Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial

ObjectivesThe study sought to evaluate the impact of diabetes mellitus on 3-year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de novo lesions.BackgroundFor treatment of de novo coronary small vessel disease, DCBs are noninferior to DES.MethodsIn this prespecified analysis of a multicenter, randomized, noninferiority trial, including 758 patients with de novo lesions in coronary vessels <3 mm who were randomized 1:1 to DCB or DES and followed over 3 years for major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus.ResultsIn nondiabetic patients (n = 506), rates of MACE (DCB 13.0% vs DES 11.5%; hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 0.73-2.09; P = 0.43), cardiac death (2.8% vs 2.9%; HR: 0.97; 95% CI: 0.32-2.92; P = 0.96), nonfatal MI (5.1% vs 4.8%; HR: 1.00; 95% CI: 0.44-2.28; P = 0.99), and TVR (8.8% vs 6.1%; HR: 1.64; 95% CI: 0.83-3.25; P = 0.16) were similar. In diabetic patients (n = 252), rates of MACE (19.3% vs 22.2%; HR: 0.82; 95% CI: 0.45-1.48; P = 0.51), cardiac death (8.8% vs 5.9%; HR: 2.01; 95% CI: 0.76-5.31; P = 0.16), and nonfatal MI (7.1% vs 9.8%; HR: 0.55; 95% CI: 0.21-1.49; P = 0.24) were similar in DCB and DES. TVR was significantly lower with DCBs vs DES (9.1% vs 15.0%; HR: 0.40; 95% CI: 0.17-0.94; P = 0.036; P = 0.011 for interaction).ConclusionsThe rates of MACE are similar in DCBs and DES in de novo coronary lesions of diabetic and nondiabetic patients. In diabetic patients, need for TVR was significantly lower with DCB versus DES. (Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs Drug Eluting Stents in Small Vessel Interventions [BASKET-SMALL2]; NCT01574534)     

Impact of treatment strategies on long-term outcome of CTO patients

BackgroundThe percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) remains debated. Therefore the aim of this large-scale observational multi-center registry was to compare the long-term outcome of CTO patients undergoing different therapeutic approaches comparing successful CTO revascularization either by PCI or coronary artery bypass graft (CABG), failed CTO-PCI and optimal medical therapy (OMT) alone.Methods and resultsA total of 6630 CTO patients were enrolled from two high-volume centers to compare different treatment strategies. All procedures were performed by high-volume CTO operators in tertiary university hospital. Successful CTO-PCI was performed in 3906 patients, failed CTO-PCI in 1479 patients, 412 patients underwent CABG surgery and 833 patients were treated with OMT. During the 5-year follow-up period, 1019 (15%) patients died. Kaplan-Meier analysis unveiled a significantly improved long-term outcome for CTO patients undergoing revascularization either by PCI or by CABG compared to patients with failed CTO-PCI or OMT alone (log-rank P < 0.001). In the multivariate Cox-regression analysis successful CTO-PCI was associated with significantly improved long-term outcome compared to patients under OMT (adj. HR 0.39, 95%CI 0.33–0.45, P < 0.001) or CABG (adj. HR 0.68, 95%CI 0.53–0.86, P = 0.002) independent of clinical confounders encompassing age, BMI, diabetes, kidney function and left ventricular function.ConclusionsThis study showed an improved long-term outcome for CTO revascularization compared to optimal medical therapy, independent from revascularization mode, with the highest survival rate in patients undergoing successful CTO-PCI.     

Impact of Intravascular Ultrasound on Chronic Total Occlusion Percutaneous Revascularization

AimWe sought to investigate the impact of IVUS use on chronic total occlusion (CTO) PCI using data from a contemporary registry of consecutive patients and applying a propensity score matching analysis.Methods and resultsWe evaluated 514 successful CTO-PCIs, median age: 67 years (IQR: 58–73), 83.5% males. IVUS-guided PCI was performed in 184 (35.8%) of cases. After using 1:1 propensity matching score analysis, two groups of 182 patients each (IVUS-guided vs. angiography-guided CTO-PCI group) were produced to form the study population.In the IVUS-guided group the median maximum stent diameter was larger and the median total stented segment was longer compared to the angiography-guided group [(3.5 mm, IQR: 3.0–4.0 vs. 3.2 mm, IQR: 3.0–3.5, p < 0.001) and (60.0 mm, IQR: 38.0–91.3 vs. 38.0 mm, IQR: 32.0–70.5, p < 0.001), respectively]. In the IVUS-guided group, retrograde recanalization was more frequently encountered compared to the angiography-guided PCI group (30.2% vs. 20.9%, p = 0.04). Procedural time was significantly longer in the IVUS-guided group, without any difference in fluoroscopy time, radiation dose and contrast volume. Multivariate linear regression analysis showed that IVUS use was the strongest independent factor associated with larger maximum diameter stents (p < 0.001) and a strong independent predictor for total stented segment length during CTO-PCI (p < 0.001).Up to 8 years follow-up, there was no difference in the incidence of the composite endpoint of all-cause death, cardiac death, myocardial infarction and target vessel revascularization between the IVUS-guided PCI and the angiography-guided PCI groups (hazard ratio: 13.7% vs. 15.9%, respectively, log-rank: p = 0.67, median follow-up time: 49.0 months, IQR: 33.0–67.0).ConclusionsUse of IVUS in CTO-PCI was associated with larger stent diameter and longer stented segments. Despite more frequent use of IVUS in retrograde CTO-PCI, there was no difference in long-term adverse events between IVUS and angiography CTO-PCI groups; nevertheless, the study was not powered to assess clinical outcomes.     

1-Year Outcomes with COMBO Stents in Small-Vessel Coronary Disease: Subgroup Analysis From the COMBO Collaboration

BackgroundSmall vessel diameter is associated with higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). The COMBO sirolimus-eluting biodegradable-polymer stent has a proprietary anti-CD34 antibody layer to enhance homogeneous endothelialization, which may be advantageous in treating small vessels.ObjectiveWe examined for differences in 1-year clinical outcomes after PCI by maximum implanted stent diameter from the COMBO collaboration.MethodsThe COMBO collaboration (n = 3614) is a patient-level pooled dataset of patients undergoing PCI with COMBO stents in the MASCOT and REMEDEE multicenter registries. Stent diameter was available in 3590 (99.3%) patients. We compared patients receiving COMBO stents <3 mm versus ≥3 mm. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI) or clinically driven TLR. Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods.ResultsThe study included 792 (22%) patients with small stents <3 mm and 2798 (78%) patients with large stents ≥3 mm. Small stent patients included more women with lower body mass index and higher prevalence of diabetes but similar prevalence of acute coronary syndrome. Risk of 1-year TLF was similar in small and large stent groups (4.4% vs. 3.8%, HR 1.12, 95% CI 0.74–1.72, p = 0.58). There were no differences in the rates of cardiac death (1.7% vs. 1.5%, p = 0.74), TV-MI (1.4% vs. 1.2%, p = 0.58) or TLR (2.7% vs. 2.1%, p = 0.31). Definite or probable ST occurred in 1.3% of the small stent and 0.7% of the large stent PCI patients, p = 0.14, HR 2.13, 95% CI 0.93–5.00, p = 0.07.ConclusionsOne-year ischemic outcomes after COMBO PCI were similar irrespective of stent diameter in this all-comers international cohort.     

Impact of metabolic syndrome on clinical outcomes after new generation drug-eluting stent implantation: The ‘obesity paradox’ phenomenon is still apparent

Background and aimNew generation drug-eluting stents (DES) have improved clinical outcomes. However, their impact on patients with metabolic syndrome (MS) is still unclear as there is no sufficient data. Therefore, we evaluated the impact of the new generation DES on patients with an isolated lesion in the proximal segment of the left anterior descending artery (pLAD) suffering from MS.Methods and resultsWe evaluated 511 patients with a pLAD lesion. Of these, 147 patients had MS. The major adverse cardiac events (MACE) including death, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR) were defined as primary end points. Stent thrombosis was also evaluated. MACEs had a trend to be higher in non-MS group (8.24% vs 3.40%, p = 0.05) during 20 months mean follow-up period. Rates of cardiac death (1.37% vs 0.68%, p = 0.67), non-fatal MI (1.92% vs 0.0%, p = 0.20), TLR (4.94% vs 2.04% MS, p = 0.21) and thrombosis (3.29% vs 1.36%, p = 0.36) were not significantly different in non-MS and MS group. The Kaplan–Meier curve revealed: MS group: 96.59% vs non-MS group: 91.75% (p = 0.04). MS was a favorable independent predictor for MACE (hazard ratio (HR) 0.34, 95% confidence interval (CI) 0.12–0.93, p < 0.03). In addition, independent predictors for MACE were BMI ≥ 30 kg/m² (HR 0.87 95% CI 0.79–0.96 p = 0.008) and diabetes mellitus (HR 2.01 95% CI 0.99–4.11, p = 0.05).ConclusionThe ‘obese paradox’ phenomenon is found in the era of new generation DES. In order to investigate the underlying mechanism for this phenomenon further studies are required.     

Synergistic increase risk of death and myocardial infarction at one year in patients with concomitant diabetes mellitus and renal failure

AimsWe tested the hypothesis that in patients with acute myocardial infarction (AMI), concomitant diabetes mellitus (DM) and renal failure (RF) increases the short- and long-term risk compared to DM or RF alone.Materials and methodsThis registry included consecutive patients with AMI treated with percutaneous coronary intervention (PCI) who completed 1-year follow-up. The primary outcome included the rate of all causes of death, AMI, and target vessel revascularization (TVR).ResultsA total of 858 patients were studied in 4 groups: DM and RF, 112 (13.1%); DM alone, 145 (16.9%); RF alone, 134 (15.6%); and no DM or RF, 467 (54.4%). The DM and RF group had more cardiogenic shock, lower ejection fraction, longer hospital stay, and higher peak troponin (all p < 0.01). After multivariable adjusted analysis, the DM and RF group had higher risk of death (HR 3.35, CI 1.69–6.67; p < 0.01), AMI (HR 2.8; CI 1.15–6.83; p = 0.02), and major adverse cardiac events (HR 1.97, CI 1.23–3.13; p < 0.01) at 1-year follow-up compared to patients with no DM or RF.ConclusionThe combination of DM and RF is the strongest independent predictor of death and AMI, but not a predictor of TVR. These findings should be evaluated in large prospective studies.     

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

BackgroundRandomized 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.Methods and MaterialsThis 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).ResultsSecond-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).ConclusionsOur 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.     

Impact of Successful Chronic Coronary Total Occlusion Recanalization on Recurrence of Ventricular Arrhythmias in Implantable Cardioverter-Defibrillator Recipients for Ischemic Cardiomyopathy (VACTO PCI Study)

BackgroundCoronary chronic total occlusion lesions (CTOs) confer an increased risk of arrhythmic events among patients with ischemic cardiomyopathy (ICM) and implantable cardioverter-defibrillator (ICD) carriers, however the impact of CTO recanalization in this population remains unassessed.AimsEvaluate the impact of CTOs percutaneous coronary interventions (PCI) on arrhythmic events.MethodsPatients with ICM and ICD from the VACTO I-II registries: patients with medically treated CTO (CTO-OMT group) and without CTO (no-CTO group) were compared after inverse-probability-weighting adjustment (IPWT) with a similar population of consecutive patients undergoing CTO-PCI. The primary endpoint was appropriate ICD therapy. The secondary endpoint was all-cause mortality.ResultsThe total of 622 patients (mean age 67 ± 10 years, mean left ventricular ejection fraction 36 ± 11%) included in the analysis was composed by: CTO-PCI patients n = 113, CTO-OMT patients n = 286, no-CTO patients n = 223. In the CTO-PCI group, compared to the CTO-OMT group, 5-year Kaplan Meier estimates for appropriate ICD therapy (20.4% vs. 56.4%, IPW-adjusted HR: 0.45, 95% CI 0.29–0.71) and mortality (8.8% vs. 23%, IPW-adjusted HR: 0.43, 95% CI 0.22–0.85) were lower, driven by infarct related artery CTO (IRA-CTO) PCI, while similar to those occurring in the no-CTO group.ConclusionsIn this large population, those with CTO receiving PCI had lower arrhythmic event rates and lower mortality compared to the CTO-OMT group, while showing an event rate similar to no-CTO patients. Sensitivity analyses suggest that the beneficial effect on the arrhythmic outcome was driven by IRA-CTO revascularization.ClassificationChronic total occlusion.     

Improved 3-Year Cardiac Survival After IVUS–Guided Long DES Implantation: A Patient-Level Analysis From 2 Randomized Trials

ObjectivesThe present study aimed to evaluate long-term cardiac survival benefit for intravascular ultrasound (IVUS)- versus angiography-guided long drug-eluting stent (DES) implantation.BackgroundAlthough the long-term benefit of IVUS guidance for DES implantation has been reported from recent randomized trials, this benefit was primarily driven by the reduction in repeat revascularization. Thus, it remains uncertain whether IVUS guidance improved survival during long-term follow-up.MethodsWe pooled the data of 2 randomized trials (IVUS-XPL [Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions] and ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in All-Comers Coronary Lesions]) and compared IVUS guidance versus angiography guidance in 2,577 patients with long lesions treated with an implanted stent length ≥28 mm. The primary end point was cardiac death at 3 years.ResultsA 3-year clinical follow-up was completed in 96%. The primary end point of cardiac death occurred in 12 patients (1.0%) in the IVUS-guided group vs 28 patients (2.2%) in the angiography-guided group (HR: 0.43; 95% CI: 0.22-0.84; P = 0.011). In addition, target lesion–related myocardial infarction occurred in 3 patients (0.2%) in the IVUS-guided group and in 9 patients (0.7%) in the angiography-guided group (HR: 0.33; 95% CI: 0.09-1.22; P = 0.081), stent thrombosis developed in 3 patients (0.2%) in the IVUS-guided group and 9 patients (0.7%) in the angiography-guided group (HR: 0.33; 95% CI: 0.09-1.23; P = 0.082), and ischemia-driven target lesion revascularization was observed in 47 patients (3.8%) in the IVUS-guided group and 80 patients (6.5%) in the angiography-guided group (HR: 0.57; 95% CI: 0.40-0.82; P = 0.002).ConclusionsIn this post hoc pooled patient-level analysis, the use of IVUS-guided long DES implantation compared with angiography-guided stent implantation improved long-term patient cardiac survival.     

In-Stent CTO Percutaneous Coronary Intervention: Individual Patient Data Pooled Analysis of 4 Multicenter Registries

ObjectivesThe authors sought to examine the outcomes of percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) chronic total occlusions (CTOs).BackgroundThe outcomes of PCI for ISR CTOs have received limited study.MethodsThe authors examined the clinical and angiographic characteristics and procedural outcomes of 11,961 CTO PCIs performed in 11,728 patients at 107 centers in Europe, North America, Latin America, and Asia between 2012 and 2020, pooling patient-level data from 4 multicenter registries. In-hospital major adverse cardiovascular events (MACE) included death, myocardial infarction, stroke, and tamponade. Long-term MACE were defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization.ResultsISR represented 15% of the CTOs (n = 1,755). Patients with ISR CTOs had higher prevalence of diabetes (44% vs. 38%; p < 0.0001) and prior coronary artery bypass graft surgery (27% vs. 24%; p = 0.03). Mean J-CTO (Multicenter CTO Registry in Japan) score was 2.32 ± 1.27 in the ISR group and 2.22 ± 1.27 in the de novo group (p = 0.01). Technical (85% vs. 85%; p = 0.75) and procedural (84% vs. 84%; p = 0.82) success was similar for ISR and de novo CTOs, as was the incidence of in-hospital MACE (1.7% vs. 2.2%; p = 0.25). Antegrade wiring was the most common successful strategy, in 70% of ISR and 60% of de novo CTOs, followed by retrograde crossing (16% vs. 23%) and antegrade dissection and re-entry (15% vs. 16%; p < 0.0001). At 12 months, patients with ISR CTOs had a higher incidence of MACE (hazard ratio: 1.31; 95% confidence interval: 1.01 to 1.70; p = 0.04).ConclusionsISR CTOs represent 15% of all CTO PCIs and can be recanalized with similar success and in-hospital MACE as de novo CTOs.     

Impact of Diabetes Mellitus on Outcomes of Percutaneous Coronary Intervention in Chronic Total Occlusions: A Systematic Review and Meta-Analysis

BackgroundPatients with diabetes mellitus (DM) have a high prevalence of coronary chronic total occlusions (CTOs). We conducted a systematic review and meta-analysis to characterize outcomes after CTO percutaneous coronary intervention (PCI) in patients without or with DM.MethodsPubMed, EMBASE, Cochrane, and Google Scholar were queried for studies comparing non-DM vs. DM patients undergoing attempted CTO PCI. The primary outcome was all-cause mortality at longest follow-up (at least 6 months). Secondary outcomes were major adverse cardiovascular events (MACE) which is a composite endpoint including myocardial infarction, cardiac or all-cause mortality and any revascularization in patients after CTO PCI, target vessel revascularization (TVR), myocardial infarction (MI), Japanese chronic total occlusion (J-CTO) score and prevalence of multivessel (MV) CTO disease. We used a random effects model to calculate odds ratios (ORs) and 95% confidence intervals (CIs).ResultsSixteen studies, including 2 randomized control trials and 14 observational studies, met inclusion criteria. At longest follow-up, all-cause mortality (OR 0.54 [95% CI 0.37–0.80], p < 0.0001) and MACE (OR 0.82 [95% CI 0.72–0.93], p < 0.00001) were significantly lower in non-DM CTO patients. MV CTO disease was less prevalent in patients without DM (OR 0.80 [95% CI 0.69–0.93], p = 0.004). However, there were no differences in MI, TVR and J-CTO score.ConclusionsNon-diabetics undergoing CTO PCI have lower all-cause mortality and MACE than diabetics. Future research may determine if DM control improves diabetics' CTO PCI outcomes.     

Long-Term Outcomes in Women and Men Following Percutaneous Coronary Intervention

BackgroundStudies examining sex-related outcomes following percutaneous coronary intervention (PCI) have reported conflicting results.ObjectivesThe purpose of this study was to examine the sex-related risk of 5-year cardiovascular outcomes after PCI.MethodsThe authors pooled patient-level data from 21 randomized PCI trials and assessed the association between sex and major adverse cardiac events (MACE) (cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]) as well as its individual components at 5 years.ResultsAmong 32,877 patients, 9,141 (27.8%) were women. Women were older and had higher body mass index, more frequent hypertension and diabetes, and less frequent history of surgical or percutaneous revascularization compared with men. By angiographic core laboratory analysis, lesions in women had smaller reference vessel diameter and shorter lesion length. At 5 years, women had a higher unadjusted rate of MACE (18.9% vs. 17.7%; p = 0.003), all-cause death (10.4% vs. 8.7%; p = 0.0008), cardiac death (4.9% vs. 4.0%; p = 0.003) and ID-TLR (10.9% vs. 10.2%; p = 0.02) compared with men. By multivariable analysis, female sex was an independent predictor of MACE (hazard ratio [HR:]: 1.14; 95% confidence interval [CI:]: 1.01 to 1.30; p = 0.04) and ID-TLR (HR: 1.23; 95% CI: 1.05 to 1.44; p = 0.009) but not all-cause death (HR: 0.91; 95% CI: 0.75 to 1.09; p = 0.30) or cardiac death (HR: 0.97; 95% CI: 0.73 to 1.29; p = 0.85).ConclusionsIn the present large-scale, individual patient data pooled analysis of contemporary PCI trials, women had a higher risk of MACE and ID-TLR compared with men at 5 years following PCI.     

Preprocedural high-sensitivity C-reactive protein predicts death or myocardial infarction but not target vessel revascularization or stent thrombosis after percutaneous coronary intervention

BackgroundHigh-sensitivity C-reactive protein (hs-CRP) elevation is associated with poor clinical outcome in patients with coronary artery disease (CAD). However, the prognostic value of preprocedural hs-CRP elevation before coronary stent implantation remains debated especially regarding restenosis and target vessel revascularization (TVR). Furthermore, whether hs-CRP elevation may predict stent thrombosis (ST) is unknown.MethodsWe included 560 consecutive patients, who underwent coronary stent implantation in our institution. Blood samples for hs-CRP determination were obtained immediately before the procedure. During a median follow-up of 12.5 months, cardiovascular events including death, myocardial infarction (MI), TVR, and ST were systematically included.ResultsMedian hs-CRP was 3.10 [25–75th percentile: 1.36-8.63] mg/l. There were 27 (4.8%) deaths, 17 (3.1%) nonfatal MI, 58 (10.5%) TVR, and 12 (2.1%) ST. The composite criteria death–MI occurred in 44 (7.9%) patients. Independent predictors of the composite death–MI were hs-CRP level [hazard ratio (HR)=1.33 (95% CI: 1.05-1.70); P=.021], diabetes (P=.003), and multivessel CAD (P=.011). The composite death–MI occurred in 31 (13.3%) of the 233 patients with hs-CRP >4.63 mg/l vs. 13 (4.0%) of the 327 patients with hs-CRP <4.63 mg/L (P<.001). By contrast, hs-CRP predicted neither TVR [HR=0.88 (0.73-1.08); P=.23] nor ST [HR=1.15 (0.77-1.71); P=.49].ConclusionHigh hs-CRP levels before coronary stent implantation are associated with risk of death or MI, but are not related to TVR or ST. These data suggest that preprocedural hs-CRP is more a predictor of global cardiovascular risk than a predictor of stent-related complications.     

Clinical Outcomes and Revascularization Strategies in Patients With Low-Flow,Low-Gradient Severe Aortic Valve Stenosis According to the Assigned Treatment Modality

ObjectivesThis study compared clinical outcomes and revascularization strategies among patients presenting with low ejection fraction, low-gradient (LEF-LG) severe aortic stenosis (AS) according to the assigned treatment modality.BackgroundThe optimal treatment modality for patients with LEF-LG severe AS and concomitant coronary artery disease (CAD) requiring revascularization is unknown.MethodsOf 1,551 patients, 204 with LEF-LG severe AS (aortic valve area <1.0 cm², ejection fraction <50%, and mean gradient <40 mm Hg) were allocated to medical therapy (MT) (n = 44), surgical aortic valve replacement (SAVR) (n = 52), or transcatheter aortic valve replacement (TAVR) (n = 108). CAD complexity was assessed using the SYNTAX score (SS) in 187 of 204 patients (92%). The primary endpoint was mortality at 1 year.ResultsLEF-LG severe AS patients undergoing SAVR were more likely to undergo complete revascularization (17 of 52, 35%) compared with TAVR (8 of 108, 8%) and MT (0 of 44, 0%) patients (p < 0.001). Compared with MT, both SAVR (adjusted hazard ratio [adj HR]: 0.16; 95% confidence interval [CI]: 0.07 to 0.38; p < 0.001) and TAVR (adj HR: 0.30; 95% CI: 0.18 to 0.52; p < 0.001) improved survival at 1 year. In TAVR and SAVR patients, CAD severity was associated with higher rates of cardiovascular death (no CAD: 12.2% vs. low SS [0 to 22], 15.3% vs. high SS [>22], 31.5%; p = 0.037) at 1 year. Compared with no CAD/complete revascularization, TAVR and SAVR patients undergoing incomplete revascularization had significantly higher 1-year cardiovascular death rates (adj HR: 2.80; 95% CI: 1.07 to 7.36; p = 0.037).ConclusionsAmong LEF-LG severe AS patients, SAVR and TAVR improved survival compared with MT. CAD severity was associated with worse outcomes and incomplete revascularization predicted 1-year cardiovascular mortality among TAVR and SAVR patients.     

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

BackgroundData regarding the best treatment for spontaneous coronary artery dissection (SCAD) are limited. The aim of the present study was to compare the clinical outcomes of conservative versus invasive treatment in SCAD patients.MethodsWe 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 2020. The study endpoints were all-cause death, cardiovascular death, myocardial infarction, heart failure, SCAD recurrence and target vessel revascularization (TVR) rates. Random effect meta-analysis was performed by comparing the clinical outcomes between the two groups. A univariate meta-regression analysis was also performed.ResultsTwenty-four observational studies with 1720 patients were included. After 28 ± 14 months, a conservative approach was associated with lower TVR rate compared with invasive treatment (OR = 0.50; 95%CI 0.28–0.90; P = 0.02). No statistical difference was found regarding all-cause death (OR = 0.81; 95%CI 0.31–2.08; P = 0.66), cardiovascular death (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, lower ejection fraction and low TIMI flow at admission were related with high overall mortality, whereas SCAD recurrence was higher among patients with fibromuscular dysplasia.ConclusionsA conservative approach was associated with similar clinical outcomes and lower TVR rates compared with an invasive strategy in SCAD patients; future prospective studies are needed to confirm these results.     

Long-Term Survival Benefit of Revascularization Compared With Medical Therapy in Patients With Coronary Chronic Total Occlusion and Well-Developed Collateral Circulation

ObjectivesThe purpose of this study was to compare the long-term clinical outcomes of patients with chronic total occlusion (CTO) and well-developed collateral circulation treated with revascularization versus medical therapy.BackgroundLittle is known about the clinical outcomes and optimal treatment strategies of CTO with well-developed collateral circulation.MethodsWe screened 2,024 consecutive patients with at least 1 CTO detected on coronary angiogram. Of these, we analyzed data from 738 patients with Rentrop 3 grade collateral circulation who were treated with medical therapy alone (n = 236), coronary artery bypass grafting (n = 170) or percutaneous coronary intervention (n = 332; 80.1% successful). Patients who underwent revascularization and medical therapy (revascularization group, n = 502) were compared with those who underwent medical therapy alone (medication group, n = 236) in terms of cardiac death and major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, and repeat revascularization.ResultsDuring a median follow-up duration of 42 months, multivariate analysis revealed a significantly lower incidence of cardiac death (hazard ratio [HR]: 0.29; 95% confidence interval [CI]: 0.15 to 0.58; p < 0.01) and MACE (HR: 0.32; 95% CI: 0.21 to 0.49; p < 0.01) in the revascularization group compared with the medication group. After propensity score matching, the incidence of cardiac death (HR: 0.27; 95% CI: 0.09 to 0.80; p = 0.02) and MACE (HR: 0.44; 95% CI: 0.23 to 0.82; p = 0.01) were still significantly lower in the revascularization group than in the medication group.ConclusionsIn patients with coronary CTO and well-developed collateral circulation, aggressive revascularization may reduce the risk of cardiac mortality and MACE.     

Novel proctorship effectively teaches interventionists coronary artery chronic total occlusion lesions

BackgroundInterventionists' experience and skills are essential factors for successful chronic total occlusion-percutaneous coronary intervention (CTO-PCI). However, the construction of theoretical strategy independent from interventionists' procedure may also improve it. We sought to assess the feasibility of CTO-PCI using an educational system supported by a single expert proctor.MethodsA total of 160 patients underwent CTO-PCI between 2009 and 2016 at 92 Japanese centers in the Hands-on proctorship project. The CTO-PCI strategy was discussed with all participants and their specialists, before and during the procedure. We divided patients into 2 groups based on the CTO-PCI experience of their interventionist: (1) the less experienced group (CTO-PCI ≤ 50 cases, n = 65) and (2) the more experienced group (CTO-PCI > 50 cases, n = 95). Baseline characteristics, procedural complications, and clinical outcomes were compared between groups.ResultsNo significant differences in patient age, sex, prevalence for coronary risk factors, and lesion complexity was observed between groups. The retrograde approach was used equivalently between groups (55.4% vs. 60.0%, p = 0.56), and procedural success rates were similar (96.9% vs. 90.5%, p = 0.12). The rate of proctor's bailout for recanalization were not frequent between groups (4.6% vs. 5.3%, p = 0.85). No procedure-related mortality was noted in either group. In addition, no significant differences in procedural cardiac complications, including coronary dissection, perforation, or tamponade, were observed between groups (10.8% vs. 14.7%, p = 0.47).ConclusionsThe expert-supported CTO-PCI maintained high success rates regardless of interventionists' experience. This highlights the importance of theoretical strategy for the management patients undergoing CTO-PCI.     

Ticagrelor vs Prasugrel in a Contemporary Real-World Cohort Undergoing Percutaneous Coronary Intervention

BackgroundPotent P2Y₁₂ agents such as ticagrelor and prasugrel are increasingly utilized across the clinical spectrum of patients undergoing percutaneous coronary intervention (PCI). There is a paucity of data supporting their use in a patient population inclusive of both acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients.ObjectivesThe authors compared the efficacy and safety of ticagrelor and prasugrel in a real-world contemporary PCI cohort.MethodsConsecutive patients undergoing PCI between 2014 and 2019 discharged on either prasugrel or ticagrelor were included from the prospectively collected institutional PCI registry. Primary endpoint was the composite of death and myocardial infarction (MI), with secondary outcomes including rates of bleeding, stroke, and target vessel revascularization at 1 year.ResultsOverall, 3,858 patients were included in the study (ticagrelor: n = 2,771; prasugrel: n = 1,087), and a majority (48.4%) underwent PCI in the context of CCS. Patients prescribed ticagrelor were more likely to be female, have a history of cerebrovascular disease, and have ACS presentation, while those receiving prasugrel were more likely to be White with a higher prevalence of prior revascularization. No difference in the risk of death or MI was noted across the groups (ticagrelor vs prasugrel: 3.3% vs 3.1%; HR: 0.88; 95% CI: 0.54-1.43; P = 0.59). Rates of target vessel revascularization were significantly lower in the ticagrelor cohort (9.3% vs 14.0%; adjusted HR: 0.71; 95% CI: 0.55-0.91; P = 0.007) with no differences in stroke or bleeding. The results were consistent in patients with CCS (HR: 0.84; 95% CI: 0.46-1.54) and ACS (HR: 1.18; 95% CI: 0.46-1.54), without evidence of interaction (P = 0.37), and confirmed across multivariable adjustment and propensity score stratification analysis.ConclusionsIn this contemporary patient population undergoing PCI, prasugrel and ticagrelor were associated with similar 1-year efficacy and safety.     

Association of Sex,Reduced Myocardial Flow Reserve,and Long-Term Mortality Across Spectrum of Atherosclerotic Disease

BackgroundCoronary vasomotor dysfunction (defined by reduced myocardial blood flow reserve [MBFR]) is associated with high cardiac risk in both men and women in absence of significant coexisting epicardial disease. Whether there is a sex-specific difference in prognostic value of reduced MBFR in patients with a greater burden of coexisting epicardial atherosclerotic disease is not well understood.ObjectivesThe purpose of this study was to examine the association of sex, MBFR, and mortality in consecutive patients with suspected or known coronary artery disease undergoing positron emission tomography myocardial perfusion imaging.MethodsUnique consecutive patients undergoing rubidium (Rb)-82 rest/stress positron emission tomography myocardial perfusion imaging from 2010-2016 were followed for a median of 3.2 years. Multivariable Cox models were built to describe the interaction of sex and MBFR on all-cause and cardiac death for the overall population and stratified by extent of calcified atherosclerosis (none: coronary artery calcium score = 0, subclinical: coronary artery calcium >0, clinical: prior myocardial infarction/percutaneous coronary intervention) and abnormal perfusion (no significant obstructive disease: summed stress score = 0, 1%-9.9%, and ≥10%) at baseline.ResultsAmong 12,594 patients, 52.8% were women. Compared with men, women had a lower prevalence of known coronary artery disease (16.5% vs 29.5%; P < 0.001) and were less likely to undergo revascularization after myocardial perfusion imaging (4.9% vs 9.7%; P < 0.001), but were more likely to have a reduced MBFR of <2 (56.2% vs 50.6%; P < 0.001). There were 1,699 (13.5%) all-cause and 490 (3.9%) cardiac deaths. In fully adjusted Cox models, reduced MBFR was independently associated with higher risk of death (HR per 0.1-U decrease: 1.09 [95% CI: 1.08-1.10]; P < 0.001), but female sex was not (HR: 0.95 [95% CI: 0.85-1.05]; P = 0.27). There was no significant interaction between sex and MBFR on death (P = 0.22) and cardiac death (P = 0.35) overall or in subgroups of patients with clinical, subclinical, and no atherosclerosis or across categories of perfusion abnormality at baseline.ConclusionsThe association between reduced MBFR and higher risk of all-cause and cardiac death did not differ by sex, regardless of extent of coexisting atherosclerosis or perfusion abnormality.     

Everolimus Eluting Stents in Patients with Diabetes Mellitus and Chronic Kidney Disease: Insights from the TUXEDO Trial

BackgroundPatients with diabetes and those with chronic kidney disease (CKD) are at increased risk of cardiovascular events. Everolimus eluting stents (EES) have been shown to be superior to paclitaxel eluting stents (PES) in patients with diabetes. However, it is not known if EES is as beneficial in diabetic patients with CKD compared with those without CKD.Methods and resultsPatients enrolled in the TUXEDO-India trial, which is a clinical trial of patients with diabetes and coronary artery disease (CAD) randomly assigned to EES vs. thin-strut PES (Taxus Element), with data on baseline renal function were selected. CKD was defined as an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m² using the Cockcroft–Gault formula. Primary outcome was target vessel failure (TVF-defined as cardiac death, TV myocardial infarction (MI) or ischemia driven TV revascularization) at 1 year. Various secondary outcomes including stent thrombosis were evaluated.Among the 1821 patients with diabetes included in this analysis, 344 (19%) had CKD. In a propensity score adjusted analysis, patients with CKD had a significant increase in MACE (HR = 2.02; 95% CI 1.17–3.50; P = 0.01); death/MI/TVR (HR = 1.99; 95% CI 1.18–3.34; P = 0.009); death/MI (HR = 2.31; 95% CI 1.30–4.08; P = 0.004); cardiac death/MI (HR = 2.40; 95% CI 1.31–4.42; P = 0.005); death (HR = 2.88; 95% CI 1.35–6.13; P = 0.006) driven by an increase in cardiac death (HR = 3.33; 95% CI 1.42–7.83; P = 0.006) when compared with those without CKD. However, stent related events (TV-MI, TVR, TLR and stent thrombosis) were not different between CKD and non CKD groups. A significant interaction between CKD status and stent type (EES vs. PES) was noted for the outcomes of TVF (P_interaction = 0.046), MACE (P_interaction = 0.02), cardiac death or MI (P_interaction = 0.05), non-target vessel related MI (P_interaction = 0.04), non-Q-wave MI (P_interaction = 0.03) and deaths/MI/TVR (P_interaction = 0.04) such that EES was superior to PES in the non-CKD cohort but not in the CKD cohort.ConclusionsIn subjects with diabetes, CKD is an independent predictor of adverse cardiovascular outcomes including increased risk of death driven largely by non-stent related events. While EES was superior to PES in patients without CKD, this was not the case in those with CKD (Clinical Trials Registry-India number, CTRI/2011/06/001830).