TAVI and PCI in Comparison to SAVR and CABG in Low and Intermediate Risk Patients With Severe Aortic Stenosis
Transcatheter Aortic Valve Implantation Combined With Percutaneous Coronary Intervention in Comparison to Surgical Aortic Valve Replacement Combined With Coronary Artery Bypass Grafting in Low and Intermediate Surgical Risk Patients With Severe Aortic Stenosis and Significant Coronary Artery Disease
# WHAT IS THIS STUDY ABOUT?
This study compares two different treatment approaches for patients with two heart conditions occurring simultaneously: a narrowed heart valve (aortic stenosis) and narrowed or blocked heart arteries (coronary artery disease). Both conditions are serious and, when they occur together, place considerable strain on the heart. The heart must work harder to pump blood through the narrowed valve while simultaneously receiving an inadequate blood supply through the blocked coronary arteries.
# WHY IS THIS STUDY NEEDED?
Until recently, the main treatment option for patients with both conditions was open-heart surgery. This major operation involves opening the chest, temporarily stopping the heart, replacing the heart valve with an artificial valve, and performing coronary artery bypass grafting to restore blood flow around the blocked arteries. Although effective, combined surgery carries significant risks, particularly in older or frailer patients, including prolonged recovery, longer hospital stays (often 2 to 3 weeks), bleeding, kidney injury, and other complications.
A newer, less invasive treatment approach is now available. This involves replacing the heart valve through a thin tube (catheter) inserted through a blood vessel in the groin, without opening the chest, and treating the blocked coronary arteries using a fine wire, a small balloon, and a metal mesh tube (stent) placed inside the artery. This approach, known as transcatheter aortic valve implantation (TAVI) combined with percutaneous coronary intervention (PCI), typically requires a shorter hospital stay of approximately 2 to 4 days and may allow an earlier return to normal activities.
However, sufficient evidence from well-designed studies is not yet available to establish whether this less invasive approach is as safe and effective as conventional surgery in patients who are not considered at high surgical risk.
This study aims to address this evidence gap.
# WHO CAN JOIN THIS STUDY?
Adults with severe aortic stenosis and significant coronary artery disease who have been assessed by a specialist heart team as having low or intermediate surgical risk may be eligible to participate.
All participants must be considered suitable for both the catheter-based treatment approach and the surgical approach, based on individual coronary anatomy, clinical characteristics, and medical history.
Patients with previous coronary artery bypass graft surgery, severely impaired left ventricular systolic function (ejection fraction below 40%), or a recent myocardial infarction within the previous 6 months are not eligible to participate.
- WHAT WILL HAPPEN IF A PATIENT JOINS THE STUDY?
Participants will receive one of two treatment approaches, selected by a specialist heart team according to individual coronary and valvular anatomy, clinical circumstances, and patient preference:
-
Catheter-based aortic valve replacement combined with coronary artery stenting (TAVI + PCI).
-
Conventional open-heart surgery involving surgical aortic valve replacement and coronary artery bypass grafting (SAVR + CABG).
Regardless of the treatment received, all participants will undergo follow-up assessments at hospital discharge, 30 days, 6 months, and 1 year after the procedure. Follow-up will include clinical assessments and appropriate cardiac investigations.
- WHAT IS THE STUDY MEASURING?
The study will evaluate the incidence of major complications, including all-cause mortality, myocardial infarction, stroke, serious bleeding, and the need for urgent repeat intervention, during the index hospitalization and within 1 year after the procedure.
Additional outcomes will include recovery duration, length of hospital stay, and changes in kidney function.
- WHERE IS THE STUDY TAKING PLACE?
The study is being conducted at Alexandria University Hospitals and other major cardiac centres across Egypt, with a planned total enrolment of 100 participants.
# WHO IS CONDUCTING THE STUDY?
The study is being conducted by Dr. Moustafa AbdelMohsen Elsayed Madkour, Department of Cardiology and Angiology, Faculty of Medicine, Alexandria University, Egypt, under the supervision of Prof. Dr. Mohamed Ahmed Sobhy and Prof. Dr. Tarek Hussien Elzawawy.
調査の概要
状態
状態
条件
条件
詳細な説明
Severe aortic stenosis (AS) is the most common valvular heart disease requiring intervention in adults, affecting approximately 2-5% of individuals over 65 years of age. Coronary artery disease (CAD) coexists in 50-75% of patients referred for treatment of severe AS, reflecting shared risk factors and pathophysiological mechanisms, including active fibrocalcific valve disease with similarities to atherosclerosis. The simultaneous presence of both conditions creates a complex hemodynamic environment. AS-related left ventricular pressure overload induces concentric hypertrophy, reduces capillary density, elevates left ventricular end-diastolic pressure, impairs coronary flow reserve, and contributes to chronic subendocardial ischemia, even in the absence of significant epicardial coronary disease. The coexistence of significant epicardial CAD further aggravates the myocardial oxygen supply-demand imbalance, potentially accelerating clinical deterioration and worsening cardiovascular outcomes.
An additional complexity involves the assessment of coronary lesion severity using fractional flow reserve (FFR), a standard invasive index for evaluating the functional significance of coronary stenoses. In the setting of severe AS, altered coronary hemodynamics and impaired hyperemic responses may affect FFR measurements, potentially resulting in overestimation of FFR values and underestimation of the functional significance of coronary lesions. The instantaneous wave-free ratio (iFR) appears comparatively less affected by these hemodynamic changes and may provide an alternative physiological assessment in patients with severe AS.
For decades, surgical aortic valve replacement (SAVR) combined with coronary artery bypass grafting (CABG) has been the standard treatment strategy for surgically eligible patients with concomitant AS and CAD. This approach provides the potential for complete and durable myocardial revascularization but is associated with substantial operative morbidity, including 30-day mortality rates of approximately 4-8% in intermediate-risk populations, mean hospital stays of 8-14 days, cardiopulmonary bypass-related acute kidney injury, neurocognitive complications, and bleeding.
The development and progressive expansion of transcatheter aortic valve implantation (TAVI) have introduced an alternative treatment strategy for patients with severe AS. Landmark clinical trials, including PARTNER 2, PARTNER 3, Evolut Low Risk, and DEDICATE-DZHK6 (2024), have demonstrated non-inferiority or superiority of TAVI compared with SAVR across selected low- and intermediate-surgical-risk populations. The combination of TAVI and percutaneous coronary intervention (PCI) offers a fully percutaneous treatment alternative that avoids median sternotomy and cardiopulmonary bypass.
Despite these advantages, the TAVI + PCI strategy presents several clinical challenges. The optimal timing of PCI in relation to TAVI remains a subject of ongoing debate. Coronary re-engagement following TAVI may be technically challenging or restricted by the implanted prosthetic valve frame, with reported failure rates in selected settings. Furthermore, PCI may result in incomplete coronary revascularization compared with surgical bypass, particularly in patients with complex multivessel coronary disease.
Robust prospective comparative evidence evaluating TAVI + PCI versus SAVR + CABG in patients with low and intermediate surgical risk remains limited. Existing evidence from retrospective registries has demonstrated conflicting findings, with some studies reporting lower in-hospital mortality following TAVI + PCI, while others have shown differences in long-term outcomes potentially favouring SAVR + CABG. Prospective comparative studies with standardized endpoint definitions and adjudication specifically addressing this patient population remain necessary.
The present study aims to contribute prospective comparative evidence regarding the clinical outcomes and safety of TAVI + PCI versus SAVR + CABG in patients with concomitant severe AS and significant CAD who are considered at low or intermediate surgical risk.
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前：moustafa A.E.M Madkour, masters in cardiology
- 電話番号：002 00201120282930
- メール：moustafa_madkor19@hotmail.com
研究連絡先のバックアップ
- 名前：mohamed Khalid Elfeky, Phd in cardiology
- 電話番号：002 00201003897779
研究場所
-
-
Alexandira
-
Alexandria、Alexandira、エジプト
- 募集
- Alexandria University Hospital
-
コンタクト：
- Mostafa Madkour, masters in cardiology
- 電話番号：002 00201120282930
- メール：moustafa_madkor19@hotmail.com
-
コンタクト：
-
主任研究者：
- Mostafa Madkour, masters in cardiology
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
This prospective comparative study will include 100 patients with severe aortic stenosis (AS) and significant coronary artery disease (CAD) who are classified as low or intermediate surgical risk, as determined by the Society of Thoracic Surgeons (STS) risk score (≤8%) and a multidisciplinary Heart Team evaluation (10, 11). Patients will undergo either TAVI with PCI or SAVR with CABG, based on individual clinical suitability, anatomical considerations and patients' preference.
Participants will be enrolled from Alexandria university hospitals and other high-volume tertiary cardiac centers across Egypt.
説明
Inclusion Criteria:
- Patients with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI by a multidisciplinary Heart Team.
- Severe aortic stenosis defined as AVA ≤1.0 cm2 and/or mean pressure gradient ≥40 mmHg (echocardiography) and at least one of the following criteria:
A. Dyspnea. B. Angina. C. Syncope. D. Decline in left ventricular ejection fraction <50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity >5.5 m/s, severe valve calcification or peak transaortic velocity progression ≥0.3 m/s per year, ) according to current guidelines.(1)
- Coronary revascularization indicated in angiographically critical stenosis defined as ≥50 for LM and ≥ 70 otherwise, or functionally significant stenosis (fractional flow reserve (FFR) value <0.80) in a coronary artery ≥2.5 mm in diameter and TIMI flow grade III.(12)
- Classified as low or intermediate surgical risk (STS score ≤8%).
- Deemed eligible for both TAVI and SAVR by the Heart Team.
- Able and willing to provide informed consent and comply with study protocol.
Exclusion Criteria:
- Previous coronary artery bypass grafting (CABG).
- Left ventricular ejection fraction (LVEF) ≤40.
- Acute myocardial infarction within 6 months of planned procedure.
- Emergent or salvage valve intervention.
- Planned open-heart surgery for another indication.
- Severe comorbid conditions limiting life expectancy to <1 year.
- Contraindications to dual antiplatelet therapy or anticoagulation.
- Inability to comply with follow-up or provide informed consent.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
TAVI and PCI
transcatheter aortic valve replacment together with percautaneous coronary intervention either in the same setting or separety |
transcatheter aortic valve intervention percautaneous coronary intervention |
|
CABG and surgical aortic valve replacment
surgical coronary artery bypass together with aortic valve replacment in the same setting |
surgical aortic valve replacment coronary artery bypass graft |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
In-Hospital Composite Endpoint
時間枠：Periprocedurally
|
he occurrence of at least one of the following events periprocedurally from the index procedure through hospital discharge, reported as the number and percentage of participants experiencing one or more events: All-cause in-hospital mortality. Non-fatal myocardial infarction. Non-fatal stroke or transient ischemic attack (TIA). Emergency coronary or valve reintervention. High-degree atrioventricular (AV) block. Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3). Each participant will be counted only once in the composite endpoint, regardless of the number of events experienced. |
Periprocedurally
|
|
One-Year Composite Endpoint
時間枠：within 12 months after the procedure
|
he occurrence of at least one of the following events within 12 months after the index procedure: All-cause mortality. Non-fatal myocardial infarction. Non-fatal stroke or transient ischemic attack (TIA). High-degree atrioventricular (AV) block. Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3). The composite endpoint will be reported as the number and percentage of participants experiencing at least one of the listed events. Each participant will be counted only once, regardless of the number of events experienced. |
within 12 months after the procedure
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
All-cause mortality
時間枠：Within 12 months after the index procedure.
|
Measure: All-cause mortality Description: Number and percentage of participants who died from any cause. Unit: Participants |
Within 12 months after the index procedure.
|
|
Non-fatal myocardial infarction
時間枠：Within 12 months after the index procedure.
|
Measure: Non-fatal myocardial infarction. Description: Number and percentage of participants experiencing non-fatal myocardial infarction. Unit: Participants |
Within 12 months after the index procedure.
|
|
Non-fatal stroke or TIA
時間枠：Within 12 months after the index procedure.
|
Measure: Non-fatal stroke or transient ischemic attack (TIA) Description: Number and percentage of participants experiencing non-fatal stroke or TIA. Unit: Participants |
Within 12 months after the index procedure.
|
|
High-degree heart block
時間枠：Within 12 months after the index procedure.
|
Measure: High-degree atrioventricular (AV) block Description: Number and percentage of participants developing high-degree AV block. Unit: Participants |
Within 12 months after the index procedure.
|
|
Major bleeding
時間枠：Within 12 months after the index procedure.
|
Measure: Major bleeding (BARC type ≥3) Description: Number and percentage of participants experiencing major bleeding classified as BARC type 3 or higher. Unit: Participants |
Within 12 months after the index procedure.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 9294175
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data (IPD) will not be shared publicly because the dataset contains potentially identifiable clinical information. Data will be securely stored and accessible only to the research team. Anonymized aggregate results will be reported in accordance with applicable ethical and institutional requirements.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。