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Turkish Society of Cardiology
Young Cardiologists
President
Dr. Muzaffer Değertekin
Coordinator for the
Board of Directors
Dr. Ertuğrul Okuyan
Coordinator for the
Board of Directors
Dr. Can Yücel Karabay
Members
Dr. Adem Aktan
Dr. Gülşah Aktüre
Dr. Bayram Arslan
Dr. İnanç Artaç
Dr. Ahmet Oğuz Aslan
Dr. Görkem Ayhan
Dr. Ahmet Anıl Başkurt
Dr. Özkan Bekler
Dr. Oğuzhan Birdal
Dr. Yusuf Bozkurt Şahin
Dr. Serkan Bulgurluoğlu
Dr. Ümit Bulut
Dr. Veysi Can
Dr. Mustafa Candemir
Dr. Murat Çap
Dr. Göksel Çinier
Dr. Ali Çoner
Dr. Yusuf Demir
Dr. Ömer Furkan Demir
Dr. Murat Demirci
Dr. Ayşe İrem Demirtola Mammadli
Dr. Süleyman Çağan Efe
Dr. Mehmet Akif Erdöl
Dr. Kubilay Erselcan
Dr. Kerim Esenboğa
Dr. Duygu Genç
Dr. Kemal Göçer
Dr. Elif Güçlü
Dr. Arda Güler
Dr. Duygu İnan
Dr. Hasan Burak İşleyen
Dr. Muzaffer Kahyaoğlu
Dr. Sedat Kalkan
Dr. Yücel Kanal
Dr. Özkan Karaca
Dr. Ahmet Karaduman
Dr. Mustafa Karanfil
Dr. Ayhan Kol
Dr. Fatma Köksal
Dr. Mevlüt Serdar Kuyumcu
Dr. Yunus Emre Özbebek
Dr. Ahmet Özderya
Dr. Yasin Özen
Dr. Ayşenur Özkaya İbiş
Dr. Çağlar Özmen
Dr. Selvi Öztaş
Dr. Hasan Sarı
Dr. Serkan Sivri
Dr. Ali Uğur Soysal
Dr. Hüseyin Tezcan
Dr. Nazlı Turan
Dr. Berat Uğuz
Dr. Örsan Deniz Urgun
Dr. İdris Yakut
Dr. Mustafa Yenerçağ
Dr. Mehmet Fatih Yılmaz
Dr. Yakup Yiğit
Dr. Mehmet Murat Yiğitbaşı
Bulletin Preparation
Göksel Çinier
Ali Nazmi Çalık
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ACC 2019Türk Kardiyoloji Derneği Genç Kardiyologlar Bülteni - ACC 2019 ()
- PARTNER 3 Trial
This trial included 1,000 patients with an STS Predicted Risk of Mortality of less than 4% (mean STS-PROM score 1.9%) treated at 71 centers. Patients in TAVR arm received SAPIEN 3 balloon expandable valves. At 1 year, the primary composite endpoint of death from any cause, stroke, and rehospitalization occurred in 8.5% of patients undergoing TAVR and 15.1% of patients treated with surgery (P < 0.001 for noninferiority; P = 0.001 for superiority). In an analysis of secondary endpoints, new-onset atrial fibrillation was lower among the TAVR-treated patients, while there was no difference in the need for new permanent pacemaker between groups. Length of hospital stay was shorter among those treated with TAVR, while bleeding was significantly greater with surgery. In terms of the echocardiographic findings, the percentage of patients with moderate or severe paravalvular aortic regurgitation did not differ significantly between the TAVR group and surgical arm, although more patients in the TAVR arm did have mild paravalvular aortic regurgitation at 1 year than those treated surgically (29.4% vs 2.1%).
https://www.nejm.org/doi/full/10.1056/NEJMoa1814052
- Evolut Low Risk Trial
This trial included critical aortic stenosis patients (n=734) with a mean age of 74, and a mean STS-PROM score of 1.9 %. The vast majority of patients received the Evolut R and PRO valves. The primary incidence of death or disabling stroke at 24 months—the study’s primary endpoint—was 5.3% in the TAVR arm and 6.7% in the surgery group, meeting the statistical definition of noninferiority. There was no difference in the risk of death at 24 months, which was 4.5% in both the TAVR and surgery arms, but the incidence of disabling stroke at 2 years was 1.1% with TAVR and 3.5% with surgery. In terms of secondary endpoints, new-onset atrial fibrillation was significantly higher in the surgical arm while the incidence of new permanent pacemaker implantation was 17.4% with TAVR arm and 6.1% with surgery, a statistically significant difference. At 1 year, rates of moderate-to-severe aortic regurgitation were also higher with the Evolut device than with surgery.
https://www.nejm.org/doi/full/10.1056/NEJMoa1816885
- AUGUSTUS Trial
This trial enrolled 4,614 A-fib patients in 33 countries who had undergone PCI or experienced ACS and were treated with a P2Y12 inhibitor. The researchers randomized patients to receive apixaban (Eliquis; Bristol-Myers Squibb) or a vitamin K antagonist and, in a double-blind comparison, to take aspirin or a placebo. Major or clinically relevant non-major bleeding, the primary outcome, was less common with apixaban than with a vitamin K antagonist (10.5% vs. 14.7%; HR 0.69; 95% CI 0.58-0.81). Aspirin use resulted in a higher bleeding rate compared with placebo (16.1% vs. 9.0%; HR 1.89; 95% CI 1.59-2.24). Compared with the patients assigned to a vitamin K antagonist, those in the apixaban group were less likely to die or be hospitalized (23.5% vs 27.4%; HR 0.83; 95% CI 0.74-0.93). There was no difference in ischemic events (a composite of stroke, MI, definite/probable stent thrombosis, or urgent revascularization) between these two study arms.
For the aspirin/placebo comparison, the rate of death or rehospitalization and the rate of ischemic events were both similar between groups.
Even though the results of the study favor apixaban over vitamin K antagonists, it does not provide enough data with regard to the early withdrawal of aspirin, the third party of therapy. This is because of a trend in more coronary thrombotic events (even statistically not significant) with placebo versus aspirin and the doubled rate of definite or probable stent thrombosis in the placebo group (0.5% vs. 0.9%). Additionally, randomization of all patients after a one week of aspirin therapy, which is the most risky time period for coronary ischemic events, leads to second thoughts about very early withdrawal of aspirin.
https://www.nejm.org/doi/full/10.1056/NEJMoa1817083
- SAFARI-STEMI Trial
Results of this trial were really surprising. Patients with STEMI undergoing primary PCI were randomized to radial access (n = 1,136) versus femoral access (n = 1,156) and primary outcome, all-cause mortality in 30 days, occurred in 1.5% of the radial group compared with 1.3% of the femoral group (p = 0.69). The rates of secondary outcomes defined as stroke, re-infarction, stent thrombosis and non-CABG TIMI major bleeding were not different between groups. Despite early termination due to futility in detecting a difference in the primary outcome, SAFARI-STEMI trial demonstrated that radial access was safe but not superior to femoral access in STEMI patients. In short, even though the pioneers of work still advocates the radial access, they point out the safety of femoral access under fluoroscopy and ultrasound guidance.
https://www.acc.org/latest-in-cardiology/clinical-trials/2019/03/16/23/57/safari-stemi
- Apple Heart Study
This was a very large study (more than 400 000 participants) whose participants were self-enrolled and designed to evaluate the power of Apple Watch to identify irregular pulse in the general population.
The watch monitor the heart rhythm passively with periodic spot measurements. Occurrence of irregular rhythm in five of six measurements triggered a notification for the user to contact a telehealth doctor and the mailing of an ECG patch to the user when appropriate. The patch was worn together with the watch for a further week to detect AF.
Results showed that 0.5% of study participants had irregular pulse notification. However, the rate of notification was highly age-dependent as it was 0.16% and 3.2% in people under and above 40 years old respectively. Positive predictive value of the watch to detect AF was 0.84.
https://www.medscape.com/viewarticle/910509#vp_1
- COACT Trial
This trial compared the efficacy and safety of immediate coronary angiography (CAG) vs. delayed angiography in patients who had been successfully resuscitated after cardiac arrest and who did not have ST-segment elevation on ECG. A total of 538 patients were included in the study. The mean time interval to CAG was 2.3 hours in immediate CAG group and 121.9 hours in the delayed CAG group. The difference of primary outcome, which was survival at 90 days, did not reach statistical significance between groups (p=0.51). Similarly, there was no significant difference between groups in terms of secondary end points, defined as survival with good cerebral performance, myocardial injury, TIMI major bleeding and need for renal-replacement therapy.
The results seem promising for our daily practice and, will likely influence relevant guidelines.
https://www.nejm.org/doi/full/10.1056/NEJMoa1816897
- WRAP-IT Trial
This trial was to evaluate an absorbable antibiotic-eluting envelope compared with control among patients undergoing placement of a cardiac implantable electronic device. The primary outcome, infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death within 12 months, occurred in 0.7% of the antibiotic envelope group compared with 1.2% of control group (p = 0.04). Cardiac implantable electronic device infections are uncommon but result in significant morbidity and mortality. This strategy reduced infectious complications in addition to standard preprocedure intravenous antibiotics and sterile technique.
https://www.nejm.org/doi/full/10.1056/NEJMoa1901111
- DEFINE-PCI Trial
The major purpose of this trial was to determine how often patients leave the cardiac catheterization laboratory with significant residual ischemia despite operators achieving excellent angiographic outcomes. In total, 500 stable and unstable angina patients with a baseline iFR value of less than 0.89, indicative of physiological impairment, underwent PCI. Mean iFR increased from 0.69 at baseline to 0.93 after the completion of PCI (average change 0.24). Of the 467 patients who had successful PCI—defined as operator-assessed residual diameter stenosis less than 50% in any treated lesion—24% had an iFR ≤ 0.89, which is hemodynamically significant. Moreover, the investigators observed no significant correlation between angiographic diameter stenosis and post-PCI physiologic measures. Nearly 30% of patients with a residual diameter stenosis ≥ 50% on angiography had an iFR ≤ 0.89. For those with a residual diameter stenosis less than 50%, more than 21% had an iFR ≤ 0.89 (P = 0.24).
The DEFINE-Guided Physiologic Stenting (GPS) study will soon be launched and that trial will randomize patients to an IFR-guided therapy with pullback or to angiographically-guided PCI and will hopefully clarify the conflicts about the topic.
https://www.tctmd.com/news/high-rate-residual-ischemia-after-pci-despite-excellent-angiographic-outcomes-define-pci
- STOPDAPT-2 Trial
This trial evaluated 1-month dual antiplatelet therapy (DAPT) compared with 12-month DAPT among patients undergoing percutaneous coronary intervention (PCI). The individuals with stable coronary artery disease comprised 62% of patient population who were randomized to 1 month of DAPT followed by clopidogrel monotherapy for 5 years (n = 1,523) versus 12 months of DAPT followed by aspirin monotherapy for 5 years (n = 1,522). The primary outcome, death, myocardial infarction (MI), stent thrombosis, stroke, TIMI major/minor bleeding at 1 year, occurred in 2.4% of the 1-month DAPT group compared with 3.7% of the 12-month DAPT group (p for superiority = 0.04). In short, among patients undergoing PCI for stable and unstable cardiovascular disease, one-month DAPT was noninferior to 12-month DAPT at preventing major adverse ischemic events and superior to 12-months DAPT at preventing TIMI major/minor bleeding.
https://www.eurekalert.org/pub_releases/2019-03/acoc-sda031819.php
- SMART-CHOICE Trial
This trial was to compare the safety and efficacy of short-duration dual antiplatelet therapy (DAPT) (3 months) compared with longer duration DAPT (12 months) among patients undergoing percutaneous coronary intervention (PCI) with a DES. In the former group, after 3 months, aspirin was discontinued and P2Y12 inhibitor monotherapy was continued. The primary outcome, major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, MI, or stroke) at 12 months, for 3 months vs. 12 months of DAPT, was 2.9% vs. 2.5%, p for noninferiority = 0.007; p for superiority = 0.46.
The results of this trial indicate that short-duration DAPT (3 months) is noninferior to longer-duration DAPT (12 months) among unselected patients undergoing PCI with a DES. However, there are some important limitations to take into consideration while interpreting the results of the study. First, nearly 10% of patients in the short-duration DAPT arm were still on aspirin at 12 months. Secondly, the effect may be different among patients with ACS in whom a longer duration of DAPT is needed versus among patients with stable ischemic heart disease in whom 6 months of DAPT is sufficient.
https://www.acc.org/latest-in-cardiology/clinical-trials/2019/03/17/00/03/smart-choice
- TREAT Trial
The major objective of the trial was to evaluate ticagrelor compared with clopidogrel among patients who received fibrinolytic therapy for ST-segment elevation myocardial infarction (STEMI). Patients were randomized a median of 11 hours after fibrinolysis and 90% had been pretreated with clopidogrel. Patients who received fibrinolytic therapy for STEMI were randomized to delayed ticagrelor (n = 1,913) versus clopidogrel (n = 1,886). The primary outcome of TIMI major bleeding occurred in 0.73% of the ticagrelor group vs. 0.69% of the clopidogrel group (p < 0.001 for noninferiority). Secondary outcomes defined as, fatal bleeding, intracranial bleeding, major adverse cardiovascular events and cardiovascular mortality, MI, stroke/transient ischemic attack, recurrent ischemia, or other arterial thrombotic events were similar between groups. Although the trial was not powered for efficacy, ticagrelor represents a safe treatment option in such patients.
http://www.onlinejacc.org/content/early/2019/03/12/j.jacc.2019.03.011
- PIONEER-HF Trial
The purpose of this trial was to assess the safety and efficacy of using sacubitril/valsartan compared with enalapril among patients hospitalized with acute decompensated HF (ADHF). A total of 881 patients were included in the study and after a follow-up period of 8 weeks, the primary outcome, time-averaged reduction in NT-proBNP, for sacubitril/valsartan vs. enalapril, was -46.7% vs. -25.3%, hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.63-0.81, p < 0.001. Not only a similar significant decline was observed in troponin T levels (-36.6% vs. 25.2%, p < 0.05), but also rehospitalization rates were lower in sacubitril/valsartan group. Adverse events such as hyperkalemia and hypotension were not different between groups.
Sacubitril/valsartan combination was alredy noted to have significant benefit among ambulatory patients with HF and this trial extends these findings to an inpatient setting. Without any doubt, the, larger trials powered for clinical endpoints are warranted.
https://www.nejm.org/doi/full/10.1056/NEJMoa1812851
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