Original Title: Effects of Ranolazine in Angina and Quality of Life after Percutaneous Coronary Intervention with Incomplete Revascularization Results from the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial. Reference: Karen P. Alexander et al. Circulation. 2016 Jan 5;133(1):39-47
Courtesy of Dr. Santiago Alonso
Persistence or return of angina after PCI is relatively frequent, which is why ranolazine is being considered to reduce angina and improve quality of life.
This multicenter double blind study randomized 2604 patients with post PCI stable angina to ranolazine vs. placebo. Quality of life questionnaires were made at baseline and months 1, 6 and 12 (Seattle Angina Questionnaire score (SAQ) and angina frequency score). There were more prior revascularizations (P=0.04) and more frequent angina episodes (SAQ score for angina frequency ≤ 60; P=0.004) in the ranolazine group.
By months 1 and 12, more ranolazine patients had abandoned the study (20.4% vs 14.1%, p<0.001 and 27.2% vs 21.3%, p<0.001 respectively). After PCI, quality of life scores improved similarly in both groups at months 1 and 12, with no significant differences.
Ranolazine improved angina frequency in diabetic patients (mean difference 3.3; 95% CI 0.6, 6.1; P=0.02) and in those with more angina episodes (SAQ score ≤ 60, mean difference 3.4; 95% CI 0.6, 6.2; P=0.02) at 6 months, but this effect did not persist at 12 months.
Conclusion
Despite the presence of symptoms after incomplete revascularization, there was no benefit in number of angina episodes or quality of life with the use of ranolazine, compared to placebo. Both arms showed clear benefits at months 1 and 12 after procedure (with no statistically significant differences between them). Subgroups with high frequency of angina and diabetics showed improvement, but it was not maintained.
Editorial Comment
As shown by the studies MERLIN-TIMI 36 and TERISA, the beneficial effect of ranolazine in diabetics and in those with more angina could lead to the use of the drug in question.
Limitations to this study are the fact that it does not consider demonstrating ischemia and also that patients often discontinued the study drug (more often ranolazine than placebo). In addition, the number of associated anti angina drugs (92% one and up to 1/3 other two anti-ischemic drugs) could have attenuated the effect of ranolazine.
Courtesy of Dr. Santiago Alonso.
Centro Cardiológico Americano. Sanatorio Americano.
Montevideo, Uruguay.
