Risk factors of asymptomatic restenosis in patients with first anterior ST elevation myocardial infarction treated by primary percutaneous coronary intervention

Background: The issue of predicting coronary artery restenosis, especially silent, in patients following primary percutaneous coronary intervention (PCI) has been extensively studied, however, risk factors have not been fully defined. Aim: To asses the frequency of silent restenosis and its predictors in patients with anterior ST elevation myocardial infarction (STEMI) treated with primary PCI and implantation of bare metal stents (BMS). Methods: We recruited a cohort of 114 patients with first anterior STEMI treated with primary PCI within 12 hours of the onset of symptoms, and with the left anterior descending coronary artery occlusion (TIMI 0) and successful flow restoration (TIMI 3). A 12-lead ECG was performed before and 60 minutes after PCI. Troponin I and CK-MB were measured on admission and after six, 12 and 24 hours. Transthoracic echocardiography (TTE) was performed at discharge. Resting TTE and coronary angiography were performed after a six month follow-up in asymptomatic patients. Results: The frequency of silent restenosis in our study group was 23.9%. The best multivariate models in logistic regression of restenosis prediction were: lower end-systolic volume of the left ventricle assessed two days after infarction longer lesion and smaller reference diameter of the stented vessel. Conclusions: Silent restenosis in patients with first anterior STEMI treated by primary PCI with the use of BMS is still frequent. The best ways to identify patients with silent restenosis at six month follow-up, apart from the lower end systolic volume in the echocardiographic study, are longer narrowing in the infarct-related artery and lower reference diameter of the treated vessel. Kardiol Pol 2010; 68, 9: 987-993Wstęp: Ze względu na fakt, że wciąż zwiększa się populacja pacjentów z nawrotem zwężenia po pierwotnej angioplastyce wieńcowej (PCI), mimo adekwatnej farmakoterapii, problem określenia czynników ryzyka restenozy po skutecznej pierwotnej PCI jest w ostatnim czasie intensywnie badany. Nawrót zwężenia może powodować objawy kliniczne, jednak u wielu pacjentów jest bezobjawowy, co znacznie utrudnia diagnostykę i opóźnia wdrożenie właściwego leczenia. Cel: W niniejszej pracy w 6-miesięcznej obserwacji oceniano częstość i czynniki ryzyka wystąpienia bezobjawowej restenozy u chorych z pierwszym w życiu zawałem z uniesieniem odcinka ST (STEMI) ściany przedniej, leczonych pierwotną PCI z implantacją stentów nieuwalniających leku (BMS). Metody: Do badania włączono 114 osób z pierwszym w życiu STEMI ściany przedniej, z zamknięciem tętnicy przedniej zstępującej (TIMI 0), leczonych pierwotną PCI w ciągu 12 godzin od początku objawów, skutecznym udrożnieniu tętnicy (TIMI 3) i implantacją BMS. Badanie EKG wykonywano przed i 60 minut po PCI, wartości troponiny I i CK-MB oznaczano przy przyjęciu, a następnie po 6, 12 i 24 godzinach. Przezklatkowe badanie echokardiograficzne wykonano 2 dni po zawale - przed wypisem ze szpitala. Po 6-miesięcznej obserwacji u pacjentów bez objawów klinicznych ponownie wykonano spoczynkowe przezklatkowe badanie echokardiograficzne i angiografię tętnic wieńcowych. Wyniki: Częstość występowania bezobjawowej restenozy w badanej grupie pacjentów wynosiła 23,9%. W analizie wieloczynnikowej metodą logistycznej regresji najlepiej przewidywały nawrót zwężenia w tętnicy dozawałowej (IRA) - niska końcowoskurczowa objętość lewej komory oceniana 2 dni po zawale, dłuższa blaszka miażdżycowa i mniejsza średnica IRA. Wnioski: Częstość występowania bezobjawowego nawrotu zwężenia u pacjentów po pierwszym w życiu STEMI ściany przedniej leczonych skuteczną PCI z użyciem BMS jest wciąż wysoka. Najlepszymi czynnikami predykcyjnymi identyfikującymi chorych z nawrotem zwężenia, poza niską objętością końcowoskurczową lewej komory w badaniu echokardiograficznym, jest dłuższe zwężenie i mała średnica IRA. Kardiol Pol 2010; 68, 9: 987-99

Artykuł oryginalnyProspektywny rejestr oceniający skuteczność i bezpieczeństwo leczenia chorych ze zmianami de novo w naczyniach wieńcowych przy użyciu stentów kobaltowo-chromowych

Background: Cobalt-chromium (Co-Cr) stents are a new type of endovascular prostheses characterised by better mechanical properties than traditional stainless steel stents. Aim: To assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Kos stent (Balton, Poland). Methods: A total of 59 patients with coronary artery diseases (76% men, aged 60±9 years, diabetes – 16.9%, smoking – 62.7%, 11.8% – acute myocardial infarction) underwent PCI for de novo lesions in native coronary vessels. The patients were followed for 6 months for the occurrence of cardiac events. Quantitative coronary angiography was performed at baseline and after 6 months. Results: In total, we implanted 62 stents in 59 coronary arteries. The mean diameter of the stents was 3.18±0.18 mm, and length – 14.62±2.12 mm. During a one-month follow-up period no cardiac events were noted. During a 6-month follow-up no death or new myocardial infarction were recorded. Control angiography was done in 55 (92%) subjects. Repeated target vessel revascularisation due to recurrent angina or in-stent restenosis was required in 10 (17%) patients; however, off-line core evaluation found significant re-narrowing in implanted stents (>50% diameter stenosis) only in 6 cases (10.9%). The mean late vessel lumen loss was 0.55±0.6 mm and stenosis 25.2±17.9%. Conclusions: Implantation of the new Co-Cr Kos stent during PCI is safe and effective.Wstęp: Stenty wieńcowe zbudowane ze stopów kobaltowo-chromowych (Co-Cr) są nowym rodzajem endoprotez o korzystniejszych właściwościach mechanicznych niż tradycyjne stenty metalowe. Cel: Ocena skuteczności i bezpieczeństwa zabiegów przezskórnych interwencji wieńcowych (PCI) z użyciem stentów wieńcowych kobaltowo-chromowych Kos firmy Balton. Metodyka: Do badań włączono kolejnych 59 chorych z objawową chorobą wieńcową. Siedmiu (11,8%) chorych stanowiło grupę pacjentów przyjętych z powodu ostrego zawału mięśnia sercowego (MI), a 22 (37,3%) z powodu objawów niestabilnej dławicy piersiowej. Średni wiek chorych wynosił 60±9 lat, cukrzyca występowała u 17% chorych, nikotynizm – u 63%, hipercholesterolemia – u 54%, obciążenie rodzinne – u 25% chorych. Do badania kwalifikowano tylko zmiany typu de novo w naczyniach wieńcowych ze stenozą ł50%

The new Polish stent Chopin. Assessment of safety and efficacy in the treatment of de-novo coronary lesions using percutaneous angioplasty

Aim: The aim of the present study was to assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Polish stent "Chopin" (Balton, Poland).Methods: The study consisted of experimental and clinical parts. In the experimental phase, the new stent was implanted into 5 pigs and control coronary angiography as well as intracoronary ultrasonography (ICUS) were performed 30 days later. In the clinical phase, 101 patients (57% of males, mean age 55.6±10 years) with symptomatic coronary artery disease (CAD) with "de novo" coronary lesions (including 12% of patients with unstable angina and 19% with acute myocardial infarction [MI]) underwent stent implantation. The patients were followed for 6 months for the occurrence of cardiac events. Quantitative coronary angiography was performed at baseline and after 6 months.Results: In total, we attempted to implant 107 stents, which resulted in the successful deployment of 106 stents to 105 coronary arteries. The mean diameter of the stents was 3.2±0.3 mm, and length - 15.4±2 mm. During a one month follow-up period no cardiac events were noted. During a 6-month follow-up no death or new MI were recorded. Repeated target vessel revascularisation due to recurrent angina and in-stent restenosis was required in 15 (15.5%) patients. Control coronary angiography was performed in 97 (96%) patients. Of 101 stents, angiographic restenosis (narrowing of dilated lesion by >50% of vessel lumen) was documented in 18.8% of cases. The mean late vessel lumen loss was 0.77±0.6 mm, and stenosis - 29.1±20%. The restenosis rate was significantly higher in patients with unstable angina rather than in those with stable angina or acute MI.Conclusions.: Implantation of the new Polish stent "Chopin" during PCI is safe and effective

Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI) : a phase 3, placebo-controlled, randomised trial

Background: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. Methods: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). Findings: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8–3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74–0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, p interaction=0·16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3·1%] with ticagrelor vs 183 (3·3%) with placebo; HR 0·96 [95% CI 0·78–1·18], p=0·68), as well as all-cause death (282 [5·1%] vs 323 [5·8%]; 0·88 [0·75–1·03], p=0·11). TIMI major bleeding occurred in 111 (2·0%) of 5536 patients receiving ticagrelor and 62 (1·1%) of 5564 patients receiving placebo (HR 2·03 [95% CI 1·48–2·76], p<0·0001), and fatal bleeding in 6 (0·1%) of 5536 patients with ticagrelor and 6 (0·1%) of 5564 with placebo (1·13 [0·36–3·50], p=0·83). Intracranial haemorrhage occurred in 33 (0·6%) and 31 (0·6%) patients (1·21 [0·74–1·97], p=0·45). Ticagrelor improved net clinical benefit: 519/5558 (9·3%) versus 617/5596 (11·0%), HR=0·85, 95% CI 0·75–0·95, p=0·005, in contrast to patients without PCI where it did not, p interaction=0·012. Benefit was present irrespective of time from most recent PCI. Interpretation: In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk