Giovanni Paolo Talarico

Prospective Randomized Comparison of Sirolimus- or Everolimus-Eluting Stent to Treat Bifurcated Lesions by Provisional Approach

OBJECTIVES This study sought to compare the procedural performance and the acute angiographic result on side-branch ostium obtained using 2 different drug-eluting stents (DES) to treat patients with bifurcated coronary lesions. BACKGROUND Drug-eluting stents are routinely used in percutaneous coronary interventions (PCI) of bifurcated coronary lesions. Different DES types have major technical differences that may influence the procedural and clinical performance in bifurcation PCI. METHODS Consecutive patients with bifurcated lesions undergoing DES implantation using a systematic provisional-stenting strategy were randomized to sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) before intervention. The procedural details for PCI were prospectively recorded to assess the occurrence of any trouble in the side-branch (SB) management (primary end point). Post-PCI angiographic result (primary end point: minimal lumen diameter at SB ostium) was evaluated offline by 3-dimensional reconstruction and quantitative coronary analysis. Clinical outcome was prospectively recorded up to 18 months to assess the occurrence of target bifurcation failure. RESULTS A total of 150 patients were enrolled in the study (29% diabetics, 17% unprotected left main). The stent was successfully implanted according to randomization in all cases. Procedural performance was not significantly different between the 2 kinds of DES. Three-dimensional reconstruction and quantitative coronary analysis showed similar post-PCI results in the main vessel and better results in the SB with EES than with SES (minimal lumen diameter at SB ostium: 1.94 ± 0.72 mm vs. 1.64 ± 0.62 mm; p = 0.013). At 18 months, target bifurcation failure occurred in 7 (9.0%) of SES-treated patients versus 8 (10.7%) of EES patients (p = 0.57). CONCLUSIONS In patients with bifurcated lesions treated by provisional stenting technique, EES compared with SES is associated with similar procedural performance and better 3-dimensional reconstruction and quantitative coronary analysis result in the SB. Both DES are associated with low rates of major adverse events and angiographic failure. (Sirolimus Versus Everolimus-Eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical Significance of Residual Side-Branch Stenosis [SEA-SIDE]; NCT00697372).

Frequency-domain optical coherence tomography findings in patients with bifurcated lesions undergoing provisional stenting

AIMS Bifurcations represent challenging lesions which may benefit from improved understanding of stent-related vessel complications. Since optical coherence tomography (OCT) allows us to detect post-stenting vessel injuries, we sought to assess the geographic pattern of stent-related complications occurring during provisional stenting of bifurcated lesions. METHODS AND RESULTS Fifty-one patients with bifurcated lesions treated by provisional stenting and undergoing intra-procedural OCT assessment were enrolled. OCT images were acquired with the aim of guiding the percutaneous coronary intervention but were re-analysed off-line for the present study. The stented bifurcation was divided into four segments [three in the main vessel (MV) and one in the side branch (SB)]. The following acute post-stenting vessel injuries/complications at the different bifurcation segments were evaluated: (i) stent under-expansion, (ii) stent malapposition, (iii) stent edge dissection, (iv) side-branch ostium dissection, (v) tissue prolapse, (vi) intracoronary thrombus, and (vii) in-stent dissection. A total of 55 bifurcation lesions undergoing provisional stenting were analysed. At least one OCT complication was detectable in all cases. Across different bifurcation sites, significant differences in the occurrence of stent complications were observed. In particular, stent malapposition was more common at the proximal MV segment (P < 0.001), while tissue prolapse was more common at the distal MV segment (P < 0.001). CONCLUSION In bifurcated interventions, OCT often detects vessel injuries/stent complications, which tend to have a specific geographical distribution. In particular, stent malapposition is more common at the proximal MV and tissue prolapse at the distal MV segment.

Glycoprotein Iib/iiia inhibitor to reduce postpercutaneous coronary intervention myonecrosis and improve coronary flow in diabetics: the ‘optimize-it’ pilot randomized study

Background Subgroup analyses of trials enrolling acute coronary syndrome patients suggest that inhibition of glycoprotein IIb/IIIa can improve the outcome of diabetic patients undergoing percutaneous coronary interventions (PCIs), possibly by improving microvascular perfusion. However, the efficacy of small-molecule IIb/IIIa receptor inhibitors to improve microvascular perfusion in stable diabetic patients undergoing elective PCI has not been specifically investigated. Methods We randomized consecutive stable diabetic patients, undergoing elective PCI, to tirofiban or placebo groups along with double antiplatelet therapy. High-dose bolus (25 μg/kg per 3 min) of tirofiban was administered immediately before PCI followed by 8 h continuous infusion (0.15 μg/kg per min). Postprocedural myonecrosis was assessed prospectively by measurement of cardiac troponin T (cTnT) at 6 and 24 h after PCI. The primary end-points were post-PCI coronary flow estimated by corrected thrombolysis in myocardial infarction frame count and post-PCI myocardial infarction. Platelet aggregation was measured by platelet function analyser-100 values. Results Forty-six patients entered the study (22 randomized to placebo and 24 randomized to tirofiban). The study drug was associated with a significant increase of platelet function analyser-100 values that peaked immediately after PCI and was maintained at 6 h (pre-PCI: 131 ± 65 s; post-PCI: 222 ± 49 s; after 6 h: 219 ± 55 s). Post-PCI corrected thrombolysis in myocardial infarction frame count was similar in tirofiban and in placebo groups (10.2 ± 3.6 vs. 12.0 ± 7.6, P = 0.30, respectively). The prevalence of raised cTnT levels was similar in the two groups (25 vs. 30%, P = 0.56, respectively). At multivariate analysis, direct stenting (associated with reduced myonecrosis) and postdilatation (associated with increased myonecrosis) predicted cTnT elevation. Conclusion A high-dose bolus of tirofiban in stable diabetic patients undergoing elective PCI, along with double antiplatelet therapy, was associated with a significant further inhibition of platelet aggregation which, however, did not translate in a lower incidence of post-PCI distal embolization.

Comparison of the transradial and transfemoral approaches for coronary angiographic evaluation in patients with internal mammary artery grafts.

Objective Transradial access for coronary angiography may offer some advantages in comparison with conventional transfemoral access in specific subgroups of patients. Therefore, the aim of this study was to compare the transradial and transfemoral approaches in patients with previous coronary artery bypass graft (CABG) surgery using the left internal mammary artery (IMA). Methods The time to left IMA cannulation, the time needed for left IMA evaluation, and total procedure time were compared in 60 patients previously submitted to CABG surgery using the left IMA. The homolateral radial access was attempted in 20 consecutive patients (TR group), whereas the transfemoral approach was undertaken in 40 patients (2: 1, TF group), matched for age, sex and number of grafts. Results In the TR group, the time to left IMA cannulation and the time needed for left IMA evaluation were 39% and 46%, respectively, lower than those in the TF group (P = 0.01 and P = 0.001, respectively), whereas total procedure time was similar. In the subgroup of patients with less than three saphenous vein grafts (n = 36), the time to left IMA cannulation, the time needed for left IMA evaluation as well as total procedure time were significantly reduced (P = 0.01, P = 0.001 and P = 0.004, respectively). The rate of ad-hoc coronary angioplasty procedures was unaffected by the access site (20% in the TR group and 27% in the TF group, P = 0.53). Conclusions The present study shows that the homolateral transradial approach facilitates left IMA evaluation in patients with previous CABG surgery undergoing coronary angiography, in particular in patients with a lower number of coronary artery bypass conduits, in the absence of an excess of periprocedural complications.

One‐year outcomes of consecutive patients treated by endeavor zotarolimus and resolute zotarolimus stents: The impact of polymer coating in drug‐eluting stent technology

Polymer‐coating represents a key component of drug‐eluting stent (DES) technology and its possible impact on vessel‐wall healing is a matter of debate. The clinical impact of different polymer‐coating may be assessed by comparing the outcome of patients treated by DES having the same stent platform and drug, and differing in the polymer. Thus, we compared the clinical outcome of patients treated by Endeavor Zotarolimus‐eluting stent (E‐ZES) and Resolute Zotarolimus‐eluting stent (R‐ZES) as they differ in the polymer‐coating only.

Comparative assessment of mammalian target of rapamycin inhibitor-eluting stents in the treatment of coronary artery bifurcation lesions: The CASTOR-Bifurcation registry†

Drug‐eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus‐eluting stents (SES) showed better outcomes than paclitaxel‐eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor‐eluting stents in the treatment of bifurcation lesions according to the provisional T‐stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus‐eluting stents (ZES) were implanted in 53 patients and everolimus‐eluting stents (EvES) in 62 patients. Primary end‐point of the study was the 12‐month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of >50% restenosis on the main vessel or TIMI flow <3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non‐ST‐segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed.

EuroSCORE predicts long-term mortality of unselected patients undergoing percutaneous coronary interventions

BACKGROUND The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a simple risk model able to predict early and late mortality after cardiac surgery. Recent data suggest that this score may also predict early clinical outcome after percutaneous coronary intervention (PCI). Data regarding EuroSCORE usefulness to predict late outcome after PCI in unselected patients are lacking. METHODS EuroSCORE was prospectively assessed in consecutive patients undergoing PCI during 18 months. The primary end-point was cardiac mortality during the follow-up after PCI. Total mortality was the secondary end-point. Kaplan-Meyer analyses were performed dividing the study population in three subgroups according to the additive EuroSCORE algorithm (low risk group: EuroSCORE 0-2; medium risk group: EuroSCORE 3-5; high-risk group: EuroSCORE ≥ 6). Receiver operating characteristics (ROC) curve and landmark analysis on cardiac mortality after 30 days were performed. RESULTS The study population comprised 1170 patients undergoing PCI. Mean follow-up duration was 633 days (range: 365-1000 days). Cardiac mortality was 2%; 2.4%; 13.2% in patients with low, medium and high EuroSCORE respectively. Kaplan-Meyer survival curves for cardiac death differed significantly between EuroSCORE groups (p<0.0001). The area under the ROC curve for the prediction of cardiac death was 0.77. Similar results were obtained for total mortality. At landmark analysis starting 30 days after PCI, EuroSCORE groups were significantly associated with different survival in the long term (P=0.014). CONCLUSION EuroSCORE risk model can be efficiently utilized to predict late mortality in consecutive, unselected, patients undergoing PCI.

Cocaine and coronary artery diseases: a systematic review of the literature.

Cocaine is associated with important cardiac complications such as sudden death, acute myocarditis, dilated cardiomyopathy, life-threatening arrhythmias, and myocardial ischemia as well as infarction. It is well known that cocaine may induce vasospasm through adrenergic stimulation of the coronary arteries. Moreover, cocaine may promote intracoronary thrombosis, triggered by alterations in the plasma constituents, and platelet aggregation, leading to subsequent myocardial infarction. The long-term use of cocaine may stimulate atherosclerosis, probably through endothelial cell dysfunction. Significant and severe coronary atherosclerosis is common in young chronic cocaine users and there is probably a relationship between the duration and frequency of cocaine use and the extent of coronary disease.

Evaluation of a strategy for treating bifurcated lesions by single or double stenting based on the Medina classification.

INTRODUCTION AND OBJECTIVES The Medina bifurcated lesion classification has been widely adopted because of its simplicity. However, no data are available on its use in helping select the best stenting technique for bifurcations. METHODS Consecutive patients with bifurcated lesions (side branch >or=2.25 mm) were prospectively assessed using the Medina classification. The treatment strategy studied involved implanting two stents in lesions with a Medina classification of 1,1,1 (M3 group) and one stent in only the main vessel in lesions with other Medina classifications (OM group). Clinical endpoints were a major adverse cardiac event (MACE) and target lesion revascularization (TLR) during hospitalization and at 12-month follow-up. RESULTS The study included 120 patients: 25 in the M3 group and 95 in the OM group. There was no difference in baseline characteristics between the groups. The treatment strategy was successfully implemented in 97% of the OM group and 68% of the M3 group (P< .001). No death or TLR was recorded during hospitalization, though three myocardial infarctions occurred postoperatively (2.1% in the OM group vs 4.0% in the M3 group; P=.6). At 12 months, there was no difference in clinical outcome between the two groups (MACE: 12.6% in the OM group vs 8% in the M3 group; P=.4; TLR: 13.7% in the OM group vs 8% in the M3 group; P=.5). Multivariate analysis showed that bare metal stent implantation (only in patients receiving a single stent) was the only independent predictor of TLR. CONCLUSIONS The planned treatment strategy of implanting a single stent in patients with bifurcated lesions not classified as Medina 1,1,1 lesions was associated with a very low rate of second stent implantation. Moreover, bare metal stent use was a predictor of TLR, suggesting that drug-eluting stents should be used routinely to treat bifurcated lesions regardless of their angiographic complexity.

Long term follow-up of “full metal jacket” of de novo coronary lesions with new generation Zotarolimus-eluting stents

BACKGROUND Diffuse coronary artery disease treatment still remains a challenge for interventional cardiologists and cardiac surgeons. There are few data on full metal jacket (FMJ) stenting, especially with new-generation drug-eluting stents. We aimed to assess the efficacy and safety of FMJ with new-generation Zotarolimus-eluting stents (n-ZES). METHODS AND RESULTS All patients who underwent FMJ with n-ZES (≥60mm stent length) in eleven Italian interventional centers participating in the Clinical Service® project were included in this analysis. The project population consisted of 120 patients and 122 lesions. Mean age was 67±10years and 95 (79.2%) patients were male. A chronic total occlusion was present in 34 lesions (27.9%). The number of stents implanted per lesion was 2.9±0.8, and the diameter of the stents was 3.0±0.5mm. Predilation and post-dilatation were performed in 107 (87.7%) and 92 (75.4%) patients, respectively. At 41±21month follow-up there were 2 patients with subacute definite stent thrombosis, 6 patients (5.0%) had cardiac death and 5 patients (4.2%) had non-fatal myocardial infarction. Seven patients (5.8%) underwent clinically-driven target lesion revascularization. Fourteen patients (11.7%) had at least one major adverse cardiac event. CONCLUSION The treatment of diffuse coronary artery disease with FMJ stenting with n-ZES appears to be effective and safe. Late and very-late ST does not seem to be an issue and the rate of restenosis and of major cardiac adverse events after more than 3-year follow-up is rather low.