Objectives The aim of this study was to compare, in a large all-comer registry, the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for ...ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery (ULMCA) stenosis. Background Limited data are available regarding clinical outcomes following DES implantation at the different ULMCA sites. Methods Patients with ULMCA stenosis treated by PCI with DES were analyzed in this multinational registry. Results A total of 1,612 patients were included: 482 were treated for ostial/mid-shaft lesions versus 1,130 for distal bifurcation lesions. At a median follow-up period of 1,250 (interquartile range: 987 to 1,564) days, PCI for distal bifurcation lesions was associated with a higher incidence of major adverse cardiac events (propensity-score adjusted hazard ratio HR: 1.48, 95% confidence interval CI: 1.16 to 1.89; p = 0.001), largely because of the higher target vessel revascularization rate observed in this group as compared to the ostial/mid-shaft lesions group (propensity-score adjusted HR: 1.68, 95% CI: 1.19 to 2.38; p = 0.003). These results were sustained following propensity-score matched analysis. With regard to all-cause death and the composite endpoint of all-cause death and myocardial infarction, propensity-score adjusted analysis suggested a trend toward higher rates of these in the distal ULMCA PCI group, although this was not observed in the propensity-score matched analysis. Conclusions This study demonstrates that PCI for ostial/mid-shaft lesions is associated with better clinical outcomes than are distal bifurcation lesions in ULMCA, largely because there is a lower need for repeat revascularization in ostial/mid-shaft lesions.
Longest Available Clinical Outcomes After Drug-Eluting Stent Implantation for Unprotected Left Main Coronary Artery Disease: The DELFT (Drug Eluting stent for LeFT main) Registry Emanuele Meliga, ...Hector Manuel Garcia-Garcia, Marco Valgimigli, Alaide Chieffo, Giuseppe Biondi-Zoccai, Andrew O. Maree, Stephen Cook, Lindsay Reardon, Claudio Moretti, Stefano De Servi, Igor F. Palacios, Stephen Windecker, Antonio Colombo, Ron van Domburg, Imad Sheiban, Patrick W. Serruys We investigated the long-term safety and efficacy of percutaneous coronary intervention with drug-eluting stent (DES) implantation for unprotected left main coronary artery (ULMCA) disease in a population of 358 consecutive patients analyzed in 7 European and U.S. tertiary care centers. After 3 years, major adverse cardiovascular event-free survival in the whole population was 73.5%. Cardiac death occurred in 9.2% of patients and reinfarction, target lesion revascularization, and target vessel revascularization occurred in 8.6%, 5.8%, and 14.2% of patients, respectively. Routine DES implantation in ULMCA disease seems encouraging, with favorable long-term clinical results.
Abstract Objectives This study aimed to assess the clinical impact of strut width (evaluated by abluminal strut surface area ASSA) on periprocedural myocardial infarction (PMI) and clinical outcomes ...in patients treated with bioresorbable scaffolds (BRS) versus first-generation sirolimus-eluting stents (SES). Background To date, there are no reports on the impact of ASSA on PMI and clinical outcomes. Methods We compared the impact of ASSA on outcomes and PMI in propensity-matched patients treated with BRS and SES. The primary outcome was the incidence of major adverse cardiac events (MACE), defined as the combination of all-cause mortality, follow-up myocardial infarction, and target vessel revascularization, at 30-days and 1-year follow-ups. The secondary endpoint was the incidence of PMI. Results After propensity-matched analysis, 499 patients (147 BRS patients vs. 352 SES patients) were evaluated. Mean ASSA was higher in patients treated with BRS versus SES (BRS: 132.3 ± 76.7 mm2 vs. SES: 67.6 ± 48.4 mm2 , p < 0.001). MACE was not significantly different between groups (30-days MACE: BRS: 0% vs. SES: 1.4%, p = 0.16, and 1-year MACE: BRS: 15.7% vs. SES: 11.4%, p = 0.67). The incidence of PMI was significantly higher in the BRS group (BRS: 13.1% vs. SES: 7.5%, p = 0.05). Multivariable analyses indicated that treatment of left anterior descending artery and ASSA were independent predictors of PMI. Conclusions BRS implantation, compared with SES implantation, was associated with a higher incidence of PMI. MACE at 30 days and 1 year were not significantly different. Left anterior descending artery percutaneous coronary intervention and ASSA were independent predictors of PMI.
Nitroprusside (NTP) is used for the treatment of slow coronary flow (SCF) after coronary interventions. The wide variation in dosage, route, and timing of its administration in the reported studies ...prevents an objective assessment of its efficacy. We report the incidence and response to a standardized NTP protocol of SCF after successful stent implantation. Selective intracoronary administration of incremental doses (initial bolus of 80 μg incremented by 40 μg) of NPT was assessed in 21 patients who developed SCF in a series of 2,212 consecutive patients who underwent successful stent placement from January to October 2005. SCF was observed only in patients treated for acute myocardial infarction (AMI; 11.5%, 12 of 105) or saphenous vein graft (SVG) stenosis (8.2%, 9 of 109). An intracoronary bolus of nitroglycerin did not restore normal Thrombolysis In Myocardial Infarction (TIMI) flow in any patient. The first 80-μg dose of NTP restored normal TIMI flow in 58% of patients (7 of 12) with AMI and in 44% of patients (4 of 9)with SVG stenosis. The maximal dose (120/160 μg) restored normal TIMI flow in all remaining patients with AMI but in only 1 additional patient with SVG stenosis. At the end of the procedure, the percent decrease in corrected TIMI frame count was significantly larger in patients with AMI (−44 ± 10%) than in those with SVG stenosis (−24 ± 16%, p = 0.02). In a large consecutive series of successful stent procedures, SCF was found only in patients with ST-elevation AMI (11.5%) or with a stenosed SVG (8.2%). In conclusion, the standardized protocol of intracoronary NTP administration succeeded in normalizing SCF in all patients with AMI but in only 5 of 9 patients with SVG stenosis. This latter subgroup requires other therapeutic strategies.
Summary Background Dual antiplatelet therapy (DAPT) cessation increases the risk of adverse events after percutaneous coronary intervention (PCI). Whether risk changes over time, depends on the ...underlying reason for DAPT cessation, or both is unknown. We assessed associations between different modes of DAPT cessation and cardiovascular risk after PCI. Methods The PARIS (patterns of non-adherence to anti-platelet regimens in stented patients) registry is a prospective observational study of patients undergoing PCI with stent implantation in 15 clinical sites in the USA and Europe between July 1, 2009, and Dec 2, 2010. Adult patients (aged 18 years or older) undergoing successful stent implantation in one or more native coronary artery and discharged on DAPT were eligible for enrolment. Patients were followed up at months 1, 6, 12, and 24 after implantation. Prespecified categories for DAPT cessation included physician-recommended discontinuation, brief interruption (for surgery), or disruption (non-compliance or because of bleeding). All adverse events and episodes of DAPT cessation were independently adjudicated. Using Cox models with time-varying covariates, we examined the effect of DAPT cessation on major adverse events (MACE composite of cardiac death, definite or probable stent thrombosis, myocardial infarction, or target-lesion revascularisation). Incidence rates for DAPT cessation and adverse events were calculated as Kaplan-Meier estimates of time to the first event. This study is registered with ClinicalTrials.gov , number NCT00998127. Findings We enrolled 5031 patients undergoing PCI, including 5018 in the final study population. Over 2 years, the overall incidence of any DAPT cessation was 57·3%. Rate of any discontinuation was 40·8%, of interruption was 10·5%, and of disruption was 14·4%. The corresponding overall 2 year MACE rate was 11·5%, most of which (74%) occurred while patients were taking DAPT. Compared with those on DAPT, the adjusted hazard ratio (HR) for MACE due to interruption was 1·41 (95% CI 0·94–2·12; p=0·10) and to disruption was 1·50 (1·14–1.97; p=0·004). Within 7 days, 8–30 days, and more than 30 days after disruption, adjusted HRs were 7·04 (3·31–14·95), 2·17 (0·97–4·88), and 1·3 (0·97–1·76), respectively. By contrast with patients who remained on DAPT, those who discontinued had lower MACE risk (0·63 0·46–0·86). Results were similar after excluding patients receiving bare metal stents and using an alternative MACE definition that did not include target lesion revascularisation. Interpretation In a real-world setting, for patients undergoing PCI and discharged on DAPT, cardiac events after DAPT cessation depend on the clinical circumstance and reason for cessation and attenuates over time. While most events after PCI occur in patients on DAPT, early risk for events due to disruption is substantial irrespective of stent type. Funding Bristol-Myers Squibb and Sanofi-Aventis.
Summary Background The anatomical SYNTAX score is advocated in European and US guidelines as an instrument to help clinicians decide the optimum revascularisation method in patients with complex ...coronary artery disease. The absence of an individualised approach and of clinical variables to guide decision making between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) are limitations of the SYNTAX score. SYNTAX score II aimed to overcome these limitations. Methods SYNTAX score II was developed by applying a Cox proportional hazards model to results of the randomised all comers SYNTAX trial (n=1800). Baseline features with strong associations to 4-year mortality in either the CABG or the PCI settings (interactions), or in both (predictive accuracy), were added to the anatomical SYNTAX score. Comparisons of 4-year mortality predictions between CABG and PCI were made for each patient. Discriminatory performance was quantified by concordance statistics and internally validated with bootstrap resampling. External validation was done in the multinational all comers DELTA registry (n=2891), a heterogeneous population that included patients with three-vessel disease (26%) or complex coronary artery disease (anatomical SYNTAX score ≥33, 30%) who underwent CABG or PCI. The SYNTAX trial is registered with ClinicalTrials.gov , number NCT00114972. Findings SYNTAX score II contained eight predictors: anatomical SYNTAX score, age, creatinine clearance, left ventricular ejection fraction (LVEF), presence of unprotected left main coronary artery (ULMCA) disease, peripheral vascular disease, female sex, and chronic obstructive pulmonary disease (COPD). SYNTAX score II significantly predicted a difference in 4-year mortality between patients undergoing CABG and those undergoing PCI (pinteraction 0·0037). To achieve similar 4-year mortality after CABG or PCI, younger patients, women, and patients with reduced LVEF required lower anatomical SYNTAX scores, whereas older patients, patients with ULMCA disease, and those with COPD, required higher anatomical SYNTAX scores. Presence of diabetes was not important for decision making between CABG and PCI (pinteraction 0·67). SYNTAX score II discriminated well in all patients who underwent CABG or PCI, with concordance indices for internal (SYNTAX trial) validation of 0·725 and for external (DELTA registry) validation of 0·716, which were substantially higher than for the anatomical SYNTAX score alone (concordance indices of 0·567 and 0·612, respectively). A nomogram was constructed that allowed for an accurate individualised prediction of 4-year mortality in patients proposing to undergo CABG or PCI. Interpretation Long-term (4-year) mortality in patients with complex coronary artery disease can be well predicted by a combination of anatomical and clinical factors in SYNTAX score II. SYNTAX score II can better guide decision making between CABG and PCI than the original anatomical SYNTAX score. Funding Boston Scientific Corporation.
Objectives Atorvastatin administered at least 7 days before the percutaneous coronary intervention (PCI) reduces the rate of periprocedural myocardial infarction (MI). It is unknown whether a single, ...high (80 mg) loading dose of atorvastatin may reduce the rate of periprocedural MI. Background Periprocedural MI is a prognostically important complication of PCI. Methods The day before the elective PCI, 668 statin-naive patients were randomly assigned to atorvastatin 80 mg (atorvastatin group; n = 338) or no statin treatment (control group; n = 330). Creatine kinase-myocardial isoenzyme (CK-MB) (upper limit of normal ULN 3.5 ng/ml) and cardiac troponin I (ULN 0.10 ng/ml) were assessed before and 6 and 12 h after the intervention. Periprocedural MI was defined as a CK-MB elevation >3× ULN alone or associated with chest pain or ST-segment or T-wave abnormalities. Results The incidence of a periprocedural MI was 9.5% in the atorvastatin group and 15.8% in the control group (odds ratio: 0.56; 95% confidence interval: 0.35 to 0.89; p = 0.014). Median CK-MB peak after PCI was 2.10 ng/ml (interquartile range 1.00 to 12.50 ng/ml) in the atorvastatin group and 3.20 ng/ml (interquartile range 1.37 to 16.07 ng/ml) in the control group (p = 0.014). The incidence of cardiac troponin I elevation >3× ULN was 26.6% in the atorvastatin group and 39.1% in the control group (odds ratio: 0.56; 95% confidence interval: 0.40 to 0.78; p < 0.001). Conclusions A single, high (80 mg) loading (within 24 h) dose of atorvastatin reduces the incidence of periprocedural MI in elective PCI.
Objectives This study sought to retrospectively appraise the incidence and management of restenosis after drug-eluting stent (DES) implantation for unprotected left main (ULM) disease. Background The ...promising role of DES for ULM has been reported. However, no detailed data are available on subsequent restenosis. Methods From the total sample of patients with ULM treated with DES, we identified those presenting with angiographic ULM restenosis. The primary end point was the long-term rate of major adverse cardiac events (MACE), that is, death, myocardial infarction (MI), or target lesion revascularization (TLR). We also adjudicated stent thrombosis according to the Academic Research Consortium. Results Post-DES restenosis in ULM occurred in 70 of 718 patients (9.7%). Of these, 59 (84.3%) were treated percutaneously (34 48.6% with additional DES, 22 31.4% with standard or cutting balloons, 2 2.9% with rotational atherectomy, and 1 1.4% with a bare-metal stent), whereas 7 (10%) patients underwent bypass surgery and 4 (5.7%) were treated medically. In-hospital MACE included no periprocedural MI and only 1 (1.4%) death. After 27.2 ± 15.4 months, MACE occurred cumulatively in 18 (25.7%) patients, with death in 4 (5.7%), MI in 2 (2.9%), and TLR in 15 (21.4%). Patients treated with medical, interventional, and surgical therapy had the following MACE rates, respectively: 50%, 25.4%, and 14.3%. Definite, probable, and possible stent thrombosis occurred in 0 (0%), 1 (1.4%), and 1 (1.4%) patient, respectively. Conclusions DES restenosis in the ULM artery can be managed in most cases with a minimally invasive approach, achieving favorable early and late results.
Background Currently, little data are available on the management of drug-eluting stent (DES) restenosis. Drug resistance may play a role in its etiology. Methods We identified all cases of either ...sirolimus-eluting or paclitaxel-eluting stent restenosis treated with repeated DES implantation. The lesions were divided into those receiving the same DES as the one that restenosed and those treated with the alternative DES. The end points analyzed were target lesion revascularization (TLR) and angiographic restenosis. Results We included 201 lesions (174 patients); the same DES was implanted in 107 lesions and a different DES in 94 lesions. Angiographic follow-up of the retreatment was available in 69.7% of the lesions. Angiographic restenosis occurred in 26.4% (19) of cases treated with the same DES and 25.8% (17) of those treated with a different DES ( P = 1.0). Target lesion revascularization occurred in 15.9% (17) and 16% (15) of lesions, respectively ( P = 1.0). A multivariate analysis confirmed the lack of association between the treatment selected and TLR (OR 0.7, 95% CIs 0.29-1.67; P = .42). A nonfocal pattern of restenosis remained associated with TLR and restenosis (OR 2.99, 95% CIs 1.24-7.24; P = .015 and OR 3.6, 95% CIs 1.5-8.8; P = .004, respectively). Conclusions Repeated DES implantation for DES restenosis is feasible and safe. The TLR rate is acceptable, with no differences between implantation of the same or a different DES. The pattern of restenosis treated is an important predictor of outcomes.
Concerns regarding radiation exposure and its effects during pregnancy are often quoted as an important barrier preventing many women from pursuing a career in Interventional Cardiology. Finding the ...true risk of radiation exposure from performing cardiac catheterisation procedures can be challenging and guidelines for pregnancy exposure have been inadequate. The Women in Innovations group of Cardiologists with endorsement of the Society for Cardiovascular Angiography and Interventions aim to provide guidance in this publication by describing the risk of radiation exposure to pregnant physicians and cardiac catheterisation personnel, to educate on appropriate radiation monitoring and to encourage mechanisms to reduce radiation exposure. Current data do not suggest a significant increased risk to the foetus of pregnant women in the cardiac catheterisation laboratory and thus do not justify precluding pregnant physicians from performing procedures in the cardiac catheterisation laboratory. However, radiation exposure amongst pregnant physicians should be properly monitored and adequate radiation safety measures are still warranted.
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