Target Vessel Failure Research Articles

BIOFLOW-III satellite-One-year clinical outcomes of diabetic patients treated with a biodegradable polymer sirolimus-eluting stent and comprehensive medical surveillance.

Drug-eluting stents with biodegradable polymer might be particularly useful in diabetic patients who are at increased risk for target lesion/target vessel revascularization. We therefore aimed at assessing the safety and performance of a biodegradable polymer sirolimus-eluting stent (BP-SES) in combination with comprehensive optimal medical therapy following coronary interventions. This prospective, multicenter registry was conducted at six centers in Israel. Aside of stent treatment, we aimed for an LDL-C level<70mg/dl; at one and six months post-intervention a diabetic consultancy was required, and follow-up data were collected at six and twelve months. The primary outcome measure was target vessel failure, a composite of cardiac death, target-vessel myocardial infarction and clinically driven target vessel revascularization. Secondary outcomes were target lesion failure, its individual components, and stent thrombosis. From August 2013 until May 2014, 120 diabetic patients with 158 lesions were treated with a BP-SES. Mean age was 63.9±9.2years, 27.5% were insulin dependent, 28.3% had a history of myocardial infarction, and 47.5% had prior coronary interventions. By visual estimation, lesions were 3.0±0.5mm in diameter and 15.2±7.4mm long; mean stent diameter and length were 3.0±0.5mm and 19.2±6.8mm. Target vessel failure and target lesion failure at 12months occurred in seven (6.4% [95% CI: 3.1-13.0]) and four patients (3.5% [95% CI: 1.3-9.2]), respectively, and definite stent thrombosis in one patient (1.0% [95% CI: 0.1-7.0]). Treatment with a BP-SES demonstrated excellent target-vessel and target-lesion revascularization rates in a high-risk diabetic patient population undergoing catheter-based revascularization followed by intensified medical care. In 120 high-risk diabetic patients with coronary artery stenosis, treatment with the Orsiro sirolimus-eluting stent with biodegradable polymer and comprehensive antidiabetic therapy resulted in excellent clinical outcomes. Target vessel revascularization occurred in 6.4% of patients and target lesion revascularization in 3.5%.

Rationale and design of the Japan-USA harmonized assessment by randomized, multicenter study of OrbusNEich's combo StEnt (Japan-USA HARMONEE): Assessment of a novel DES platform for percutaneous coronary revascularization in patients with ischemic coronary disease and non–ST-elevation acute coronary syndrome

Tissue trauma associated with stent implantation continues to generate early thrombosis rates of 0.9% to 1.3% for both bare-metal and drug-eluting stent platforms. The Combo sirolimus-eluting stent combines an abluminal, bioabsorbable polymer with a luminal CD34+ antibody designed to capture endothelial progenitor cells. This article describes the design and methods of the HARMONEE trial (NCT02073565), which represents the first randomized controlled trial of the Combo design against a best-in-class contemporary everolimus-eluting stent. Up to 50 sites in Japan and the United States will enroll 286 subjects (271 evaluable) in each of 2 arms, for a total sample size of 572 subjects (542 evaluable). The statistical plan includes both superiority to imputed bare-metal stent control and noninferiority to everolimus-eluting stent on a primary clinical end point of target vessel failure at 1 year. In addition, fractional flow reserve assessment to evaluate the physiology of target vessels in the entire population will augment the end point definition of ischemia-driven target vessel revascularization. Finally, key safety considerations will be evaluated with a subpopulation with optical coherence tomography imaging for strut coverage, late strut malapposition, and plaque volume, as well as serial human antimurine antibody assessments. As the first international prospective randomized coronary intervention study under the "Harmonization by Doing" program, this study represents a unique collaboration between regulators and investigators in Japan and the United States.

Everolimus- versus zotarolimus-eluting stent following percutaneous coronary chronic total occlusion intervention

BackgroundAlthough studies have demonstrated comparable efficacy and safety profiles of everolimus- and zotarolimus-eluting stents (EES and ZES, respectively) for a broad spectrum of coronary artery diseases, there is paucity of data concerning their safety and efficacy for coronary chronic total occlusions (CTOs). This study compared the clinical performance of EES and ZES following successful percutaneous coronary intervention for CTOs. MethodsThe cohort included 539 consecutive CTO patients who underwent successful PCI using EES (n=313) and ZES (n=226) between September 2006 and August 2014. The primary outcome was defined as the composite of death, myocardial infarction, and target vessel revascularization. ResultsDuring a median follow-up of 3.3years, in both groups, the primary outcome occurred in 12.2% of patients. After multivariable adjustment, no significant difference was observed between the two groups in the risk of primary outcome [hazard ratio (HR) 1.03, 95% confidence interval (CI) 0.59–1.79, P=0.930 for ZES compared with EES]. Similarly, there were no significant differences in the risk of death (adjusted HR 0.96, 95% CI 0.43–2.15, P=925), death or myocardial infarction (adjusted HR 0.93, 95% CI 0.46–1.88, P=0.829), and target vessel failure (adjusted HR 0.96, 95% CI 0.51–1.82, P=0.902). The incidence of definite/probable stent thrombosis was relatively low [0% (ZES) vs. 1.0% (EES), P=0.19]. ConclusionNo significant differences were observed between EES and ZES in terms of clinical outcomes for coronary CTOs at 3.3years.

Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): the PLATINUM PLUS all-comers randomised trial.

The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES. We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44). At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.

Midterm and one-year outcome of amphilimus polymer free drug eluting stent in patients needing short dual antiplatelet therapy. Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTer rEgistry)

BackgroundTo assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. MethodsWe performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥type-3a) at 6-month and 1-year. Results106 patients (8.7%) were discharged with ≤3-month DAPT (83±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p=0.007) with all bleeding events occurred within 3months. The landmark analysis (started at 90days, ended at 1year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). ConclusionsThe results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings.

9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

ObjectivesThe aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. BackgroundPolyzene-F–coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. MethodsPatients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. ResultsOf 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. ConclusionsThe COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.

Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): the PLATINUM PLUS all-comers randomised trial.

The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES. We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44). At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.

Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial

ObjectivesThe aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). BackgroundThe introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. MethodsIn this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. ResultsOverall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: −0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. ConclusionsThis randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.

Ezetimibe in Combination With Statins Ameliorates Endothelial Dysfunction in Coronary Arteries After Stenting: The CuVIC Trial (Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction After Coronary Stenting), a Multicenter Randomized Controlled Trial.

We sought to investigate whether treatment with ezetimibe in combination with statins improves coronary endothelial function in target vessels in coronary artery disease patients after coronary stenting. We conducted a multicenter, prospective, randomized, open-label, blinded-end point trial among 11 cardiovascular treatment centers. From 2011 to 2013, 260 coronary artery disease patients who underwent coronary stenting were randomly allocated to 2 arms (statin monotherapy, S versus ezetimibe [10 mg/d]+statin combinational therapy, E+S). We defined target vessel dysfunction as the primary composite outcome, which comprised target vessel failure during treatment and at the 6- to 8-month follow-up coronary angiography and coronary endothelial dysfunction determined via intracoronary acetylcholine testing performed in cases without target vessel failure at the follow-up coronary angiography. Coadministration of ezetimibe with statins further lowered low-density lipoprotein cholesterol levels (83±23 mg/dL in S versus 67±23 mg/dL in E+S; P<0.0001), with significant decreases in oxidized low-density lipoprotein and oxysterol levels. Among patients without target vessel failure, 46 out of 89 patients (52%) in the S arm and 34 out of 96 patients (35%) in the E+S arm were found to have coronary endothelial dysfunction (P=0.0256), and the incidence of target vessel dysfunction at follow-up was significantly decreased in the E+S arm (69/112 (62%) in S versus 47/109 (43%) in E+S; P=0.0059). A post hoc analysis of post-treatment low-density lipoprotein cholesterol-matched subgroups revealed that the incidence of both target vessel dysfunction and coronary endothelial dysfunction significantly decreased in the E+S arm, with significant reductions in oxysterol levels. The CuVIC trial (Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction after Coronary Stenting) has shown that ezetimibe with statins, compared with statin monotherapy, improves functional prognoses, ameliorating endothelial dysfunction in stented coronary arteries, and was associated with larger decreases in oxysterol levels.

Bioresorbable scaffold implantation in patients with indication for oral anticoagulation: A propensity matched analysis

ObjectivesTo examine ischemic and bleeding outcomes in patients on triple antithrombotic therapy (TAT) compared with dual antiplatelet therapy (DAPT) after the implantation of bioresorbable scaffolds (BRS). BackgroundThe optimal antithrombotic regimen in patients undergoing percutaneous coronary intervention that have an indication for oral anticoagulation is unclear, in particular among those undergoing BRS implantation. MethodsConsecutive patients of a single-center, all-comers BRS registry were included. Patients were followed up after 30days, 6 and 12months, and thereafter yearly. Outcome parameters were target vessel failure (TVF), major adverse cardiac events (MACE) including target lesion revascularization (TLR), scaffold thrombosis (ST), death, myocardial infarction, and any bleeding as defined by BARC. Patients on TAT were matched to patients on DAPT. ResultsA total of 607 patients were included. Fifty-five patients receiving TAT were matched with 165 patients treated with DAPT. Acute coronary syndrome was an indication for coronary angiography in 50.9% vs 50.4% groups (p=0.97). Major adverse cardiac events occurred in 16.4% of TAT patients vs. 8.9% DAPT patients (p=0.12), TLR in 5.5% vs. 1.9% (p=0.17), ST in 3.6% vs. 1.9% (p=0.46), and TVF in 3.6 vs. 1.9% (p=0.46). Patients died in 7.3% in the TAT group vs. 5.1% in the DAPT group (p=0.26). No severe bleeding was recorded in either of the groups. ConclusionThere was no difference in bleeding or ischemic events between the patients on TAT and those on DAPT after BRS implantation. The high rate of scaffold thrombosis in all of these patients, however, is not negligible.

Biodegradable polymer-based, argatroban-eluting, cobalt-chromium stent (JF-04) for treatment of native coronary lesions: final results of the first-in-man study and lessons learned.

The aim of the study was to investigate the six-month angiographic and nine-month clinical follow-up outcomes in a first-in-man study using the biodegradable polymer-based cobalt-chromium argatroban-eluting stent (JF-04) for treatment of native coronary atherosclerotic lesions. A total of 31 patients with either stable or unstable angina, or silent myocardial ischaemia, exhibiting de novo coronary lesions were enrolled at seven Japanese sites. The lesions were treated with the JF-04 stent after predilatation. The primary endpoint was angiographic in-stent late loss six months after implantation. The secondary endpoints included angiographic restenosis and in-stent volume obstruction by intravascular ultrasound at six months and target vessel failure (TVF) at nine months. Procedural success was achieved in 100% of cases. At six months, angiographic in-stent late loss was 1.01±0.48 mm and binary restenosis was observed in nine cases (29.0%). Among these restenotic cases, most (n=8) demonstrated advanced angiographic restenosis patterns, including diffuse/proliferative restenosis and total occlusion. At nine months, TVF was observed in four cases (12.9%), exclusively attributed to target vessel revascularisation. This argatroban-eluting stent failed to inhibit neointimal hyperplasia sufficiently, despite the theoretical benefits and promising clinical experience with local drug delivery.

TCT-357 Impact of Gender and Age on 3-Year Clinical Outcome and Chest Pain of Patients With Coronary Artery Disease Treated With Contemporary Drug-Eluting Stents: A Patient-Level Pooled Analysis

BACKGROUND Women report more often chest pain following percutaneous coronary intervention (PCI), yet little is known about the impact of age on these symptoms. We aimed to assess age and gender-related differences in chest pain following PCI with newergeneration drug-eluting stents (DES). METHODS A patient-level pooled analysis of the TWENTE and DUTCH PEERS randomized trials (NCT01066650; NCT01331707) was performed, in which patients were treated with newer generation permanent polymer DES. The primary endpoint of both studies was target vessel failure (TVF); secondary endpoints included MACE (composite of any death, any myocardial infarction (MI), emergent CABG or target lesion revascularization) and POCE (composite of any death, any MI and any revascularization). RESULTS Clinical follow-up was available in 3,188 patients (99.8%). Women had more risk factors including diabetes (24.2% vs. 17.8%, p65 years. Women 65 years, both women and men reported similar levels of chest pain at rest or mild exertion (8.8% and 8.7%, p=0.76); in this subgroup gender did not independently predict chest pain (adjusted OR 1.27 95%-CI:0.8-1.9, p=0.26). Nevertheless, in women and men similar 3-year rates of TVF, MACE, and POCE were found (11.6% vs. 11.3%, p=0.81; 13.6% vs. 12.5%, p=0.43; 18.8% vs. 18.0%, p=0.60, respectively). CONCLUSION While for both genders the incidence of adverse cardiovascular events was low and similar, women

TCT-326 Major predictors of long-term clinical outcomes after percutaneous coronary intervention for coronary bifurcation lesions with 2-stent strategy: Patient-Level Analysis of the Korean Bifurcation Pooled Cohorts

Purpose: We investigated outcomes and predictors of target vessel failure (TVF) in patients with bifurcation lesion treated by PCI utilizing the 2-stent strategy with drug-eluting stent (DES). Meth...

Procedural and Long-Term Outcomes of Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions

There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions. We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43±1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS- and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS. Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings.

Long-term outcome of patients with very small coronary artery disease: A comparison of drug-eluting and bare metal stents

BackgroundAmong patients with very small vessel disease and chronic kidney disease (CKD), the comparative efficacy of bare metal stents (BMSs) versus drug-eluting stents (DESs) is not frequently addressed. This study aimed to evaluate the long-term outcomes of patients with very small vessel disease managed with percutaneous coronary intervention. MethodsOur study included 158 consecutive patients undergoing percutaneous coronary intervention from January 2003 to December 2013. The primary end points were cardiovascular death and target vessel failure, which consisted of cardiovascular death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. ResultsBMSs were used in 37 patients, while DESs were utilized in 121 patients. During the mean follow-up period of 2.7 ± 2.2 years (median 2.1 years; interquartile range, 1.3−4.2 years), the target vessel failure rate was 48.6% versus 28.1% (BMS vs. DES, p = 0.020) and the cardiovascular death rate was 27% versus 18.2% (BMS vs. DES, p = 0.241). The use of a DES (hazard ratio: 0.44, 95% confidence interval: 0.24–0.79, p = 0.006) remained the most significant predictor of target vessel failure after multivariate analysis. In CKD subgroup analysis, the benefit of a 2.25 mm DES was evident only in the subgroup with CKD, but such a benefit disappeared in those without CKD. ConclusionCompared with BMSs, implantation of DESs in a patient population with very small vessel disease effectively reduced target vessel failure. However, the beneficial effects of DESs appeared to be evident only in the subgroup with CKD.

Long-Term Prognosis of Deferred Acute Coronary Syndrome Lesions Based on Nonischemic Fractional Flow Reserve

BackgroundDeferring percutaneous coronary intervention in nonischemic lesions by fractional flow reserve (FFR) is associated with excellent long-term prognosis in patients with stable ischemic heart disease (SIHD). Although FFR is increasingly used for clinical decision making in acute coronary syndrome (ACS) patients with intermediate lesions, its effect on long-term prognosis has not been well established. ObjectivesThis study investigated the clinical and prognostic utility of FFR in ACS patients with percutaneous coronary intervention deferred on the basis of nonischemic FFR. MethodsWe studied 206 consecutive ACS patients with 262 intermediate lesions and 370 patients with SIHD (528 lesions) in whom revascularization was deferred on the basis of a nonischemic FFR (>0.75). The primary outcome measure was a composite of myocardial infarction and target vessel failure (major adverse cardiovascular events [MACE]). ResultsIn the entire cohort, the long-term (3.4 ± 1.6 years) MACE rate was higher in the ACS group than in the SIHD group (23% vs. 11%, p < 0.0001). After propensity score matching (200 patients/group), MACE remained significantly higher (ACS 25% vs. SIHD 12%; p < 0.0001). On Cox proportional hazards analysis for MACE, ACS had a hazard ratio of 2.8 (95% confidence interval: 1.9 to 4.0; p < 0.0001). In both the matched and unmatched cohorts, across all FFR categories, ACS patients had a significantly higher annualized myocardial infarction/target vessel revascularization rate compared with SIHD (p < 0.05). Receiver-operating characteristic analysis identified FFR cutoffs (best predictive accuracy for MACE) of <0.84 for ACS (MACE 21% vs. 36%; p = 0.007) and <0.81 for SIHD (MACE 17% vs. 9%; p = 0.01). ConclusionsDeferring percutaneous coronary intervention on the basis of nonischemic FFR in patients with an initial presentation of ACS is associated with significantly worse outcomes than SIHD. Caution is warranted in using FFR values derived from patients with SIHD for clinical decision making in ACS patients.

Major Predictors of Long-Term Clinical Outcomes After Percutaneous Coronary Intervention for Coronary Bifurcation Lesions With 2-Stent Strategy: Patient-Level Analysis of the Korean Bifurcation PooledCohorts.

This study investigated the long-term outcomes and predictors of target vessel failure (a composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization) in patients with bifurcation lesion treated by percutaneous coronary intervention (PCI) utilizing the 2-stent strategy with a drug-eluting stent(DES). There are limited data on outcomes of the 2-stent strategy in bifurcation PCI. Patient-level pooled analysis was performed with patients undergoing PCI with 2-stent strategy from the Korean Bifurcation Pooled Cohorts. A total of 951 patients (70.7% men) with a median age of 64 years underwent bifurcation PCI with the 2-stent strategy. True bifurcation was observed in 73.2% of patients and 39.1% of patients had left main bifurcation lesions. The crush technique was used most frequently (44.4%) and final kissing ballooning was performed in 83.6%. The 3-year cumulative incidence of target vessel failure, cardiac death, myocardial infarction, stent thrombosis, and target vessel revascularization was 17.0%, 2.3%, 2.5%, 1.7%, and 14.3%, respectively. The independent predictors of target vessel failure were left main bifurcation (adjusted hazard ratio [HR]: 2.09; 95% confidence interval [CI]: 1.43 to 3.03), high Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score (>32; adjusted HR: 2.00; 95% CI: 1.28 to 3.14), diabetes mellitus (adjusted HR: 1.41; 95% CI: 1.00 to 1.99), second-generation DES (adjusted HR: 0.26; 95% CI: 0.12 to 0.57), use of noncompliant balloon (adjusted HR: 0.53, 95% CI: 0.36 to 0.79), and final kissing ballooning (adjusted HR: 0.44; 95% CI: 0.29 to 0.68). 2-stent strategy with DES is associated with feasible procedural and acceptable long-term clinical outcomes in bifurcation PCI. Several characteristics were identified as important periprocedural predictors of long-term adverse outcomes.

Resultados de los stents Resolute Integrity y Promus Element en el infarto de miocardio: análisis del ensayo aleatorizado DUTCH PEERS (TWENTE II)

Introduction and objectivesIn acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. MethodsThe prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non—ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. ResultsOf all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF: 5.1% vs 4.9%; P = .81) and 447 patients with non—ST-segment elevation MI (TVF: 9.0% vs 7.5%; P = .56). ConclusionsResolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.Full English text available from:www.revespcardiol.org/en

Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From the DUTCH PEERS (TWENTE II) Randomized Trial

Introduction and objectivesIn acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. MethodsThe prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non—ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. ResultsOf all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non—ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56). ConclusionsResolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.

Two-year outcome after treatment of severely calcified lesions with newer-generation drug-eluting stents in acute coronary syndromes: A patient-level pooled analysis from TWENTE and DUTCH PEERS

BackgroundData on medium-term outcome of patients with acute coronary syndrome (ACS), treated with newer-generation durable polymer drug-eluting stents (DES) in severely calcified coronary lesions, are scarce. We aimed to assess the impact of severe coronary lesion calcification on clinical outcome of patients with ACS, treated with newer-generation DES. MethodsThe TWENTE and DUTCH PEERS randomized trials comprise 1779 ACS patients, who were categorized into patients with versus without severe target lesion calcification. We performed a patient-level pooled analysis to assess 2-year outcome, including target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or target vessel revascularization (TVR). ResultsPatients with severe target lesion calcification (n=340, 19.1%) were older (66.8±10.6 years vs. 62.8±11.5 years, p<0.001) and had more often diabetes (22.1% vs. 16.8%, p=0.02) and hypercholesterolemia (51.5% vs. 42.9%, p=0.005) than other patients (n=1439, 79.9%). In addition they showed a higher TVF rate (12.4% vs.7.0%, p=0.001), mainly related to a difference in TVR (6.8% vs. 3.3%, p=0.003). There was a borderline significant between-group difference in cardiac death (3.6% vs. 1.8%, p=0.05), but not in target vessel MI (3.8% vs.2.6%, p=0.23) and definite stent thrombosis (0.9% vs. 0.6%, p=0.71). Multivariate analysis demonstrated that severe lesion calcification was an independent risk factor of TVF (adjusted HR; 1.58, 95% CI: 1.23–2.03; p<0.001). ConclusionsIn patients with ACS, treatment of severely calcified lesions with newer-generation DES was associated with an overall higher clinical event risk – related in particular to a higher TVR rate, while the risk of MI was low.