The Great Swedish Debate. Håkan Pärsson Department Vascular Surgery Helsingborgs Lasarett, University Lund

Transcription

1 The Great Swedish Debate Håkan Pärsson Department Vascular Surgery Helsingborgs Lasarett, University Lund

2 My Disclosures Trying to bribe the moderators

3 What do my patients expect? Balanced information Proved technique Standardized, no surprises Safe Long-term durability

4 Proved and tested! Table 1. Major events in the development of carotid surgery Eur J Vasc Endovasc Surg 27, (2004)

5 Standardized! No need for fancy filters or flow-reversal with undefined indications, applications or influence.

6 Risk of Stroke in the Subsequent Year Risk of Stroke in the Subsequent Year Why I primarily offer CEA (if not included in ACST-2) 50 69% Stenosis Safe; numerous studies with consistent data with a low stroke and complication rate Medical therapy Surgical therapy ECST NASCET ACAS ACST-1 A % Stenosis Year of Study B Year of Study NASCET 1998

7 Risk (%; 95% CI) Baseline B Any stroke or perioperative death Gain at 5 years: 5 9% (95% CI ), p< years: 6 1% (95% CI ), p= B Any non-perioperative stroke Gain at 5 years: 5 9% (95% CI ), p< years: 6 1% (95% CI ), p= % 16 9% 10 9% 10 0% % 10 8% 6 9% Years Perioperative events/ceas (%)+other events Years /1509 (2 9%)+56 14/360 (3 9%)+140 Years /23 (0 0%)+43 2/87 (2 3%)+48 Immediate Deferred Number at risk Immediate Deferred Immediate Deferred 4 1% 0 5 Years /6540 (0 9% py) 140/6553 (2 1% py) Years Events/person-years Years /3042 (1 4% py) 48/3003 (1 6% py) 10 Immediate Deferred ACST-1 Halliday et al Lancet 2010;

8 Hazard ratio (CAS vs CEA) Proved and safe 8 Peri-procedural Post-procedural < < Age group (years) Figure 4: CAS versus CEA hazard ratio for events by age group and for the periprocedural and postprocedural periods Hazard ratios (95% CIs) were adjusted by study. Events during the periprocedural period included stroke in either hemisphere plus deaths, whereas events in the postprocedural period included ipsilateral strokes only. CEA=carotid endarterectomy. CAS=carotid artery stenting. CSTC Howard et al Lancet;

9 A Primary Composite End Point Subgroup All patients Age yr yr 75 yr Sex Male Female Status Symptomatic Asymptomatic Stenosis Severe Moderate No. of Events/No. of Patients 205/ /791 83/ / / / / / / /350 Hazard Ratio (95% CI) P Value for Interaction Stenting Better Endarterectomy Better B Stroke or Death Subgroup All patients Age yr yr 75 yr Sex Male Female Status Symptomatic Asymptomatic Stenosis type Severe Moderate No. of Events/No. of Patients 169/ /791 67/ / / / / / / /350 Hazard Ratio (95% CI) P Value for Interaction Brott et al N Engl J Med 2016; 374: (CREST)

10 Fatal or disabling stroke Stenting (n=752) Endarterectomy (n=811) Hazard ratio* (95% CI) Number of events* Cumulative 1-year risk (SE)* Cumulative 5-year risk (SE)* Number of events* Absolute risk difference (95% CI) Contralateral % (0 4) 4 6% (0 9) % (0 3) 2 5% (0 7) 1 92 (1 04 to 3 53) 0 9% ( 0 1 to 1 8) 2 1% ( 0 2 to 4 3) carotid or vertebrobasilar stroke Severe carotid 72/ % (1 0) 10 8% (1 3) 62/ % (0 8) 8 6% (1 1) 1 25 ( ) 1 7% ( 0 8 to 4 1) 2 2% ( 1 1 to 5 4) restenosis ( 70%) or occlusion *Calculated from the end of the procedural period (30 days after completed treatment) for the first four outcomes and from immediately after completed treatment for the last outcome, until the end of follow-up. p<0 05. Table 3: Per-protocol analysis of cumulative risks and hazard ratios of main outcome events Cumulative 1-year risk (SE)* Cumulative 5-year risk (SE)* At 1 year At 5 years % (0 4) 3 4% (0 8) % (0 4) 4 3% (0 9) 0 93 (0 53 to 1 60) 0 5% ( 1 5 to 0 6) 0 9% ( 3 2 to 1 4) Any stroke % (0 6) 8 9% (1 2) % (0 5) 5 8% (1 0) 1 53 (1 02 to 2 31) 1 1% ( 0 4 to 2 6) 3 1% (0 0 to 6 2) Ipsilateral carotid stroke % (0 4) 4 7% (0 9) % (0 4) 3 4% (0 8) 1 29 (0 74 to 2 24) 0 2% ( 0 9 to 1 3) 1 2% ( 1 1 to 3 6) ICSS Bonati et al Lancet 2015; 385:

11 Consistent better outcome! Figure 2. Stroke/death rates for average risk asymptomatic patients undergoing CAS and CEA in various registries. # Results reported separately for patients aged <65 and :'.65 years. ## Results reported separately for males and females. Table 3. Registries reporting outcomes after CEA vs. CAS in high risk for CEA asymptomatic patients. Registry Publication year Source data and numbers Stroke/death rates Suspicion of selection bias Authors corrected for bias Spangler 14 VSGNE Database (2003e2013) In hospital stroke/death 1.2% (CEA) Yes No ,336 CEA and 544 CAS vs. 1.6% (CAS); p ¼ 0.78 Schermerhorn 16 SVS Vascular Registry (2001e2011) 30 day stroke/death 3.7% (CEA) a Yes Yes ,370 CEAs and 3,737 CAS and 4.8% (CAS) a Giles Nationwide Inpatient Sample Database (2004e2007) 482,394 CEA and 56,564 CAS In hospital stroke/death 1.2% (CEA) Yes vs. 1.5% (CAS); p <.05 Yes CEA ¼ carotid endarterectomy; CAS ¼ carotid artery stenting; VSGNE ¼ Vascular Study Group of New England; SVS ¼ Society for Vascular Surgery. a In hospital or 30 day death/stroke rates that were higher than the 3% AHA/ASA risk thresholds. 3 Paraskevas et al EJVES 2016

12 Table 2. Death, Stroke, or Myocardial Infarction and Composite Measure of Complications within 30 Days after Index Procedure.* Outcome Stenting Endarterectom y (N = 1089) (N = 364) P Value no. of patients/total no. (%) Death, stroke, or myocardial infarction 35/1072 (3.3) 9/348 (2.6) 0.60 Death or stroke 31/1072 (2.9) 6/348 (1.7) 0.33 Death or major stroke 6/1072 (0.6) 2/348 (0.6) 1.00 Death 1/1072 (0.1) 1/348 (0.3) 0.43 All stroke 30/1072 (2.8) 5/348 (1.4) 0.23 Major stroke 5/1072 (0.5) 1/348 (0.3) 1.00 Ipsilateral 4/1072 (0.4) 1/348 (0.3) 1.00 Nonipsilateral 1/1072 (0.1) 0/ Minor stroke 26/1072 (2.4) 4/348 (1.1) 0.20 Ipsilateral 22/1072 (2.1) 4/348 (1.1) 0.36 Nonipsilateral 4/1072 (0.4) 0/ Myocardial infarction 5/1072 (0.5) 3/348 (0.9) 0.41 Composite measure of complications 31/1089 (2.8) 17/364 (4.7) 0.13 Cranialnerve injury 1/1089 (0.1) 4/364 (1.1) 0.02 Peripheralnerve injury 0/1089 0/364 NA Vascular injury 8/1089 (0.7) 3/364 (0.8) 1.00 Noncerebral bleeding 21/1089 (1.9) 6/364 (1.6) 0.83 Endarterectomy incision or puncturesite bleeding 3/1089 (0.3) 4/364 (1.1) 0.07 Other complications 0/1089 0/364 NA * The data in the table are for the intentiontotreat population; they include only the most serious event for each patient and only each patient s first occurrence of the event. Patients who did not complete 30day followup and did not have any death, stroke, or myocardial infarction events are not included. NA denotes not applicable. P values were calculated with Fisher s exact test. One patient who was randomly assigned to the stenting group crossed over to the endarterectomy group. ACT Rosenfield et al NEJM 2016

13 Durability! N Engl J Med 2016; 374: (CREST)

14 What do I tell my patients? Always go first class; CEA CAS CEA