| Study . | PIAF . | STAF . | HOT CAFÉ . | RACE . | AFFIRM . | AF-CHF . | Metaanalysis‡ . |
|---|---|---|---|---|---|---|---|
No. of patients | 252 | 200 | 205 | 522 | 4060 | 1376 | 5239 |
Follow-up, years | 1 | 1.6 | 1.7 | 2.3 | 3.5 | 3.1 | – |
Primary endpoint | Symptom improvement | Composite of ACM, cardiovascular events, CPR, TE | Composite of ACM, TE, bleeding | Composite of CVD, hospitalizations for CHF, TE, bleeding, pacemaker, AAD adverse effects | All-cause mortality | Cardiovascular mortality | – |
Difference in primary endpoint | Symptoms improved in 70 RhyC vs. 76 RC patients (p = 0.317) | 5.54%/year vs. 6.09%/year RhyC vs. RC (p = 0.99) | No difference (OR, 1.98, 95% CI, 0.28–22.3; p > 0.71) | 22.6% vs. 17.2% RhyC vs. RC (HR, 0.73; 90% CI, 0.53–1.01; p = 0.11) | 23.8% vs. 21.3% RhyC vs. RC (HR, 1.15; 95% CI, 0.99–1.34; p = 0.08) | 27% vs. 25% RhyC vs. RC (HR, 1.06; 95% CI, 0.86–1.3; p = 0.59) | – |
Mortality | Not assessed | 2.5%/year vs. 4.9%/year RhyC vs. RC | 3 (2.9%) vs. 1 (1%) RhyC vs. RC | 6.8% vs. 7% RhyC vs. RC (for CVD) | As above | 32% vs. 33% RhyC vs. RC (p = 0.68) | 14.6% vs. 13% RhyC vs. RC (OR 0.87; 95% CI, 0.74–1.02; p= 0.09) |
Thrombo-embolic event | Not assessed | 3.1%/year vs. 0.6%/year RhyC vs. RC | 3 (2.9%) vs. 1 (1%) RhyC vs. RC | 7.9% vs. 5.5% RhyC vs. RC | Stroke: 7.1% vs. 5.5% RhyC vs. RC (p = 0.79); SE: 0.4% vs. 0.5% RhyC vs. RC (p = 0.62) | 3% vs. 4% RhyC vs. RC (p = 0.32) | 3.9% vs. 3.5% RhyC vs. RC (OR 0.50; 95% CI, 0.14–1.83; p = 0.3) |
Heart failure | Not assessed | Improved: 16 vs. 26; worsened: 39 vs. 29 RhyC vs. RC patients (p = 0.18) | No difference | 4.5% vs. 3.5% RhyC vs. RC | 2.7% vs. 2.1% RhyC vs. RC (p = 0.58)† | 28% vs. 31% RhyC vs. RC (p = 0.17) | – |
Hospitalizations | 69% vs. 24% RhyC vs. RC (p = 0.001)* | 54% vs. 26% RhyC vs. RC (p < 0.001) | 1.03 vs. 0.05 per pt RhyC vs. RC (p < 0.001) | More in RhyC (for DCC) | 80% vs. 73% RhyC vs. RC (p < 0.001) | During the first year, 46% vs. 39% RhyC vs. RC (p = 0.0063) | – |
Quality of life | No difference | No difference | Not assessed, but better functional capacity in RhyC | No difference | No difference, but trend towards better functional capacity in RhyC | Not yet available | – |
Other findings | Better exercise tolerance but more adverse effects of AAD in RhyC (25% vs. 14%; p = 0.036) | 18 out of total 19 primary endpoints occurred when patients were in AF | In RhyC, better exercise tolerance (p < 0.001), smaller LA and LV sizes, better LV systolic function | On-treatment analysis: more CHF in RC; smaller LA and LV sizes, better LV systolic function in RhyC | On-treatment analysis: maintenance of sinus rhythm was associated with lower mortality (HR, 0.53; 95% CI, 0.39–0.72; p <0.0001) | On-treatment analysis: no survival benefit from maintenance of sinus rhythm (HR, 1.11; 95% CI, 0.78–1.58; p = 0.568) | – |
| Study . | PIAF . | STAF . | HOT CAFÉ . | RACE . | AFFIRM . | AF-CHF . | Metaanalysis‡ . |
|---|---|---|---|---|---|---|---|
No. of patients | 252 | 200 | 205 | 522 | 4060 | 1376 | 5239 |
Follow-up, years | 1 | 1.6 | 1.7 | 2.3 | 3.5 | 3.1 | – |
Primary endpoint | Symptom improvement | Composite of ACM, cardiovascular events, CPR, TE | Composite of ACM, TE, bleeding | Composite of CVD, hospitalizations for CHF, TE, bleeding, pacemaker, AAD adverse effects | All-cause mortality | Cardiovascular mortality | – |
Difference in primary endpoint | Symptoms improved in 70 RhyC vs. 76 RC patients (p = 0.317) | 5.54%/year vs. 6.09%/year RhyC vs. RC (p = 0.99) | No difference (OR, 1.98, 95% CI, 0.28–22.3; p > 0.71) | 22.6% vs. 17.2% RhyC vs. RC (HR, 0.73; 90% CI, 0.53–1.01; p = 0.11) | 23.8% vs. 21.3% RhyC vs. RC (HR, 1.15; 95% CI, 0.99–1.34; p = 0.08) | 27% vs. 25% RhyC vs. RC (HR, 1.06; 95% CI, 0.86–1.3; p = 0.59) | – |
Mortality | Not assessed | 2.5%/year vs. 4.9%/year RhyC vs. RC | 3 (2.9%) vs. 1 (1%) RhyC vs. RC | 6.8% vs. 7% RhyC vs. RC (for CVD) | As above | 32% vs. 33% RhyC vs. RC (p = 0.68) | 14.6% vs. 13% RhyC vs. RC (OR 0.87; 95% CI, 0.74–1.02; p= 0.09) |
Thrombo-embolic event | Not assessed | 3.1%/year vs. 0.6%/year RhyC vs. RC | 3 (2.9%) vs. 1 (1%) RhyC vs. RC | 7.9% vs. 5.5% RhyC vs. RC | Stroke: 7.1% vs. 5.5% RhyC vs. RC (p = 0.79); SE: 0.4% vs. 0.5% RhyC vs. RC (p = 0.62) | 3% vs. 4% RhyC vs. RC (p = 0.32) | 3.9% vs. 3.5% RhyC vs. RC (OR 0.50; 95% CI, 0.14–1.83; p = 0.3) |
Heart failure | Not assessed | Improved: 16 vs. 26; worsened: 39 vs. 29 RhyC vs. RC patients (p = 0.18) | No difference | 4.5% vs. 3.5% RhyC vs. RC | 2.7% vs. 2.1% RhyC vs. RC (p = 0.58)† | 28% vs. 31% RhyC vs. RC (p = 0.17) | – |
Hospitalizations | 69% vs. 24% RhyC vs. RC (p = 0.001)* | 54% vs. 26% RhyC vs. RC (p < 0.001) | 1.03 vs. 0.05 per pt RhyC vs. RC (p < 0.001) | More in RhyC (for DCC) | 80% vs. 73% RhyC vs. RC (p < 0.001) | During the first year, 46% vs. 39% RhyC vs. RC (p = 0.0063) | – |
Quality of life | No difference | No difference | Not assessed, but better functional capacity in RhyC | No difference | No difference, but trend towards better functional capacity in RhyC | Not yet available | – |
Other findings | Better exercise tolerance but more adverse effects of AAD in RhyC (25% vs. 14%; p = 0.036) | 18 out of total 19 primary endpoints occurred when patients were in AF | In RhyC, better exercise tolerance (p < 0.001), smaller LA and LV sizes, better LV systolic function | On-treatment analysis: more CHF in RC; smaller LA and LV sizes, better LV systolic function in RhyC | On-treatment analysis: maintenance of sinus rhythm was associated with lower mortality (HR, 0.53; 95% CI, 0.39–0.72; p <0.0001) | On-treatment analysis: no survival benefit from maintenance of sinus rhythm (HR, 1.11; 95% CI, 0.78–1.58; p = 0.568) | – |
AAD, antiarrhythmic drugs; ACM, all-cause mortality; AF, atrial fibrillation; AF-CHF, Atrial Fibrillation and Congestive Heart Failure; AFFIRM, Atrial Fibrillation Follow-up Investigation of Rhythm Management; CHF, congestive heart failure; CI, confidence intervals; CPR, cardiopulmonary resuscitation; CVD, cardiovascular death; DCC, direct current cardioversion; HR, hazard ratio; HOT CAFÉ, How to Treat Chronic Atrial Fibrillation; HR, hazard ratio; LA, left atrium; LV, left ventricle; OR, odds ratio; PIAF, Pharmacological Intervention in Atrial Fibrillation; RACE, Rate Control versus Electrical Cardioversion; RC, rate control; RhyC, rhythm control; STAF, Strategies of Treatment of Atrial Fibrillation; TE, thromboembolic event.
including cardioversion; †reported as an adverse event; ‡mortality analysis: AFFIRM, HOT CAFÉ, PIAF, RACE, STAF; ischaemic stroke analysis: AFFIRM, HOT CAFÉ, STAF.
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