One-year outcome of biolimus eluting stent with biodegradable polymer in all comers: the Italian Nobori Stent Prospective Registry.

OBJECTIVES: INSPIRE-1 (Italian Nobori Stent ProspectIve REgistry-1) was designed and conducted to assess clinical performance of Nobori biolimus A9-eluting stent (BES) implantation in an unrestricted "real-world" cohort of patients. METHODS: Unrestricted consecutive high-risk patients treated with BES with biodegradable polymer (Nobori, Terumo, Tokyo, Japan) between February 2008 and July 2012 were prospectively enrolled in an independent multicenter registry and divided in two groups: complex and non complex lesions. RESULTS: 1066 patients (1589 lesions) treated with Nobori BES were analyzed. The majority of patients (57%) were treated for at least one complex lesion and presented a high-risk clinical profile (previous CABG 17.6%, diabetes mellitus 33.1%, chronic kidney disease 14.3%). Angiographic success rate was achieved in 96.2% cases. At 1 year, the primary endpoint, (composite of cardiac death, myocardial infarction, and clinically driven target vessel revascularization), occurred in 39 (4.0%) patients, and was higher in the complex lesions (5.2% vs. 2.5%, P = 0.032). Target lesion failure (TLF, secondary endpoint) occurred in 45 (4.6%) patients, and was more frequent in the complex lesions group (6.2% vs. 2.7%, P = 0.011), mainly due to a higher incidence of any target lesion revascularization (4.8% vs. 2.7%; P = 0.095). Definite and probable stent thrombosis (ST) rate was 0.6% and 0.5% respectively, with no difference between groups. CONCLUSIONS: In unrestricted daily practice, BESs were implanted predominantly in high risk patients with complex lesions. Despite this, the Nobori BES was associated with a relatively low rate of primary endpoint and TLF, with a higher risk in patients with complex lesions.

"Do least harm" philosophy may suffice for percutaneous coronary intervention in octogenarians.

BACKGROUND: Octogenarians represent one of the most rapidly expanding segments of the population and an ever growing number are undergoing percutaneous coronary intervention (PCI). A simplified approach with incomplete or "culprit-lesion" only PCI may be an option even in multivessel disease, to minimize periprocedural complications while still allowing a meaningful clinical recovery in patients with inherent functional limitations related to age itself. We tried to determine the effects of either complete or partial PCI on procedural and long-term outcome in a consecutive series of octogenarians. METHODS: In-hospital and 1-year clinical outcomes were collected in elderly patients treated with PCI between January 1998 and March 2004 in our institution. RESULTS: In a total of 165 octogenarians, 73 elderly patients (44%) underwent complete (COM) and 92 (56%) incomplete (INC) revascularization. Major in-hospital cardiac events were similar in the two subgroups. At 1-year follow-up 65% of patients in the COM and 68% in the INC group (P = ns) referred improvement in angina status and quality of life. Clinically driven repeat PCI was necessary in 16% of COM and 15% of INC patients. Recurrent PCI was mostly required to treat a restenotic index lesion in both groups, while only five patients in the INC group (5.4%) required PCI of a different lesion. CONCLUSIONS: Current PCI coronary techniques are safe and effective in octogenarians. Restenosis remains the main cause for recurrent events after bare metal stents. Percutaneous revascularization limited to the culprit lesion may suffice in most patients, with favorable clinical outcome at 1 year.

Evidence for a "gender paradox" in diabetic patients undergoing percutaneous coronary intervention: adverse preprocedural risk but favorable long-term clinical outcome in women.

BACKGROUND: The aim of this study was to assess the impact of gender on procedural and late clinical outcome in a large cohort of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in a single center. METHODS: The study included a cohort of 542 consecutive diabetic patients (414 men, 128 women), undergoing PCI for stable and unstable angina. Clinical events were assessed every 6 months for a mean follow-up period of 24 months. RESULTS: Compared to men, women were older and less often smokers. Insulin requirement was present in a substantially higher percentage of women than men (27 vs 18%, p = 0.03). Presentation with stable angina was more frequent in women, whereas silent ischemia was more prevalent in men. Adverse baseline clinical and angiographic characteristics in women (smaller vessels and longer lesion lengths) were associated with a more frequent need for multiple coronary stenting (23 vs 15% women vs men, p < 0.001) and a higher incidence of peripheral complications (3.2 vs 1.2%, p = 0.049). However, there were no statistically significant gender-related differences in major in-hospital events. Long-term clinical outcome was similar with equivalent incidence of death (4.9 vs 5.3%, p = 0.8), nonfatal myocardial infarction (2.4 vs 4.5%, p = 0.1), need for surgical or repeat percutaneous revascularization between women and men. CONCLUSIONS: Diabetic patients show an increased rate of major adverse cardiac events and target vessel revascularization after PCI. In these patients, female gender is associated with higher procedural complexity and peripheral complications; however, long-term clinical outcome of diabetic women is similar to that of men.

Different quantitative apoptotic traits in coronary atherosclerotic plaques from patients with stable angina pectoris and acute coronary syndromes.

BACKGROUND: Apoptosis in human atherosclerotic coronary plaques possibly causes plaque destabilization by contributing to the weakening and breaking down of the fibrous cap. We tested the hypothesis that apoptosis is quantitatively increased in unstable atherosclerotic plaques. METHODS AND RESULTS: We analyzed the expression of apoptotic genes such as BAX, CASP1, FAS, FAS L, FOS, MDM2, NFkB2, P53, PCNA, TERT, and XRCC1 in coronary plaques collected with directional coronary atherectomy from 15 patients with stable angina and 15 with acute coronary syndromes without ST elevation (ACS). Total RNA was extracted and cDNA was amplified with a specific set of primers and TaqMan probes. Apoptosis was also revealed by DNA laddering. To clarify the source of mRNAs, we performed in situ reverse transcriptase-polymerase chain reaction coupled with immunocytochemistry and found a substantial overlap between the mRNAs of the above genes and vascular smooth muscle cells. Gene expression analysis showed that the proapoptotic genes (ie, BAX, CASP1, FAS, FAS L, FOS, NFkB2, P53, PCNA) were significantly more expressed (P<0.001) in ACS plaques, whereas the antiapoptotic genes (ie, MDM2, TERT, XRCC1) were more transcribed (P<0.001) in stable angina plaques. Total gDNA gel electrophoresis identified a laddering pattern in the ACS plaques as evidence of end-point apoptosis. Western blotting substantially confirmed the above data. CONCLUSIONS: Our findings support the idea that ACS plaques are committed to apoptosis through an established meshwork of gene activation and inactivation, whereas stable angina plaques retain active cell homeostasis and repair mechanisms.

Intracoronary beta-radiation for the treatment of patients at very high risk for recurrence of in-stent restenosis: a single center experience.

BACKGROUND: Intracoronary brachytherapy has significantly reduced the recurrence of in-stent restenosis. The aim of this study was to evaluate the feasibility, safety and efficacy of intracoronary beta-radiation in patients at very high risk for recurrence of in-stent restenosis. METHODS: We analyzed 42 patients with 50 lesions submitted to catheter-based beta-radiation (Beta-Cath System, Novoste Corporation, Norcross, GA, USA) for in-stent restenosis. Thirty-eight lesions were at the second restenosis, 8 at the third, and 4 at the fourth; a diffuse pattern was present in 78%. RESULTS: Balloon angioplasty was performed for 30 lesions (60%) and the cutting balloon technique for 20 (40%). In 12 lesions further 14 stents had to be deployed (28%). The delivery catheter was successfully positioned in 96% of the procedures. The mean dwell time was 179 +/- 50 s with a radiation dose ranging from 18.4 to 25.3 Gy, depending on the vessel size. A complete angiographic success without coronary dissection and without any additional stenting after radiation delivery was achieved in 86%. At follow-up (7.2 +/- 2.1 months), the overall restenosis rate was 30.4% (14 lesions). A recurrence was detected in 1/11 lesions with initial focal pattern and in 13/39 lesions with initial diffuse pattern. The restenosis rate was higher in patients in whom a geographic miss had occurred (p < 0.05 vs lesions without geographic miss) and in those in whom a new stent had been deployed (p < 0.05 vs lesions treated without a stent). CONCLUSIONS: Brachytherapy reduces the in-stent restenosis rate in patients who are at very high risk of recurrence. The restenosis pattern, geographic miss and new stent deployment seem to be negative prognostic factors for recurrence of restenosis.

Immediate and late results of coronary angioplasty in patients with severe left ventricular dysfunction.

BACKGROUND: Severe coronary artery disease in patients with a markedly depressed left ventricular function is associated with a poor prognosis. Even though coronary angioplasty (PTCA) has been offered as an alternative to bypass surgery, the role of PTCA in the treatment of patients with severe left ventricular dysfunction has not been well defined. The aim of the present study was to evaluate the immediate and long-term results in patients with severe left ventricular dysfunction < or = 35% who underwent PTCA. METHODS: One hundred and twenty-five patients with a left ventricular ejection fraction < or = 35% who underwent PTCA were analyzed. RESULTS: The mean left ventricular ejection fraction was 29.7%. Eighty-seven patients (69.6%) had multivessel disease and 41 (32.8%) had previous coronary artery bypass graft. Intra-aortic balloon pumping was used in 12% of cases. Angiographic success was achieved in 96% of patients. Complete revascularization was achieved in 56 patients (44.8%). Major complications occurred in 4% of the population and 2 patients died (1.6%). During the long-term follow-up re-PTCA due to angiographic restenosis was performed in 41 patients (34%); 12 patients (10.4%) died. The only parameter which significantly correlated with death was the presence of an occluded left anterior descending coronary artery not recanalized neither with PTCA nor with coronary artery bypass graft. CONCLUSIONS: These data suggest that PTCA may be an effective treatment for coronary artery disease in patients with left ventricular dysfunction and is associated with high procedural success rate and low complications; however, the long-term follow-up seems not to be influenced by the PTCA procedure.