Lower Target Vessel Revascularization Research Articles

The utility of geriatric nutritional risk index to predict outcomes in chronic limb-threatening ischemia.

To assess geriatric nutritional risk index (GNRI) in patients with chronic limb-threatening ischemia (CLTI). The prevalence of CLTI continues to rise, with major amputation and mortality remaining prominent. Frailty is a vital risk factor for adverse outcomes in cardiovascular care. The GNRI is a nutrition-based surrogate for frailty that has been utilized in Southeast Asia to predict adverse events in CLTI. It has not yet been evaluated in a primarily Western population, nor in the context of wound healing. Between 8August 2017 and April 2019, we identified patients undergoing endovascular interventions for CLTI at our institution, categorized into low GNRI (≤ 94, frail) versus normal GNRI (> 94, reference). We analyzed the risks of major adverse limb events (MALE), its individual components [mortality, major amputation, and target vessel revascularization (TVR)], amputation free survival (AFS), and wound healing using Kaplan-Meier and multivariate cox-proportional hazard regression analyses. A total of 255 patients were included in the analysis, with follow up of 14 ± 9.1months. Lower GNRI was associated with higher cumulative event rates for MALE (71.0% vs. 43.3%, p< 0.001), mortality (34.3% vs. 15.2%, p< 0.001), major amputation (31.2% vs. 15.8%, p= 0.002), and freedom from AFS (56.0% vs. 28.2%, p< 0.001). There was a trend toward lower TVR and higher wound healing with higher GNRI score. Our single-center, retrospective evaluation of GNRI (as a surrogate for frailty) correlated with increased risks of MALE, mortality, and major amputation. Future directions should focus not only on the recognition of these patients, but risk-factor modification to optimize long-term outcomes.

Meta-analysis Comparing Outcomes of Percutaneous Coronary Intervention of Native Artery Versus Bypass Graft in Patients With Prior Coronary Artery Bypass Grafting

Percutaneous coronary intervention (PCI) is common in patients with prior coronary artery bypass graft surgery (CABG), however the data on the association between the PCI target-vessel and clinical outcomes are not clear. We aimed to investigate long-term clinical outcomes of patients with prior CABG who underwent PCI of either bypass graft or native artery. We performed a systematic review and meta-analysis of observational studies comparing PCI of either bypass graft or native artery in patients with prior CABG. Twenty-two studies comprising 40,984 patients were included. The median follow-up duration was 2 (1 to 3) years. Compared with bypass graft PCI, native artery PCI was frequent (61% vs 39%) and was associated with lower major adverse cardiac events (MACE) (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.45 to 0.57, p <0.001), lower all-cause death (OR 0.65, 95% CI 0.49 to 0.87, p = 0.004), lower myocardial infarction (OR 0.56, 95% CI 0.45 to 0.69, p <0.001), and lower target vessel revascularization (TVR) (OR 0.62, 95% CI 0.51to 0.76, p <0.001). There was no significant difference in the early incidence of major bleeding or stroke between the 2 cohorts. In 6 studies involving 2,919 patients with ST-elevation myocardial infarction, there was no significant differences between the 2 cohorts. The increase in TVR risk with bypass graft PCI was associated with MACE. In conclusion, in observational studies involving patients with prior CABG, native artery PCI was associated with lower MACE, all-cause death, myocardial infarction, and TVR compared with bypass graft PCI at a median follow-up of 2 years. Native artery PCI might be considered the preferred treatment for bypass graft failure.

Invasive versus conservative management in spontaneous coronary artery dissection: a meta-analysis and meta-regression study

Abstract Background There is a paucity of data regarding the best treatment for spontaneous coronary artery dissection (SCAD). Purpose To compare the prognostic impact of conservative versus invasive treatment in patients with SCAD. Methods We systematically searched the literature for studies evaluating the comparative efficacy and safety of invasive revascularization versus medical therapy for the treatment of SCAD from 1990 to 2019. Random-effect meta-analysis was performed comparing clinical outcomes between the two groups. Results 24 observational studies with 1720 patients were included. After 28±14 months, a conservative approach reduced target vessel revascularization rate compared with invasive treatment (OR=0.50; 95% CI 0.28–0.90; P=0.02). No difference was found regarding all-cause mortality (OR=0.81; 95% CI 0.31–2.08; P=0.66), cardiovascular mortality (OR=0.89; 95% CI 0.15–5.40; P=0.89), myocardial infarction (OR=0.95; 95% CI 0.50–1.81; P=0.87), heart failure (OR 0.96; 95% CI 0.41–2.22; P=0.92) and SCAD recurrence (OR=0.94; 95% CI 0.52–1.72; P=0.85). The meta-regression analysis suggested that male gender, diabetes mellitus, smoking habit, prior coronary artery disease, left main coronary artery involvement and lower ejection fraction at admission are related with higher overall mortality, whereas SCAD recurrence was higher among patients with fibromuscular dysplasia. Conclusion A conservative approach provides similar clinical outcomes and lower target vessel revascularization rates compared to an invasive strategy in the setting of SCAD; therefore, when feasible, it should be preferred in this scenario. Forest plots on the study outcomes Funding Acknowledgement Type of funding source: None

A comparison of the outcome of therapy between fractional flow reserve guided- versus coronary angiography guided-strategy in acute coronary syndrome patients with moderate coronary lesions

To compare the outcomes between coronary angiography (CAG ) guided- and fractional flow reserve (FFR) guided-strategy in acute coronary syndrome (ACS) patients with moderate lesions. Totally, 249 ACS subjects with moderate lesions examined by CAG in Beijing Anzhen Hospital from July 1, 2014 to July 30, 2015 were included in the present analysis. Among them, 98 patients were further examined by FFR and 151 were not. All the patients were treated with medication either guided by CAG or by FFR. Subjects were followed up for an average of 10 months. The end points included death, nonfatal myocardial infarction (MI), target vessel revascularization (TVR), and hospitalization costs. Major adverse cardiac events (MACE) were defined as death, nonfatal MI, and TVR. At the end of follow-up, 29 patients had MACE with 6 cases (6.5%) in the FFR-guided group, and 23 cases (16.2%) in the CAG-guided group (P=0.036). Patients treated with FFR-guided strategy had significantly lower rate of TVR than those treated with CAG-guided strategy (5.4% vs 14.8%, P=0.045). No statistical difference was observed in nonfatal MI (2.2% vs 3.5%, P=0.242) between the two groups, and no cardiac death occurred in the two groups. However, the rate of patients treated with stains (P=0.033) and the hospitalization costs (P=0.001) were significantly increased in the FFR-guided group. FFR-guided strategy for patients with ACS results in lower TVR and MACE, but higher cost when compared with CAG-guided strategy.

Efficacy of various percutaneous interventions for in-stent restenosis: comprehensive network meta-analysis of randomized controlled trials.

In-stent restenosis (ISR) remains a difficult problem in interventional cardiology. The relative efficacy and safety of available interventions is not clear. We aimed to perform a network meta-analysis using both direct evidence and indirect evidence to compare all available interventions. We systematically searched electronic databases for randomized trials comparing ≥2 treatments for ISR. A network meta-analysis was performed using a Bayesian approach. Eleven treatments were compared in 31 studies with 8157 patient-years follow-up. Compared with balloon angioplasty, everolimus-eluting stent (hazard ratio [95% credibility interval], 0.13 [0.048-0.35]), paclitaxel-eluting balloon (0.32 [0.20-0.49]), paclitaxel-eluting cutting balloon (0.054 [0.0017-0.5]), paclitaxel-eluting stent (0.39 [0.24-0.62]), and sirolimus-eluting stent (0.32 [0.18-0.50]) are associated with lower target vessel revascularization. Balloon angioplasty is not different from cutting balloon (0.73 [0.31-1.5]), excimer laser (0.89 [0.29-2.7]), rotational atherectomy (0.96 [0.53-1.7]), and vascular brachytherapy (0.60 [0.35-1.0]). In drug-eluting stent ISR, balloon angioplasty was inferior to everolimus-eluting stent (0.19 [0.049-0.76]), paclitaxel-eluting balloon (0.43 [0.18-0.80]), paclitaxel-eluting stent (0.35 [0.13-0.76]), and sirolimus-eluting stent (0.36 [0.11-0.86]) for target vessel revascularization. There was no difference between treatments in probable or definitive stent thrombosis. The results of binary restenosis and target lesion revascularization were similar. Paclitaxel-eluting cutting balloon, everolimus-eluting stent, and paclitaxel-eluting balloon have the highest probability of being in the top 3 treatments based on low target lesion revascularization, but there was no statistical significant difference between them. Balloon angioplasty is inferior to all drug-eluting treatments for ISR, including drug-eluting stent ISR. Drug-eluting stent, particularly everolimus-eluting stent, or paclitaxel-eluting cutting balloon and paclitaxel-eluting balloon should be preferred for treating ISR.

First- versus second-generation drug-eluting stents for the treatment of coronary bifurcations

Randomized controlled trials have demonstrated that second-generation drug-eluting stents (DESs) for the treatment of obstructive coronary artery disease are associated with comparable, if not improved, clinical outcomes as compared to those of their first-generation counterparts. The aim of this study was to compare the long-term clinical outcomes associated with first- versus second-generation DESs for the treatment of coronary bifurcation lesions. This was a retrospective study of consecutive de novo bifurcation lesions, excluding those at the left main, treated with either second-generation DES (everolimus-eluting or resolute zotarolimus-eluting stents) between October 2006 and October 2011 (199 bifurcation lesions in 192 patients) or first-generation DES (sirolimus-eluting or paclitaxel-eluting stents) between April 2002 and December 2005 (289 bifurcation lesions in 273 patients). Second-generation DES use in this setting was associated with less major adverse cardiac events (MACE) (23.1% vs. 14.4%, p=0.02) as well as lower target vessel revascularization (TVR) rates (15.5% vs. 8.3%, p=0.01) at 2-year follow-up. Target lesion revascularization, both per patient (12.6% vs. 7.4%, p=0.02) and per bifurcation (11.8% vs. 7.0%, p=0.03), was also improved with second-generation DES over the same follow-up period. Propensity-score adjusted analysis suggested that second-generation DES was associated with a lower incidence of MACE (HR, 0.53; 95% CI, 0.33-0.85; p=0.01) and TVR (HR, 0.44; 95% CI, 0.24-0.83; p=0.01). Our results suggest that the use of second-generation DES for the treatment of bifurcation lesions is associated with better clinical outcomes as compared to first-generation DES, largely due to a lower need for repeat revascularization.

ACEF score in the risk stratification of patients undergoing percutaneous coronary interventions of chronic coronary total occlusion

Purpose: The Age, Creatinine, and Ejection Fraction (ACEF) score can reliably predict clinical outcomes in patients undergoing elective coronary artery bypass surgery. However, its utility in patients undergoing percutaneous coronary intervention of a chronic total occlusion is not known. Methods: ACEF score was calculated in 308 consecutive patients treated with PCI of CTO between January 2008 and June 2012. Patients with successful recanalization of CTO were divided according to the ACEF score tertiles: ACEFlow ≤ 0.89 (n=80, 26%), ACEFmid 0.90-1.10 (n=68, 22%), and ACEFhigh > 1.10 (n=73, 24%). Patients with failed recanalization were excluded from the analysis (n=87 [28%]). Follow up was available in 206 patients (93%) with a median of 25 months (10-37). Clinical endpoints assessed at the follow-up were major adverse cardiovascular events (MACE), overall death, non-fatal myocardial infarction (MI) and target vessel revascularization (TVR). Results: The 3 groups did not differ significantly with respect to the angiographic characteristics. At the follow-up, MACE rate was significantly lower in the lowest ACEF score tertile (ACEFlow = 7%, ACEFmid = 14%, ACEFhigh = 21%, HR: 0.46 (0.26-0.81), p<0.01). At Kaplan-Mayer analysis, MACE-free survival was significantly higher in the lowest ACEF score tertiles (Log-Rank: 5.36, p<0.01). This difference in outcome was mainly driven by lower TVR rate in the ACEFlow group (ACEFlow = 3%, ACEFmid = 9%, ACEFhigh = 15%, HR: 0.47 (0.25-0.87), p=0.02). No significant difference was found both in death and non-fatal MI. Conclusions: ACEF score represents a simple tool in the prognostication of patients treated with PCI of CTO. In addition, it provides the evidence about the benefit of revascularization of a CTO in patients with the lowest ACEF score.

Two-Year Follow-Up of Outcomes of Second-Generation Everolimus-Eluting Stents Versus First-Generation Drug-Eluting Stents for Stenosis of Saphenous Vein Grafts Used as Aortocoronary Conduits

Second-generation everolimus-eluting stents (EESs) have demonstrated superiority in efficacy and safety compared with first-generation drug-eluting stents (DESs) in the treatment of native coronary artery lesions. The present study evaluated and compared the safety and efficacy of EESs and first-generation DESs in saphenous vein graft lesions. The EES group consisted of 88 patients with 96 lesions, and the first-generation DES group consisted of 243 patients with 317 lesions (sirolimus-eluting stents, n = 212; paclitaxel-eluting stents, n = 105). The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (composite of all-cause death, myocardial infarction, and target vessel revascularization), and definite stent thrombosis at 2 years. The groups had similar baseline characteristics and graft ages (128.1 ± 77.5 vs 132.4 ± 90.8 months, p = 0.686). The EES group had more type C lesions and less embolic protection device use. The peak postprocedure values of creatinine kinase-MB and troponin I were similar between the 2 groups. Overall, major adverse cardiovascular events occurred in 18.2% of EES patients and 35.0% of first-generation DES patients (p = 0.003), mainly driven by a lower target vessel revascularization rate (6.8% vs 24.5%, p <0.001). The target lesion revascularization rate was lower in the EES group (1.1% vs 11.6%, p = 0.005). Stent thrombosis was low and similar between the 2 groups (0% vs 0.8%, p = 1.000). On multivariate analysis, the type of DES implanted and graft age were the only independent predictors of major adverse cardiovascular events. In conclusion, the superiority of EESs compared with first-generation DESs shown in native artery lesions has been extended to saphenous vein graft lesions and should be considered as the DES of choice for this lesion type.

Everolimus‐Eluting Stents Versus Sirolimus‐ or Paclitaxel‐Eluting Stents: Two‐Year Results from the Guthrie Health Off‐Label Stent (GHOST) Registry

We sought to compare the safety and effectiveness of everolimus-eluting stents (EES) versus first generation drug-eluting stents (FG-DES; sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]). In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2-year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG-DES groups. Secondary end-points included all-cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end-points in 2 propensity-matched subgroups: EES versus SES; EES versus PES. Complete 2-year follow-up was available in 1,911 (90%) patients. Compared to FG-DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10-1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22-0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months. The use of EES compared to FG-DES appears to be associated with reductions in ST and TVR at 2-year follow-up. Improved outcomes with EES are observed in comparison with SES as well as PES.

5-Year Outcomes Following Percutaneous Coronary Intervention With Drug-Eluting Stent Implantation Versus Coronary Artery Bypass Graft for Unprotected Left Main Coronary Artery Lesions: The Milan Experience

We sought to evaluate at 5 years the occurrence of cardiac death; cardiac death, and/or myocardial infarction (MI); cardiac death, MI, and/or stroke; target vessel revascularization; and major adverse cardiac and cerebrovascular events following percutaneous coronary intervention (PCI) with drug-eluting stent (DES) versus coronary artery bypass graft (CABG) in unprotected left main coronary artery lesions. Preliminary results at 1 year showed comparable occurrence of major adverse cardiac and cerebrovascular events in our center between PCI and CABG. All consecutive patients with an unprotected left main coronary artery stenosis electively treated with DES implantation versus CABG in our center, between March 2002 and July 2004, were analyzed. A propensity analysis was performed to adjust for baseline differences between the 2 cohorts. We included 249 patients in the study: 107 were treated with PCI and DES implantation and 142 with CABG. At 5-year clinical follow-up, no difference was found between PCI and CABG in the occurrence of cardiac death (adjusted odds ratio [OR]: 0.502; 95% confidence interval [CI]: 0.162 to 1.461; p = 0.24). The PCI group showed a trend toward a lower occurrence of the composite end point of cardiac death and MI (adjusted OR: 0.408; 95% CI: 0.146 to 1.061; p = 0.06). Percutaneous coronary intervention was associated with a lower rate of the composite end point of death, MI, and/or stroke (OR: 0.399; 95% CI: 0.151 to 0.989; p = 0.04). Indeed, CABG was correlated with lower target vessel revascularization (adjusted OR: 4.411; 95% CI: 1.825 to 11.371; p = 0.0004). No difference was detected in the occurrence of major adverse cardiac and cerebrovascular events (adjusted OR: 1.578; 95% CI: 0.825 to 3.054; p = 0.18). At 5-year clinical follow-up, there was still no difference in the occurrence of major adverse cardiac and cerebrovascular events between elective PCI with DES implantation and CABG in unprotected left main coronary artery lesions in this single-center experience. There was an advantage of PCI in the composite end point of death, MI, and/or stroke, whereas a benefit in the need for reintervention was still found in CABG.

Stent choice in primary percutaneous coronary intervention: drug-eluting stents or bare metal stents?

The controversial choice between bare metal stents and drug-eluting stents (DES) in primary percutaneous coronary intervention (PCI) seems to be driven by a growing body of evidence. Although evidence supporting the use of DES in the setting of ST-segment elevation myocardial infarction (STEMI) has been demonstrated, including a lower target vessel revascularization (TVR) rate without increased mortality, at present the proportion of DES implants in STEMI patients is low. This may be due to higher costs of DES, cultural issues, lack of concerns about restenosis in STEMI, lack of information on patient bleeding risk and the need for surgery within a limited time. In addition, initial enthusiasm about the efficacy of DES in reducing restenosis is now decreasing as a result of the safety concerns regarding in-stent thrombosis. Moreover, DES requires long-term dual antiplatelet therapy (DAT), which may pose problems in patients prone to bleeding or in candidates for elective surgery. Nevertheless, benefits associated with use of DES include significantly lower TVR rates without remarkable adverse effects in terms of death and myocardial infarction. Data about the efficacy of DES are still limited to 1-year follow-up in most trials. Uncoated stents permit early arterial wall healing, requiring a shorter duration of DAT and are potentially associated with a reduced risk of thrombus formation at long-term follow-up. Importantly, however, this potential late threat has not been confirmed in recent data from the limited number of studies with longer than 2-years follow-up. Anatomical features and individual risk profiles can sometimes help in the choice of the most suitable type of stent. In conclusion, stent choice in primary PCI cannot be standardized for all patients and appears to be influenced by various factors that need to be considered to provide better revascularization in terms of both efficacy and safety.

Safety and Effectiveness of Drug-Eluting and Bare-Metal Stents for Patients With Off- and On-Label Indications

Our main objective was to evaluate the longer-term safety and efficacy of drug-eluting stents (DES) in off-label indications as compared with bare-metal stents (BMS). DES are frequently implanted in patients with off-label indications. However, the longer-term safety and effectiveness of DES among patients with off-label indications are not well understood. Propensity score matching analysis was performed in a population-based cohort that included 6,944 off-label and 9,126 on-label patients who received percutaneous coronary interventions (PCIs) in Ontario, Canada, between December 1, 2003, and March 31, 2006. Off-label indications were defined on the basis of clinical and procedural characteristics. For patients with off-label indications, rates of repeat target vessel revascularization at 3 years were significantly lower among patients treated with DES compared with those treated with BMS (11.6% vs. 15.3%, p < 0.001). Myocardial infarction rates were not significantly different between patients treated with DES and BMS (p = 0.52). Mortality rates were significantly lower among off-label patients treated with DES compared with BMS at 3 years of follow-up (6.9% vs. 10.5%, p < 0.001). For patients with on-label indications, the use of DES was associated with significantly lower rates of target vessel revascularization, but composite rates of myocardial infarction or death were not significantly different from BMS. For patients with off-label indications, DES implantation was associated with lower target vessel revascularization without an associated increase in longer-term risk of myocardial infarction or death compared with BMS.

Usage patterns and 2‐year outcomes with the TAXUS express stent: Results of the US ARRIVE 1 registry

It is unclear how well the long-term safety and effectiveness of drug-eluting stents observed in tightly defined randomized controlled trials (RCT) translates to expanded use in routine practice. The FDA-mandated TAXUS Express(2) ARRIVE 1 postmarket registry was designed to consecutively enroll patients receiving > or = 1 TAXUS stent in low-, medium-, and high-volume US sites (n = 50). All cardiac events plus an additional 20% sample of records were monitored and all endpoints were independently adjudicated. Detailed follow-up data through 2 years were compiled for 2,487 patients (95%). Simple-use (on-label) ARRIVE 1 patients (35%) had outcomes similar to 4 pooled TAXUS RCTs for death (3.5% vs. 3.4%, respectively, P = 0.78), Q-wave myocardial infarction (QWMI, 0.7% vs. 0.9%, P = 0.72), and stent thrombosis (ST, 2.2% vs. 1.2%, P = 0.12), but lower target vessel revascularization (7.8% vs. 13.4%, P < 0.0001). Compared with simple-use, cases representing expanded use to treat broader patient/lesion characteristics showed higher 2-year rates for death (7.4% vs. 3.5%, respectively, P = 0.0003), target lesion revascularization (9.4% vs. 5.8%, P = 0.0031), and ST (3.4% vs. 2.2%, P = 0.061, concentrated early in the first year). By including methods usually found in RCT, ARRIVE 1 captured a broad spectrum of disease treated in standard practice with high levels of ascertainment of clinical outcomes. In the more complicated cases, expectedly higher adverse event rates were seen compared to that found in the simple-use cases or pivotal RCT. These results have now been included in the Directions for Use, to aid in physician and patient decision-making.