the propensity score-matched analysis, the outcome was comparable.

4-Year outcome of bioactive stents versus everolimus-eluting stents in acute coronary syndrome.

OBJECTIVES: The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial. DESIGN: We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years. RESULTS: Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006). CONCLUSIONS: In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.

Validation of Quantitative Flow Ratio-Derived Virtual Angioplasty with Post-Angioplasty Fractional Flow Reserve-The QIMERA-I Study.

Background: Quantitative flow ratio (QFR) virtual angioplasty with pre-PCI residual QFR showed better results compared with an angiographic approach to assess post-PCI functional results. However, correlation with pre-PCI residual QFR and post-PCI fractional flow reserve (FFR) is lacking. Methods: A multicenter prospective study including consecutive patients with angiographically 50-90% coronary lesions and positive QFR results. All patients were evaluated with QFR, hyperemic and non-hyperemic pressure ratios (NHPR) before and after the index PCI. Pre-PCI residual QFR (virtual angioplasty) was calculated and compared with post-PCI fractional flow reserve (FFR), QFR and NHPR. Results: A total of 84 patients with 92 treated coronary lesions were included, with a mean age of 65.5 ± 10.9 years and 59% of single vessel lesions being the left anterior descending artery in 69%. The mean vessel diameter was 2.82 ± 0.41 mm. Procedural success was achieved in all cases, with a mean number of implanted stents of 1.17 ± 0.46. The baseline QFR value was 0.69 ± 0.12 and baseline FFR and NHPR were 0.73 ± 0.08 and 0.82 ± 0.11, respectively. Mean post-PCI FFR increased to 0.87 ± 0.05 whereas residual QFR had been estimated as 0.95 ± 0.05, showing poor correlation with post-PCI FFR (0.163; 95% CI:0.078-0.386) and low diagnostic accuracy (30.9%, 95% CI:20-43%). Conclusions: In this analysis, the results of QFR-based virtual angioplasty did not seem to accurately correlate with post-PCI FFR.

Continuous Thermodilution Method to Assess Coronary Flow Reserve.

Coronary flow reserve (CFR) is a well-validated flow-based physiological parameter that has shown value in clinical risk stratification. CFR can be invasively assessed, classically by Doppler and, more recently, by thermodilution with saline boluses (CFRthermo-bolus). Alternatively, continuous thermodilution is a novel operator-independent, highly-reproducible technique to invasively quantify maximum absolute coronary flow (AF). This study aimed to assess the feasibility of this method to quantify resting AF and to determine CFR (CFRThermo-infusion) as compared with CFRthermo-bolus. Sixty-two consecutive patients with suspicion of coronary disease and absence of significant epicardial lesions were prospectively investigated. AF at maximal hyperemia (20 mL/min) and at lower infusion rates (6-8-10-12 mL/min) were systematically measured using a dedicated catheter and a temperature/pressure guidewire. The absence of baseline Pd/Pa decrease at 6 (0.15 ± 0.2%), 8 (0.17 ± 0.18%) and 10 mL/min (0.2 ± 0.12%) demonstrated absence of hyperemia at ≤10 mL/min (all p = NS). However, at 12 mL/min hyperemia was confirmed by a significant decrease in Pd/Pa (1.3 ± 1.5%, p <0.01) and increase in AF from 10 mL/min to 12 mL/min (31.4 ± 28.1 mL, p <0.05). All curve tracings at 10 mL/min (129/129, 100%) were adequate versus only (7/15, 53%) and (15/18, 17%) at 6 mL/min, and 8 mL/min, respectively, and this infusion-rate was considered to determine resting-AF. CFRThermo-infusion was determined as the ratio of hyperemic-AF (20 mL/min) by resting-AF (10 mL/min). Mean CFRThermo-infusion was 2.56 ± 0.9 and CFRthermo-bolus 2.49 ± 1. Both parameters showed a good correlation (r = 0.76; p <0.001) and intraclass agreement (ICC = 0.76; p <0.001).The continuous thermodilution method enables to quantify resting-AF providing a novel clinical tool to determine CRF. CFRThermo-infusion shows a good correlation with CFRthermo-bolus..

Long-term clinical outcome of titanium-nitride-oxide-coated stents versus everolimus-eluting stents in acute coronary syndrome: Final report of the BASE ACS trial.

BACKGROUND: The BASE ACS randomized trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), compared with everolimus-eluting stents (EES), for the primary endpoint of major adverse cardiac events (MACE) in patients presenting with acute coronary syndrome (ACS) at 12-month follow-up. We report the final long-term clinical outcome of the trial. METHODS: We randomly assigned 827 patients with ACS to receive either BAS (417) or EES (410). The primary endpoint was MACE: a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analysis was performed by intention to treat. Follow-up was planned at 12months, and yearly thereafter through 7years. RESULTS: Mean follow-up duration was 4.2±1.9years (median 5.0years). At 5-year follow-up, BAS was non-inferior to EES for the primary endpoint of MACE (14.4% versus 17.8%, respectively; hazard ratio for BAS versus EES, 0.82; 95% confidence interval, 0.58-1.16; p=0.26 for superiority; p<0.001 for non-inferiority). The rate of non-fatal MI was lower in the BAS group (5.9% versus 9.7%, respectively, p=0.028). The rates of cardiac death and ischemia-driven TLR were comparable (2.8% versus 3.8%, and 8.3% versus 9.9%; p=0.76 and p=0.58, respectively). CONCLUSIONS: In the current final report of the randomized BASE ACS trial in patients with ACS, BAS implantation was associated with a rate of cumulative MACE at long-term follow-up that was statistically non-inferior to EES.

Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2.

INTRODUCTION AND OBJECTIVES: The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. METHODS: A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. RESULTS: The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen.

Stent-oriented versus patient-oriented outcome in patients undergoing early percutaneous coronary intervention for acute coronary syndrome: 2-year report from the BASE-ACS trial.

BACKGROUND: The BASE-ACS trial demonstrated an outcome of the titanium-nitride-oxide-coated bioactive stents (BAS) statistically non-inferior to that of the everolimus-eluting stents (EES) at 12-month follow-up in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial with particular focus on stent-oriented versus patient-oriented outcome at 24-month follow-up. METHODS: A total of 827 patients with ACS were randomly assigned to receive either BAS (417) or EES (410). Stent-oriented outcome was defined as a composite of cardiac death, target vessel-related non-fatal myocardial infarction, or ischemia-driven target lesion revascularization. Patient-oriented outcome was defined as a composite of all-cause death, any non-fatal myocardial infarction, or any revascularization. RESULTS: Clinical follow-up for 24 months was completed in 406 (97.4%) patients in the BAS group and in 398 (97.1%) in the EES group. Stent-oriented outcome at 24-month follow-up occurred at similar frequencies in the two stent groups (10.1% for BAS versus 11.2% for EES, P=0.53). Likewise, patient-oriented outcome at 24-month follow-up was similar in the two groups (16.3% versus 19.8%, respectively, P=0.2). CONCLUSIONS: In patients presenting with ACS, the rates of both stent-oriented and patient-oriented outcomes at 24-month follow-up in the BAS group were similar to those in the EES group.

A prospective randomised comparison of titanium-nitride-oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome: the BASE-ACS trial.

AIMS: Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when compared with paclitaxel-eluting stents in patients with acute myocardial infarction (MI). In a prospective randomised non-inferiority study design, we compared the safety and efficacy of BAS versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: We randomised 827 patients with ACS (1:1) to either BAS (417) or EES (410). The primary endpoint was a composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) at 12-month follow-up. Analyses were performed by intention to treat. At 12-month follow-up, the primary composite endpoint occurred in 9.6% of patients in the BAS group and 9.0% of those in the EES group (HR [hazard ratio] 1.04, 95% CI [confidence interval] 0.81-1.32, p=0.81, p for non-inferiority =0.001). Non-fatal MI was significantly less frequent in the BAS as compared with the EES group (2.2% vs. 5.9%, p=0.007). However, the individual rates of cardiac death and ischaemia-driven TLR were similar between the two groups (1.9% vs. 1.0%, p=0.39, and 6.5% vs. 4.9%, p=0.37, respectively). CONCLUSIONS: In patients presenting with ACS, BAS achieved a clinical outcome that was non-inferior to EES at 12-month follow-up.