一個更好且低侵入性的選擇
一個更好且低侵入性的選擇
讓您有症狀的主動脈瓣狹窄病患(包含手術低風險病患)能獲得更好的治療
PARTNER 3試驗顯示了前所未有的臨床結果
術後的第一年，SAPIEN 3 經導管主動脈瓣置換術死亡率和致殘性中風發生率是傳統手術的三分之一倍
從死亡率和致殘性中風發生率來看
術後一年內，進行SAPIEN 3 經導管主動脈瓣置換術的患者有99%可免於發生上述併發症；而傳統手術的患者則是97.1%。(P = 0.03)
術後一年內，進行SAPIEN 3 經導管主動脈瓣置換術的患者有99%可免於發生上述併發症；而傳統手術的患者則是97.1%。(P = 0.03)
比較術後發生率2.9%的死亡或致殘性中風事件 (P = 0.03)
PARTNER 3試驗：主要結果
| 30天 | 一年 | ||||
| SAPIEN 3 TAVR (n = 496) |
Surgery (n = 454) |
SAPIEN 3 TAVR (n = 496) |
Surgery (n = 454) |
P-Value | |
| 總死亡率 | 0.4% | 1.1% | 1.0% | 2.5% | P = 0.09 |
| 中風發生率 | 0.6% | 2.4% | 1.2% | 3.1% | P = 0.04 |
| 再入院率** | 3.4% | 6.5% | 7.3% | 11.0% | P = 0.046 |
一年內總死亡率、中風發生率、再入院率：經導管主動脈瓣置換術8.5%；傳統手術15.1% (P=0.001)
| 30天 | ||
| SAPIEN 3 TAVI (n = 496) |
Surgery (n = 454) |
|
| 總死亡率 | 0.4% | 1.1% |
| 中風發生率 | 0.6% | 2.4% |
| 再入院率** | 3.4% | 6.5% |
一年內總死亡率、中風發生率、再入院率：經導管主動脈瓣置換術8.5%；傳統手術15.1% (P=0.001)
| 一年 | |||
| SAPIEN 3 TAVR (n = 496) |
Surgery (n = 454) |
P-Value | |
| 總死亡率 | 1.0% | 2.5% | P = 0.09 |
| 中風發生率 | 1.2% | 3.1% | P = 0.04 |
| 再入院率** | 7.3% | 11.0% | P = 0.046 |
一年內總死亡率、中風發生率、再入院率：經導管主動脈瓣置換術8.5%；傳統手術15.1% (P=0.001)
生活品質的改善†
永久心臟節律器安裝機率低
* PARTNER 3試驗指出，SAPIEN 3 經導管主動脈瓣置換術在主要結果(總死亡率、中風發生率、再入院率)或其他多項次要結果的表現都優於傳統開心手術。
† Excludes multiplicity adjustment Leon 2019.
** 再入院率(包含瓣膜本身疾病、手術或心臟衰竭導致的再入院)
With Transcatheter aortic valve implantation (TAVI), you can give your severe Aortic Stenosis (AS) patients a faster recovery.2
TAVI patients recovered more rapidly than surgical patients.2
Abbreviations: KCCQ, Kansas City Cardiomyopathy Questionnaire; OS, overall survival; MCID, minimal clinically important difference.
With the low-risk indication and proven superiority over surgery* nothing stands in the way of a TAVI evaluation for patients who want the low-risk option.1
Only TAVI with SAPIEN 3 is proved superior to surgery.1
You can reduce their risk by nearly 50%.
*The PARTNER 3 Trial proved SAPIEN 3 TAVI is superior for the primary endpoint and multiple pre-specified secondary endpoints.
References: 1. FDA Letter: SAPIEN approval letter 2011. 2. Mack MJ, Leon MB, Thourani VH. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705. 3. Fifteen Years of TAVR; Where Are They Now? American College of Cardiology, July 20, 2017. https://www.acc.org/latest-in-cardiology/articles/2017/07/19/15/42/fifteen-years-of-tavr-where-are-we-now. 4. Leon MB, Mack MJ. PARTNER 3: transcatheter or surgical aortic valve replacement in low risk patients with aortic stenosis. Presented at ACC 2019; March 2019; New Orleans, LA. 5. The Partner 3 Trial Clinical Study Report; April 2019.