Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.,The New England Journal of Medicine

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Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2019-11-07 00:00:00 , DOI: 10.1056/nejmoa1909406
Gregg W Stone ₁ , A Pieter Kappetein ₁ , Joseph F Sabik ₁ , Stuart J Pocock ₁ , Marie-Claude Morice ₁ , John Puskas ₁ , David E Kandzari ₁ , Dimitri Karmpaliotis ₁ , W Morris Brown ₁ , Nicholas J Lembo ₁ , Adrian Banning ₁ , Béla Merkely ₁ , Ferenc Horkay ₁ , Piet W Boonstra ₁ , Ad J van Boven ₁ , Imre Ungi ₁ , Gabor Bogáts ₁ , Samer Mansour ₁ , Nicolas Noiseux ₁ , Manel Sabaté ₁ , Jose Pomar ₁ , Mark Hickey ₁ , Anthony Gershlick ₁ , Pawel E Buszman ₁ , Andrzej Bochenek ₁ , Erick Schampaert ₁ , Pierre Pagé ₁ , Rodrigo Modolo ₁ , John Gregson ₁ , Charles A Simonton ₁ , Roxana Mehran ₁ , Ioanna Kosmidou ₁ , Philippe Généreux ₁ , Aaron Crowley ₁ , Ovidiu Dressler ₁ , Patrick W Serruys ₁ ,

Affiliation

From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S., R. Mehran), the Cardiovascular Research Foundation (G.W.S., D.K., N.J.L., R. Mehran, I.K., P.G., A.C., O.D.), Mount Sinai Heart at Mount Sinai Saint Luke's (J. Puskas), and New York-Presbyterian Hospital and Columbia University Medical Center (D.K., N.J.L., I.K.) - all in New York; Erasmus Medical Center, Rotterdam (A.P.K.), Medisch Centrum Leeuwarden, Leeuwarden (P.W.B., A.J.B.), and Academic Medical Center, University of Amsterdam, Amsterdam (R. Modolo) - all in the Netherlands; University Hospitals Cleveland Medical Center, Cleveland (J.F.S.); the London School of Hygiene and Tropical Medicine (S.J.P., J.G.) and the International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London (P.W.S.), London, John Radcliffe Hospital, Oxford (A. Banning), and University Hospitals of Leicester NHS Trust, Leicester (M.H., A.G.) - all in the United Kingdom; Hôpital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.); Piedmont Heart Institute, Atlanta (D.E.K., W.M.B.); Semmelweis University, Budapest (B.M., F.H.), and the University of Szeged, Szeged (I.U., G.B.) - both in Hungary; Centre Hospitalier de l'Université de Montréal (S.M., N.N.) and Hôpital du Sacré-Coeur de Montréal (E.S., P.P., P.G.), Montreal; Hospital Clinic, Barcelona (M.S., J. Pomar); Medical University of Silesia, Katowice, and American Heart of Poland, Ustron - both in Poland (P.E.B., A. Bochenek); University of Campinas, Campinas, Brazil (R. Modolo); Abbott Vascular, Santa Clara, CA (C.A.S.); and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.).

Background

Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established.

Methods

We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt–chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction.

Results

At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], −0.9 to 6.5; P=0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, −1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, −1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, −1.9 percentage points; 95% CI, −3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, −0.8 percentage points; 95% CI, −2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0).

Conclusions

In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.)

中文翻译：

PCI或CABG后左主干冠脉疾病的五年结局。

背景

与左冠状动脉旁路移植术（CABG）相比，当代药物洗脱支架经皮冠状动脉介入治疗（PCI）的长期预后尚不清楚。

方法

我们随机分配了1905名具有低或中等解剖复杂性的左主冠状动脉疾病患者（根据参与研究中心的评估），接受含氟聚合物钴-铬依维莫司洗脱支架的PCI手术（PCI组，948例患者）或CABG （CABG组，957例患者）。主要结局是死亡，中风或心肌梗死的综合结果。

结果

在第5年时，PCI组的22.0％的患者和CABG组的19.2％的患者发生了主要预后事件（差异为2.8个百分点； 95％的置信区间[CI]为-0.9至6.5 ； P = 0.13）。与CABG组相比，PCI组死于任何原因的发生率更高（分别为13.0％和9.9％；差异为3.1个百分点； CI为95％，从0.2至6.1）。在PCI和CABG组中，明确的心血管死亡发生率（分别为5.0％和4.5％；差异为0.5个百分点； 95％CI为-1.4至2.5）和心肌梗死（分别为10.6％和9.1％；差异为1.4）个百分点； 95％CI，-1.3至4.2）没有显着差异。PCI后所有脑血管事件的发生率均低于CABG后（3.3％vs. 5.2％；差异为-1.9个百分点； CI为95％，-3.8至0），尽管两组的卒中发生率没有显着差异（2.9％和3.7％；差异为-0.8个百分点； CI为95％，-2.4至0.9）。PCI术后缺血驱动血运重建术比CABG术后更为频繁（16.9％vs. 10.0％；差异为6.9个百分点； 95％CI为3.7至10.0）。