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Haemodynamic effects of nicardipine were studied in 12 patients with documented coronary artery disease. Following nicardipine 10 mg, given intravenously to patients at rest, the heart rate increased, mean arterial pressure decreased, cardiac index increased, and systemic vascular resistance decreased significantly. Compared with the control exercise values, significant increases in heart rate and cardiac index and significant decreases in mean arterial pressure, systemic vascular resistance, and left ventricular end diastolic pressure occurred when nicardipine, 10 mg i.v., was given to the patients during exercise. All 12 patients complained of angina during the exercise phase, but following treatment with nicardipine, 10 mg i.v., only four patients reported angina when exercising to the same level. Exercise capacity on oral nicardipine treatment tended to increase whilst the ejection fraction response to exercise did not change. Thus, nicardipine was a potent vasodilator, which produced a marked reduction of systemic vascular resistance and left ventricular end diastolic pressure during exercise. [ABSTRACT FROM AUTHOR]

Background: In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events.Methods/design: The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years.Discussion: The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome.Trial Registration: trialregister.nl NTR1108. [ABSTRACT FROM AUTHOR]

Background: Randomized 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., Objectives: This 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)., Methods: BIOFLOW 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., Results: Among 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., Conclusions: In 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., Competing Interests: Funding Support and Author Disclosures This study was funded by BIOTRONIK AG, Bülach, Switzerland. Dr Kandzari has received institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Inc, Medtronic, Orbus Neich, and Teleflex; and has received personal consulting honoraria from Cardiovascular Systems, Inc, Medtronic, and Terumo. Dr Koolen has received lecturer and consultant fees from Medtronic; and has been a proctor for Biotronik. Dr Doros has been a consultant for Pfizer, Sarepta, Novartis, Softworld, and Lipocine. Drs Garcia-Garcia and Bennett have received research grants from Abbott Vascular and Biotronik AG; and have received speaker fees from Abbott Vascular, Biotronik AG, Boston Scientific, and Terumo. Dr Cutlip has received salary support from Baim Institute. Dr Waksman has received consultant fees from Abbott Vascular, Biotronik, Boston Scientific, MeAlliance, SIS Medical, Medtronic, and Philips Volcano; is on the advisory board for Abbott Vascular, Boston Scientific, Medtronic, and Philips Volcano; has received grant support from Abbott Vascular, Biotronik, and Boston Scientific; and is on the Speakers Bureau for AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES)., Background: Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes., Methods: BIOFLOW 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) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed., Results: Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively., Conclusions: In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946)., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Patients with diabetes mellitus are prone to increased adverse outcomes after percutaneous coronary intervention, even with contemporary drug-eluting stents. Randomized controlled trials have demonstrated comparable clinical outcomes between an ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES) and a thin-strut durable-polymer everolimus-eluting stent (DP-EES) that has specific labeling for patients with diabetes. We aimed to evaluate the safety and efficacy of the BP-SES in patients with diabetes mellitus. To determine the performance of the BP-SES in diabetic patients, patient-level data from the BIOFLOW II, IV, and V randomized controlled trials were pooled. The primary end point was target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel myocardial infarction, ischemia-driven target lesion revascularization, and definite or probable stent thrombosis, at 1 year. Among 1,553 BP-SES and 791 DP-EES patients, 757 diabetic patients were identified. Of the diabetic patients included in this analysis (494 BP-SES vs 263 DP-EES), the proportion of insulin- and noninsulin-treated patients was similar between groups. The 1-year TLF rate in the diabetic population was 6.3% in the BP-SES group and 8.7% in the DP-EES group (hazard ratio 0.82, 95% confidence interval 0.047 to 1.43, p = 0.493). There were no significant differences, based on stent type or diabetes treatment regimen, in TLF hazards. In a patient-level pooled analysis of the diabetic population from randomized trials, 1-year clinical safety and efficacy outcomes were similar in patients treated with ultrathin BP-SES and thin-strut DP-EES., (Copyright © 2019. Published by Elsevier Inc.)

Background: Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture, and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies., Objectives: The authors sought to compare late-term clinical outcomes among patients treated with an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial., Methods: BIOFLOW 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 randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed., Results: Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 2-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference; 95% confidence interval: -8.16% to -0.91%; p = 0.015), driven by differences in target vessel myocardial infarction (MI) (5.3% vs. 9.5%; p = 0.01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%; p = 0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (p = 0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% vs. 1.0%; p = 0.045)., Conclusions: In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years, favoring treatment with BP SES over DP EES. Significantly lower cumulative target lesion revascularization and late/very late stent thrombosis were also observed with BP SES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946)., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Presentation with acute coronary syndromes (ACS) constitutes a high-risk subset of patients with worse outcome after percutaneous coronary intervention. We report clinical outcomes in subjects with ACS from the BIOFLOW V trial (BIOTRONIK - A 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) comparing an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP-SES) with a thin strut (81 μm) durable polymer everolimus-eluting stent (DP-EES)., Methods and Results: Among 1334 patients randomized to 2:1 treatment with either BP-SES or DP-EES, 677 (50.7%) ACS patients without ST-segment-elevation myocardial infarction (MI; 454 BP-SES and 223 DP-EES) were identified in the retrospective post hoc analysis. The primary end point of 12-month target lesion failure, individual component end points, and stent thrombosis were evaluated. Recurrent MI was defined as a ≥50% increase of creatine kinase-myocardial band or in the absence of creatine kinase-myocardial band, troponin >50% increase over previous level and >3× the upper limit of normal). All events were adjudicated by a blinded independent clinical events committee. Overall, baseline clinical, angiographic, and procedural characteristics of the ACS population were similar between the 2 treatment groups. At 12 months, target lesion failure occurred in 5.6% (24/426) of BP-SES patients versus 11.0% (23/209) in DP-EES patients ( P=0.02); target lesion failure composite components were cardiac death, 0% versus 1.0% ( P=0.11); target vessel-related MI, 3.5% versus 9.7% ( P=0.003); and clinically driven target lesion revascularization, 2.8% versus 3.4% ( P=0.80). Spontaneous target vessel MI was 0.5% (2/425) for BP-SES versus 2.4% (5/206) for DP-EES ( P=0.041). Stent thrombosis rates at 1 year were similar (0.5% versus 1.0%; P=0.601)., Conclusions: In the ACS subgroup population of the BIOFLOW V study, treatment with BP-SES compared with DP-EES was associated with a significantly lower rate of 12-month target lesion failure, a difference driven by significantly lower periprocedural MI and spontaneous MI. These findings support treatment with an ultrathin strut BP-SES in ACS patients undergoing percutaneous coronary intervention., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02389946.

Aims: Echocardiography and tomographic imaging have documented dynamic changes in aortic stenosis (AS) geometry and severity during both the cardiac cycle and stress-induced increases in cardiac output. However, corresponding pressure gradient vs. flow relationships have not been described., Methods and Results: We recruited 16 routine transcatheter aortic valve implantations (TAVI's) for graded dobutamine infusions both before and after implantation; 0.014″ pressure wires in the aorta and left ventricle (LV) continuously measured the transvalvular pressure gradient (ΔP) while a pulmonary artery catheter regularly assessed cardiac output by thermodilution. Before TAVI, ΔP did not display a consistent relationship with transvalvular flow (Q). Neither linear resistor (median R2 0.16) nor quadratic orifice (median R2 < 0.01) models at rest predicted stress observations; the severely stenotic valve behaved like a combination. The unitless ratio of aortic to left ventricular pressures during systolic ejection under stress conditions correlated best with post-TAVI flow improvement. After TAVI, a highly linear relationship (median R2 0.96) indicated a valid valve resistance., Conclusion: Pressure loss vs. flow curves offer a fundamental fluid dynamic synthesis for describing aortic valve pathophysiology. Severe AS does not consistently behave like an orifice (as suggested by Gorlin) or a resistor, whereas TAVI devices behave like a pure resistor. During peak dobutamine, the ratio of aortic to left ventricular pressures during systolic ejection provides a 'fractional flow reserve' of the aortic valve that closely approximates the complex, changing fluid dynamics. Because resting assessment cannot reliably predict stress haemodynamics, 'valvular fractional flow' warrants study to explain exertional symptoms in patients with only moderate AS at rest.

Background: Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution., Study Design and Objectives: This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization., Conclusions: The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention., Methods: BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946., Findings: Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208)., Interpretation: The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology., Funding: BIOTRONIK., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Objectives: The 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)., Background: The 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., Methods: In 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., Results: Overall, 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; p noninferiority  = 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., Conclusions: This 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., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Sirolimus-eluting stents (SES) have been shown to be superior to Endeavor zotarolimus-eluting stents (ZES) and comparable to Resolute ZES at eight-month angiography in patients treated for total coronary occlusions (TCO). This study investigated clinical outcome at three-year follow-up., Methods and Results: The PRISON III trial investigated the efficacy and safety of SES against ZES (Endeavor and Resolute) in two study phases. In the first phase, 51 patients were randomised to receive SES and 46 to Endeavor ZES. In the second phase, 103 and 104 patients were randomised to SES or Resolute ZES, respectively. Between one and three years there were only a few additional clinical events in all groups. As a result, the rates of target lesion revascularisation 12.2% vs. 19.6%, p=0.49, target vessel failure 14.3% vs. 19.6%, p=0.68, and definite or probable stent thrombosis 4.1% vs. 2.2% were comparable between SES and Endeavor ZES at three years. In the second study phase, the rates of target lesion revascularisation 10% vs. 5.9%, p=0.42, target vessel failure 10% vs. 7.9%, p=0.79 and definite or probable stent thrombosis 1.0% vs. 0% were similar between SES and Resolute ZES., Conclusions: The present study demonstrated a low incidence of clinical events between one- and three-year follow-up with either SES compared to Endeavor ZES or SES versus Resolute ZES in patients treated for total coronary occlusions.

Objectives: We aimed to investigate, in patients with ST-segment elevation myocardial infarction (STEMI), whether the previously reported clinical benefits of sirolimus-eluting stent(s) (SES) in terms of reducing a major adverse cardiac and cerebrovascular event (MACCE) compared with bare-metal stent(s) (BMS) were maintained over a 5-year time period., Background: In the prospective single-centre randomized DEBATER trial, SES significantly reduced the rate of MACCE in STEMI patients within 1 year compared with BMS, mainly driven by a reduction of target lesion revascularization. Randomized data on the long-term safety and efficacy of SES in STEMI patients are conflicting and limited., Patients and Methods: Between January 2006 and May 2008, a total of 907 STEMI patients were randomized to receive SES or BMS. The primary endpoint was MACCE defined as the composite of death, myocardial infarction, stroke, repeat revascularization and bleeding. Five-year follow-up data were collected by reviewing hospital records, telephone calls and a written questionnaire., Results: At 5 years, the rate of MACCE between the SES group and the BMS group was no longer significantly different (33.3 vs. 39.3%, P=0.12). The cumulative incidence of death and myocardial infarction was similar in both groups (11.0 vs. 9.7%, P=0.51). Repeat revascularization was performed in 21.1 and 25.8% of patients, respectively (P=0.12). The rate of very late stent thrombosis (1-5 years of follow-up) was very low in both groups (2.0 vs. 0.7%, P=0.12)., Conclusion: The benefits of SES in STEMI patients in terms of reducing MACCE faded over time. We found no safety concerns in terms of SES in the long term, with extremely low rates of very late stent thrombosis.

In this study effects of a brief mindfulness-based stress reduction intervention were examined in cardiac patients who had a percutaneous coronary intervention (PCI). One-hundred-and-fourteen patients (mean age 55 ± 7 years, 18 % women) were randomly assigned to a 4-session mindfulness group intervention or a minimal mindfulness self-help control group that received a booklet containing identical information. Compared to self-help, the group intervention showed larger increases in psychological and social quality of life (p < .05, partial η(2) = .04 and .05, respectively). For symptoms of anxiety and depression, and for perceived stress, this effect was evident only in patients younger than 60 years (p < .01, partial η(2) = .10 and .15, respectively). These effects were partially or fully mediated by increase in mindfulness. The brief group mindfulness intervention seems beneficial for cardiac PCI patients regarding general psychosocial quality of life, although for specific psychological symptoms, this intervention can be recommended only for nonelderly patients.

In this review we discuss cardiovascular mortality, incidence and prevalence of heart disease, and cardiac interventions and surgery in the Netherlands. We combined most recently available data from various Dutch cardiovascular registries, Dutch Hospital Data (LMR), Statistics Netherlands (CBS), and population-based cohort studies, to provide a broad quantitative update. The absolute number of people dying from cardiovascular diseases is declining and cardiovascular conditions are no longer the leading cause of death in the Netherlands. However, a substantial burden of morbidity persists with 400,000 hospitalisations for cardiovascular disease involving over 80,000 cardiac interventions annually. In the Netherlands alone, an estimated 730,000 persons are currently diagnosed with coronary heart disease, 120,000 with heart failure, and 260,000 with atrial fibrillation. These numbers emphasise the continuous need for dedicated research on prevention, diagnosis, and treatment of heart disease in our country.

Background: In this study, we sought to analyze the stochastic behavior of Catherization Laboratories (Cath Labs) procedures in our institution. Statistical models may help to improve estimated case durations to support management in the cost-effective use of expensive surgical resources., Methods: We retrospectively analyzed all the procedures performed in the Cath Labs in 2012. The duration of procedures is strictly positive (larger than zero) and has mostly a large minimum duration. Because of the strictly positive character of the Cath Lab procedures, a fit of a lognormal model may be desirable. Having a minimum duration requires an estimate of the threshold (shift) parameter of the lognormal model. Therefore, the 3-parameter lognormal model is interesting. To avoid heterogeneous groups of observations, we tested every group-cardiologist-procedure combination for the normal, 2- and 3-parameter lognormal distribution., Results: The total number of elective and emergency procedures performed was 6,393 (8,186 h). The final analysis included 6,135 procedures (7,779 h). Electrophysiology (intervention) procedures fit the 3-parameter lognormal model 86.1% (80.1%). Using Friedman test statistics, we conclude that the 3-parameter lognormal model is superior to the 2-parameter lognormal model. Furthermore, the 2-parameter lognormal is superior to the normal model., Conclusions: Cath Lab procedures are well-modelled by lognormal models. This information helps to improve and to refine Cath Lab schedules and hence their efficient use.

Aims: We investigated whether sirolimus-eluting stents (SES) are superior to next-generation zotarolimus-eluting stents (ZES) in treating patients with total coronary occlusions (TCO)., Methods and Results: In a prospective, randomised trial we compared the SES with the zotarolimus-eluting stent (ZES; Endeavor or Resolute) after successful recanalisation of TCO. During the first phase of the trial, 51 patients were assigned to receive the SES and 46 patients to receive the Endeavor ZES. In the second phase we randomised 103 patients to the SES group and 104 patients to the Resolute ZES group. The primary endpoint was in-segment late lumen loss at eight-month follow-up. At eight months, patients in the SES group had less in-segment and in-stent late loss as compared to the Endeavor group: -0.13±0.3 mm vs. 0.27±0.6 mm (p=0.0002) and -0.13±0.5 mm vs. 0.54±0.5 mm (p<0.0001), respectively. In contrast, the SES and the Resolute ZES showed comparable amounts of in-segment (-0.03±0.7 mm vs. -0.10±0.7 mm, p=0.6) and in-stent (0.03±0.8 mm vs. 0.05±0.8 mm, p=0.9) late loss., Conclusions: In the treatment of TCOs, the SES was associated with superior angiographic outcomes compared to the Endeavor ZES. On the other hand, the SES and the Resolute ZES showed comparable angiographic outcomes.

Stent boost (SB) imaging is an enhancement of the radiologic edge of the stent by digital management of regular X-ray images. The purpose of the present study was to validate SB imaging by comparison with the anatomical standard using intravascular ultrasound (IVUS). We investigated SB and IVUS after stent implantation in 68 arteries in 60 patients. Based on those findings, we added high-pressure dilatation in four patients and another stent implantation in four patients. We defined the SB criteria for adequate stent deployment as: complete stent expansion, stent minimum diameter ≥70% of reference diameter, and stent minimum diameter ≥2.0 mm; and IVUS criteria for adequate stent deployment as: minimal stent area ≥5.0 mm(2). If the reference vessel was <2.8 mm, adequate stent deployment was defined as minimum stent area ≥4.5 mm(2). IVUS findings indicated inadequate stent deployment in 21/72 observations (29%). Seven SB images showed inadequate stent expansion. SB predicted inadequate findings of IVUS with 100% specificity, 33% sensitivity, and 81% agreement. Although the sensitivity of SB image for adequate stent deployment is low, the specificity is sufficiently high for it to be the first-line for monitoring just after stent implantation in centers where IVUS is not used routinely.

Background: Percutaneous recanalization of total coronary occlusion (TCO) was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST) with drug-eluting stents (DES) for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO., Methods/design: The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany) compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA) in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence tomography is performed in the first 60 randomized patients at 9 months to assess neointima thickness, percentage of neointima coverage, and stent strut malapposition and coverage. Personnel blinded to the allocated treatment will review all angiographic and optical coherence assessments. Secondary clinical endpoints include major adverse cardiac events, clinically driven target vessel revascularization, target vessel failure and stent thrombosis to 5-year clinical follow-up. An independent clinical event committee blinded to the allocated treatment will review all clinical events., Trial Registration: Clinical Trials.gov: NCT01516723. Patient recruitment started in February 2012.

Objectives: The goal of this study was to demonstrate superiority of sirolimus-eluting stents (SES) over bare-metal stents (BMS) and of abciximab over no abciximab in primary percutaneous coronary intervention (PCI)., Background: Drug-eluting stents (DES) are increasingly used in primary PCI, but the recommendations for use in primary PCI are based on a few randomized controlled trials with selected patients. The usefulness of abciximab in primary PCI is not established., Methods: Nine hundred seven patients referred to the Catharina Hospital were randomized to SES or BMS, and to abciximab or no abciximab in a prospective, randomized, open 2 × 2 factorial trial with blinded evaluation. Primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction (MI), stroke, repeat revascularization, and bleeding at 1 year (stent arm) and the composite of death, target vessel MI, target vessel revascularization (TVR), and bleeding at 30 days (abciximab arm)., Results: At 1 year, the rate of MACCE was lower in the SES arm (16.5% vs. 25.8%, p = 0.001), mainly driven by less repeat revascularization (9.8% vs. 16.8%; p = 0.003) and without influencing the cumulative incidence of death and MI (5.2% vs. 5.8%; p = 0.68). At 30 days, the rate of the composite of death, target vessel MI, TVR, and bleeding was lower in the abciximab arm (8.2% vs. 12.4%, p = 0.04), mainly driven by less TVR due to less stent thrombosis (1.2% vs.7.4%, p < 0.001). However, bleeding complications occurred more frequently in the abciximab group (5.7% vs. 2.8%, p = 0.03)., Conclusions: Primary PCI with SES reduces adverse events at 1 year, mainly by reduction of repeat revascularization, whereas abciximab reduces early stent thrombosis, at the expense of more bleeding complications. (Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction [DEBATER]; NCT00986050)., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The vascular tissue reaction to acute incomplete stent apposition (ISA) is not well known. The aim of this study was to characterize the vascular response to acute ISA in vivo and to look for predictors of incomplete healing., Methods and Results: Optical coherence tomography studies of 66 stents of different designs, implanted in 43 patients enrolled in 3 randomized trials, were analyzed sequentially after implantation and at 6 to 13 months. Seventy-eight segments with acute ISA were identified in 36 of the patients and matched with the follow-up study by use of fiduciary landmarks. The morphological pattern of healing in the ISA segments was categorized as homogeneous, layered, crenellated, bridged, partially bridged, or bare, depending on the persistence of ISA and on the coverage. After 6 months, acute ISA volume decreased significantly, and 71.5% of the ISA segments were completely integrated into the vessel wall. Segments with acute ISA had higher risk of delayed coverage than well-apposed segments (relative risk 2.37, 95% confidence interval 2.01-2.78). Acute ISA size (estimated as ISA volume or maximum ISA distance per strut) was an independent predictor of ISA persistence and of delayed healing at follow-up., Conclusions: Neointimal healing tends to reduce ISA, with the malapposed stent struts often integrated completely into the vessel wall, resulting in characteristic morphological patterns. Coverage of ISA segments is delayed with respect to well-apposed segments. The larger the acute ISA, the greater the likelihood of persistent malapposition at follow-up and delayed healing.

Aims: To test the efficacy of sequential application of drug-coated balloon (DCB) and bare metal stent (BMS) for treatment of de novo coronary lesions, comparing the sequence of application (DCB first vs. BMS first)., Methods and Results: In a multicentre pilot trial, 26 patients with de novo coronary lesions were randomised to receive a paclitaxel-coated balloon application followed by BMS implantation (DCB first) or vice versa (BMS first). Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were performed post-procedure and at six months, with OCT % neointimal volume obstruction as primary endpoint. Longitudinal geographical miss was only observed in DCB first (23.1 vs. 0.0%, p=0.220). Implantation of BMS first resulted in fewer malapposed struts (p=0.013) but similar coverage at six months. No significant difference was found regarding the primary endpoint (25.5 vs. 24.9%, p=0.922), mean thickness of coverage (261 vs. 225 µm, p=0.763), late loss (0.53 vs. 0.45 mm, p=0.833), binary restenosis (27.3 vs. 16.7% in-segment, p=0.640) or clinical endpoints., Conclusions: Sequential application of DCB and not pre-mounted BMS for treatment of de novo coronary lesions results in efficient inhibition of neointimal hyperplasia. The sequence of application (DCB first vs. BMS first) does not seem to influence the outcome, except for better apposition in BMS first.

Objectives: This study sought to demonstrate the noninferiority of endothelial progenitor cell capturing stents (ECS) relative to drug-eluting stents (DES) regarding target lesion failure (TLF) and the composite of cardiac death, myocardial infarction, and target lesion repeat revascularization within 1 year., Background: A "pro-healing" approach for prevention of in-stent restenosis is theoretically favorable over the use of cytotoxic/cytostatic drugs released from DES to treat coronary artery disease. Promoting accelerated endothelialization of the stent, ECS have shown promising results in studies with patients carrying noncomplex lesions., Methods: We undertook an international, clinical trial in 26 centers planning to randomize 1,300 patients with stable coronary artery disease and with a high risk of restenosis between treatment, with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was higher and treatment of new patients with an ECS would be unreasonable., Results: At 1 year evaluating 304 patients receiving ECS and 318 receiving DES, TLF occurred in 17.4% of the ECS-treated patients and in 7.0% of the DES-treated patients (p = 0.98 for noninferiority)., Conclusions: Within 1 year, inhibition of intimal hyperplasia by the ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. Furthermore, long-term follow-up is pivotal to fully appreciate the clinical value of ECS, including the effect on late intimal hyperplasia regression., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Early coronary stent thrombosis occurs most frequent after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI)., Objectives: To identify the specific predictors of, respectively, acute and subacute stent thrombosis in patients after primary PCI for STEMI., Patients/methods: Consecutive STEMI patients with angiographically confirmed early stent thrombosis were enrolled and compared in a 2 : 1 ratio with a matched control group. Clinical outcome was collected up to 1 year., Results: Of 5842 STEMI patients treated with primary PCI, 201 (3.5%) presented with a definite early stent thrombosis. Of these, 97 (1.7%) had acute stent thromboses and 104 (1.8%) had subacute stent thromboses. Postprocedurally discovered dissection, undersizing and smaller stent diameter were the strongest predictors for acute stent thrombosis. No glycoprotein IIb/IIIa therapy and the use of drug-eluting stents were also associated with acute stent thrombosis. Lack of clopidogrel therapy in the first 30 days after the index PCI was the strongest predictor for subacute stent thrombosis. Mortality rates at 1-year follow-up were lower for acute stent thrombosis than for subacute stent thrombosis (8.3% vs. 13.2%, P = 0.294). The incidence of definite recurrent stent thrombosis at 1-year follow up was significantly lower after a first definite acute stent thrombosis than after a first definite subacute stent thrombosis (6.4% vs. 19.3%, P = 0.007 at 1 year)., Conclusions: The specific risk factors for, respectively, acute and subacute stent thrombosis after primary PCI vary greatly. Mortality rates are high for both categories of stent thrombosis. However, recurrent stent thrombosis occurs more frequently after subacute stent thrombosis., (© 2010 International Society on Thrombosis and Haemostasis.)

Chronic oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and in patients with atrial fibrillation with CHADS2 score >1. When these patients undergo percutaneous coronary intervention with placement of a stent, there is also an indication for treatment with aspirin and clopidogrel. Unfortunately, triple therapy is known to increase the bleeding risk. For this group of patients, the bottom line is to find the ideal therapy in patients with indications for both chronic anticoagulation therapy and percutaneous intervention to prevent thromboembolic complications such as stent thrombosis without increasing the risk of bleeding. (Neth Heart J 2010;18:444-50.).

Objectives: This study sought to comprehensively identify predictors of stent thrombosis (ST)., Background: Given the devastating consequences of ST, efforts should be directed toward risk stratification to identify patients at highest risk for ST., Methods: Consecutive patients with angiographic ST were enrolled. Patients who did not suffer from a ST were randomly selected in a 2:1 ratio and were matched for: 1) percutaneous coronary intervention (PCI) indication; 2) same date of index PCI; and 3) same interventional center., Results: Of 21,009 patients treated with either a bare-metal or drug-eluting stent, 437 patients (2.1%) presented with a definite ST. A total of 140 STs were acute, 180 were subacute, 58 were late, and 59 were very late. Undersizing of the coronary stent, Thrombolysis In Myocardial Infarction flow grade <3, present malignancy, presence of intermediate coronary artery disease proximal and distal to the culprit lesion, dissection, lack of aspirin, bifurcation lesions, ejection fraction <30%, and younger age were associated with ST. The lack of clopidogrel therapy at the time of ST in the first 30 days after the index PCI (hazard ratio [HR]: 36.5, 95% confidence interval [CI]: 8.0 to 167.8), between 30 days and 6 months after the index PCI (HR: 4.6, 95% CI: 1.4 to 15.3), and beyond 6 months (HR: 5.9, 95% CI: 1.7 to 19.8) after the index PCI was strongly associated with ST., Conclusions: Important correlates of ST were identified. Discontinuation of clopidogrel, undersizing of the coronary stent, present malignancy, and intermediate (>or=50% to <70% stenosis) coronary artery disease proximal to the culprit lesion were the strongest predictors of ST.

Fractional Flow Reserve (FFR), calculated by coronary pressure measurement, is the invasive gold standard to assess the hemodynamic significance of a coronary stenosis. FFR reliably indicates whether a stenosis is responsible for inducible ischemia and if percutaneous coronary intervention is appropriate. False positive or negative FFR is rare. Occasionally, however, a clinical or angiographic condition is encountered in which in first instance the FFR measurement contradicts the intuitive feeling of the interventionalist. Further examination in such cases, however, often reveals a clear physiologic explanation and in this manner FFR "lifts the veil". Two such patients are presented in this case report and the reasons for apparent or actual false positive or negative FFR are discussed., ((c) 2008 Wiley-Liss, Inc.)

Objectives: The objective of this study was to investigate the underlying stenosis severity of the culprit lesion in acute myocardial infarction., Background: It is widely believed that myocardial infarction often occurs in angiographically mild luminal stenosis. This, however, is in contradiction with experience from interventional practice in primary PCI., Methods: We performed quantitative coronary angiography (QCA) in 250 consecutive patients referred for acute percutaneous coronary intervention (PCI) because of acute myocardial infarction (AMI). Fundamental for analysis was that a realistic estimate of underlying luminal narrowing before the infarction could be made angiographically that QCA could be performed and that one of two criteria was met: (1) spontaneous reflow allowing assessment of the lumen proximal and distal to the culprit lesion, or (2) coronary artery closed at arrival but reflow after uncomplicated wiring allowing assessment of the lumen proximal and distal to the culprit lesion., Results: Of 250 consecutive patients (mean age 61.7 +/- 12.7 years, 48 women) referred for acute PCI, 156 patients (62%) fulfilled at least one of the above criteria for reliable QCA. In 151 of these patients (96%) the severity of the underlying stenosis was >50% and in 103 (66%) it was >70%. There were no differences in stenosis severity between the left anterior descending [LAD, (72 +/- 13)%, n = 57], left circumflex [Cx, (74 +/- 10)%, n = 20], and right coronary artery territory [RCA, (74 +/- 12)%, n = 76] (ANOVA, P = 0.76). There were no differences in stenosis severity between women [(73 +/- 13)%, n = 36] and men [(75 +/- 11)%, n = 120; P = 0.35]., Conclusion: In contrast to what is often believed, the majority of myocardial infarctions occurs in significant stenosis., (Copyright 2007 Wiley-Liss, Inc.)

Background: Variable results of cardiac resynchronization therapy (CRT) on diastolic function have been described. We investigated 3 and 12 months' effect of CRT on diastolic function and left ventricular (LV) filling pressures and their relation to LV reverse remodeling., Methods: Fifty-two patients' (36 male, 69 +/- 8 years, QRS duration 170 +/- 29 milliseconds) echo-Doppler was performed before and 3 and 12 months after CRT. Tissue Doppler early diastolic annular (Em) and color M-mode-derived flow propagation (Vp) velocities were used to estimate LV filling pressures by E/Em and E/Vp ratios., Results: After 12 months, LV reverse remodeling (end-systolic volume decrease >15%) was observed in 58%. Despite a significantly more compromised baseline diastolic function of patients without LV reverse remodeling, multivariate analysis revealed that only LV dyssynchrony could predict LV reverse remodeling. Grades 2 and 3 diastolic function improved only in LV reverse remodeling patients (from 34% to 13% to 10%), whereas a nonsignificant increase from 59% to 67% to 72% was observed in patients without reverse remodeling. Irrespective of LV volume response, short-term symptomatic benefit was related to decreased filling pressure. However, after 12 months, E/Em and E/Vp only significantly decreased in patients with LV reverse remodeling (from 16.0 +/- 6 to 10.4 +/- 4 and 2.2 +/- 0.6 to 1.5 +/- 0.4, respectively)., Conclusions: Left ventricular reverse remodeling induced by CRT is accompanied by improvement in diastolic function and estimated LV filling pressure. Short-term symptomatic benefit was related to decreased filling pressure. However, for longer-term symptomatic improvement and decreased filling pressures, LV reverse remodeling appeared mandatory.

Background: Venesection of red blood cells in healthy well-trained subjects decreased the maximum oxygen uptake parallel with the reduction in hemoglobin (Hb) level. Based on the large Hb decrease that is seen after total joint surgery, one could expect a decrease in performance as well. The purpose of this study was to investigate whether autologous blood enhanced performance on a bicycle ergometer in patients after total hip arthroplasty., Study Design and Methods: Nine patients scheduled for elective total hip arthroplasty in an accelerated stay program participated in a preoperative autologous blood donation (PABD) program. Weeks before the scheduled surgery, patients donated 4 units of blood and received standard erythropoietin treatment. Physical fitness was assessed during exercise test on a bicycle ergometer. Each patient was matched with three previously tested patients., Results: Patients in both groups were 69.0 years old (range, 66-74 years vs. 61-77 years). None of the patients had relevant cardiovascular abnormalities. On average patients received 3.3 units of blood because 3 units were not transfused. The PABD group showed a Hb decrease of 0.5 g per dL (4%) on the fourth postoperative day versus 4.4 g per dL (31%) in the control group. The decline in power output on Day 4 was significantly less in the PABD group compared with the control group (t test, p = 0.026)., Conclusion: From this pilot study it can be concluded that correction of the postoperative Hb decrease was associated with a lower decrease in maximum power output, compared to the control group. On Days 23 and 39, however, the difference in performance between the PABD group and control group had disappeared.

Aims: The aim of this study was to investigate the physiologic parameters: fractional flow reserve (FFR), hyperaemic trans-stent gradient (HTG), and wall shear stress (WSS) at implantation and at 6-month follow-up in the drug-eluting sirolimus stent and in its bare metal counterpart implanted in pairs within the same patient., Methods and Results: Twenty patients, accepted for percutaneous coronary intervention of at least two coronary arteries with comparable vessel and stenosis characteristics, received at random one sirolimus-eluting stent and one bare metal stent (BMS). Coronary pressure, FFR, HTG, and WSS were measured just after stent implantation and at 6-month follow-up. At 6-month follow-up, FFR was significantly higher in the sirolimus group compared with the bare metal group (0.91+/-0.05 vs. 0.83+/-0.10, P=0.027) and HTG was significantly lower (1.2+/-1.2 vs. 7.5+/-8.1 mmHg, P<0.001). In-stent WSS at 6 months remained normal in the sirolimus group but was elevated in the bare metal group (1.6+/-0.7 vs 3.9+/-3.1 Pa, respectively, P=0.003)., Conclusion: The physiologic characteristics of the drug-eluting sirolimus stents were superior to those of the equivalent BMS. Six months after implantation, FFR was significantly higher, HTG was significantly lower in arteries treated by a sirolimus stent, and normal WSS was maintained within the drug-eluting stent.

The optimal revascularization strategy, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), for patients with multivessel coronary artery disease (MVD) remains controversial. The aim of the present study was to compare the long-term outcomes after selective PCI of only hemodynamically significant lesions (fractional flow reserve, or FFR < 0.75) to CABG of all stenoses in patients with MVD. In 150 patients with MVD referred for CABG, FFR was determined in 381 coronary arteries considered for bypass grafting. If the FFR was less than 0.75 in three vessels or in two vessels including the proximal left anterior descending (LAD) artery, CABG was performed (CABG group). If only one or two vessels were physiologically significant (not including the proximal LAD), PCI of those lesions was performed (PCI group). Of the 150 patients, 87 fulfilled the criteria for CABG and 63 for PCI. There were no significant differences in the angiographic or other baseline characteristics between the two groups. At 2-year follow-up, no differences were seen in adverse events, including repeat revascularization (event-free survival 74% in the CABG group and 72% in the PCI group). A similar number of patients were free from angina (84% in the CABG group and 82% in the PCI group). Importantly, the results in both groups were as good as the surgical groups in previous studies comparing PCI and CABG in MVD. In patients with multivessel disease, PCI in those with one or two hemodynamically significant lesions as identified by an FFR < 0.75 yields a similar favorable outcome as CABG in those with three or more culprit lesions despite a similar angiographic extent of disease., ((c) 2004 Wiley-Liss, Inc.)

The aim of the study was to compare acute and long-term angiographic and clinical outcome of balloon angioplasty and elective stenting in de novo lesions in the body of a saphenous vein graft (SVG). A total of 150 patients, with de novo lesions in SVG, were randomly assigned to balloon angioplasty or elective Wiktor I stent implantation. The angiographic restenosis rate at 6-month follow-up was 32.8% in the balloon group and 19.1% in the stent group (P = 0.069). At 1-year follow-up, target vessel revascularization rate was 31.4% vs. 14.5% (P < 0.05), and event-free survival was 60.0% vs. 76.3% (P < 0.05) for the balloon and stent group, respectively. Elective stent implantation in de novo SVG lesions is associated with a significant lower target vessel revascularization rate and a significant higher event-free survival at 1-year follow-up as compared to balloon angioplasty., (Copyright 2003 Wiley-Liss, Inc.)

Objective: To investigate the value of coronary pressure derived fractional flow reserve (FFR) measurements in supporting decisions about medical or surgical treatment in patients with angiographically equivocal left main coronary artery stenosis., Design: A two centre prospective single cohort follow up study., Interventions: FFR of the left main coronary artery was determined in 54 consecutive patients with angiographically equivocal left main coronary artery disease. If FFR was >/= 0.75, medical treatment was chosen; if FFR was < 0.75, surgical treatment was chosen., Main Outcome Measures: Freedom from death, myocardial infarction, or any coronary revascularisation procedure., Results: In 24 patients (44%), FFR was >/= 0.75 and medical treatment was chosen (medical group). In the remaining 30 patients (56%), FFR was < 0.75 and bypass surgery was performed (surgical group). Mean (SD) follow up was 29 (15) months (range 12-65 months). Survival among patients at three years of follow up was 100% in the medical group and 97% in the surgical group. Event-free survival was 76% in the medical group and 83% in the surgical group., Conclusions: FFR supports decision making in equivocal left main coronary artery disease. If FFR is below 0.75, the decision for bypass surgery is supported. If FFR is above 0.75, a conservative approach is justified.

Background: PTCA of a coronary stenosis without documented ischemia at noninvasive stress testing is often performed, but its benefit is unproven. Coronary pressure-derived fractional flow reserve (FFR) is an invasive index of stenosis severity that is a reliable substitute for noninvasive stress testing. A value of 0.75 identifies stenoses with hemodynamic significance., Methods and Results: In 325 patients for whom PTCA was planned and who did not have documented ischemia, FFR of the stenosis was measured. If FFR was >0.75, patients were randomly assigned to deferral (deferral group; n=91) or performance (performance group; n=90) of PTCA. If FFR was <0.75, PTCA was performed as planned (reference group; n=144). Clinical follow-up was obtained at 1, 3, 6, 12, and 24 months. Event-free survival was similar between the deferral and performance groups (92% versus 89% at 12 months and 89% versus 83% at 24 months) but was significantly lower in the reference group (80% at 12 months and 78% at 24 months). In addition, the percentage of patients free from angina was similar between the deferral and performance groups (49% versus 50% at 12 months and 70% versus 51% at 24 months) but was significantly higher in the reference group (67% at 12 and 80% at 24 months)., Conclusions: In patients with a coronary stenosis without evidence of ischemia, coronary pressure-derived FFR identifies those who will benefit from PTCA.