Retrospective multicenter observational study of the interventional management of coronary disease in the very elderly: the NINETY.

OBJECTIVES: The aim of this observational, multicenter study was to describe the outcome of very elderly patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: There is a paucity of data among nonagenarians undergoing PCI. METHODS: All consecutive patients 90 years of age or older undergoing PCI with stent implantation between April 2002 and June 2009 were included in the study. The primary endpoint was the long-term rate of net adverse cardiac events (NACE), that is, death, myocardial infarction (MI), target lesion revascularization, and life-threatening or major bleedings. RESULTS: One hundred forty-six nonagenarians were divided in three groups according to clinical setting: 27 (group A) stable angina or silent ischemia, 85 (group B) unstable angina or non-ST elevation MI, and 34 (group C) with ST elevation MI (STEMI). At 30 days, the incidence of NACE was significantly lower in patients in Group A vs. B or C (0% vs. 17.3% vs. 31.2%, P = 0.006), and the frequency of definite stent thrombosis was higher in Group C vs. A or B (9.4% vs. 0% vs. 0%, P = 0.007), respectively. Up to a median follow-up of 24 months, NACE rate was 33.3% in group A, 49.3% in group B, and 50% in group C (P = 0.32). There were no significant differences between groups in the individual components of the primary endpoint. CONCLUSIONS: PCI in nonagenarians is safe and feasible with acceptable major bleeding rates. However, long-term results show high mortality rates particularly in the STEMI group.

Long-term outcomes of elective drug-eluting stenting of the unprotected left main coronary artery in patients with normal left ventricular function.

OBJECTIVES: To evaluate the early and long-term outcomes of patients with normal left ventricular function who undergo elective unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) with drug-eluting stents (DES). BACKGROUND: Although the standard of care for patients with ULMCA disease is coronary artery bypass surgery, the current guidelines recommend PCI in clinical conditions that predict an increased risk of adverse surgical outcomes. The long-term outcomes of patients with low risk of adverse surgical outcomes who undergo PCI are unknown. METHODS: Data from a multicenter international registry, which included 221 consecutive patients from four institutions with normal left ventricular function who underwent elective ULMCA PCI with DES from 2002 to 2009, were collected. RESULTS: There was no cardiac death, Q-wave myocardial infarction, target lesion revascularization (TLR), stent thrombosis, or stroke within the first 30 days. Seven (3%) patients had periprocedural myocardial infarction. Follow-up angiography was performed in 136 (62%) patients. Kaplan-Meier event-free survival curves at 1 year for cardiac death and TLR rates were 97.7% ± 1.0% and 92.9% ± 1.8%, respectively. At the mean follow-up of 44.8 ± 22.8 months, the event-free rates for cardiac death and TLR were 95.5% ± 1.5% and 88.9% ± 2.3%, respectively. Multivariate analyses identified the predictors of cardiac death: age ≥ 75 years (P = 0.015) and history of myocardial infarction (P = 0.017). CONCLUSIONS: Elective ULMCA PCI with DES in patients with normal left ventricular function is safe and effective with excellent short-term outcomes and favorable long-term outcomes and may be a viable option for low-risk patients with normal left ventricular function.

Results of percutaneous drug-eluting stent implantation for unprotected left main coronary disease according to left ventricular systolic function.

OBJECTIVES: We aimed to appraise the early and long-term outcome after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients with unprotected left main disease (ULM) and left ventricular systolic dysfunction (LVD). BACKGROUND: PCI with DES has being performed with increasing frequency in subjects with ULM and LVD, but few specific data are available. SETTING AND PATIENTS: We identified patients undergoing PCI with DES for ULM at our Center and distinguished those with ejection fraction (EF) >50% from those with 40% 50%, 32.0% with 40% 50%, 41.6% in those with 40%

Multicenter international registry of unprotected left main coronary artery percutaneous coronary intervention with drug-eluting stents in patients with myocardial infarction.

BACKGROUND: Patients who present with myocardial infarction (MI) and unprotected left main coronary artery (ULMCA) disease represent an extremely high-risk subset of patients. ULMCA percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in MI patients has not been extensively studied. METHODS: In this retrospective multicenter international registry, we evaluated the clinical outcomes of 62 consecutive patients with MI who underwent ULMCA PCI with DES (23 ST-elevation MI [STEMI] and 39 non-ST-elevation MI [NSTEMI]) from 2002 to 2006. RESULTS: The mean age was 70 +/- 12 years. Cardiogenic shock was present in 24%. The mean EuroSCORE was 10 +/- 8. Angiographic success was achieved in all patients. Overall in-hospital major adverse cardiac event (MACE) rate was 10%, mortality was 8%, all due to cardiac deaths from cardiogenic shock, and one patient suffered a periprocedural MI. At 586 +/- 431 days, 18 patients (29%) experienced MACE, 12 patients (19%) died (the mortality rate was 47% in patients with cardiogenic shock), and target vessel revascularization was performed in four patients, all of whom had distal bifurcation involvement (two patients underwent repeat PCI and two patients underwent bypass surgery). There was no additional MI. Two patients had probable stent thrombosis and one had possible stent thrombosis. Diabetes [hazard ratio (HR) 4.22, 95% confidence interval (CI) (1.07-17.36), P = 0.04), left ventricular ejection fraction [HR 0.94, 95% CI (0.90-0.98), P = 0.005), and intubation [HR 7.00, 95% CI (1.62-30.21), P = 0.009) were significantly associated with increased mortality. CONCLUSIONS: Patients with MI and ULMCA disease represent a very high-risk subgroup of patients who are critically ill. PCI with DES appears to be technically feasible, associated with acceptable long-term outcomes, and a reasonable alternative to surgical revascularization for MI patients with ULMCA disease. Randomized trials are needed to determine the ideal revascularization strategy for these patients.

Early and long-term results of percutaneous coronary intervention for unprotected left main trifurcation disease.

OBJECTIVES: We aimed to conduct a retrospective cohort study focusing on our 5-year experience in the percutaneous treatment of unprotected left main (ULM) trifurcation disease. BACKGROUND: Percutaneous treatment of ULM trifurcation remains a challenging and rare procedure for most interventional cardiologists. Moreover, data on long-term outcomes are lacking. METHODS: We retrieved all patients with ULM trifurcation disease treated percutaneously at our Institution since 2002, and adjudicated baseline, procedural, and outcome data. The primary end point was the long-term rate of major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, bypass surgery, or target vessel revascularization). RESULTS: A total of 27 patients underwent percutaneous coronary intervention with stent implantation for ULM trifurcation disease, with 14 (52%) cases of true trifurcations, i.e., with concomitant significant stenoses of the distal ULM/ostial left anterior descending plus ostial ramus intermedius and ostial circumflex. Bare-metal stents were implanted in 8 (29%) patients and drug-eluting stents (DES) in 26 (96%), with a main branch stent only strategy in 11 (40%), T stenting in 9 (33%), and V stenting in 6 (27%). Procedural and clinical success occurred in 26 (96%), with one postprocedural death. Angiographic follow-up was obtained in 22 patients (81%), and clinical follow-up was completed in all subjects after a median of 28 +/- 17 months, showing overall MACE in 9 (33%), with cardiac death in 4 (15%), myocardial infarction in 1 (4%), coronary artery bypass grafting (CABG) in 4 (15%), and percutaneous target vessel revascularization in 5 (19%). Definite stent thrombosis was adjudicated in 1 (3%) patient. Treatment of a true trifurcation lesion and recurrence of angina during follow-up were significantly associated with an increased risk of MACE (P = 0.029 and P = 0.050, respectively). CONCLUSIONS: Percutaneous treatment of ULM trifurcation disease is feasible, associated with favorable mid-term results, and may be considered given its low invasiveness in patients at high surgical risk or with multiple comorbidities.

Late and very late stent thrombosis following drug-eluting stent implantation in unprotected left main coronary artery: a multicentre registry.

AIMS: To evaluate the occurrence of late and very late stent thrombosis (ST) following elective drug-eluting stent (DES) implantation in unprotected left main coronary artery (LMCA) stenosis in a large multicentre registry. METHODS AND RESULTS: All 731 consecutive patients who had sirolimus- or paclitaxel-eluting stent electively implanted in de novo lesions on unprotected LMCA in five centres were included. ST was defined according to Academic Research Consortium definitions. Four (0.5%) patients had a definite ST: three early (two acute and one subacute) and one late ST, no cases of very late definite ST were recorded. All patients survived from the event. Three patients had a probable ST. Therefore, 7/731 (0.95%) patients had a definite or a probable ST and all were on dual antiplatelet therapy at the time of the event. Possible (eight late and 12 very late) ST occurred in 20 (2.7%) patients. At 29.5 ± 13.7 months follow-up, a total of 45 (6.2%) patients had died; 31 (4.2%) of cardiac death. Ninety five (12.9%) patients had a target-vessel and 76 (10.4%) a target-lesion revascularization. Angiographic follow-up was performed in 548 patients (75%): restenosis occurred in 77 (14.1%) patients. CONCLUSION: Elective treatment of LMCA stenosis with DES appears safe with a 0.9% incidence of definite and probable ST at 29.5 ± 13.7 months.

Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V).

Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher) and paclitaxel-eluting stents (Taxus), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor) and everolimus-eluting stents (Xience V), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.

A new electrophysiology era: zero fluoroscopy.

Catheter ablations are traditionally performed under fluoroscopic guidance. Besides other peri-interventional risks, radiation exposure should be considered for its stochastic and deterministic effects on health. These effects are cumulative and lifelong and raise great concerns especially in the younger population. A document of the American College of Cardiology recommends that all catheterization laboratories adopt the principles of 'ALARA' (radiation doses 'As Low As Reasonably Achievable'), making radiation reduction an ethical issue. In electrophysiology, thanks to the recent development of electroanatomic navigation systems, we are witnessing the birth of a new era in which almost all arrhythmias may be treated without the use of fluoroscopy. In the present review, we start by describing risks to health due to radiation exposure for conventional transcatheter ablations and we continue by reporting the current state of art of the zero fluoroscopy approach.

Impact of pre-diabetes and diabetes on cardiovascular outcomes.

The present paper examines major evidences on the correlation between pre-diabetes, diabetes and cardiovascular risk, especially focusing on early and multifactorial treatment strategies holding the potential to delay the occurrence of micro- and macro-vascular complications causing impaired quality of life and reduced survival.

Unprotected left main coronary disease and ST-segment elevation myocardial infarction: a contemporary review and argument for percutaneous coronary intervention.

Acute occlusion involving the unprotected left main coronary artery (ULMCA) is a clinically catastrophic event, often leading to abrupt and severe circulatory failure, lethal arrhythmias, and sudden cardiac death. Although coronary artery bypass grafting (CABG) is the standard of care for ULMCA disease in patients with stable ischemic heart disease, uncertainty surrounds the optimal revascularization strategy for patients with ST-elevation myocardial infarction (MI) and ULMCA occlusion who survive to hospitalization, and treatment guidelines in this setting are vague. Percutaneous coronary intervention (PCI) is technically feasible in most patients, has the advantage of providing more rapid reperfusion compared with CABG with acceptable short- and long-term outcomes, and is associated with a lower risk of stroke. PCI of the ULMCA should be considered as a viable alternative to CABG for selected patients with MI, including those with ULMCA occlusion and less than Thrombolysis In Myocardial Infarction flow grade 3, cardiogenic shock, persistent ventricular arrhythmias, and significant comorbidities. The higher risk of target vessel revascularization associated with ULMCA PCI compared with CABG is an acceptable tradeoff given the primary need for rapid reperfusion to enhance survival.

Impact of routine angiographic follow-up after percutaneous coronary drug-eluting stenting for unprotected left main disease: the Turin Registry.

BACKGROUND: Most cardiologists performing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main disease (ULM) mandate mid-term angiographic follow-up, yet there are few data supporting this approach. We aimed to retrospectively compare the outcome of patients with ULM treated with DES according to their follow-up management strategy. METHODS: Patients with ULM stenosis undergoing PCI with DES and surviving up to 6 months were retrospectively identified from our ongoing database. We distinguished those undergoing clinical follow-up only, those with clinically driven angiographic follow-up, and those with routine angiographic follow-up. The primary end-point was the long-term rate of major adverse cardiac events (MACE, i.e., death, myocardial infarction, bypass surgery, or repeat ULM PCI). RESULTS: A total of 198 patients were included: 55 (28%) in the clinical follow-up group, 64 (32%) in the clinically driven angiographic follow-up group, and 79 (40%) in the routine angiographic follow-up group. After 37.0 +/- 15.7 months, mortality was similar in the 3 groups (respectively 7.3, 4.7, and 5.9%, p = 0.27). However, MACE were significantly more common in the clinically driven angiographic follow-up group (42.2 vs. 7.3 and 26.1%, p = 0.02), mainly due to the expected increase in repeat revascularization in those undergoing angiographic follow-up (23.4 vs. 1.8 and 13.14%). Notably, there were no differences in the rate of stent thrombosis across the three groups, with rates of 3.1 vs. 1.8 and 2.5% (p = 0.35). CONCLUSIONS: An expectant management can be safely adopted in most patients with ULM treated percutaneously, as long as a low threshold for control coronary angiography is maintained.

Current management of unprotected left main coronary artery disease: run-in survey of the RITMO (Registro Italiano sul Trattamento del tronco coMune non protettO) study.

The optimal approach for a significant unprotected left main coronary stenosis (ULM) is debated, in light of the recent progresses of percutaneous coronary intervention (PCI). However, coronary artery bypass grafting (CABG) is still considered the first choice treatment. Randomized trials comparing PCI and CABG are ongoing, yet patient selection will considerably limit their clinical applicability. We thus designed a prospective multicenter registry which will include patients with ULM disease independently from the subsequent medical, interventional or surgical treatment: the RITMO Study (Registro Italiano sul Trattamento del tronco coMune non protettO). During the RITMO run-in phase, we conducted a systematic survey of Italian catheterization laboratories to define current management strategies for ULM. A total of 240 Italian catheterization laboratory were sent an email questionnaire on current practices for ULM, with 45 (19%) detailed replies, for a total of 61,370 annual coronary angiographies. Data provided from responders showed a 5% (95% interval: 2-16) prevalence of ULM, with 50% (9-99) of ULM treated surgically and 10% (0-81) treated percutaneously. In conclusion, treatment of ULM in Italy remains prevalently surgical, even if PCI is performed in a sizable portion of patients with ULM.

Impact of multivessel stenting on top of percutaneous revascularization for unprotected left main disease in the drug-eluting stent era: insights from the Turin registry.

OBJECTIVE: Drug-eluting stents (DESs) are commonly used in patients with unprotected left main (ULM) disease. Although multivessel disease and stenting are frequent in this population, pertinent details on short-term and long-term outcomes are lacking. SETTING AND PATIENTS: We identified consecutive patients with DES treatment for ULM. We distinguished patients presenting isolated ULM stenting (group A) from those with additional treatment of at least another major vessel (group B). The primary end point was major adverse cardiovascular events (i.e. death, myocardial infarction or target vessel revascularization). We compared the impact of a DES-only versus a hybrid DES and bare metal stent strategy for non-ULM lesions. RESULTS: A total of 189 patients were included, 25% in group A and 75% in group B. In-hospital events were similarly favorable (cardiac death in 0 and 2%, respectively, P = 0.58). A total of 99% patients were followed for a median of 25 months, yielding major adverse cardiovascular events in 17 and 37.5% (P = 0.011). Specifically, death occurred in 4 and 8.5% (P = 0.52), cardiac death in 0 and 7% (P = 0.12), myocardial infarction in 6.5 and 9% (P = 0.76) and target vessel revascularization in 4.3 and 22% (P = 0.006). Adoption of a systematic DES-only strategy for non-ULM lesions conferred significant benefits on major adverse cardiovascular events and repeat non-ULM revascularizations in comparison to a hybrid strategy (22 versus 45%, P < 0.001, and 9 versus 19%, P = 0.004, respectively), at both bivariate and multivariable analyses. CONCLUSION: Multivessel stenting on top of DES implantation for ULM can be performed with favorable early results. Systematic DES implantation for both ULM and non-ULM lesions is pivotal to maximize clinical results and minimize long-term recurrences.

Incidence and management of restenosis after treatment of unprotected left main disease with drug-eluting stents 70 restenotic cases from a cohort of 718 patients: FAILS (Failure in Left Main Study).

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.

A prospective multicentre observational study on the management of unprotected left main coronary artery disease: rationale and design of the Registro Italiano sul Trattamento del tronco comune non protetto study.

BACKGROUND: The optimal approach for a significant unprotected left main coronary stenosis is debated in light of the recent progresses of percutaneous coronary intervention. However, bypass surgery is still considered the first choice treatment. Randomized trials comparing percutaneous intervention and bypass grafting are ongoing, yet patient selection will limit their applicability. We designed a prospective multicentre registry, which will include patients with unprotected left main disease independent of the subsequent medical, interventional or surgical treatment. OBJECTIVE: The aim of this study is to evaluate prospectively the prevalence, treatment, and prognosis of patients with unprotected left main stenosis. STUDY DESIGN: More than 30 Italian care centres will participate. Patients with unprotected left main stenosis will be enrolled, excluding those with only mild atherosclerotic irregularities or patent grafts. The primary endpoint will be the 12-month occurrence of major adverse cardiac and cerebral events (MACCE, i.e. the composite of death, non-fatal myocardial infarction, stroke, or coronary revascularization by percutaneous intervention or bypass surgery). Secondary endpoints will be the occurrence of individual components of the primary endpoint at 1, 6, 24, and 60 months, the rate of major adverse cardiac and cerebral events without stroke, functional class, and quality of life. Analyses will be stratified according to lesion severity, as well as other patient, lesion, and procedural characteristics. EXPECTED RESULTS AND IMPLICATIONS: This multicentre prospective registry of patients with unprotected left main coronary stenosis treated medically, percutaneously or surgically will provide important and updated data on the prevalence, therapeutic choices, and prognosis of this important patient population.

Impact of diabetes mellitus on early and long-term results of percutaneous drug-eluting stent implantation for unprotected left main coronary disease.

BACKGROUND: We aimed to appraise the outcomes of diabetic patients with unprotected left main (ULM) disease treated with drug-eluting stents. Percutaneous coronary intervention with drug-eluting stent implantation is increasingly used for ULM disease. However, there are no data on the clinical results of drug-eluting stents for ULM disease in patients with diabetes. METHODS: We collected baseline and outcome data from all patients undergoing percutaneous coronary intervention with drug-eluting stents for ULM disease at our institution since 2002. We identified three groups: insulin-requiring diabetes mellitus patients, noninsulin-requiring diabetes mellitus patients, and nondiabetes mellitus individuals. The primary end point was the rate of major adverse cardiac events, that is, cardiac death, myocardial infarction, or target vessel revascularization. We also appraised stent thrombosis according to the Academic Research Consortium. RESULTS: A total of 185 patients were enrolled, 25/185 (14%) insulin-requiring diabetes mellitus patients, 30/185 (16%) noninsulin-requiring diabetes mellitus patients, and 130/185 (70%) nondiabetes mellitus individuals. In-hospital adverse events were overall uncommon and not significantly different across groups. After a median follow-up period of 23.1 months, major adverse cardiac events had occurred in similar rates across groups: 6/25 (24%) insulin-requiring patients with diabetes mellitus, 8/30 (27%) noninsulin-requiring patients with diabetes mellitus, and 31/128 (24%) nondiabetes mellitus individuals (P = 0.96). No case of definite or probable stent thrombosis was adjudicated. Intriguingly, possible stent thrombosis was nonsignificantly more common among insulin-requiring diabetes mellitus patients than among noninsulin-requiring diabetes mellitus patients or nondiabetes mellitus individuals [1/25 (4%) vs. 0/30 (0%) and 1/128 (0.8%), respectively, P = 0.30]. CONCLUSION: Drug-eluting stents provide favorable early and long-term results in both selected patients with diabetes and nondiabetic individuals undergoing percutaneous coronary intervention for ULM disease. Nonetheless, further randomized data are eagerly awaited to definitely confirm or disprove these findings.