Repeat Revascularization In Patients Research Articles

The effect of treatment timing on repeat revascularization in patients with stable ischemic heart disease

ObjectivesIn patients with stable ischemic heart disease, there is no evidence for the effect of revascularization treatment timing on the need for repeat procedures. We aimed to determine if repeat revascularizations differed among patients who received coronary artery bypass graft surgery after the time recommended by physicians compared with those who had timely percutaneous coronary intervention. MethodsWe identified 25,520 British Columbia residents 60 years or older who underwent first-time nonemergency revascularization for angiographically proven, stable left main or multivessel ischemic heart disease between January 1, 2001, and December 31, 2016. We estimated unadjusted and adjusted cumulative incidence functions for repeat revascularization, in the presence of death as a competing risk, after index revascularization or last staged percutaneous coronary intervention for patients undergoing delayed coronary artery bypass grafting compared with timely percutaneous coronary intervention. ResultsAfter adjustment with inverse probability of treatment weights, at 3 years, patients who underwent delayed coronary artery bypass grafting had a statistically significant lower cumulative incidence of a repeat revascularization compared with patients who received timely percutaneous coronary intervention (4.84% delayed coronary artery bypass grafting, 12.32% timely percutaneous coronary intervention; subdistribution hazard ratio, 0.16, 95% CI, 0.04-0.65). ConclusionsPatients who undergo delayed coronary artery bypass grafting have a lower cumulative incidence of repeat revascularization than patients who undergo timely percutaneous coronary intervention. Patients who want to wait to receive coronary artery bypass grafting will see the benefit of lower repeat revascularization over percutaneous coronary intervention unaffected by a delay in treatment.

Impact of body mass index on long-term outcomes in patients undergoing percutaneous coronary intervention stratified by diabetes mellitus: a retrospective cohort study

BackgroundPatients with diabetes mellitus (DM) caused by obesity have increased in recent years. The impact of obesity on long-term outcomes in patients undergoing percutaneous coronary intervention (PCI) with or without DM remains unclear.MethodsWe retrospectively analysed data from 1918 patients who underwent PCI. Patients were categorized into four groups based on body mass index (BMI, normal weight: BMI < 25 kg/m2; overweight and obese: BMI ≥ 25 kg/m2) and DM status (presence or absence). The primary endpoint was the occurrence of major adverse cardiac and cerebrovascular events (MACCE; defined as all-cause death, myocardial infarction, stroke, and unplanned repeat revascularization).ResultsDuring a median follow-up of 7.0 years, no significant differences in MACCE, myocardial infarction, or stroke were observed among the four groups. Overweight and obese individuals exhibited lower all-cause mortality rates compared with normal-weight patients (without DM: hazard ratio [HR]: 0.54, 95% confidence interval [CI]: 0.37 to 0.78; with DM: HR: 0.57, 95% CI: 0.38 to 0.86). In non-diabetic patients, the overweight and obese group demonstrated a higher risk of unplanned repeat revascularization than the normal-weight group (HR:1.23, 95% CI:1.03 to 1.46). After multivariable adjustment, overweight and obesity were not significantly associated with MACCE, all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization in patients with and without diabetes undergoing PCI.ConclusionOverweight and obesity did not demonstrate a significant protective effect on long-term outcomes in patients with and without diabetes undergoing PCI.

Abstract 15875: Immediate Complete Revascularization Reduces Recurrent Myocardial Infarction and Repeat Revascularization in Patients Presenting With Acute Myocardial Infarction

Introduction: Studies have suggested that complete revascularization has better outcome compared with culprit-only revascularization for the treatment of enzyme-positive acute coronary syndrome. However, the optimal timing of complete revascularization remains unclear. We conducted a meta-analysis of randomized controlled trials (RCT) comparing immediate complete revascularization with staged revascularization in patients with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with multi-vessel disease. Methods: We systematically searched the Cochrane Central Register of Controlled Trials, Embase, PubMed and clinicaltrials.gov databases for RCT comparing immediate complete revascularization with staged revascularization in patients with enzyme-positive acute coronary syndrome. The pooled outcome were major cardiovascular adverse event (MACE), all-cause death, cardiovascular death, recurrent MI and repeat revascularization. The random effect and Mantel-Haenszel method was used to analyze the data. Heterogeneity was measured using I 2 . Results: Five studies met the inclusion criteria ( 1187 patients in immediate complete revascularization group and 1176 patients in staged revascularization group). We did not find any significant difference in the rate of MACE (OR: 0.75 [95 % CI: 0.44-1.29] I 2 : 35%, p value = 0.30). Similarly, there was no significant difference in the rates of all-cause death (OR: 0.93 [95 % CI: 0.47-1.86] I 2 : 40%, p value = 0.84)and cardiac death (OR: 1.02 [95 % CI: 0.52-1.98] I 2 : 14%, p value = 0.96). However, immediate complete revascularization group had significant reduction in the rates of repeat revascularization (OR: 0.59 [95 % CI: 0.43-0.82] I 2 : 0%, p value = 0.002) and recurrent MI (OR: 0.52 [95 % CI: 0.32-0.84] I 2 : 1%, p value = 0.008). Subgroup analysis including STEMI patients only showed similar rate of MACE ((OR: 0.92 [95 % CI: 0.60-1.41] I 2 : 0%, p value = 0.70). Conclusions: Our results suggest that immediate complete revascularization is safe. There was significant reduction in recurrent MI and need for repeat revascularization in patients undergoing immediate complete revascularization.

Characterization of lipidic plaque materials at calcified atheroma: its association with calcification thickness evaluated by optical coherence tomography and near-infrared spectroscopy imaging

Abstract Introduction The degree of calcification and its thickness have been considered to affect stent expansion, leading to an increases risk of repeat revascularization in patients receiving PCI. Pathophysiologically, accumulation of lipidic materials within vessel wall could trigger the formation of plaque calcification. Elucidating characteristics of lipidic plaque components at calcified atheroma may enable to identify phenotypes with thick calcification which less likely responds to PCI. Purpose This study investigated the relationship of calcification thickness with lipidic plaque materials at calcified atheroma by using OCT and near-infrared spectroscopy (NIRS) imaging. Methods We analyzed 52 calcified lesions (culprit/non culprit lesions=44/8) in 47 CAD patients (stable CAD/ACS=36/11) from the REASSURE-NIRS registry (NCT04864171). OCT and NIRS imaging evaluated 4-mm segment exhibiting maximum superficial calcification arc. Calcification thickness on OCT imaging, its arc on IVUS imaging, and NIRS-derived lipid arc were analyzed at every 1-mm interval cross-sectional images. In addition, yellow-calcification ratio (YCR = lipid arc/calcification arc) was calculated (Figure 1). Results 53% of study subjects exhibited chronic kidney disease and 70% of them received a statin (averaged on-treatment LDL-C =89mg/dL). Throughout OCT and NIRS/IVUS imaging analysis of 260 cross-sectional images, the averaged calcification arc, its maximum thickness, lipid arc and YCR were 210° (167–285°), 0.78mm (0.62–0.95mm), 95° (31–169°) and 0.33 (0.09–0.59), respectively. As expected, thicker calcification more likely exhibited a greater calcification arc (r=0.30, p&amp;lt;0.001). Furthermore, a greater thickness of calcification was associated with smaller lipidic plaque burden, reflected by yellow arc (r=−0.36, p&amp;lt;0.001) and YCR (r=−0.36, p&amp;lt;0.001) (Figure 2). After adjusting age, gender and ACS, calcification arc (p&amp;lt;0.001) and YCR (p&amp;lt;0.001) continued to predict thicker calcification. Conclusion Thickening of calcification was associated with severer calcification arc, which was accompanied by the shrinkage of lipidic plaques. Our findings suggest the evaluation of lipidic plaque component as a potential tool to identify calcified atheroma harbouring thick calcification, which may cause a greater risk of stent underexpansion. Funding Acknowledgement Type of funding sources: None.

Percutaneous catheter-based repeat revascularization in patients with previous PCI or CABG: a comprehensive review of the evidence

Repeat revascularization after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) is one of the most common long-term complications which warrants continuous clinical follow up. Re-interventions negatively impact long-term survival in patients with coronary artery disease. The repeat revascularization after PCI can be either a target lesion revascularization (stent thrombosis/in-stent restenosis) or a revascularization of native coronary artery after PCI (target vessel revascularization/non-target vessel revascularization). The EVENT registry reports that repeat revascularization rates in patients undergoing PCI is 12% in the first year of follow up. Repeat revascularization with additional stent deployment increases the rate of stent thrombosis and restenosis, thereby leading to recurrent ischemic events. Repeat revascularization after CABG can be either in the early postoperative period or later due to native disease progression or late graft stenosis. The need for re-intervention after surgical or percutaneous revascularization is inevitable and is dependent on modifiable and non-modifiable risk factors.

Repeat Revascularization over 10 Years Following Carotid Endarterectomy or Carotid Stent Placement: An Analysis of Carotid Revascularization Endarterectomy Versus Stenting Trial

To identify rates of and factors associated with repeat revascularization in a large cohort of patients prospectively followed over 10 years in Carotid Revascularization Endarterectomy versus Stenting Trial. We compared the effect of carotid angioplasty and stenting (CAS) versus carotid endarterectomy (CEA) on risk of repeat revascularization after adjusting for age, sex, symptomatic status, and initial severity of stenosis (≥70% vs. <70%) using Cox proportional hazards analysis. We used Kaplan-Meier analysis to assess repeat revascularization-free survival for the overall cohort. Repeat revascularization was performed in 90 (3.9%, 95% confidence interval [CI] 3.1%-4.8%) of 2318 patients; 6 (6.7%, 95% CI 2.5%-14.0%) patients experienced the composite end point of any stroke, myocardial infarction, ordeath within 30 days after repeat revascularization. Therewas no difference in risk of repeat revascularization in patients who underwent CAS (compared with CEA) as theindex procedure (hazard ratio 0.92, 95% CI 0.69-1.23, P=0.5765). Patient's age (hazard ratio 1.01, 95% CI 1.01-1.02, P < 0.0001) was associated with performance of repeat revascularization. Mean ± SD repeat revascularization-free survival was 8.2 ± 0.1 years and 8.0 ± 0.1 years for CAS and CEA, respectively (log-rank test P= 0.0823). A low rate of repeat revascularization was seen without any significant difference among patients who underwent CEA or CAS over 10 years. The 6.7% rate of composite end point within 30 days after procedure highlights the need for standardizing the indications for repeat revascularization.

IMPACT OF PRIOR PERCUTANEOUS CORONARY INTERVENTION ON THE SHORT-TERM OUTCOME OF CORONARY ARTERY BYPASS SURGERY

IntroductionThe emergence of drug-eluting stents (DES) has resulted in greater utilization of coronary stents in patients with Class I Indications for Coronary Artery Bypass Surgery. The need for repeat revascularization in patients treated with PCI has led to an increasing percentage of CABG in patients with prior PCI. A study from the Society of Thoracic Surgeons 2018 Adult Cardiac surgery Database revealed that 28.9% of patients referred for CABG had a prior PCI. Several studies have demonstrated worse mid-term and long-term outcomes after CABG in patients with prior PCI. This study aimed to assess the impact of prior successful PCI on the short-term outcome after CABG surgery.Aim of the workThis study aimed to assess the impact of prior successful PCI on the short-term outcome after CABG surgery. Subjects and MethodsThis was a prospective cohort study that included a total of 60 patients admitted at The New Alexandria University Hospital from January 2018 to January 2020. Of these, 30 patients (50%) CABG surgery on native coronary arteries (Group A), and the remaining 30 patients (50%) had prior PCI before CABG (Group B). The primary outcomes of interest were postoperative myocardial infarction, cardiac death, postoperative bleeding, exploration for bleeding. Secondary outcomes included the duration of the ICU stay, the ventilation time, and the inotropic use.

Predictors of repeat myocardial revascularization for the long-term after percutaneous coronary interventions in patients with combination of coronary artery disease and chronic obstructive pulmonary disease

Aim. To assess the influence of concomitant chronic obstructive pulmonary disease (COPD) on the frequency of repeat myocardial revascularization in patients with coronary artery disease (CAD) after percutaneous coronary interventions (PCI), as well as to determine independent predictors of repeat revascularization in patients with concominant COPD. Materials and methods. A prospective cohort study included 646 patients with CAD, of which 254 had concominant COPD. All patients underwent PCI (46.9% for acute coronary syndrome in the main group and 44.9% in the control group. Remaining interventions were elective). The frequency of repeat myocardial revascularization and the time till re-intervention was registered during the follow-up period up to 36 months. Results. COPD increases risk of repeat myocardial revascularization (hazard ratio - HR 1.46; 95% confidence interval - CI 1.03-2.06), repeat PCI (HR 1.62; 95% CI 1.03-2.32) and is accompanied by an earlier onset of re-intervention. An independent predictors of repeat myocardial revascularization in the Cox regression model are: glomerular filtration rate (p=0.001), ankle-brachial index (p=0.004), frequent exacerbations of COPD (p=0.028), total number of coronary artery stenosis (p=0.039) and blood concentration of C-reactive protein (p=0.066). Conclusions. COPD is a significant risk factor of re-intervention after PCI in patients with acute and chronic forms of CAD and leads to its earlier performing. The patients with frequent COPD exacerbations have the highest risk of repeat myocardial revascularization during follow-up.

TCT-388 Very Long-Term (>10 Years) Safety and Effectiveness of Drug-Eluting or Bare-Metal Stents for Unprotected Left Main Coronary Disease

Limited data are available on the long-term effects of drug-eluting stents (DES) versus bare-metal stents (BMS) on rates of death, myocardial infarction (MI), and repeat revascularization in patients with left main coronary artery disease. In this observational cohort of the MAINCOMPARE registry,

Revascularization in “no option” patients with refractory angina: Frequency, etiology and outcomes

A significant proportion of patients with complex, advanced coronary artery disease have refractory angina (RA) despite maximal pharmacological therapy and are deemed suboptimal candidates for revascularization. These patients are frequently termed "no-option" patients. However, despite this designation, many subsequently undergo coronary revascularization. We sought to determine the incidence, etiology and outcome of revascularization in "no-option" patients. We examined a comprehensive, prospective RA database to identify 342 of 1363 (25.1%) patients who subsequently underwent revascularization after a median interval of 2.2 years from the "no-option" diagnosis. Coronary revascularization was achieved by percutaneous coronary intervention (PCI) (n = 274, 20.1%), coronary bypass graft surgery (n = 44, 3.2%) or both (n = 24, 1.8%). During a median follow-up of 5.1 years, patients who underwent revascularization had lower annual mortality (2% vs. 4.4%, P < .001). Detailed paired angiographic records were available for 181 PCI patients with a combined 302 lesions. Of these interventions, 48% were for a new lesion, 31% for an existing lesion and 21% for restenosis. The location was a native vessel in 77% and a bypass graft in 23%. The "no-option" or non-revascularizable designation is frequently based on angiography at a single time-point. However, coronary artery disease is a progressive and dynamic process and new lesions often develop in such patients. Given the association between revascularization and better survival, careful consideration should be given to repeat revascularization in patients with refractory angina previously classified as "no-option".

Control angiography for perioperative myocardial Ischemia after coronary surgery: meta-analysis

BackgroundPerioperative myocardial ischemia (PMI) in patients undergoing coronary artery bypass grafting (CABG) is associated with poor outcome. The aim of this study was to pool the available data on the outcome after control angiography and repeat revascularization in patients with perioperative myocardial ischemia (PMI) after coronary artery bypass grafting (CABG).MethodsA literature review was performed through PubMed, Scopus, ScienceDirect and Google Scholar to identify studies published since 1990 evaluating the outcome of PMI after CABG.ResultsNine studies included 1104 patients with PMI after CABG and 1056 of them underwent control angiography early after CABG. Pooled early mortality after reoperation for PMI without control angiography was 43.6% (95%CI 29.7-57.6%) and 79.8% of them (95%CI 64.4-95.2%) had an acute graft failure detected at reoperation. Among patients who underwent control angiography for PMI, 31.7% had a negative finding at angiography (95%CI 25.6-37.8%) and 62.1% had an acute graft failure (95%CI 56.6-67.6%). Repeat revascularization was performed after early control angiography in 46.3% of patients (95%CI 39.9-52.6%; 54.2% underwent repeat surgical revascularization; 45.8% underwent percutaneous coronary intervention). Pooled early mortality after control angiography with or without repeat revascularization was 8.9% (95%CI 6.7-11.1%). Three studies reported on early mortality rates which did not differ between repeat surgical revascularization and PCI (11.7% vs. 9.2%, respectively; risk ratio 1.45, 95%CI 0.67-3.11). In these three series, early mortality after conservative treatment was 5.9% (95%CI 3.6-8.2%).ConclusionsControl angiography seems to be a valid life-saving strategy to guide repeat revascularization in hemodynamically stable patients suffering PMI after CABG.

Coronary Artery Bypass Surgery versus Percutaneous Coronary Intervention for Left Main Coronary Artery Disease with Chronic Kidney Disease

Percutaneous coronary intervention (PCI) has emerged as an alternative treatment to coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease (ULMCAD). However, the optimal treatment for ULMCAD concomitant with chronic kidney disease (CKD) was rarely addressed. Herein, we compare the long-term outcomes of these patients treated with CABG or PCI.From January 2004 to December 2010, 185 patients with ULMCAD and CKD undergoing PCI (n = 84) or CABG (n = 101) were matched for the selection criteria. The primary end points included all-cause death, myocardial infarction (MI), stroke, repeat revascularization and major adverse cardiovascular and cerebrovascular event (MACCE).The mean age was 73.4 ± 10.3 years with male (84%) predominance. Baseline characteristics of both groups were similar, except that patients in CABG group were more frequently associated with significant stenosis of right coronary artery and triple vessel disease. Furthermore, most patients belonged to higher surgical risk population (EuroSCORE ≥ 6, PCI group: 80.9%, CABG group: 75.2%). After treatment, the 30-day mortality was 3.5% in PCI and 8.9% in CABG (P = 0.14). During the median follow-up of 3.5 years, the risk of MACCE (67% versus 55%, P = 0.048), MI (15.5% versus 6.9%, P = 0.024), and repeat revascularization (30.9% versus 7.9%, P < 0.001) was significantly higher in the PCI compared with CABG. There were no significant differences in long-term all-cause death, stroke, and impact on renal function.CABG was associated with significantly less long-term risk of MI and repeat revascularization in patients with ULMCAD and CKD.

Temporal Trends in Clinical Outcomes Following Percutaneous Coronary Intervention in Patients with Renal Insufficiency.

Aim: Renal insufficiency is associated with worse clinical outcomes in patients with coronary artery disease. Since the introduction of percutaneous coronary intervention (PCI), the revascularization therapy has evolved with advances of devices, improvements in operator techniques, and the establishment of medical therapy. We examined temporal trends of the clinical outcomes following PCI in patients with renal insufficiency.Methods: Patients with renal insufficiency after PCI at Juntendo University across three eras (plain balloon angioplasty, bare metal stent (BMS), and drug-eluting stent (DES)) were examined in this study. The primary endpoint was a composite of all-cause mortality, nonfatal acute coronary syndrome, nonfatal stroke, and repeat revascularization within 3-years after the index revascularization.Results: A total of 1,420 patients were examined. Baseline characteristics have become unfavorable over time, whereas administration rate of medications for secondary prevention has increased. The event-free survival rates for the endpoint were different among the groups. Adjusted relative risk reduction for the endpoint was 35% and 51% in the BMS and DES eras (using the plain angioplasty era as reference). The adjusted relative risk reduction of the DES era was 26% compared with that of the BMS era.Conclusions: The incidence of cardiovascular events after PCI has reduced during the 26-year period mainly because of the reduction in repeat revascularization in patients with renal insufficiency, despite the higher risk profiles in the recent era.

Abstract 18926: Metformin is Associated With Improved Skeletal Muscle Glucose Uptake and Improves Skeletal Muscle Energetics. There is Limited Data of the Impact of Metformin Us on Need for Repeat Revascularization in Patients With Symptomatic Peripheral Artery Disease (pad) Treated With Endovascular Revascularization

Background: Metformin is associated with improved skeletal muscle glucose uptake and improves skeletal muscle energetics. There is limited data of the impact of metformin us on need for repeat revascularization in patients with symptomatic peripheral artery disease (PAD) treated with endovascular revascularization. Methods: We compared need for vessel revascularization (TLR) rates in patients with diabetes mellitus (DM) treated with metformin and without, to non-DM enrolled in the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2006 and 2015. Results: In the study cohort of 2140 interventional procedures, 57.4% were performed in DM (n=268 on metformin and n=961 not on metformin). Frequency of hypertension, hyperlipidemia and chronic kidney disease was higher in DM not on metformin compared to DM on metformin (p&lt;0.001 for all comparisons). Lesion and stent lengths were similar in both groups. Revascularization free survival compared to the non-DM (control) was similar for DM on metformin (HR=0.95, 95%CI: 0.56-1.60; p=0.85) compared to DM not on metformin (HR=1.84, 95%CI: 0.98-3.45; p=0.06; Figure 1A). Overall survival compared to non-DM (control), was similar for DM on metformin (HR=1.70, 95%CI: 0.64-4.54; p=0.29) and significantly worse for DM not on metformin (HR=4.55, 95%CI: 2.44-8.48; p&lt;0.001; Figure 1B). Conclusions: Metformin therapy in symptomatic PAD patients with DM following endovascular revascularization is associated with improved survival and lower need for repeat revascularization compared to diabetics not treated with metformin.

The Impact of Side Branch Predilatation on Procedural and Long-term Clinical Outcomes in Coronary Bifurcation Lesions Treated by the Provisional Approach

Introduction and objectivesIt is uncertain whether side branch predilatation before main vessel stenting is necessary. We evaluated the effect of side branch predilatation on outcomes in percutaneous coronary intervention for true nonleft main bifurcation determined by the Medina classification using the provisional approach. MethodsTarget vessel failures (composite of cardiac death, myocardial infarction, or target vessel revascularization) were compared between patients who underwent side branch predilatation (predilatation group, n = 175) and those who did not (nonpredilatation group, n = 662). ResultsFinal kissing-balloon inflation (57.1% vs 35.8%; P < .001) was performed more frequently and the cross-over rate to a 2-stent technique (14.9% vs 5.1%; P < .001) was higher in the predilatation group. During a median follow-up of 21 months, the predilatation group had a higher incidence of target vessel failures (14.3% vs 6.8%; P = .002) and target vessel revascularization (12.0% vs 5.6%; P = .003), but not of cardiac death or myocardial infarction compared with the nonpredilatation group. On multivariate analysis, side branch predilatation was associated with a higher occurrence of target vessel failures (adjusted hazard ratio = 2.11; 95% confidence interval, 1.27-3.50; P = .004). These results remained consistent after a propensity score-matched population analysis (for target vessel failures, adjusted hazard ratio = 2.63; 95% confidence interval, 1.09-6.34; P = .0031) and they were also constant among the various subgroups, according to the bifurcation angle, calcification, and diameter stenosis of the side branch. ConclusionsSide branch predilatation before main vessel stenting may be associated with an increased risk of repeat revascularization in patients with true nonleft main bifurcation treated by the provisional approach.Trial registration: ClinicalTrials.gov number: NCT00851526.

Efecto en los resultados de la intervención y los resultados clínicos a largo plazo de la predilatación de la rama lateral para lesiones coronarias en bifurcación tratadas con la técnica de stent condicional

Introduction and objectivesIt is uncertain whether side branch predilatation before main vessel stenting is necessary. We evaluated the effect of side branch predilatation on outcomes in percutaneous coronary intervention for true nonleft main bifurcation determined by the Medina classification using the provisional approach. MethodsTarget vessel failures (composite of cardiac death, myocardial infarction, or target vessel revascularization) were compared between patients who underwent side branch predilatation (predilatation group, n = 175) and those who did not (nonpredilatation group, n = 662). ResultsFinal kissing-balloon inflation (57.1% vs 35.8%; P < .001) was performed more frequently and the cross-over rate to a 2-stent technique (14.9% vs 5.1%; P < .001) was higher in the predilatation group. During a median follow-up of 21 months, the predilatation group had a higher incidence of target vessel failures (14.3% vs 6.8%; P = .002) and target vessel revascularization (12.0% vs 5.6%; P = .003), but not of cardiac death or myocardial infarction compared with the nonpredilatation group. On multivariate analysis, side branch predilatation was associated with a higher occurrence of target vessel failures (adjusted hazard ratio = 2.11; 95% confidence interval, 1.27-3.50; P = .004). These results remained consistent after a propensity score-matched population analysis (for target vessel failures, adjusted hazard ratio = 2.63; 95% confidence interval, 1.09-6.34; P = .0031) and they were also constant among the various subgroups, according to the bifurcation angle, calcification, and diameter stenosis of the side branch. ConclusionsSide branch predilatation before main vessel stenting may be associated with an increased risk of repeat revascularization in patients with true nonleft main bifurcation treated by the provisional approach.Trial registration: ClinicalTrials.gov number: NCT00851526.Full English text available from: www.revespcardiol.org/en

4-Year Clinical Outcomes and Predictors of Repeat Revascularization in Patients Treated With New-Generation Drug-Eluting Stents: A Report From the RESOLUTE All-Comers Trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention)

The aim of the study was to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Minneapolis, Minnesota) and XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Abbott Park, Illinois) in the RESOLUTE (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) All-Comers trial. Data on long-term outcomes of new-generation drug-eluting stents are limited, and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown. Patients were randomly assigned to treatment with the R-ZES (n = 1,140) or the EES (n = 1,152). We assessed pre-specified safety and efficacy outcomes at 4 years including target lesion failure and stent thrombosis. Predictors of revascularization at 4 years were identified by Cox regression analysis. At 4 years, the rates of target lesion failure (15.2% vs. 14.6%, p = 0.68), cardiac death (5.4% vs. 4.7%, p = 0.44), and target vessel myocardial infarction (5.3% vs. 5.4%, p = 1.00), clinically-indicated target lesion revascularization (TLR) (7.0% vs. 6.5%, p = 0.62), and definite/probable stent thrombosis (2.3% vs. 1.6%, p = 0.23) were similar with the R-ZES and EES. Independent predictors of TLR were age, insulin-treated diabetes, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score, treatment of saphenous vein grafts, ostial lesions, and in-stent restenosis. Independent predictors of any revascularization were age, diabetes, previous percutaneous coronary intervention, absence of ST-segment elevation myocardial infarction, smaller reference vessel diameter, SYNTAX score, and treatment of left anterior descending, right coronary artery, saphenous vein grafts, ostial lesions, or in-stent restenosis. R-ZES and EES demonstrated similar safety and efficacy throughout 4 years. TLR represented less than one-half of all repeat revascularization procedures. Patient- and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap. (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention [RESOLUTE-AC]; NCT00617084).

The FREEDOM trial: a definitive answer to coronary artery bypass grafting or stents in patients with diabetes and multivessel coronary artery disease

For the last two decades, there has been intense debate between cardiologists and surgeons regarding what the most effective mode is, of revascularization in patients with diabetes already receiving optimal medical therapy, who additionally require invasive coronary artery intervention on symptomatic and/or prognostic grounds. The debate began in earnest with the original interim analyses of the BARI trial, suggesting a survival advantage for the subset of patients with diabetes receiving coronary artery bypass grafting (CABG) rather than angioplasty [1], and was confirmed in the final 10-year follow-up with respective survival rates of 58 vs 46% (P=0.025) [2]. Since then, the recent publications of the 5-year outcomes of the SYNTAX Trial [3] and the ASCERT registry [4 ]h ave provided strong evidence that CABG, in comparison with percutaneous coronary intervention (PCI), offers a strong survival benefi ta s well as a marked reduction in myocardial infarction (MI) and repeat revascularization in patients with intermediate and more severe coronary artery disease (CAD) as judged by SYNTAX scores of >22. Because of the perception that patients with diabetes often have more severe and aggressive forms of CAD, intuitively there is an impression that they are also therefore likely to derive greater clinical benefit from CABG than from PCI. Others have argued, however, that significant advances in both medical therapy and stent technology would have eliminated the former—if any— benefit of CABG over PCI. Consequently, until the recent publication of the FREEDOM Trial [5], the relative merits of both interventions in patients with diabetes have also been fiercely debated. The main reason for the controversy was that, until the FREEDOM Trial, there was not a single trial in patients with diabetes, adequately powered, to give a definitive answer regarding whether CABG offered a survival or any other clinical benefit over PCI. It is therefore informative not only to examine the results of the FREEDOM trial, but also in the context of whether its findings are consistent with other evidence. The FREEDOM trial randomized 1900 patients with diabetes and multivessel CAD, already receiving aggressive medical therapy, to CABG or PCI with drug-eluting stents. This trial therefore included more patients with diabetes than the total from all the subgroups from the other randomized trials. The primary 5-year composite outcome of death from any cause, non-fatal MI or stroke, occurred in 26.6% of the PCI group and 18.7% of the CABG group (P=0.005). The benefit of CABG was driven by superior outcomes in both rates of death from any cause (10.6 vs 14.9%; P= 0.049) and MI (6.0 vs 13.9%; P< 0.001), but at the cost of a higher risk of stroke in the CABG group (5.2 vs 2.4%; P=0.03). And it is important to appreciate that this benefit of CABG over PCI was still evident although all patients were receiving aggressive medical therapy. It is alsoworth noting the relative risk of non-fatal stroke between CABG and PCI was 2.41 at 1 year, narrowing to 1.72 at 5 years [5]. The absolute clinical difference in stroke rates between CABG and PCI was actually small, being 2.1% (30 of 1444) and 0.82% (12 of 1471), respectively, at 1 year and 4.8% (65 of 1344) and 2.8% (42 of 1500) at 5 years. The early difference in stroke is almost certainly a consequence of the very well-recognized perioperative risk of stroke with CABG, with subsequent rates being more similar between the interventions. The same phenomenon was observed in the SYNTAX trial with CABG patients receiving less in the way of single and dual anti-platelet medication in the postoperative period [5]. Are the results of the FREEDOM trial consistent with other evidence? The answer is overwhelmingly, yes, from several other sources. Probably, the second-most definitive piece of evidence regarding the relative benefits of interventions in patients with diabetes is a subset analysis of the collaborative analysis of individual patient data from 7812 patients from 10 trials, of whom 1243 had diabetes, by Hlatky and co-workers. At a median follow-up of 5.9 years, mortality was substantially lower in the CABG group than in the PCI group (hazard ratio [HR]: 0.70, 95% confidence interval [CI]: 0.56–0.87) [6]. Since this analysis, several other pieces of data have emerged supporting the use of CABG rather than PCI in patients with diabetes. In the BARI 2D trial, 2368 patients with both type 2 diabetes and CAD were randomized to intensive medical therapy alone or to additionally undergo either prompt revascularization with PCI or CABG, according to the preference of the treating physician [7]. At 5 years, there was no significant difference in the composite primary end point between the PCI and medical therapy groups. In contrast, in the CABG group, the rate of major cardiovascular

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