-
1.
Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry.
Tamburino, C, Capodanno, D, Di Salvo, ME, Sanfilippo, A, Cascone, I, Incardona, V, Longo, G, Giacoppo, D, Capranzano, P, Sgroi, C, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2012;(9):1062-8
Abstract
AIMS: The pivotal ATLANTA first-in-man study showed the promising safety and efficacy profile of the novel Catania™ stent in a population with ~20% American College of Cardiology/American Heart Association (ACC/AHA) type C coronary lesions. The ATLANTA 2 registry was designed to evaluate the 12-month safety and efficacy of the Catania stent in a broader real world scenario. METHODS AND RESULTS The ATLANTA 2 registry was a prospective, non-randomised, single-arm study of patients with symptomatic ischaemic heart disease and de novo lesions of native coronary arteries. A total of 300 patients (396 lesions) were recruited and 482 Catania stents were implanted. At 12 months, major adverse cardiac events were 8.8%, mainly driven by target lesion revascularisation (6.5%). Cardiac death and non-fatal myocardial infarction occurred in 2.5% and 0.7% of patients, respectively. Subacute definite or probable stent thrombosis was 0.7%. No late stent thrombosis was recorded. Compared with patients treated with drug-eluting stents or bare metal stents in the study period, those treated with Catania stents experienced similar outcomes at one year. CONCLUSIONS The 12-month results of the ATLANTA 2 registry confirmed the positive results of the ATLANTA first-in-man trial in a more complex population. A randomised trial is needed to assess the comparative value of the Catania stent over currently-used drug-eluting stents or bare metal stents.
-
2.
Comparison between the first and second generation bioresorbable vascular scaffolds: a six month virtual histology study.
Brugaletta, S, Garcia-Garcia, HM, Diletti, R, Gomez-Lara, J, Garg, S, Onuma, Y, Shin, ES, van Geuns, RJ, de Bruyne, B, Dudek, D, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2011;(9):1110-6
Abstract
AIMS: To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS). METHODS AND RESULTS IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10 ± 0.46 mm2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57 ± 1.3 mm2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external elastic membrane area (y=0.68x-0.1; r=0.58, p=0.03). CONCLUSIONS Based on 6-months IVUS-VH analysis, the BVS 1.1 appears to have a different backscattering signal compared to the BVS 1.0, which may reflect differences in the speed of chemical and structural alteration.
-
3.
Thrombus aspiration plus intra-infarct-related artery administration of tirofiban improves myocardial perfusion during primary angioplasty for acute myocardial infarction.
Yan, HB, Li, SY, Song, L, Wang, J, Wu, Z, Chi, YP, Zheng, B, Zhao, HJ, Li, QX, Zhang, XJ, et al
Chinese medical journal. 2010;(7):877-83
Abstract
BACKGROUND We developed a new combined strategy of thrombus aspiration plus intra-infarct-related artery (IRA) bolus administration of tirofiban via the aspiration catheter in patients with ST-segment elevation myocardial infarction (STEMI). This strategy can reduce the distal embolism and achieve highly localized concentrations of tirofiban, which can improve myocardial reperfusion without increasing the risk of bleeding. The aim of this study was to investigate whether this combined strategy is superior to thrombus aspiration alone in improving myocardial perfusion in patients with STEMI undergoing primary angioplasty. METHODS This single center study included 108 matched control patients with STEMI, angioplasty after thrombus aspiration, and 108 study patients with STEMI plus intra-IRA administration of 500 microg of tirofiban. Both groups had subsequent 12-hour intravenous infusion of 0.1 microg x kg(-1) x min(-1) of tirofiban after angioplasty. The primary end points were Thrombolysis in Myocardial Infarction (TIMI) flow immediately after angioplasty, ST-segment elevation resolution (STR) (> 70%) at 90 minutes after angioplasty, and the peak of creatine kinase-MB (CK-MB) and troponin I (TnI). The secondary end points were the left ventricular ejection fraction (LVEF) in the hospital and at nine months follow-up, cardiac death, target vessel revascularization (TVR), re-infarction and the combination of these three as major adverse cardiac events (MACE) within nine months and any bleeding events. RESULTS Baseline characteristics of the two groups were well-balanced. The TIMI 3 flow showed a better tendency in the intra-IRA group than in the aspiration alone group (97.22% vs. 87.04%, chi(2) = 7.863, P = 0.049). The peak of CK-MB (83.9 (68.9 - 310.5) U/L vs. 126.1 (74.7 - 356.7) U/L, P = 0.034) and TnI (42.7 (14.7 - 113.9) ng/ml vs. 72.5 (59.8 - 135.3) ng/ml, P = 0.029) were lower in the intra-IRA group than in the aspiration alone group. LVEF in the hospital favored the intra-IRA group, (45.7 +/- 8.3)% to (42.9 +/- 12.1)%, t = 1.98, P = 0.049. There was a tendency towards a lower MACE at 9-month follow-up in the intra-IRA group although it did not reach statistical difference (Log-rank chi(2) = 2.865, P = 0.09). There was no statistical difference in any bleeding events between the two groups. CONCLUSIONS Thrombus aspiration plus intra-IRA bolus administration of tirofiban combined with angioplasty may be related with improved myocardium perfusion, saved more myocardium, and resulted in a better clinical prognosis.
-
4.
A randomized controlled, phase 2 trial of the viral serpin Serp-1 in patients with acute coronary syndromes undergoing percutaneous coronary intervention.
Tardif, JC, L'Allier, PL, Grégoire, J, Ibrahim, R, McFadden, G, Kostuk, W, Knudtson, M, Labinaz, M, Waksman, R, Pepine, CJ, et al
Circulation. Cardiovascular interventions. 2010;(6):543-8
Abstract
BACKGROUND Vascular inflammation can lead to plaque instability and acute coronary syndromes (ACS). Viruses produce potent immunomodulating proteins that regulate key inflammatory pathways. A myxoma virus-derived serpin Serp-1 reduces inflammatory cell invasion and plaque growth in vascular injury models. Our objective was to evaluate the safety and efficacy of Serp-1 in patients with ACS undergoing percutaneous coronary intervention. METHODS AND RESULTS This double-blind pilot trial included 48 ACS patients undergoing percutaneous coronary intervention randomly assigned to Serp-1 at doses of 5 μg/kg (n=19) or 15 μg/kg (n=17) or to placebo (n=12). Serp-1 was given by intravenous bolus immediately before intervention and 24 and 48 hours later. Patients were assessed for safety (primary objective) and efficacy outcomes, including biomarker analysis. In-stent neointimal hyperplasia was evaluated by intravascular ultrasound at 6 months. Key safety outcomes including coagulation parameters and adverse events did not differ between Serp-1 and placebo groups. A dose-dependent reduction in troponin I levels was observed with Serp-1 at 8, 16, 24, and 54 hours (P<0.05) and in creatine kinase-MB levels at 8, 16, and 24 hours after dose (P<0.05). The composite of death, myocardial infarction, or coronary revascularization occurred in 2 of 12 patients with placebo, 5 of 19 in the low-dose group, and none of 17 patients with the high-dose (P=0.058). Intravascular ultrasound did not detect changes in neointimal hyperplasia among groups. CONCLUSIONS This is the first study of a viral serpin demonstrating its safety in ACS patients. The significant reduction in myocardial damage biomarkers supports further assessment of Serp-1 in ACS patients undergoing stent deployment. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00243308.
-
5.
Novel approaches for preventing or limiting events (Naples) II trial: impact of a single high loading dose of atorvastatin on periprocedural myocardial infarction.
Briguori, C, Visconti, G, Focaccio, A, Golia, B, Chieffo, A, Castelli, A, Mussardo, M, Montorfano, M, Ricciardelli, B, Colombo, A
Journal of the American College of Cardiology. 2009;(23):2157-63
Abstract
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 >3x 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 >3x 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.
-
6.
Assessment of the absorption process following bioabsorbable everolimus-eluting stent implantation: temporal changes in strain values and tissue composition using intravascular ultrasound radiofrequency data analysis. A substudy of the ABSORB clinical trial.
García-García, HM, Gonzalo, N, Pawar, R, Kukreja, N, Dudek, D, Thuesen, L, Ormiston, JA, Regar, E, Serruys, PW
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2009;(4):443-8
Abstract
AIMS: The main objective was to use IVUS-backscatter radiofrequency (IVUS-RF) to assess the degradation of a bioabsorbable stent by measuring serial changes in dense calcium (DC) and necrotic core (NC) as assessed by intravascular ultrasound-Virtual Histology (IVUS-VH) and in the strain as assessed by palpography. METHODS AND RESULTS In the ABSORB trial, 27 patients treated with a single bioabsorbable everolimus-eluting stent (BVS, Abbott Vascular, Santa Clara, CA, USA) were all imaged with IVUS-RF post-stenting and at 6-month follow-up, and 13 and 12 patients were also investigated pre-stenting with IVUS-VH and palpography respectively. From pre- to post-stenting, with VH (n = 13), there was an increase in mean "DC" (9.8 vs. 25.4%, p = 0.0002) and "NC" (15.5 vs. 30.5%, p = 0.0002). In palpography (n = 12), the mean number of frames with Rotterdam Classification (ROC) III/IV per cm decreased from 1.22 +/- 1.91 to 0.12 +/- 0.31 (p = 0.0781) and the mean cumulative strain values (all frames with ROC I-IV scores) changed from 0.50 +/- 0.27 to 0.20 +/- 0.10% (p = 0.0034). Comparing post-stenting with follow-up (n = 27), VH showed a decrease in "DC" (29.7% vs. 21.1%, p = 0.0001). "NC" also decreased (26.9 vs. 21.5%, p = 0.0027). For palpography (n = 25 patients), an increase in the mean number of frames with ROC III/IV per cm was observed from 0.09 +/- 0.26 to 0.22 +/- 0.36 (p = -0.1563) while the mean cumulative strain values (all frames with ROC I-IV scores) changed from 0.15 +/- 0.10 to 0.26 +/- 0.12% (p < 0.0001). CONCLUSIONS IVUS-VH changes at 6 months suggest alteration of the BVS with reduction of RF backscattering by polymeric struts. Strained plaques on the palpograms were almost abolished following stent implantation. However, strain values reappeared within 6 months suggesting an increase in endoluminal deformability of the stented vessel.
-
7.
Comparison of coronary flow reserve and fractional flow reserve in patients with versus without diabetes mellitus and having elective percutaneous coronary intervention and abciximab therapy (from the PREDICT Trial).
Kini, AS, Kim, MC, Moreno, PR, Krishnan, P, Ivan, OC, Sharma, SK
The American journal of cardiology. 2008;(6):796-800
Abstract
Patients with diabetes mellitus (DM) have poor long-term outcome after percutaneous coronary intervention (PCI) partly because of microvascular disease and distal embolization. Microvascular obstruction can be assessed by measuring coronary flow reserve (CFR). The Prediction of CK-MB RElease During Successful Stenting Correlating with Indicators of Microvascular ObstruCTion (PREDICT) trial compared the CFR in patients with versus without DM during PCI. Patients undergoing elective PCI were prospectively enrolled according to diabetic (n = 36) and nondiabetic (n = 36) status. All patients received drug-eluting stent with abciximab and were followed for 30-day major adverse cardiac events. CFR and FFR (fractional flow reserve) before and after stenting were measured before and after intracoronary adenosine bolus. Procedural success, MB enzyme of creatine-kinase (CK-MB), troponin I, and high-sensitive C-reactive protein elevation, vascular complications, and major adverse cardiac events were not different. FFR before stenting was 0.77 +/- 0.03 in patients with DM versus 0.76 +/- 0.02 in patients without DM (p = 0.69). FFR after stenting was 0.97 +/- 0.03 and 0.99 +/- 0.01 (p = 0.26), respectively. CFR before stenting was 1.36 +/- 0.31 in patients with DM versus 1.49 +/- 0.25 in patients without DM (p = 0.064). However, CFR after stenting was significantly lower in patients with versus without DM (1.89 +/- 0.30 versus 2.44 +/- 0.67, p <0.001, respectively). CFR after stenting only moderately correlated with CK-MB and high-sensitive C-reactive protein after PCI but did not correlate with 30-day major adverse cardiac events. In conclusion, patients with DM have significantly lower CFR after stenting despite equivalent FFR and myonecrosis compared with patients without DM, indicating greater microvascular obstruction after PCI despite abciximab.
-
8.
Effects of persistent platelet reactivity despite aspirin therapy on cardiac troponin I and creatine kinase-MB levels after elective percutaneous coronary interventions.
Gulmez, O, Yildirir, A, Kaynar, G, Konas, D, Aydinalp, A, Ertan, C, Ozin, B, Muderrisoglu, H
Journal of thrombosis and thrombolysis. 2008;(3):239-46
Abstract
BACKGROUND Creatinine kinase-MB (CK-MB) and cardiac troponin I (cTnI) elevations are highly specific for myonecrosis after percutaneous coronary intervention (PCI). Aspirin is used to prevent thrombotic complications. Several studies have shown that some individuals exhibit a reduced or completely missing antiplatelet response to aspirin. The aim of this study is to investigate the effects of platelet reactivity despite aspirin therapy on CK-MB and cTnI levels after elective percutaneous coronary interventions despite 600 mg loading dose of clopidogrel. METHODS One hundred fourteen (mean age 61.2+/-9.3 years, 78.1% male) patients receiving 300 mg daily enteric coated aspirin for at least 7 days with documented coronary artery disease were included in the study. Platelet reactivity despite aspirin was measured by platelet function analyzer (PFA)-100 collagen/epinephrine cartridge. Blood samples for CK-MB and cTnI were obtained before and at 6, 24, and 36 h after the PCI. Persistent platelet reactivity was defined when collagen/epinephrine closure time<165 s. RESULTS A total of 87 (76.4%) patients were noted to have normal platelet reactivity (Group A), and 27 (23.6%) had persistent platelet reactivity (Group B). The elevations of CK-MB and cTnI levels were statistically significant within the groups (both P<0.001). However, there were no significant differences in the CK-MB and cTnI levels of the groups at baseline and after PCI for all studied hours. CONCLUSION Persistent platelet reactivity was not associated with increased risk of CK-MB, cTnI elevations in low-to-intermediate risk PCI patients.
-
9.
Outlook of drug-eluting stent implantation for unprotected left main disease: insights on long-term clinical predictors.
Vecchio, S, Chechi, T, Vittori, G, Biondi Zoccai, GG, Lilli, A, Spaziani, G, Giuliani, G, Falchetti, E, Margheri, M
The Journal of invasive cardiology. 2007;(9):381-7
Abstract
BACKGROUND Percutaneous coronary intervention (PCI) has been increasingly employed to treat unprotected left main coronary artery (LMCA) stenosis, with variable success. This strategy has been applied to patients undergoing drug-eluting stent (DES) implantation for unprotected LMCA stenosis. METHODS From April 2003 to June 2006, 114 consecutive patients with de novo unprotected LMCA stenosis underwent PCI with DES, and were followed over a mean period of 17.1 +/- 9.1 months. The primary endpoint of the study was the occurrence of major adverse cardiovascular events (MACE) (cardiac death, myocardial infarction [MI] or target lesion revascularization [TLR]). RESULTS LMCA stenting was successfully performed in all patients. In-hospital mortality was 3.5%, with no in-hospital non-fatal MI or emergency coronary artery bypass grafts. During the follow-up period, the all-cause mortality rate was 7.9%, with 3.5% cardiac-related deaths. TLR was performed in 7.9% of patients, and the MACE rate was 14.9%. All non-surviving patients were at high surgical risk (EuroSCORE > 6) and had a significantly higher EuroSCORE than surviving patients that patients with a EuroSCORE < or = 11 had significantly improved survival rates over those with a EuroSCORE > 11 (p < 0.0001). Moreover, most of the patients who died of cardiac causes were diabetic (71.4% vs. 26.6%; p < 0.05). Acute coronary syndromes, as clinical presentation, and non-ostial LMCA disease were also significantly more common within non-surviving patients (100% vs. 67%; p < 0.05, and 92.3% vs. 66.3%; p = 0.05, respectively). CONCLUSIONS Stenting of unprotected LMCA appears to be associated with a favorable mid-term outlook, especially in selected patients.
-
10.
Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial.
Erbel, R, Di Mario, C, Bartunek, J, Bonnier, J, de Bruyne, B, Eberli, FR, Erne, P, Haude, M, Heublein, B, Horrigan, M, et al
Lancet (London, England). 2007;(9576):1869-1875
Abstract
BACKGROUND Coronary stents improve immediate and late results of balloon angioplasty by tacking up dissections and preventing wall recoil. These goals are achieved within weeks after angioplasty, but with current technology stents permanently remain in the artery, with many limitations including the need for long-term antiplatelet treatment to avoid thrombosis. We report a prospective multicentre clinical trial of coronary implantations of absorbable magnesium stents. METHODS We enrolled 63 patients (44 men; mean age 61.3 [SD 9.5 years]) in eight centres with single de novo lesions in a native coronary artery in a multicentre, non-randomised prospective study. Follow-up included coronary angiography and intravascular ultrasound at 4 months and clinical assessment at 6 months and 12 months. The primary endpoint was cardiac death, non-fatal myocardial infarction, or clinically driven target lesion revascularisation at 4 months FINDINGS 71 stents, 10-15 mm in length and 3.0-3.5 mm in diameter, were successfully implanted after pre-dilatation in 63 patients. Diameter stenosis was reduced from 61.5 (SD 13.1%) to 12.6 (5.6%) with an acute gain of 1.41 mm (0.46 mm) and in-stent late loss of 1.08 mm (0.49 mm). The ischaemia-driven target lesion revascularisation rate was 23.8% after 4 months, and the overall target lesion revascularisation rate was 45% after 1 year. No myocardial infarction, subacute or late thrombosis, or death occurred. Angiography at 4 months showed an increased diameter stenosis of 48.4 (17.0%). After serial intravascular ultrasound examinations, only small remnants of the original struts were visible, well embedded into the intima. Neointimal growth and negative remodelling were the main operating mechanisms of restenosis. INTERPRETATION This study shows that biodegradable magnesium stents can achieve an immediate angiographic result similar to the result of other metal stents and can be safely degraded after 4 months. Modifications of stent characteristics with prolonged degradation and drug elution are currently in development.