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1.
Catheter Cardiovasc Interv ; 95(2): 175-184, 2020 02.
Article En | MEDLINE | ID: mdl-31033154

OBJECTIVES: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. BACKGROUND: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient. METHODS: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months. RESULTS: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar. CONCLUSIONS: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.


Absorbable Implants , Cardiovascular Agents/administration & dosage , Coronary Artery Disease/therapy , Coronary Stenosis/therapy , Drug-Eluting Stents , Everolimus/administration & dosage , Percutaneous Coronary Intervention/instrumentation , Polymers/chemistry , Sirolimus/administration & dosage , Aged , Cardiovascular Agents/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/mortality , Coronary Stenosis/physiopathology , Europe , Everolimus/adverse effects , Female , Humans , Japan , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Prospective Studies , Prosthesis Design , Republic of Korea , Risk Factors , Single-Blind Method , Sirolimus/adverse effects , Time Factors , Treatment Outcome
2.
Am J Cardiol ; 120(9): 1487-1494, 2017 Nov 01.
Article En | MEDLINE | ID: mdl-28842146

The utility of the electrocardiogram (ECG) in patients with acute left circumflex (LC) coronary occlusion is not established. This study aimed at determining the clinical, angiographic, and prognostic characteristics associated with the different patterns of ST-segment changes in patients with LC occlusion. A cohort of 314 patients with LC occlusion was categorized according to the admission ECG: (1) ST-segment elevation (ST-E, n=208), (2) isolated ST-segment depression in precordial leads (ST-D, n=62), and (3) negligible ST-segment changes (No-ST, n=44). Clinical variables, coronary angiography, and 30-day major adverse cardiac event (MACE) (in-hospital ventricular fibrillation, 1-month mortality, or heart failure) were compared among the three groups. As compared with No-ST, patients with ST-E or ST-D presented more advanced Killip class, higher troponin peak, lower LV ejection fraction, and were independently associated with MACE (odds ratio 5.43, 95% confidence interval 1.09 to 27.20 and odds ratio 3.39, 95% confidence interval 0.66 to 17.50, respectively). Patients with ST-D were tardily reperfused, had more often mitral regurgitation (23.1% vs 9.3% in ST-E and 3.3% in No-ST, p=0.03), and presented ST-segment elevation in leads V7 to V9 in 12 of 16 cases with available recordings. Culprit proximal LC predominated in ST-D (41.9%), distal LC in ST-E (42.8%), and obtuse marginal in No-ST (59.1%) (all p<0.01). The No-ST had smaller coronary vessels and more collaterals. In conclusion, the three ST-segment patterns of LC occlusion identify patients with different clinical, angiographic, and prognostic characteristics. Patients with ST-depression pattern require a prompt reperfusion therapy and could be better recognized by recording leads V7 to V9.


Coronary Occlusion/diagnosis , Coronary Occlusion/physiopathology , Electrocardiography , Acute Disease , Aged , Coronary Angiography , Coronary Occlusion/therapy , Female , Heart Conduction System/physiopathology , Humans , Male , Middle Aged , Predictive Value of Tests , Prognosis , Retrospective Studies
4.
Circulation ; 133(23): 2235-42, 2016 Jun 07.
Article En | MEDLINE | ID: mdl-27151531

BACKGROUND: The arrhythmogenesis of ventricular myocardial ischemia has been extensively studied, but models of atrial ischemia in humans are lacking. This study aimed at describing the electrophysiological alterations induced by acute atrial ischemia secondary to atrial coronary branch occlusion during elective coronary angioplasty. METHODS AND RESULTS: Clinical data, 12-lead ECG, 12-hour Holter recordings, coronary angiography, and serial plasma levels of high-sensitivity troponin T and midregional proatrial natriuretic peptide were prospectively analyzed in 109 patients undergoing elective angioplasty of right or circumflex coronary arteries. Atrial coronary branches were identified and after the procedure patients were allocated into two groups: atrial branch occlusion (ABO, n=17) and atrial branch patency (non-ABO, n=92). In comparison with the non-ABO, patients with ABO showed: (1) higher incidence of periprocedural myocardial infarction (20% versus 53%, P=0.01); (2) more frequent intra-atrial conduction delay (19% versus 46%, P=0.03); (3) more marked PR segment deviation in the Holter recordings; and (4) higher incidence of atrial tachycardia (15% versus 41%, P=0.02) and atrial fibrillation (0% versus 12%, P=0.03). After adjustment by a propensity score, ABO was an independent predictor of periprocedural infarction (odds ratio, 3.4; 95% confidence interval, 1.01-11.6, P<0.05) and atrial arrhythmias (odds ratio, 5.1; 95% confidence interval, 1.2-20.5, P=0.02). CONCLUSIONS: Selective atrial coronary artery occlusion during elective percutaneous transluminal coronary angioplasty is associated with myocardial ischemic damage, atrial arrhythmias, and intra-atrial conduction delay. Our data suggest that atrial ischemic episodes might be considered as a potential cause of atrial fibrillation in patients with chronic coronary artery disease.


Angioplasty, Balloon, Coronary/adverse effects , Arrhythmias, Cardiac/etiology , Coronary Circulation , Coronary Occlusion/etiology , Coronary Vessels/physiopathology , Heart Conduction System/physiopathology , Action Potentials , Aged , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/physiopathology , Atrial Natriuretic Factor/blood , Biomarkers/blood , Chi-Square Distribution , Constriction, Pathologic , Coronary Angiography , Coronary Occlusion/diagnosis , Coronary Occlusion/physiopathology , Electrocardiography, Ambulatory , Female , Heart Atria/physiopathology , Heart Rate , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Myocardial Infarction/blood , Myocardial Infarction/diagnosis , Myocardial Infarction/etiology , Odds Ratio , Propensity Score , Prospective Studies , Risk Factors , Time Factors , Troponin T/blood
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