Angiographic Endpoints Research Articles

Randomized trial of standard versus ClearWay-infused abciximab and thrombectomy in myocardial infarction

Patients with ST-elevation myocardial infarction (STEMI) are at substantial risk of suboptimal procedural results and late adverse events. Angiography and optical coherence tomography (OCT) studies have identified residual coronary thrombus and microcirculatory injury as potential culprits for these adverse outcomes. We hypothesized that coronary thrombectomy and local infusion of glycoprotein IIb/IIIa inhibitors by means of a dedicated infusion device can synergistically improve results of percutaneous coronary intervention (PCI) for STEMI, as appraised by OCT. A total of 128 patients with STEMI will be randomized, to one of the following: abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A), thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration (groups C or T+C) will result in a significant reduction of intrastent thrombus formations when compared with intravenous or intracoronary abciximab with or without thrombectomy (groups A or T+A). The primary endpoint will be the number of cross-sections with thrombus area more than 10% immediately after stent implantation as assessed with OCT. Additional angiographic, ECG and clinical endpoints will be collected and adjudicated. This trial will provide important mechanistic insights on the most appropriate invasive treatment strategy for patients with STEMI and significant thrombus burden, by exploiting its factorial design and reliance on sensitive OCT endpoints.

Polymer-free Sirolimus-eluting Versus Polymer-based Paclitaxel-eluting Stents: An Individual Patient Data Analysis of Randomized Trials

Introduction and objectivesThe angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate. We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents. MethodsPatient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the 2 drug-eluting stents (ISAR-TEST) clinical trial and the LIPSIA Yukon clinical trial (randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus) were pooled. The angiographic (primary) endpoint was in-stent late lumen loss at 6 months to 9 months. The clinical (secondary) endpoints were death or myocardial infarction, cardiac death or myocardial infarction, target lesion revascularization, and myocardial infarction. ResultsA total of 686 patients (polymer-free sirolimus-eluting stents, n=345 vs polymer-based paclitaxel-eluting stents, n=341) and 751 lesions (polymer-free sirolimus-eluting stents, n=383 vs polymer-based paclitaxel-eluting stents, n=368) were included in the study. Control angiography (606 lesions, 80.6%) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents (0.53 [0.59] mm vs 0.46 [0.57] mm; P=.15). Median follow-up was 34.8 months. Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0.49-2.80; P=.71), cardiac death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0.72-1.89; P=.50), target lesion revascularization (relative risk=0.98; 95% confidence interval, 0.65-1.47; P=.93), and myocardial infarction (relative risk=1.79; 95% confidence interval, 0.85-3.76; P=.12). ConclusionsIn this pooled analysis, polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy.

Stents liberadores de rapamicina sin polímero frente a stents liberadores de paclitaxel con polímero: un análisis de datos de pacientes procedentes de ensayos aleatorizados

Introduction and objectivesThe angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate. We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents. MethodsPatient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the 2 drug-eluting stents (ISAR-TEST) clinical trial and the LIPSIA Yukon clinical trial (randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus) were pooled. The angiographic (primary) endpoint was in-stent late lumen loss at 6 months to 9 months. The clinical (secondary) endpoints were death or myocardial infarction, cardiac death or myocardial infarction, target lesion revascularization, and myocardial infarction. ResultsA total of 686 patients (polymer-free sirolimus-eluting stents, n=345 vs polymer-based paclitaxel-eluting stents, n=341) and 751 lesions (polymer-free sirolimus-eluting stents, n=383 vs polymer-based paclitaxel-eluting stents, n=368) were included in the study. Control angiography (606 lesions, 80.6%) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents (0,53 [0,59] mm vs 0,46 [0,57] mm; P=.15). Median follow-up was 34.8 months. Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0,49-2.80; P=.71), cardiac death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0,72-1.89; P=.50), target lesion revascularization (relative risk=0,98; 95% confidence interval, 0,65-1.47; P=.93), and myocardial infarction (relative risk=1.79; 95% confidence interval, 0,85-3.76; P=.12). ConclusionsIn this pooled analysis, polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy.Full English text available from:www.revespcardiol.org.

The REMEDEE Trial: A Randomized Comparison of a Combination Sirolimus-Eluting Endothelial Progenitor Cell Capture Stent With a Paclitaxel-Eluting Stent

This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months. Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations. One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events. The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group. In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.

Objective Assessment of Transcatheter Arterial Chemoembolization Angiographic Endpoints: Preliminary Study of Quantitative Digital Subtraction Angiography

PurposeTo explore the significance of quantitative digital subtraction angiography (DSA; Q-DSA) in the assessment of chemoembolization endpoints. Materials and MethodsTwenty patients with hepatocellular carcinoma treated with chemoembolization were included in the study. All DSA series before and after chemoembolization were postprocessed with Q-DSA. The maximal enhancement and time to peak (TTP) were measured for several homologous anatomic landmarks, including the origin and embolized site of the tumor-feeding artery, parenchyma of the tumor, and ostia of the pre- and postprocedure catheter. The TTP, tumor blood supply time, and maximal enhancement of the time density curve (TDC) were analyzed. ResultsOf the 20 DSA series collected, 18 were successfully postprocessed. The TTPs of the landmarks before and after treatment were 3.60 seconds±1.02 and 3.57 seconds±0.78 at the ostia of the catheter, 3.91 seconds±1.01 and 4.09 seconds±1.14 at the origin site of the tumor-feeding artery, and 4.07 seconds±1.02 and 5.60 seconds±1.56 s the embolized site of the main tumor-feeding artery, respectively. Statistical differences were detected between pre- and postprocedural TTP of the embolized site of the feeding artery (P<.01), as well as between pre- and postprocedural tumor blood supply time (P<.01). The mean maximal TDC enhancements of selected tumor spots were 3.01 units±1.04 and 0.81 units±0.35 before and after the procedure (P<.01), respectively. ConclusionsQ-DSA may provide a feasible quantitative measurement in the assessment of chemoembolization endpoints.

Resolute zotarolimus-eluting stent to treat bifurcated lesions according to the provisional technique: A procedural performance comparison with sirolimus- and everolimus-eluting stents

Different drug-eluting stents (DES) may have different performance in bifurcation PCI. Thus, we compared the performance of a novel zotarolimus-eluting stent (ZRS) with that obtained using two other DES in bifurcation PCI. Consecutive patients with bifurcated lesions undergoing DES implantation were treated by a provisional approach with sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) during a former period, and then by ZRS in a second period. The PCI procedural details were prospectively recorded and angiographic results were evaluated by a 3-dimensional quantitative coronary analysis software. Primary procedural end-point was "side-branch (SB) trouble" (occurrence, after MV stenting, of: SB TIMI flow<3 or need of specific wires for SB rewiring, or failure to re-wire/dilate the SB). Primary angiographic end-point was post-PCI minimal-lumen-diameter at SB-ostium. During the study, 225 patients were enrolled and treated by ZRS (n=75), by SES (n=75) or by EES (n=75). Among procedural characteristics, "SB trouble" occurred in 4% of patients treated by ZRS, a figure significantly lower compared to SES (16%, P=0.014) and non-significantly lower compared to EES (11%, P=0.12). At multivariable analysis, DES type, pre-PCI SB flow <3 and bifurcation complexity were the only predictors of "SB trouble". After the procedure, minimal-lumen-diameter at SB ostium was significantly larger with ZRS compared to SES (1.94 vs. 1.64 mm, P=0.008) and similar to that of EES. ZRS is associated to improved performance and SB angiographic results compared to SES. These results support the hypothesis that DES selection may influence the procedural course and the acute angiographic result of bifurcation PCI.

CRT-63 Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation A Novolimus-eluting Coronary Stent System With Bioabsorbable Polymer Compared To a Zotarolimus-eluting Coronary Stent System: 12- Month Clinical And 6-month Angiographic and IVUS Results: The Excella BD Study

To evaluate the safety and effectiveness of the Elixir DESyneTM BD Novolimus Eluting Coronary Stent System (CSS) with a bioabsorbable polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System through the assessment of clinical, angiographic, and IVUS endpoints. 149 patients were

CRT-65 Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation Of The Elixir DESyneTm Novolimus-eluting Coronary Stent System With Durable Polymer Compared To The Endeavor Zotarolimus-eluting Coronary Stent System: 3-year Clinical Results And 9-month Angiographic And IVUS Results: The Excella II Study

To evaluate safety and effectiveness of the Elixir DESyneTM Novolimus-Eluting Coronary Stent System (CSS) compared to the Endeavor Zotarolimus-Eluting CSS through assessment of clinical, angiographic, and IVUS endpoints. 210 patients were randomized 2:1 either to the DESyne CSS loaded with 5mcg per

Abstract 18720: Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation a Novolimus-Eluting Coronary Stent System with Bioabsorbable Polymer Compared to a Zotarolimus-Eluting Coronary Stent System: 12- Month Clinical and 6-Month Angiographic and IVUS Results: the EXCELLA BD Study

Aims: To evaluate the safety and effectiveness of the Elixir DESyne TM BD Novolimus Eluting Coronary Stent System (CSS) with a bioabsorbable polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System through the assessment of clinical, angiographic, and IVUS endpoints. Method and Results: 149 patients were randomized 3:1, either to the Elixir DESyne BD Novolimus Eluting CSS loaded with 5mcg per mm of stent length of Novolimus, a sirolimus metabolite, eluted via a bioabsorbable polylactide-based polymer, or to the Endeavor Zotarolimus-eluting CSS loaded with 10mcg per mm of stent length of Zotarolimus eluted via a durable phosphoryl choline polymer. All patients were analyzed for the primary endpoint of in-stent late lumen loss (LLL) assessed by QCA at 6 months. Moreover, all patients underwent evaluation for the secondary endpoints including the Device-orientated Composite Endpoint (DoCE) defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization; clinically-indicated Target Vessel Revascularization (TVR), and stent thrombosis at 1, 6, 9, and 12 months and annually through 5 years. Lesions were also evaluated for angiographic endpoints at 6 months including: in-segment LLL, percent diameter stenosis, minimal lumen diameter post-procedure and at 6 months, and angiographic binary restenosis (ABR) (≥50%). A subset of patients underwent intravascular ultrasound (IVUS) evaluation including percent (%) neointimal obstruction at 6 months. The study met the primary endpoint demonstrating both non-inferiority and superiority of the DESyne BD compared to the control (0.12±0.15 vs 0.67±0.47, p&lt;0.001), additionally, in-stent ABR was significantly lower for DESyne BD (0% vs 7.9%, p=0.003). Excellent clinical results at 6 months were demonstrated for both devices. Clinical results through 12 months and additional angiographic and IVUS results will be presented. Conclusion: Clinical results through 12 months and complete angiographic and IVUS results will be presented.

Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial

This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions. The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2™ stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11±0.18 mm vs. 0.14±0.23 mm, p=0.16; non-inferiority p<0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p>0.05, respectively). The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355).

TCT-583 Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation a Novolimus-Eluting Coronary Stent System with Bioabsorbable Polymer Compared to a Zotarolimus-Eluting Coronary Stent System: 12- Month Clinical and 6-Month Angiographic and IVUS Results: the EXCELLA BD Study

To evaluate the safety and effectiveness of the Elixir DESyneTM BD Novolimus Eluting Coronary Stent System (CSS) with a bioabsorbable polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System through the assessment of clinical, angiographic, and IVUS endpoints. A total of 149

Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents

Background— Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. Methods and Results— Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES ( P noninferiority &lt;0.0001, and P superiority =0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P =0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P noninferiority &lt;0.0001, and P superiority =0.24) at 278±63 days after index stent implantation. Conclusions— One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01035450.

Angiographic outcomes of radial artery versus saphenous vein in coronary artery bypass graft surgery: A meta-analysis of randomized controlled trials

The efficacy of coronary artery bypass graft (CABG) surgery for patients with ischemic heart disease is dependent on the patency of the selected conduit. The left internal thoracic artery is considered to be the best conduit for CABG. However, the preferred conduit between the radial artery (RA) and saphenous vein (SV) remains controversial. The present meta-analysis aims to establish the current level IA evidence on patency outcomes comparing the RA and SV. Electronic searches were performed using 6 databases from their inception to March 2012. Two reviewers independently identified all relevant randomized controlled trials (RCTs) comparing patency outcomes of RA and SV grafts after CABG. Data were extracted and meta-analyzed according to angiographic end points at specified follow-up intervals. Five relevant RCTs were identified for inclusion in the present meta-analysis. Angiographic results indicated that the RA was significantly more likely to be completely patent and less likely to be associated with graft failure or complete occlusion at 4 years' follow-up and beyond. However, the RA was significantly more likely to be associated with string sign at 1 year of follow-up. While acknowledging the limitations of heterogeneous surgical techniques, results from the present meta-analysis suggest potential superiority of the RA compared with the SV at midterm angiographic follow-up. However, the increased incidence of string sign associated with the RA is of potential clinical concern. Further research should be directed at correlating angiographic findings of string sign and graft failure to clinical symptoms and major adverse cardiac and cerebrovascular events at long-term follow-up.

Angiographic and Clinical Outcomes of Stent Postdilatation in ST-Elevation Myocardial Infarction

Stent postdilatation is commonly performed to optimise stent deployment during percutaneous coronary intervention (PCI). However, it is controversial in the setting of acute myocardial infarction (AMI) due to the theoretically increased risk of thrombus embolization causing no-reflow. This study aimed to evaluate the immediate angiographic effects and long-term clinical outcomes of stent postdilatation in the setting of ST-elevation myocardial infarction (STEMI). This was a single-centre retrospective observational study involving patients who presented with STEMI and received primary PCI, from July 2009 till June 2010. The angiographic endpoints were final TIMI coronary flow (TMF) and TIMI myocardial perfusion (TMP) score. The clinical endpoint was a composite endpoint of major adverse cardiac events (MACEs) i.e. AMI, target vessel revascularisation or cardiac death at one, six and twelve months after PCI. One hundred and sixty patients with a mean age of 62 years were included in this study. Seventy-one patients (44.4%) had stent postdilatation and 89 patients (55.6%) did not. Patient demographics, risk factors, clinical presentation and baseline angiographic and procedural characteristics, were similar among these two subgroups. There was also no significant difference in the proportions of patients achieving grade III in final TMF (60/71 vs. 74/89, respectively, p>0.05) and final TMP (52/71 vs. 64/89, respectively, p>0.05), as well as the MACE-free survival probability by Kaplan-Meier estimate (85.1% vs. 86.9%, p=0.95), between the two subgroups. Stent postdilatation does not seem to have any detrimental effects on patients' final angiographic results and long-term clinical outcomes, in the setting of STEMI.

Implantation of a Drug-Eluting Stent With a Different Drug (Switch Strategy) in Patients With Drug-Eluting Stent Restenosis: Results From a Prospective Multicenter Study (RIBS III [Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent

This study sought to assess the effectiveness of a strategy of using drug-eluting stents (DES) with a different drug (switch) in patients with DES in-stent restenosis (ISR). Treatment of patients with DES ISR remains a challenge. The RIBS-III (Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent) study was a prospective, multicenter study that aimed to assess results of coronary interventions in patients with DES ISR. The use of a different DES was the recommended strategy. The main angiographic endpoint was minimal lumen diameter at 9-month follow-up. The main clinical outcome measure was a composite of cardiac death, myocardial infarction, and target lesion revascularization. This study included 363 consecutive patients with DES ISR from 12 Spanish sites. The different-DES strategy was used in 274 patients (75%) and alternative therapeutic modalities (no switch) in 89 patients (25%). Baseline characteristics were similar in the 2 groups, although lesion length was longer in the switch group. At late angiographic follow-up (77% of eligible patients, median: 278 days) minimal lumen diameter was larger (1.86 ± 0.7 mm vs. 1.40 ± 0.8 mm, p = 0.003) and recurrent restenosis rate lower (22% vs. 40%, p = 0.008) in the different-DES group. At the last clinical follow-up (99% of patients, median: 771 days), the combined clinical endpoint occurred less frequently (23% vs. 35%, p = 0.039) in the different-DES group. After adjustment using propensity score analyses, restenosis rate (relative risk: 0.41, 95% confidence interval [CI]: 0.21 to 0.80, p = 0.01), minimal lumen diameter (difference: 0.41 mm, 95% CI: 0.19 to 0.62, p = 0.001), and the event-free survival (hazard ratio: 0.56, 95% CI: 0.33 to 0.96, p = 0.038) remained significantly improved in the switch group. In patients with DES ISR, the implantation of a different DES provides superior late clinical and angiographic results than do alternative interventional modalities.

Coronary Pressure–Derived Fractional Flow Reserve Measurements

Evaluation of new coronary devices and demonstration of their conformity to essential principles of safety and effectiveness requires clinical trials in human subjects. Today, many trials designed to address device-oriented safety and effectiveness rely on quantitative coronary angiographic lesion severity, as an objective reproducible end point to determine whether revascularization for progressive luminal renarrowing after device therapy is clinically indicated. Given the known limitations of angiography to reflect clinical ischemia, concern exists regarding the applicability of such angiographic end points. An invasive objective functional (physiological) assessment of moderate stenoses by coronary pressure–derived fractional flow reserve has evident potential as an adjunct to quantitative coronary angiography in clinical trials. To be implemented as a potential core laboratory technique, standardization in technique and archiving of permanent data storage are imperative. The intent of this report is to propose standards for fractional flow reserve data acquisition and interpretation in coronary device research. Controlled trials with predefined safety and efficacy end points are a critical element in the assessment of new therapies or devices, for approval by regulatory bodies, and subsequent adoption for clinical use by the medical community. It is important that randomized trials adopt meaningful clinical end points that relate to the pathophysiological mechanism(s) most likely responsible for the clinical outcome.1–3 In coronary device investigations, clinically driven repeat revascularization of the target lesion is a key (device-oriented) outcome measure of clinical effectiveness.1 Adjudication of this end point has been based on the presence of clinical symptoms and angiographic lesion severity as determined by a central core laboratory using quantitative coronary angiography (QCA), such that even moderate stenosis (>50% diameter stenosis) by QCA may be considered clinically significant. Most clinical trial designs do not require functional assessment prior to repeat …

Primary Endpoint Results of the EVOLVE Trial: A Randomized Evaluation of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent

This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.). Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy. A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography. The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months. The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225).

Sirolimus-Eluting Stents for the Treatment of Infrapopliteal Arteries in Chronic Limb Ischemia: Long-term Clinical and Angiographic Follow-up

To present the 5-year angiographic and clinical results of a retrospective registry assessing the performance of sirolimus-eluting stents (SES) in the treatment of infrapopliteal atherosclerotic disease. From 2004 to 2009, 158 patients (95 men; mean age 71.9 years) with chronic lower limb ischemia (Rutherford categories 3-6) underwent primary SES placement in focal infrapopliteal lesions. The angiographic endpoint was patency, defined as freedom from in-stent stenosis (ISS) >50%. Clinical endpoints were death, amputation, and bypass surgery. Results were correlated with patient and lesion characteristics and cumulative outcomes were assessed with Kaplan-Meier analysis. Technical success was achieved in all cases. The primary patency rates were 97.0% after 6 months, 87.0% after 12 months, and 83.8% at 60 months. In-stent stenosis was predominantly observed in the first year after stent placement. Female gender was associated with a higher rate of ISS. During clinical follow-up of 144 (91%) patients over a mean 31.1±20.3 months, there were 27 (18.8%) deaths, 4 (2.8%) amputations, and no bypass surgery. Clinical status improved in 92% of the patients with critical limb ischemia (CLI) and 77% of the patients suffering from claudication (p=0.022). Treatment of focal infrapopliteal lesions with SES showed encouraging long-term angiographic results in this registry. Clinical improvement was evident, but more pronounced in CLI patients than in patients suffering from claudication. Further studies are needed to evaluate the potential clinical benefit of SES as compared to balloon angioplasty or bare metal stents in the treatment of infrapopliteal lesions.

Use of Endothelial Progenitor Capture Cell Stent During Percutaneous Treatment of Coronary Bifurcations

The treatment of bifurcation lesions remains a challenge with poor immediate results and higher restenosis rate than in nonbifurcated lesions. Drug-eluting stents improve the outcome after coronary stenting, but are associated with a small but statistically significant increase in late and very late stent thrombosis. Thus, aim of the present study was to evaluate the angiographic and clinical results of a new type of stent (coated with murine monoclonal antihuman CD34 antibodies designed to attract circulating endothelial progenitor cells to rapidly establish a functional endothelial layer and promote healing stent implantation) in a cohort of consecutive patients with coronary bifurcation lesions. Between December 2007 and July 2008, a total of 43 consecutive patients were enrolled and 47 consecutive bifurcation lesions were treated with endothelial progenitor capture cell stents. The angiographic end points binary restenosis rate inside the stent (within 5 mm of the stent edges or in the segments treated with balloon angioplasty) was 5% (2.1% in the main branch and 10.5% in the side branch). No stent thrombosis was observed. Clinical follow-up was completed in all patients at mean time of 34.5 days after percutaneous coronary interventions by clinical evaluation and 12.3 months with a telephone contact. Angina at rest was present in 3 patients (7.9%). No in-hospital, 30-days, or 12-months major adverse cardiac events (death, myocardial infarction, and repeat revascularization coronary artery bypass graft or percutaneous coronary angioplasty) were reported. The use of endothelial progenitor capture cell in the setting of coronary bifurcation appears to be feasible and safe with no incidence of late stent thrombosis and a very low rate of repeated revascularization.

Plasma myeloperoxidase concentration predicts the presence and severity of coronary disease in patients with chest pain and negative troponin-T

A non-negligible proportion of patients with chest pain with negative cardiac troponin may harbor a disrupted coronary plaque. A marker of plaque rupture upstream from myocardial necrosis may help identify high-risk patients among this patient population. The purpose of this study was to investigate the correlation of plasma myeloperoxidase (MPO) concentration and angiographic coronary disease among patients with suspected troponin-negative coronary syndromes. Patients presenting with chest pain and negative cardiac troponin-T concentration and undergoing coronary angiography were enrolled in our study. Plasma MPO concentration was measured using a single blood sample collected prior to cardiac catheterization. The primary angiographic endpoint was the presence of at least one coronary stenosis causing a 70% or more diameter reduction; secondary endpoints were number of diseased vessels, presence of coronary thrombus, and lesion ulceration. The main clinical endpoint was coronary revascularization. Three hundred and eighty-nine patients were enrolled. Presence of coronary stenosis causing a 70% or more diameter reduction increased with increasing quartiles of myeloperoxidase concentration (P<0.0001), as did the presence of coronary thrombus (P<0.0001) and plaque ulceration (P<0.0001). The need for percutaneous coronary revascularization also increased with increasing quartiles of systemic myeloperoxidase levels (P<0.0001). Coronary surgical revascularization did not differ among myeloperoxidase quartiles. Among patients with chest pain without troponin elevation, a single measurement of plasma MPO concentration can help identify patients with a higher risk of having significant coronary stenoses and high-risk angiographic features.