Valeria Magni

5-year outcomes following percutaneous coronary intervention with drug-eluting stent implantation versus coronary artery bypass graft for unprotected left main coronary artery lesions: The Milan experience

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

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.

Dual Antiplatelet Therapy After Percutaneous Coronary Intervention With Stent Implantation in Patients Taking Chronic Oral Anticoagulation

OBJECTIVES The purpose of this study was to evaluate the safety of dual antiplatelet therapy in patients in whom long-term anticoagulation (AC) with warfarin is recommended. BACKGROUND The optimal antithrombotic strategy after percutaneous coronary intervention (PCI) for patients receiving AC is unclear. METHODS Consecutive patients who underwent stent implantation and were discharged on triple therapy (defined as the combination of aspirin and thienopyridines and AC) were analyzed. RESULTS Of the 127 patients with 224 lesions, 86.6% were men, with a mean age of 69.9 +/- 8.8 years. Drug-eluting stents (DES) were positioned in 71 (55.9%), and bare-metal stents (BMS) were positioned in 56 (44.1%) patients. Atrial fibrillation (AF) was the main indication (59.1%) for AC treatment. The mean triple therapy duration was 5.6 +/- 4.6 months, and clinical follow-up was 21.0 +/- 19.8 months. During the triple therapy period, 6 patients (4.7%) developed major bleeding complications; 67% occurred within the first month. No significant differences between DES and BMS were observed in the incidence of major (5.6% vs. 3.6%, respectively, p = 1.0) and minor (1.4% vs. 3.6%, respectively, p = 0.57) bleeding and mortality (5.6% vs. 1.8%, respectively, p = 0.39). A significant difference was observed in favor of DES in target vessel revascularization (14.1% vs. 26.8%, p = 0.041). CONCLUSIONS While receiving triple therapy, major bleeding occurred in 4.7% of patients; one-half of the events were lethal, and most occurred within the first month.

Predictors of cardiac death in patients with coronary chronic total occlusion not revascularized by PCI

BACKGROUND Limited data are available on clinical outcome of patients with previously failed or not attempted chronic total occlusion (CTO) recanalization by percutaneous coronary intervention (PCI). The aim of the study is to determine prevalence and predictors of cardiac death in patients with CTO not revascularized by PCI. METHODS Double-center study analyzing data of 1.345 consecutive patients with at least one CTO between 1998 and 2008. Of these, 847 patients were successfully revascularized (Revascularized group) and 498 patients were not revascularized (Not revascularized group) either due to failure of CTO-PCI (n=337) or because no attempt was made (n=161). RESULTS At 4-year clinical follow-up, Not revascularized patients had a significantly higher rate of cardiac mortality (8.5% vs. 2.5%, p<0.0001) and sudden cardiac death (2.7% vs. 0.5%, p=0.001) compared to those Revascularized. The separate adjusted Cox-model analysis made for Not revascularized patients showed the most significant independent predictors of cardiac death were: chronic renal failure [HR (CI), 6.0 (2.66-13.80)], low-LVEF [5.7 (2.84-11.58)], insulin-dependent diabetes mellitus (IDDM) 4.6 [(1.96-10.97)]. In the Revascularized group, the presence of 3-vessel disease was the only significant independent predictor of cardiac death [4.4 (1.40-13.70)]. CONCLUSIONS CTO patients Not revascularized had a significant higher rate of cardiac mortality and sudden cardiac death compared to those Revascularized. Within Not revascularized patients, the presence of low-LVEF, or CRF or IDDM was associated with an incidence of cardiac death at least 4 times higher than those without the same risk factors.

Long-Term Follow-Up on a Large Cohort of “Full-Metal Jacket” Percutaneous Coronary Intervention Procedures

Background—Limited long-term data exist on patients who have undergone drug-eluting stenting of very long lesions (requiring ≥60 mm of continuous stent) in native coronary arteries (“full-metal jacket”). Methods and Results—We examined consecutive procedures taking place between March 2002 and 2007 at 2 high-volume centers in Milan, Italy. Exclusion criteria were percutaneous coronary intervention for restenosis, percutaneous coronary intervention to a bypass graft, or percutaneous coronary intervention for acute ST-elevation myocardial infarction (MI). We identified 658 full-metal jacket lesions in 617 patients. Average age of the cohort was 62.0±10.6; 32.8% were diabetic, 51.5% had a previous MI, and 33.4% had undergone a previous percutaneous transluminal coronary angioplasty. Mean ejection fraction was 52.1±10.4%. The lesion was a chronic total occlusion in 33.0%. Median duration of clinical follow-up was 39 months (interquartile range, 28 to 50). Six-month follow-up was achieved in 97% of patients; 2-year follow-up was achieved in 91%. All-cause mortality rate was 7.3%; cardiac death rate was 3.6%. Non–procedure-related MI rates were 3.5%. Target lesion revascularization rates were 23.4%. There were 17 cases of Academic Research Consortium–defined definite or probable stent thrombosis (2.6%): 5 acute, 2 subacute, 6 late, and 4 very late. Ten of the 17 cases occurred while the patient was receiving dual antiplatelet therapy; 4 of the 17 after premature termination of 1 or both antiplatelets, and 3 of the 17 occurred while the patient was receiving single-antiplatelet therapy, after having completed the prescribed course of dual antiplatelet therapy. Conclusion—When very long lesions (≥60 mm) were treated using overlapping drug-eluting stents, 23.4% required a further procedure for restenosis at 3-year follow-up. However, MI, stent thrombosis, and cardiac mortality rates were relatively low.

Evaluation of intermediate coronary stenosis with intravascular ultrasound and fractional flow reserve: Its use and abuse

Clinical decision making in patients with intermediate coronary stenosis is still debated. Intravascular ultrasound (IVUS) examination and/or functional assessment of coronary stenosis by fractional flow reserve (FFR) are currently used to define the severity of such lesions. There are very few studies with a small sample size that have a head‐to‐head comparison between IVUS and FFR in the evaluation of angiographically de novo intermediate lesions. There are no randomized, controlled trials to demonstrate the superiority of IVUS versus FFR in providing improved clinical outcomes in comparison with angiography alone. However, the issue of superiority might be irrelevant, because IVUS and FFR could be complementary techniques to be used in the catheterization laboratory to provide critical anatomic and functional data that permit more accurate decisions in the management of the patient.

Clinical Outcomes After Unrestricted Implantation of Everolimus-Eluting Stents

OBJECTIVES The aim of this study was to evaluate the efficacy and safety of unrestricted everolimus-eluting stent (EES) implantation in a contemporary cohort of real-world patients. BACKGROUND The randomized SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials have evaluated the performance of EES, resulting in their approval by the Food and Drug Administration, but data regarding unselected usage, including off-label indications are lacking. METHODS Consecutive patients treated with EES (either PROMUS, Boston Scientific Corp., Natick, Massachusetts, or XIENCE-V, Abbott Vascular Devices, Santa Clara, California) between October 2006 and February 2008 were analyzed. End points were cardiac death, myocardial infarction (MI), ischemic-driven target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE) (a composite of cardiac death, MI, TLR) during follow-up. RESULTS We identified 345 patients (573 lesions) treated with EES. The majority of patients (71.9%) were treated for > or =1 off-label or untested indication. Clinical follow-up was completed in 99%. At a median follow-up of 378 days (interquartile range 334 to 473), MACE occurred in 36 (10.6%) patients, TLR in 27 (7.9%), MI in 7 (2.1%), and cardiac death in 7 (2.1%). Definite and probable ST was observed in 3 (0.9%) cases. Off-label EES implantation was not associated with a statistically significant increased risk of MACE (12.2% vs. 6.3%, p = 0.17), TLR (9.3% vs. 4.2%, p = 0.18), or ST (0.8% vs. 1.1%, p = 1.0). On multivariable analysis, previous bypass surgery (p = 0.002) and diabetes (p = 0.03) were associated with MACE. CONCLUSIONS In unrestricted daily practice, EES were implanted predominantly for off-label indications and associated with a relative low rate of MACE and TLR.

Midterm and one-year outcome of amphilimus polymer free drug eluting stent in patients needing short dual antiplatelet therapy. Insight from the ASTUTE registry (AmphilimuS iTalian mUlticenTer rEgistry)

BACKGROUND To assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS We performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥type-3a) at 6-month and 1-year. RESULTS 106 patients (8.7%) were discharged with ≤3-month DAPT (83±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p=0.007) with all bleeding events occurred within 3months. The landmark analysis (started at 90days, ended at 1year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). CONCLUSIONS The results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings.

Impact and evolution of right ventricular dysfunction after successful MitraClip implantation in patients with functional mitral regurgitation

Background Right ventricular dysfunction (RVdysf) is a predictor of poor outcome in patients with heart failure and valvular disease. The aim of this study was to evaluate the evolution and the impact of RVdysf in patients with moderate–severe functional mitral regurgitation (FMR) successfully treated with MitraClip. Methods and results From October 2008 to July 2014, 60 consecutive high surgical risk FMR patients were evaluated and stratified into two groups: RVdysf group (TAPSE < 16 mm and/or S′TDI < 10 cm/s, 21 patients) and No-RVdysf group (38 patients). The overall mean age of patients was 73 ± 8 (83% male). Ischemic FMR etiology was present in 67%. Mean LVEF was 30 ± 10%. Overall mean time follow-up was 565 ± 310 days. The only significant difference between the two groups was a greater prevalence of stroke, ICD and use of aldosterone antagonist in RVdysf group. Acute procedural success was achieved in 90% of patients. At 6-month echo-matched analysis significant RV function improvement was observed in patients with baseline RVdysf (TAPSE 15 ± 3.0 vs. 19 ± 4.5, p = 0.007; S′TDI 7 ± 1.2 vs. 11 ± 2.8, p < 0.0001; baseline vs. 6-month, respectively). The mean improvement in the 6-min walking test was significant in both groups (120 and 143 m, RVdysf and No-RVdysf groups, respectively). At Kaplan–Meier analysis, the presence of RVdysf did not affect the outcome in terms of freedom from composite efficacy endpoint. Conclusions This study shows that successful MitraClip implantation in patients with FMR and concomitant right ventricular dysfunction yields significant improvement of RV function at mid-term follow-up. Further data on larger population will be required to confirm our observations.

PFO closure with only fluoroscopic guidance: 7 years real-world single centre experience

To evaluate the safety and the efficacy of fluoroscopy‐guided only (Fluo‐G) and of echocardiography‐guided (Echo‐G; trans‐esophageal echocardiography—TEE—or intracardiac echocardiography‐ICE) percutaneous closure of patent foramen ovale (PFO).