Impact of anemia on long-term outcomes after percutaneous coronary intervention for chronic total occlusion.

OBJECTIVES: A single-centre, observational study was performed in order to investigate the relationship between anemia and outcomes after percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). BACKGROUND: Anemia has been identified as adverse predictor in patients with coronary artery disease undergoing coronary revascularization. Data on the impact of anemia on outcomes in patients undergoing PCI for CTO lesions are lacking. METHODS: A total of 1,964 patients undergoing CTO PCI were stratified according to the presence/absence of anemia (hemoglobin of <13 g/dl for men and <12 g/dl for women). The primary endpoint was all-cause mortality. Median follow-up was 2.6 (interquartile range 1.1-3.1) years. RESULTS: Of the 1,964 patients, 297 (15.1%) had anemia. Anemic as compared to nonanemic patients had and an increased all-cause mortality (27.9% versus 9.1%, P < 0.001), and associations remained significant after multivariable adjustments (adjusted HR 2.26, 95% CI 1.71-2.98, P < 0.001). All-cause mortality decreased with increasing hemoglobin tertiles (T1: 18.6%, T2: 8.6%, T3: 8.2%, log rank P < 0.001). Procedural success was associated with reduced all-cause mortality both in anemic (21.8% versus 47.2%, adjusted HR 0.59, 95% CI 0.37-0.93, P = 0.02) and nonanemic patients (7.8% versus 16.3%, adjusted HR 0.64, 95% CI 0.42-0.98, P = 0.02, interaction P = 0.69). CONCLUSIONS: Although anemia is associated with an increased all-cause mortality in patients undergoing CTO PCI, the survival benefit associated with successful CTO recanalization is maintained.

Hemodynamic classification of paravalvular leakage after transcatheter aortic valve implantation compared with angiographic or echocardiographic classification for prediction of 1-year mortality.

OBJECTIVES: We sought to assess angiographic, echocardiographic and hemodynamic grading of paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI) with respect to prediction of 1-year mortality. BACKGROUND: Meaningful criteria for the severity of PVL are needed to allow intraprocedural guidance and patient management after TAVI. METHODS: We pooled the prospective TAVI databases of 2 German centers. During TAVI, PVL was assessed angiographically and by the aortic regurgitation index (ARI). ARI was calculated as ratio of the gradient between diastolic blood pressure and left ventricular end-diastolic pressure to systolic blood pressure times hundred. In addition, we performed transthoracic echocardiography before discharge. RESULTS: A total of 723 patients undergoing TAVI with self-expandable (20.9%) or balloon-expandable (79.1%) valves were included. Grades of PVL as assessed during the procedure by angiography or ARI (below the previously defined cut-off of 25) did not show a significant association with 1-year mortality (P = 0.312 and 0.776, respectively). One-year mortality was 15.7% (39/249) in patienths with an ARI < 25 and 16.5% (71/430) in patients with an ARI ≥ 25. Echocardiographic classes of PVL at discharge showed a significant (P = 0.029) association with 1-year mortality, which was 11.5% (37/322) in patients with no/trace PVL, 18.0% (62/345) in patients with mild PVL and 23.1% (6/26) in patients with more than mild PVL. These findings prevailed after multivariable adjustment. CONCLUSIONS: ARI did not help identify PVLs that are relevant to 1-year survival. Angiographic assessment during the procedure was less predictive than echocardiographic assessment before discharge.

Coronary dominance and prognosis in patients with chronic total occlusion treated with percutaneous coronary intervention.

AIM: The prognostic value of coronary artery dominance pattern in patients with chronic total occlusions (CTO) is unknown. The aim of this study was to assess the influence of coronary vessel dominance on short and long-term outcomes in patients undergoing percutaneous coronary intervention (PCI) for CTO. METHODS AND RESULTS: Our study population consisted of 2002 consecutive patients (17% females, mean age 65.2 ± 10.7 years) who underwent PCI of at least one coronary CTO lesion at our center between 01/2005 and 12/2013. Based on the origin of the posterior descending coronary artery, coronary circulation was categorised into left, right, and balanced coronary dominance. Right coronary dominance (RD) was present in 88% (n = 1759), left coronary dominance (LD) in 7% (n = 136), and balanced coronary dominance (BD) in 5% (n = 107) of the study population. After a median follow-up duration of 2.6 years [interquartile range 1.1-3.1 years] all-cause mortality was significantly higher in patients with LD as compared with RD and BD (log rank = 0.001). Accordingly, the presence of a LD system was identified as a significant predictor for all-cause mortality (adjusted HR 1.7, 95% CI: 1.2-2.6, P = .007) and major adverse cardiac events (MACE) (adjusted HR 1.4, 95% CI: 1.1-1.8, P = 0.02). CONCLUSION: Our data suggest that LD is an independent predictor of increased all-cause death and MACE in patients with CTO. Therefore, assessment of coronary vessel dominance by angiography may contribute to risk stratification in these patients.

Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves.

AIMS: We sought to evaluate the frequency of early hypo-attenuated leaflet thickening (HALT) of the SAPIEN 3 transcatheter aortic valve (S3). METHODS AND RESULTS: Of 249 patients who had undergone S3 implantation, we studied 156 consecutive patients (85 women, median age 82.2 ± 5.5 years) by electrocardiogram (ECG)-triggered dual-source computed tomography angiography (CTA) after a median of 5 days post-transcatheter aortic valve implantation. The prosthesis was assessed for HALT. Apart from heparin, peri-interventional antithrombotic therapy consisted of single- (aspirin 29%) or dual- (aspirin plus clopidogrel 71%) antiplatelet therapy. Hypo-attenuated leaflet thickening was found in 16 patients [10.3% (95% confidence interval (CI) 5.5-15.0%)] of the patients. None of the baseline and procedural variables were significantly associated with HALT, nor did we find a significant association with the antithrombotic regimen, either peri-interventionally or at the time of CTA. Hypo-attenuated leaflet thickening was found in 6 of 45 patients with peri-interventional single-antiplatelet therapy and in 10 of 111 patients with dual-antiplatelet therapy at the time of intervention [13.3% (95% CI 3.4-23.3%) vs. 9% (95% CI 3.7-14.3%), P = 0.42]. Hypo-attenuated leaflet thickening was not associated with clinical symptoms, but a small, albeit significant difference in mean pressure gradient at the time of CTA (11.6 ± 3.4 vs. 14.9 ± 5.3 mmHg, P = 0.026). Full anticoagulation led to almost complete resolution of HALT in 13 patients with follow-up CTA. CONCLUSION: Irrespective of the antiplatelet regimen, early HALT occurred in 10% of our patients undergoing transcatheter aortic S3 implantation. Early HALT is clinically inapparent and reversible by full anticoagulation.

Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: the Bifurcations Bad Krozingen (BBK) II angiographic trial.

AIMS: In percutaneous coronary intervention for de-novo coronary bifurcation lesions, the optimal technique for provisional side-branch stenting is still a matter of debate. We tested whether in this setting culotte stenting reduces the incidence of restenosis as compared with T-and-protrusion (TAP) stenting. METHODS AND RESULTS: This trial included 300 patients with a coronary bifurcation lesion requiring a side-branch stent. Patients were randomly assigned to culotte stenting or TAP stenting using drug-eluting stents in a 1:1 fashion. Primary endpoint was maximal per cent diameter stenosis of the bifurcation lesion at 9-month angiographic follow-up. As clinical endpoints we assessed target lesion re-intervention (TLR) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, and TLR).Angiographic follow-up was available in 91% of the patients. After culotte stenting, the maximum per cent diameter stenosis in the treated bifurcation lesion was 21 ± 20% as compared with 27 ± 25% after TAP stenting (P = 0.038). The respective corresponding binary restenosis rates were 6.5 and 17% (P = 0.006). The 1-year incidence of TLR was 6.0% after culotte stenting vs. 12.0% after T-stenting (P = 0.069). Target lesion failure occurred in 6.7% of the culotte group and in 12.0% of the TAP group (P = 0.11). Only one patient of the culotte group incurred a definite stent thrombosis during 1-year follow-up. CONCLUSIONS: Compared with the TAP stenting, culotte stenting was associated with a significantly lower incidence of angiographic restenosis.

Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction.

BACKGROUND: The combination of glycoprotein IIb/IIIa inhibitors and heparin has not been compared with bivalirudin in studies specifically involving patients with non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). We compared the two treatments in this patient population. METHODS: Immediately before PCI, we randomly assigned, in a double-blind manner, 1721 patients with acute non-ST-segment elevation myocardial infarction to receive abciximab plus unfractionated heparin (861 patients) or bivalirudin (860 patients). The study tested the hypothesis that abciximab and heparin would be superior to bivalirudin with respect to the primary composite end point of death, large recurrent myocardial infarction, urgent target-vessel revascularization, or major bleeding within 30 days. Secondary end points included the composite of death, any recurrent myocardial infarction, or urgent target-vessel revascularization (efficacy end point) and major bleeding (safety end point) within 30 days. RESULTS: The primary end point occurred in 10.9% of the patients in the abciximab group (94 patients) and in 11.0% in the bivalirudin group (95 patients) (relative risk with abciximab, 0.99; 95% confidence interval [CI], 0.74 to 1.32; P=0.94). Death, any recurrent myocardial infarction, or urgent target-vessel revascularization occurred in 12.8% of the patients in the abciximab group (110 patients) and in 13.4% in the bivalirudin group (115 patients) (relative risk, 0.96; 95% CI, 0.74 to 1.25; P=0.76). Major bleeding occurred in 4.6% of the patients in the abciximab group (40 patients) as compared with 2.6% in the bivalirudin group (22 patients) (relative risk, 1.84; 95% CI, 1.10 to 3.07; P=0.02). CONCLUSIONS: Abciximab and unfractionated heparin, as compared with bivalirudin, failed to reduce the rate of the primary end point and increased the risk of bleeding among patients with non-ST-segment elevation myocardial infarction who were undergoing PCI. (Funded by Nycomed Pharma and others; ISAR-REACT 4 ClinicalTrials.gov number, NCT00373451.).

Longitudinal compression of the platinum-chromium everolimus-eluting stent during coronary implantation: predisposing mechanical properties, incidence, and predictors in a large patient cohort.

OBJECTIVES: To assess the longitudinal compression behavior of platinum-chromium everolimus-eluting stents, evaluate frequency of inadvertent longitudinal compression during percutaneous intervention, and define patient- and lesion-related predictors of this complication. BACKGROUND: Platinum-chromium stents of Element family have unique design features to improve flexibility that may, however, impair longitudinal stability. Incidence of longitudinal stent compression during implantation and predictors for this complication are not well understood. METHODS: Five contemporary stent platforms were longitudinally compressed in a bench test experiment, and spring constant, yield force, and ultimate strength were calculated from force-strain curves. We also evaluated all coronary cases treated with an Element stent from January 1, 2010, to October 31, 2011, for documented longitudinal compression. We compared baseline characteristics and periprocedural data between patients with and without longitudinal stent compression and assessed predictors for this event by multiple logistic regression models. RESULTS: Yield force and ultimate strength were significantly lower for the Element compared with all other tested stents. In 20 patients (1.4%) and 20 lesions (0.7%) from 1,392 cases with 2,839 atherosclerotic lesions longitudinal stent compression was reported. Ostial segments, number of stents, and the presence of a bifurcation were significant predictors (adjusted odds ratios [95% confidence intervals]: 8.33 [3.30-21.28], 1.57 [1.01-2.45], 3.57 [1.36-9.35], respectively). CONCLUSION: The Element stent exhibits the lowest overall longitudinal strength compared with four contemporary platforms. Longitudinal compression of the Element stent is a rare complication and occurs more frequently in ostial or bifurcation lesions and with multiple stents.

Collagen plug vascular closure devices and reduced risk of bleeding with bivalirudin versus heparin plus abciximab in patients undergoing percutaneous coronary intervention for non st-segment elevation myocardial infarction.

INTRODUCTION: In ISAR-REACT-4 (abciximab and heparin vs. bivalirudin for non-ST-elevation myocardial infarction [NSTEMI]), bivalirudin reduced the risk of bleeding after percutaneous coronary intervention (PCI) compared with unfractionated heparin plus abciximab (UFH + abciximab). Vascular closure devices (VCDs) may also prevent bleeding complications, and thus attenuate the benefit of bivalirudin. This analysis examined whether there exists an interaction on bleeding between VCDs and bivalirudin versus UFH + abciximab after PCI. METHODS: Patients with NSTEMI were randomly assigned to either receive UFH + abciximab or bivalirudin for PCI. The use of a VCD after femoral access was left to the operator's discretion. The effect of randomized treatment in patients who received a VCD was compared to that in patients with manual compression of the femoral access site. The primary end-point of this analysis was the 30-day incidence of ISAR-REACT-4 major bleeding. RESULTS: A total of 1,711 patients were enrolled in this analysis. Among the 365 (21.3%) patients receiving a VCD, 188 (51.5%) were treated with UFH + abciximab and 177 (48.5%) with bivalirudin. ISAR- REACT-4 major bleeding was higher with UFH + abciximab than with bivalirudin, independent of whether a VCD was used (4.8% vs. 2.3% with VCD and 4.6% vs. 2.7% without VCD, Pint = 0.76). There were also no interactions between randomized treatment and VCDs with respect to any of the ischemic end-points or net clinical outcome (Pint > 0.56). CONCLUSIONS: In patients undergoing PCI for NSTEMI, the reduction of major bleeding by bivalirudin compared with UFH + abciximab was not affected whether a VCD was used.

Long-term outcome of percutaneous catheter intervention for de novo coronary bifurcation lesions with drug-eluting stents or bare-metal stents.

BACKGROUND: The purpose of this study was to assess the long-term risks and benefits of drug-eluting stents (DESs) compared with bare-metal stents (BMSs) for treatment of coronary bifurcation lesions. METHODS: Our registry comprised 1,038 patients treated for coronary bifurcation lesion according to the provisional T-stenting strategy who were followed up for 3 years. RESULTS: Target lesion revascularization rates were 24.3% for BMSs (n = 337), 15.6% for sirolimus-eluting stents (SESs, n = 422), and 17.3% for paclitaxel-eluting stents (PESs, n = 279) (P = .003 BMSs vs DESs, P = .54 SESs vs PESs). The respective incidences were 11.4%, 9.5%, and 14.8% (P = .65, P = .13) for death and myocardial infarction and 9.9%, 6.5%, and 10.6% (P = .72, P = .19) for death. Propensity score adjusted hazard ratios (95% CI) for DESs versus BMSs were 0.49 (0.35-0.68, P < .001) for target lesion revascularization, 0.94 (0.64-1.40, P = .078) for death and myocardial infarction, and 0.85 (0.55-1.32, P = .47) for death. We did not find any significant differences between SESs and PESs, except for an increased risk of death after PESs compared with SESs (but not BMSs) in the subgroup receiving a side-branch stent (adjusted hazard ratio 2.45, 95% CI 1.05-5.73, P = .035). CONCLUSIONS: Compared with BMSs, both PESs and SESs substantially reduced the long-term need for repeated revascularization but did not increase the risk of death and myocardial infarction.

Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions.

AIMS: We investigated whether routine T-stenting reduces restenosis of the side branch as compared with provisional T-stenting in patients with de novo coronary bifurcation lesions. METHODS AND RESULTS: Our randomized study assigned 101 patients with a coronary bifurcation lesion to routine T-stenting with sirolimus-eluting stents (SES) in both branches and 101 patients to provisional T-stenting with SES placement in the main branch followed by kissing-balloon angioplasty and provisional SES placement in the side branch only for inadequate results. Primary endpoint was per cent diameter stenosis of the side branch at 9 month angiographic follow-up. Angiographic follow-up in 192 (95%) patients revealed a per cent stenosis of the side branch of 23.0 +/- 20.2% after provisional T-stenting (19% with side-branch stent) and of 27.7 +/- 24.8% (P = 0.15) after routine T-stenting (98.2% with side-branch stent). The corresponding binary restenosis rates were 9.4 and 12.5% (P = 0.32), prompting re-intervention in 5.0 and 7.9% (P = 0.39), respectively. In the main branch, binary restenosis rates were 7.3% after provisional and 3.1% after routine T-stenting (P = 0.17). The overall 1 year incidence of target lesion re-intervention was 10.9% after provisional and 8.9% after routine T-stenting (P = 0.64). CONCLUSIONS: Routine T-stenting with SES did not improve the angiographic outcome of percutaneous coronary intervention of coronary bifurcation lesions as compared with stenting of the main branch followed by kissing-balloon angioplasty and provisional side-branch stenting.

Long-term results after PCI of unprotected distal left main coronary artery stenosis: the Bifurcations Bad Krozingen (BBK)-Left Main Registry.

AIMS: Percutaneous coronary intervention (PCI) of unprotected distal left main stenosis (UDLM) is increasingly performed as an alternative to surgical treatment. The optimal strategy for stenting in this setting is still a matter of debate. Therefore, this analysis investigated the long-term clinical outcome of a single- versus a double-stenting strategy for treatment of UDLM. METHODS AND RESULTS: From a large registry, 867 consecutive patients with UDLM undergoing either single or double stenting with drug-eluting stents (DES) were identified. Follow-up was up to 10 (median 3.1, interquartile range 1.1-5.3) years. Primary endpoint was MACE consisting of all-cause death, myocardial infarction, or target lesion re-intervention (TLR). Secondary clinical endpoints included these single endpoints and stent thrombosis. MACE occurred in 41.5% after single and in 49.0% after double stenting (P = 0.03). TLR was lower after single (17.4%) as compared to double stenting (27.2%; P < 0.01). Between single and double stenting, there were no significant differences for death (26.4 versus 23.3%; P = 0.31), death or myocardial infarction (29.1 versus 27.2%; P = 0.55), or definite/probable stent thrombosis (1.3 versus 2.1%; P = 0.42). CONCLUSIONS: Compared with single stenting, double stenting was associated with a significantly higher long-term risk of MACE. This was driven by a higher incidence of TLR, whereas the risk of death, MI, or stent thrombosis was similar between the two strategies.

Outcomes after percutaneous coronary intervention for chronic total occlusion according to baseline renal function.

BACKGROUND: Chronic kidney disease (CKD) adversely affects outcomes in patients with coronary artery disease. Data on the impact of renal impairment on prognosis of patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) are scarce. METHODS: A total of 2002 patients undergoing CTO PCI were stratified according to baseline renal function (group 1: estimated glomerular filtration rate [eGFR] ≥ 90 ml/min/1.73 m2, group 2: 60 to 89 ml/min/1.73 m2, group 3: 30 to 59 ml/min/1.73 m2, and group 4: <30 ml/min/1.73 m2). The primary outcome measure was all-cause mortality at a median follow-up of 2.6 (interquartile range 1.1-3.1) years. RESULTS: All-cause mortality increased with decreasing renal function (group 1: 5.0%, group 2: 9.5%, group 3: 26.4%, and group 4: 38.7%, log rank p < 0.001). Continuous eGFR values were significantly related with all-cause mortality (adjusted HR 0.98, 95% CI 0.98-0.99, p < 0.001). Procedural failure was associated with all-cause mortality both in patients with an eGFR < 60 ml/min/1.73 m2 (42.6 vs. 23.7%, adjusted HR 1.59, 95% CI 1.08-2.32, p = 0.02) and in those with an eGFR ≥ 60 ml/min/1.73 m2 (14.6 vs. 6.5%, adjusted HR 1.73, 95% CI 1.15-2.60, p = 0.009, interaction p = 0.47). CONCLUSIONS: Although renal impairment is associated with all-cause mortality in patients undergoing CTO PCI, successful CTO recanalization is related to improved survival irrespective of renal function.

Medium-Term Follow-Up of Early Leaflet Thrombosis After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to investigate medium-term outcomes in patients with leaflet thrombosis (LT). BACKGROUND: The clinical significance of early LT after transcatheter aortic valve replacement, diagnosed by computed tomography angiography in approximately 10% of patients, is uncertain. METHODS: In this observational study, computed tomographic angiography was performed a median of 5 days after transcatheter aortic valve replacement and assessed for evidence of LT. Follow-up consisted of clinical visits, telephone contact, or questionnaire. RESULTS: LT was diagnosed in 120 of 754 patients (15.9%). Patients with LT were less likely male (36.7% vs. 47.0%, p = 0.045), with a lower rate of atrial fibrillation (28.3% vs. 41.5%, p = 0.008). Peri- and post-procedural characteristics were comparable between groups (e.g., valve implantation technique; p = 0.116). During a median follow-up period of 406 days, there were no significant differences in the primary endpoint of all-cause mortality and the secondary combined endpoint of stroke and transient ischemic attack between patients with LT and those without LT (18-month Kaplan-Meier estimate for mortality 86.6% vs. 85.4%, p = 0.912; for stroke- or transient ischemic attack-free survival 98.5% vs. 96.8%, p = 0.331). In univariate and multivariate analyses, LT was not predictive of either endpoint, whereas male sex (p = 0.03), atrial fibrillation (p = 0.002), and more than mild paravalvular leak (p = 0.015) were associated with all-cause mortality. CONCLUSIONS: In this prospective observational cohort undergoing post-transcatheter aortic valve replacement computed tomographic angiography, LT was not associated with increased mortality or rates of stroke over a follow-up period of 406 days.

Temporal changes in outcomes of women and men undergoing percutaneous coronary intervention for chronic total occlusion: 2005-2013.

OBJECTIVE: Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) has undergone impressive progress during the last decade, both in strategies and equipment. It is unknown whether technical refinement has translated into improved outcomes in women undergoing CTO-PCI. METHOD AND RESULTS: A total of 2002 consecutive patients (17% females, mean age 65.2 ± 10.7 years) undergoing PCI of at least one CTO lesion at our center between 01/2005 and 12/2013 were evaluated. The incidence of adverse events was compared between two time series (2005-2009 and 2010-2013). A significant increase in adverse lesion characteristics over time was noted in both, women and men (p < 0.001), while technical success rates significantly increased in men but not in women (ptrend < 0.001 in men and ptrend=0.9 in women). The incidence of procedural complications was significantly higher in women as compared to men and increased over the study period in women (p < 0.05) but not in men. Accordingly, multivariate logistic regression analysis identified female sex as a strong predictor of PCI-related complications in recent years, while this was not the case in earlier years (adjusted HR 2.03, 95% CI 0.62-6.6, p = 0.2 and adjusted HR 4.7, 95% CI 1.8-12.3, p = 0.002, respectively, p < 0.001 for log LH ratio). In addition, major adverse cardiovascular events (MACE) after a 3-year follow-up significantly declined in men (log rank = 0.046), while no changes were observed in women. CONCLUSION: While higher success rates and a reduced rate of MACE have been achieved in men, the incidence of procedural complications in women undergoing CTO-PCI has increased over time.

Clinical implications of periprocedural myocardial injury in patients undergoing percutaneous coronary intervention for chronic total occlusion: role of antegrade and retrograde crossing techniques.

AIMS: Periprocedural myocardial injury (PMI) is frequently observed after percutaneous coronary interventions (PCI) for chronic total occlusion (CTO). We aimed to investigate the prognostic impact of PMI with the antegrade as compared to the retrograde crossing technique. METHODS AND RESULTS: A total of 1,909 patients undergoing CTO PCI were stratified according to the presence/absence of PMI (elevation of cardiac troponin T [cTnT] >5x99th percentile of normal), and divided according to tertiles of the difference between peak and baseline cTnT within 24 hours (∆cTnT). The primary endpoint was all-cause mortality at a median follow-up of 3.1 (interquartile range 3.0-4.4) years. PMI occurred in 19.4% and 25.4% after antegrade (n=1,447) and retrograde (n=462) procedures (p<0.001). PMI was significantly associated with mortality after antegrade (adjusted HR 1.39, 95% CI: 1.02-1.88, p=0.04), but not retrograde CTO PCI (adjusted HR 0.93, 95% CI: 0.53-1.63, p=0.80, pint=0.02). With the antegrade, but not with the retrograde approach, mortality also increased with tertiles of ∆cTnT (T1: 11.0%, T2: 18.6%, T3: 21.6%, log-rank p<0.001). CONCLUSIONS: Periprocedural myocardial injury was significantly associated with all-cause mortality following antegrade, but not retrograde CTO PCI. Hence, the higher risk of PMI following retrograde procedures did not translate into worse survival.

Impact of the type of transcatheter heart valve on the incidence of early subclinical leaflet thrombosis.

OBJECTIVES: The aim of this study was to investigate whether balloon-expandable and self-expandable transcatheter heart valves (THVs) differ in terms of the incidence of early subclinical leaflet thrombosis (LT). METHODS: Electrocardiographic-gated cardiac dual-source computed tomography angiography was performed at a median of 5 days after transcatheter aortic valve implantation and assessed for evidence of LT. RESULTS: Of the 629 consecutive patients, 538 (86%) received a balloon-expandable THV and 91 (14%) a self-expandable THV. LT was documented in 77 (14%) patients with a balloon-expandable valve and in 16 (18%) with a self-expandable valve (P = 0.42). Similarly, LT was not significantly related to THV size (P = 0.62). Corresponding to a lower rate of atrial fibrillation in the group with LT [25 (27%) vs 222 (41%), P = 0.01], anticoagulation at the time of computed tomography angiography was less frequent in this group [21 (23%) vs 183 (34%), P = 0.03]. Among the other potentially relevant covariables, there was no significant difference in the clinical baseline and the procedural characteristics between patients with and without LT (age 82 ± 6 years vs 82 ± 6 years, P = 0.51; ejection fraction 49 ± 10% vs 50 ± 10%, P = 0.47). In multivariate logistic regression analysis, including potentially relevant covariables, valve type was not significantly associated with LT (P = 0.36). In the univariate and multivariate analyses, only the lack of anticoagulation at the time of computed tomography angiography was predictive of thrombus formation [0.563 (0.335-0.944), P = 0.03; 0.576 (0.343-0.970), P = 0.04]. CONCLUSIONS: In this large retrospective study of 629 patients, the type and the size of THV was not predictive of early LT.

A Randomized Trial to Assess Regional Left Ventricular Function After Stent Implantation in Chronic Total Occlusion: The REVASC Trial.

OBJECTIVES: The aim of this study was to investigate whether percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) improves left ventricular function. BACKGROUND: The benefit of PCI in CTOs is still controversial. METHODS: Patients with CTOs who were candidates for PCI were eligible for the study and were randomized to PCI or no PCI of CTO. Relevant coexisting non-CTO lesions were treated as indicated. Patients underwent cardiac magnetic resonance imaging at baseline and at 6 months. The primary endpoint was the change in segmental wall thickening (SWT) in the CTO territory. Secondary endpoints were improvement of regional wall motion and changes in left ventricular volumes and ejection fraction. Furthermore, major adverse coronary events after 12 months were assessed. RESULTS: The CTO PCI group comprised 101 patients and the no CTO PCI group 104 patients. The change in SWT did not differ between the CTO PCI (4.1% [interquartile range: 14.6 to 19.3]) and no CTO PCI (6.0% [interquartile range: 8.6 to 6.0]) groups (p = 0.57). Similar results were obtained for other indexes of regional and global left ventricular function. Subgroup analysis revealed that only in patients without major non-CTO lesions (basal SYNTAX [Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery] score ≤13) CTO PCI was associated with larger improvement in SWT than no CTO PCI (p for interaction = 0.002). Driven by repeat intervention, major adverse coronary event rates at 12 months were significantly lower in the CTO PCI group (16.3% vs. 5.9%; p = 0.02). CONCLUSIONS: No benefit was seen for CTO PCI in terms of the primary endpoint, SWT, or other indexes of left ventricular function. CTO PCI resulted in clinical benefit over no CTO PCI, as evidenced by reduced major adverse coronary event rates at 12 months.

Survival after percutaneous coronary intervention for chronic total occlusion in elderly patients.

AIMS: Few data are available on outcomes of percutaneous coronary intervention (PCI) for coronary chronic total occlusions (CTO) in very elderly patients in the drug-eluting stent (DES) era. We aimed to investigate long-term survival in a single-centre cohort of elderly patients following CTO PCI using DES. METHODS AND RESULTS: A total of 2,002 consecutive patients who underwent PCI of a CTO at our centre between January 2005 and December 2013 were followed for a median of 2.6 years (interquartile range 1.1-3.1 years). Four hundred and nine (409) patients were older than 75 years. The absolute reduction in all-cause mortality by successful CTO PCI was numerically greater in elderly patients as compared to younger patients (22.1% vs. 7.2% at three years). In multivariate models, successful CTO PCI was significantly associated with improved survival in both elderly (adjusted hazard ratio [HR] 0.58, 95% confidence interval [CI]: 0.39 to 0.87; p=0.009) and younger patients (adjusted HR 0.59, 95% CI: 0.40 to 0.86; p=0.006). CONCLUSIONS: In the DES era, elderly patients (≥75 years) derive a similar survival benefit from successful CTO PCI to younger patients. These findings suggest that CTO PCI, when indicated, should not be withheld from the elderly.

Course of early subclinical leaflet thrombosis after transcatheter aortic valve implantation with or without oral anticoagulation.

BACKGROUND: After transcatheter aortic valve implantation, early leaflet thickening, presumably reflecting thrombus, has recently been described on computed tomography angiography (CTA) in ~10% of the patients. We sought to investigate the impact of the antithrombotic regimen on the course of leaflet thickening. METHODS: The study comprised 51 patients with leaflet thickening. Based on the time period, patients without an established indication for anticoagulation were put on phenprocoumon plus clopidogrel for at least 3 months or on dual antiplatelet therapy with aspirin and clopidogrel. Follow-up CTAs were evaluated for leaflet restriction, assessed by four-point-grading score, and maximal thickness. FINDINGS: The anticoagulation and the dual antiplatelet therapy group comprised 29 and 22 patients, respectively. After a median of 86 days, we obtained follow-up CTAs in 22 patients on anticoagulation and in 16 patients on dual antiplatelet therapy. Leaflet thickening progressed in 11 on dual antiplatelet therapy, but always regressed onanticoagulation. The course of leaflet restriction and maximal thickness was significantly different between the two groups (P < 0.001): in the dual antiplatelet therapy group, maximal thickness increased by a mean of 1.37 ± 1.67 mm (P = 0.005) and leaflet restriction score by a median 1[quartiles 0;2] (P = 0.013), whereas in the anticoagulation group, maximal thickness regressed by 2.57 ± 1.52 mm (P < 0.001) and leaflet restriction score decreased by 1[-4;0] (P = 0.001). After a median of 91 days after discontinuation of anticoagulation, CTA performed in ten patients revealed a significant recurrent increase in leaflet restriction score and maximal thickness (P = 0.023, P = 0.007). In the entire cohort, changes in leaflet restriction correlated significantly with changes in transvalvular pressure gradients (r = 0.511, P < 0.001). INTERPRETATION: The course of leaflet restriction was fundamentally different depending on the presence or absence of anticoagulation, with consistent regression under phenprocoumon, but mostly progression under antiplatelet therapy alone. Changes in leaflet restriction were associated with changes in transvalvular pressure gradients.