[Türkçe]

Turkish Society of Cardiology Young Cardiologists Bulletin Year: 1 Number: 1 / 2018


Turkish Society of Cardiology
Young Cardiologists

President:
Muzaffer Değertekin
Coordinator for the
Board of Directors
Bülent Mutlu

Members
Göksel Çinier
Cem Çöteli
Alper Karakuş
Ümit Yaşar Sinan
Elif Hande Özcan Çetin
Emrah Erdoğan
İbrahim Rencüzoğulları
Murat Çap
Ümit Bulut
Sedat Kalkan
Mustafa Adem Yılmaztepe
Süleyman Çağan Efe
Dursun Akaslan
Oğuzhan Birdal
Muhammet Dural
Serhat Sığırcı
Kerim Esenboğa
Füsun Helvacı
Örsan Deniz Urgun
Betül Kocaş
Gökay Taylan
Duygu İnan

Bulletin Preparation
Göksel Çinier
Ali Nazmi Çalık


 



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TCT 2018 in San DiegoTürk Kardiyoloji Derneği Genç Kardiyologlar Bülteni - TCT 2018 in San Diego ()

In COAPT trial, which was designed to assess the safety and efficacy of transcatheter mitral leaflet approximation using MitraClip among symptomatic heart failure (HF) patients with secondary mitral regurgitation (MR), patients with HF and grade 3-4+ MR who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT) were randomized to MitraClip + GDMT (n = 302) vs. GDMT alone (n = 312). The results of this landmark trial indicated that transcatheter mitral valve approximation using the MitraClip on a background of maximally tolerated GDMT was superior to GDMT alone in reducing HF hospitalization and mortality in symptomatic HF patients with grade 3-4+ MR. Improvements were also observed in LV dimensions and patient symptoms. The device had excellent safety.

These results come on the heels of the recently published MITRA-FR trial, which did not show a benefit in this patient population. Possible reasons for differences include enrollment of patients with more severe MR (EROA >30 in COAPT vs. >20 in MITRA-FR) and less dilated ventricles (LVEDV 101 vs. 135, respectively). Procedural complications and success in reducing MR were also higher in the COAPT trial. These are truly landmark findings and will likely have a significant impact on the management of patients with secondary MR.
https://www.nejm.org/doi/full/10.1056/NEJMoa1806640

IMPERIAL trial evaluated the safety and efficacy of Boston Scientific’s Eluvia drug-eluting stent (DES) compared with Cook Medical’s Zilver PTX DES for patients with peripheral artery disease. The results of this trial indicated that the Eluvia DES resulted in superior primary patency at 12 months compared with the Zilver PTX DES for femoropopliteal peripheral interventions. Revascularization rates were also numerically lower in the Eluvia arm. Although both stents were self-expanding and elute paclitaxel, there were differences in dose and duration of elution. Nevertheless, there was no difference in ankle-brachial index or walking impairment between the two groups at 12 months.
https://www.thelancet.com/pb-assets/Lancet/pdfs/S0140-6736(18)32262-1.pdf

The results of CorMicA (Coronary Microvascular Angina) trial were really interesting. The goal of the trial was to evaluate the efficacy of a tiered assessment among patients with angina without evidence of obstructive coronary artery disease (CAD). Patients with no evidence of anatomical or functional epicardial disease were randomized in a 1:1 fashion to either a diagnostic procedure to assess for microvascular/vasospastic angina (n = 75) or standard care after the initial angiogram (n = 76). In the active assessment arm, patients were treated with beta-blockers and lifestyle modification if they had evidence of microvascular angina, calcium channel blockers and lifestyle modification if they had evidence of vasospastic angina, and if neither was present, then antianginal therapies were stopped.

The results of this trial revealed that a tiered approach for assessment for microvascular and/or vasospastic angina among patients with stable angina and no evidence of significant epicardial disease was superior to usual care. This approach allowed for a change in diagnosis in more than half of the patients, and there was diagnostic certainty regarding microvascular/vasospastic angina in >80% of patients. By tailoring therapy accordingly, there were proportional improvements in angina from the patients’ perspective. These were very interesting findings and suggested a greater role for these measures in routine practice, although provocative testing for vasospastic angina currently has a Class IIb indication in the US guidelines (recommended only if empiric treatment trial is ineffective).
http://www.onlinejacc.org/content/early/2018/09/12/j.jacc.2018.09.006

RADIOSOUND-HTN trial compared the effectiveness of three different strategies for renal denervation (RDN) among patients with resistant hypertension. Patients with resistant hypertension were randomized in a 1:1:1 manner to receive either treatment with radiofrequency RDN of the main renal arteries (RFM-RDN) (n = 39) vs. radiofrequency RDN of the main renal arteries, side branches, and accessories (RFB-RDN) (n = 39) vs. endovascular ultrasound-based RDN of the main renal artery (USM-RDN) (n = 42). The RADIOSOUND-HTN trial showed that among patients with resistant hypertension, RDN using the Paradise endovascular ultrasound RDN system resulted in a greater reduction in ambulatory SBP at 3 months compared with radiofrequency ablation of the main renal artery alone, but not over radiofrequency ablation of the side branches in addition to the main artery.
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.037654

In SECURE-PCI trial, two loading doses of atorvastatin (80 mg) given early among patients presenting with acute coronary syndrome (ACS) for whom an early invasive approach was planned were compared. Patients presenting with ACS were randomized in a 1:1 fashion to receive either two loading doses of atorvastatin 80 mg before and 24 hours after a planned early invasive approach (n = 2,087) or placebo (n = 2,104). All patients in both groups were to receive 40 mg/d of atorvastatin after the procedure through 30 days.

The SECURE-PCI trial showed that routine administration of two early doses of high-dose atorvastatin was not superior to placebo in reducing cardiovascular events at 30 days among patients presenting with ACS and scheduled to undergo an early invasive approach.

Nonetheless, among patients who underwent PCI, there were significant reductions in MACE and non–PCI-related MI. This benefit was maintained irrespective of timing of administration of statin prior to PCI and the mechanism for benefit in these patients is likely due to the pleiotropic effects of statins.
https://jamanetwork.com/journals/jama/fullarticle/2675023

The 5-year results of SYNTAX trial were also announced in TCT 2018. Given the recent advances in the fields of both coronary artery bypass grafting (CABG) as well as percutaneous coronary intervention (PCI) (especially drug-eluting stent [DES] PCI), the goal of this trial was to compare the relative efficacy of CABG versus DES-PCI (using TAXUS stents) in all-comers with severe three-vessel disease (3-VD) or left main (LM) disease, who were deemed eligible for either CABG or PCI.

In the overall LM subset, MACCE rates at 5 years were similar between PCI and CABG (36.9% vs. 31.0%, p = 0.12), with higher rates of stroke with CABG (1.5% vs. 4.3%, p = 0.03) and higher rates of repeat revascularization with PCI (26.7% vs. 15.5%, p < 0.01).

In the overall 3-VD subset, MACCE rates at 5 years were higher in the PCI arm compared with CABG (37.5% vs. 24.2%, p < 0.001), including a higher risk of all-cause mortality (14.6% vs. 9.2%, p = 0.006), MI (9.2% vs. 4.0%, p = 0.001), and repeat revascularization (25.4% vs. 12.6%, p < 0.001), with a similar risk of stroke (3.0% vs. 3.5%). When stratified by SYNTAX score, patients with low (0-22) SYNTAX scores had comparable MACCE rates with PCI or CABG (33.3% vs. 26.8%, p = 0.21), with a higher rate of repeat revascularization (25.4% vs. 12.6%, p = 0.038) with PCI.

The SYNTAX score is increasingly becoming a valuable tool to risk-stratify patients with respect to the optimal revascularization strategy. Patients with LM disease and low and intermediate SYNTAX scores, for example (i.e., lesser complexity), may do equally well with PCI and CABG over 5 years of follow-up. On the other hand, patients with complex 3-VD may do better with CABG. These are very important findings, and could result in a paradigm shift in how LM disease is treated.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60141-5/fulltext

The goal of the PREPARE-CALC trial was to assess the safety and efficacy of rotational atherectomy vs. cutting balloon angioplasty prior to stent implantation among patients with calcified coronary lesions.

Patients with severely calcified coronary lesions were randomized in a 1:1 fashion to either rotational atherectomy (n = 100) or balloon modification using either a scoring or a cutting balloon (n = 100). All patients received the Orsiro sirolimus-eluting stent.

The results of this trial indicated that, among patients with severely calcified coronary lesions, the routine use of rotational atherectomy increased stent deliverability compared with the use of balloon modification techniques, but angiographic late lumen loss and other clinical outcomes were similar at 9 months.
https://www.acc.org/~/media/Clinical/PDF-Files/Approved-PDFs/2018/09/21/TCT-2018-Slides/Sept24-Mon/3pmET_PREPARE-CALC-tct-2018.pdf

The main objective of OAC-ALONE trial was to evaluate the safety and efficacy of eliminating antiplatelet therapy among patients with atrial fibrillation (AF) also on oral anticoagulation (OAC) and stable coronary artery disease (CAD) who had received stents more than 1 year ago.

Patients with stable CAD with percutaneous coronary intervention (PCI) >1 year ago and AF on OAC were randomized in a 1:1 fashion to either OAC + single antiplatelet therapy (SAPT) (n = 346) or OAC alone (n = 344).

Although this was a very important topic to study, this trial was unfortunately terminated early due to slow enrollment, partly because enrolling physicians did not feel comfortable stopping APT in stented patients and lower than expected event rates.

In short, due to premature cessation of the OAC-ALONE trial, noninferiority of OAC alone could not be established compared with OAC + SAPT among patients with AF and stable CAD with remote PCI.
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.036768

In REDUCE-FMR trial, the safety and efficacy of transcatheter mitral annuloplasty in reducing regurgitant volumes among symptomatic heart failure (HF) patients with dilated left ventricles (LVs) and secondary mitral regurgitation (MR) was evaluated. 

Patients with HF and moderate to severe MR were randomized in a 2:1 fashion to transcatheter mitral annuloplasty with the Carillon device (n = 87) or a sham procedure (n = 33).

The results of this trial indicated that, among patients with HF with dilated LVs and moderate to severe secondary MR, transcatheter mitral annuloplasty with the Carillon device significantly reduced the degree of MR at 1 year compared with sham controls. Among patients with available data, there were also reductions noted in LV volumes. Procedural safety seemed reasonable in this small trial.

Functional MR is a tough condition to treat. This device uses a different approach than the MitraClip for MR reduction. The trial specifically enrolled patients with dilated LVs and used a percutaneous device (Carillon) that is inserted into the coronary sinus and reduces MR much like an annuloplasty band. Results from the ongoing CARILLON FDA pivotal randomized trial are awaited.

The SOLVE-TAVI trial, which was designed to compare the safety and efficacy of the Edwards Sapien S3 valve vs. Medtronic’s CoreValve among patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis, also sought to compare conscious sedation vs. general anesthesia in this patient population in a 2x2 factorial design.

Patients undergoing TAVR were randomized in a 1:1 fashion to either: a) TAVR with the Edwards Sapien S3 valve (n = 219) or the Medtronic CoreValve Evolut R (n = 219), or b) conscious sedation with local anesthesia (n = 218) vs. general anesthesia (n = 220).
The results of this trial indicated that both the Edwards Sapien S3 valve and Medtronic CoreValve Evolut R have equivalent clinical outcomes at 30 days. Stroke rates were higher with Edwards Sapien S3. The trial also showed that conscious sedation was equivalent to general anesthesia for TAVR, with no differences in moderate to severe PVL, clinical outcomes, or length of stay, but with a lower need for inotropic agents. 

This was an important trial because it provides head-to-head comparison between the two commercially available contemporary TAVR valves. However, the trial was underpowered for most individual endpoints. Longer-term outcomes were also needed, as were hemodynamic comparisons between the two valves (for instance, patient-prosthesis mismatch, valve thrombosis, etc.).

The ULTIMATE trial sought to compare intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with angiography-guided PCI among an all-comers group of patients undergoing PCI.

In this multicenter and prospective trial, patients undergoing coronary revascularization were randomized to IVUS-guided PCI (n = 724) versus angiography-guided PCI (n = 724). 

Among an all-comers group of patients undergoing PCI, IVUS-guided PCI was beneficial. IVUS-guided PCI was associated with a lower frequency of target vessel failure at 12 months compared with angiography-guided PCI. All components of the composite outcome were numerically lower in the IVUS-guided PCI group. However, the greatest benefit seemed to be reducing target vessel revascularization. Multiple randomized trials now support the use of IVUS guidance in optimizing coronary stent implantation as a mechanism to reduce adverse cardiac events.
http://www.onlinejacc.org/content/early/2018/09/14/j.jacc.2018.09.013


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